Ondansetron sirup

ondansetron sirup

Pharma Franchise – PCD Pharma Company I PCD I Creogenic Pharma • Home • About us • Company Ondansetron sirup • Vision & Mission • Quality • Certifications • Products • Tablets • Capsules • Injections • Syrups • Ayurvedic • Paediatric • Ointments • Services • Pharma Franchise • Third Party Contract Manufacturing • Track Order • Blog • Contact • Pay Now • 8264379214 The brand name of Ondansetron Syrup presented by Creogenic Pharma is VOMILOP.

Below mentioned are some of the details about this product. • Composition of Product: Ondansetron 4mg • Marketed By: Creogenic Pharma • Prescription Required: Yes, as it belongs to Schedule ‘H’ • Form: Tablet, Syrup • Shelf Ondansetron sirup 2 Years or 24 months from the date of manufacturing What is Ondansetron Syrup? Ondansetron is a drug that is used to block various chemical messenger that causes nausea or vomiting during various medical treatment procedures. How Ondansetron Works?

Ondansetron is consumed orally which is used to prevent nausea or vomiting during medical procedures such ondansetron sirup chemotherapy, radiation treatment or some form of surgery.

Ondansetron works by stopping the chemical messenger called serotonin. Dosage of Ondansetron Syrup? The Dosage of Ondansetron should be decided by a physician for every patient depending on various factors such as Age, Weight, Mental Status, Allergic History etc. of the patient. It is not recommended for use of Ondansetron in children without the guidance of a Pediatric Consultant. Dose alteration should only be administered as per the guidance of the Physician.

Read More Ondansetron Tablet Ondansetron adalah obat yang digunakan untuk mencegah serta mengobati mual dan muntah yang ondansetron sirup disebabkan oleh efek samping kemoterapiradioterapiatau operasi. Obat ini hanya boleh dikonsumsi dengan resep dokter. Ondansetron adalah ondansetron sirup (antimual) yang termasuk dalam kelompok antagonis reseptor serotonin (reseptor ondansetron sirup 3). Serotonin sendiri ondansetron sirup zat kimia yang secara alami diproduksi tubuh untuk berbagai tujuan.

Salah satunya adalah untuk mengatur gerakan usus dan saluran pencernaan secara menyeluruh. Pada beberapa kondisi tertentu, seperti saat kemoterapi, radioterapi, atau operasi, kadar serotonin tubuh akan meningkat. Begitu pula dengan jumlah serotonin yang berikatan dengan reseptor 5HT 3. Hal ini dapat menyebabkan efek mual dan muntah. Ondansetron bekerja dengan cara memblokir efek serotonin (5HT 3). Dengan begitu, efek mual dan muntah pada kondisi-kondisi di atas dapat teratasi atau bahkan dicegah.

Merek dagang ondansetron: Ceteron, Fudanton, Maxtron, Narfoz, Nausimex, Ondansetron HCl 2H20, Ondansetron HCI Dihydrate, Ondansetron Hydrochloride Dihydrate, Vometron, Zetral Apa itu Ondansetron?

Golongan Obat resep Kategori Antiemetik antagonis reseptor serotonin Manfaat Mencegah dan mengobati mual dan muntah. Digunakan oleh Dewasa dan anak-anak Ondansetron untuk ibu hamil dan menyusui Kategori B : Studi pada binatang percobaan tidak memperlihatkan adanya risiko terhadap janin, tetapi belum ada studi terkontrol pada wanita hamil.Belum diketahui apakah ondansetron dapat terserap ke dalam ASI atau tidak.

Bila Anda sedang menyusui, jangan menggunakan obat ini sebelum berkonsultasi dulu dengan dokter. Ondansetron sirup obat Tablet, tablet cepat larut, sirop, suntik, dan infus Peringatan Sebelum Menggunakan Ondansetron Perhatikan beberapa hal berikut sebelum menggunakan obat ini: • Beri tahu dokter jika Anda memiliki riwayat alergi, terutama terhadap ondasentron atau obat golongan penghambat serotonin lain, seperti granisetron.

• Beri tahu dokter jika Anda sedang menderita penyakit liver, gangguan pencernaan, diare atau muntah yang berat, hipokalemia, kekurangan magnesium, gagal jantung, gangguan irama jantung, terutama perpanjangan interval QT jantung di EKG, atau bradikardia.

• Beri tahu dokter jika Anda baru menjalani operasi perut. • Beri tahu dokter jika ada anggota keluarga Anda yang mengalami perpanjangan interval QT jantung atau henti jantung mendadak. • Beri tahu dokter jika Anda berencana atau sedang menggunakan obat lain, termasuk suplemen atau produk herbal.

• Beri tahu dokter jika Anda sedang hamil, menyusui, atau ondansetron sirup kehamilan. • Jangan mengemudikan atau melakukan kegiatan yang membutuhkan kewaspadaan ketika mengonsumsi ondansetron, karena obat ini bisa menyebabkan pusing dan kantuk. • Ondansetron sirup minum minuman beralkohol selama menjalani pengobatan dengan ondansetron karena bisa meningkatkan risiko terjadinya efek samping.

• Segera temui dokter jika terjadi reaksi alergi obat atau overdosis. Dosis dan Aturan Pakai Ondansetron Dosis penggunaan ondansetron berbeda-beda, tergantung pada tujuan pengobatan yang dijalani, bentuk sediaan obat, dan usia pasien. Berikut adalah penjelasannya: 1. Mencegah mual dan muntah akibat radioterapi Bentuk obat: Obat minum D ewasa • Radioterapi total (seluruh tubuh): 8 mg, dikonsumsi 1–2 jam sebelum pelaksanaan radioterapi.

• Radioterapi abdomen tunggal dosis tinggi: 8 mg, diminum 1–2 jam sebelum terapi, lalu setiap 8 jam selama 1–2 hari setelah terapi. • Radioterapi abdomen harian: 8 mg, diminum 1–2 jam sebelum radioterapi, lalu setiap 8 jam selama radioterapi diberikan. Bentuk obat: Suntik dan infus Dewasa • 8 mg, disuntikkan ke dalam pembuluh darah vena (intravena/IV) atau otot (intramuskular/IM) tepat sebelum radio Lansia ≥ 75 tahun • 8 mg, infus IV selama 15 menit, bisa diikuti dengan 2 dosis lanjutan sebanyak 8 mg, diberikan 4 jam dan 8 jam setelah dosis awal.

2. Mencegah mual dan muntah akibat kemoterapi Bentuk obat: Obat minum P asien dewasa dan anak usia > 12 tahun • Kemoterapi dengan efek emetogenik (memicu mual) biasa: 8 mg, diberikan 30 menit hingga 2 jam sebelum kemoterapi, dilanjutkan lagi 8 jam atau 12 jam setelahnya sebanyak 8 mg. • Kemoterapi dengan efek emetogenik berat: 24 mg dosis tunggal, diberikan 30 menit hingga 2 jam sebelum kemoterapi.

• Lanjutan setelah kemoterapi selesai: 8 mg, 2 ondansetron sirup sehari, hingga 5 hari setelah kemoterapi. A nak usia 4–11 tahun • Kemoterapi dengan efek emetogenik biasa: 4 mg, diberikan 30 menit sebelum kemoterapi.

Dosis yang sama akan diberikan lagi 4 jam dan 8 jam setelah dosis awal. Bentuk obat: Suntik atau infus D ewasa • Kemoterapi dengan efek emetogenik biasa: 8 mg atau 0,15 mg/kgBB melalui suntik IV secara perlahan. • Kemoterapi dengan efek emetogenik berat: 8 mg suntik IV atau IM sebelum kemo Dosis perawatan dapat diberikan melalui infus sebanyak 1 mg/jam selama 24 jam, atau melalui suntikan 8 mg yang diberikan 4 jam dan 8 jam setelah dosis awal.

Lansia usia < 75 tahun • D osis maksimal 16 mg infus IV selama ≥ 15 menit. Lansia usia ≥ 75 tahun • D osis awal 8 mg infus IV selama ≥15 menit. D osis lanjutan adalah 8 mg yang diberikan 4 jam dan 8 jam setelah dosis awal. Anak ≥6 ondansetron sirup • 0,15 mg /kgBB (dosis maksimal 8 mg) melalui melalui infus IV, diberikan 30 menit sebelum kemoterapi.

Dosis dapat diulang i kembali 4 jam dan 8 jam setelah dosis awal. 3. Mengatasi mual dan muntah sesudah operasi Bentuk obat: Obat minum Dewasa • 16 mg, diberikan 1 jam sebelum pemberian obat bius. Anak dengan BB ≥40 kg • 4 mg, diberikan 1 jam sebelum pemberian obat bius.

Dosis lanjutan 4 mg setelah 12 jam. Bentuk obat: Suntik D ewasa • 4 mg, diberikan melalui suntik IV atau IM sebelum pemberian obat bius. Anak dengan BB > 40 kg: • 4 mg, diberikan melalui suntik IV sebelum pemberian Dosis maksimal adalah 4 mg per dosis.

Anak usia ≥1 bulan dengan BB≤ 40 kg: • 0,1 mg/kgBB, diberikan melalui suntik IV sebelum pemberian Cara Menggunakan Ondansetron dengan Benar Ondansetron bentuk suntik dan infus akan diberikan oleh dokter atau petugas medis atas arahan dokter. Pastikan untuk membaca petunjuk pada kemasan obat dan mengikuti anjuran dokter saat mengonsumsi ondansetron dalam bentuk obat minum.

Ondansetron minum tersedia dalam bentuk tablet, tablet cepat larut, dan sirop. Obat ini bisa dikonsumsi sebelum atau sesudah makan, tetapi pastikan untuk mengikuti petunjuk dokter dalam mengonsumsinya. Ondansetron tablet perlu dikonsumsi bersama segelas air. Sementara itu, ondansetron dalam bentuk tablet cepat larut hanya diletakkan di lidah dan ditunggu hingga larut sebelum ditelan dengan air liur.

Untuk mengonsumsi ondansetron sirop, gunakan alat takar yang tersedia dalam kemasan. Jangan menggunakan sendok makan atau sendok teh, karena dosis bisa menjadi tidak tepat. Kocok botol sebelum menuang obat ke sendok takar.

Ondansetron minum biasanya perlu dikonsumsi sekitar 1 jam sebelum kemoterapi, radioterapi, atau operasi. Khusus setelah kemoterapi, Anda mungkin perlu melanjutkan penggunaan obat ini selama beberapa hari setelahnya, sesuai anjuran dari dokter.

ondansetron sirup

Bagi pasien yang lupa mengonsumsi ondansetron, disarankan untuk segera mengonsumsinya jika jeda dengan jadwal konsumsi berikutnya tidak terlalu dekat. Jika sudah dekat, abaikan dosis tersebut dan jangan menggandakan dosis selanjutnya.

Simpan ondansetron di tempat kering dan sejuk yang terhindar dari sinar matahari langsung. Jauhkan obat ini dari jangkauan anak-anak. Interaksi Ondansetron dengan Obat Lain Efek interaksi yang bisa terjadi jika ondansetron bersamaan dengan obat-obatan tertentu antara lain: • Penurunan efektivitas dari ondansetron jika digunakan dengan obat penginduksi CYP3A4 yang kuat, seperti carbamazepine, fenitoin, atau rifampicin • Penurunan efek antinyeri dari tramadol • Peningkatan efektivitas ondansetron jika digunakan bersama dexamethasone sodium phoshate • Peningkatan risiko terjadinya sindrom serotonin jika digunakan dengan selective serotonin reuptake inhibitors ( SSRI), serotonin norepinephrine reuptake inhibitors (SNRI), MAOI, mirtazapine, fentanyl, atau lithium • Peningkatan risiko terjadinya perpanjangan interval QT atau aritmia jika digunakan dengan atenolol, doxorubicin, daunorubicin, trastuzumab, erythromycin, ketoconazole, atau antiaritmia, seperti amiodarone • Peningkatan risiko terjadinya hipotensi berat dan hilangnya kesadaran jika digunakan bersama apomorphine.

Efek Samping dan Bahaya Ondansetron Ondansetron dapat menimbulkan efek samping yang berbeda-beda pada tiap orang. Efek samping yang mungkin terjadi antara lain: • Ondansetron sirup kepala atau pusing • Rasa seperti melayang • Konstipasi • Kelelahan dan tubuh terasa lemah • Rasa menggigil • Kantuk Hubungi dokter jika efek samping tersebut tidak kunjung membaik atau semakin memburuk. Segera ke dokter jika Anda mengalami reaksi alergi obat atau efek samping yang lebih serius, seperti: • Penglihatan menjadi buram atau penglihatan hilang untuk sementara waktu • Nyeri perut • Kram otot atau kaku otot ondansetron sirup Nyeri dada • Jantung berdetak dengan lambat, cepat, atau tidak beraturan • Gejala sindrom serotonin, yang bisa ditandai dengan jantung berdebar, halusinasi, kehilangan kordinasi tubuh, rasa sangat pusing, demam, rasa gelisah atau cemas, otot berkedut, serta mual, muntah, dan diare yang berat
Show table of contents Hide table of contents • ondansetron sirup.

Name of the medicinal product • 2. Qualitative and quantitative composition • 3. Pharmaceutical form • 4. Clinical particulars • 4.1 Therapeutic indications • 4.2 Posology and method of administration • 4.3 Contraindications • 4.4 Special warnings and precautions for use • 4.5 Interaction with other medicinal products and other forms of interaction • 4.6 Fertility, pregnancy and lactation • 4.7 Effects on ondansetron sirup to drive and use machines • 4.8 Undesirable effects • 4.9 Overdose • 5.

Pharmacological properties • 5.1 Pharmacodynamic properties • 5.2 Pharmacokinetic properties • 5.3 Preclinical safety data • 6. Pharmaceutical particulars • 6.1 List of excipients • 6.2 Incompatibilities • 6.3 Shelf life • 6.4 Special precautions for storage • 6.5 Nature and contents of container • 6.6 Special precautions for disposal and other handling • 7. Marketing ondansetron sirup holder • 8. Marketing authorisation number(s) • 9. Date of first authorisation/renewal of the authorisation • 10.

Date of revision of the text Adults: The management of nausea and vomiting induced by cytotoxic chemotherapy and radiotherapy, and for the prevention of post-operative nausea and vomiting in adults.

Paediatric Population: Ondansetron is indicated for the management of chemotherapy-induced nausea and vomiting (CINV) in children aged ≥6 months. No studies have been conducted on the use of orally administered ondansetron in the prevention and treatment of PONV in children aged ≥1 month administration by IV injection is recommended for this purpose. Posology Chemotherapy and radiotherapy induced nausea and vomiting (CINV) Adults: The emetogenic potential of cancer treatment varies according to the doses and combinations of chemotherapy and radiotherapy regimens used.

The selection of dose regimen should be determined by the severity of the emetogenic challenge. Emetogenic chemotherapy and radiotherapy: Ondansetron can be given either by rectal, oral (tablets or syrup), intravenous or intramuscular administration. For oral administration: 8mg taken 1 to 2 hours before chemotherapy or radiation treatment, followed by 8mg every 12 hours for a maximum of 5 days to protect against delayed or prolonged emesis.

For highly emetogenic chemotherapy): a single dose of up to 24mg ondansetron taken with 12mg oral dexamethasone sodium phosphate, 1 to 2 hours before chemotherapy, may be used. To protect against delayed or prolonged emesis after the first 24 hours, oral or rectal treatment with Ondansetron should be continued for up to 5 days after a course of treatment.

The recommended dose for oral administration is 8mg twice daily. Paediatric Population: CINV in children aged ≥6 months and adolescents The dose for CINV can be calculated based on body surface area (BSA) or weight – see below. In paediatric clinical studies, ondansetron was given by IV infusion diluted in 25 to 50 mL of saline or other compatible infusion fluid and infused over not less than 15 minutes. Weight-based dosing results in higher total daily doses compared to BSA-based dosing (sections 4.4).

Ondansetron injection should be diluted in 5% dextrose or 0.9% sodium chloride or other compatible infusion fluid (see section 6.6) and infused intravenously over not less than 15 minutes. There are no data from controlled clinical trials on the use of ondansetron in the prevention of delayed or prolonged CINV.

There are no data from controlled clinical trials on the use of ondansetron for radiotherapy-induced nausea and vomiting in children. Dosing by BSA: Ondansetron should be administered immediately before chemotherapy as a single intravenous dose of 5 mg/m ondansetron sirup. The intravenous dose must not exceed 8 mg. Oral dosing can commence twelve hours later and may be continued for up to 5 days (Table 1).

The total dose over 24 hours (given as divided doses) must not exceed adult dose of 32 mg. Table 1: BSA-based dosing for Chemotherapy - Children aged ≥6 months and adolescents BSA Day 1 (a, b) Days 2 – 6 (b) < 0.6m 2 5mg/m 2 i.v. plus 2mg syrup after 12 hrs 2mg syrup every 12 hours ≥ 0.6 m 2 to ≤ 1.2 m 2 5mg/m 2 i.v.

ondansetron sirup 4mg syrup or tablet after 12 hrs 4mg syrup or tablet every 12 hrs >1.2m 2 5mg/m 2 or 8mg IV plus 8mg syrup or tablet after 12 hours 8mg syrup or tablet every 12 hours a The intravenous dose must not exceed 8mg. b The total dose over 24 hours (given as divided doses) must not exceed adult dose of 32 mg Dosing by bodyweight: Weight-based dosing results in higher total daily doses compared to BSA-based dosing (sections 4.4.

and ondansetron sirup. Ondansetron should be administered immediately before chemotherapy as a single intravenous dose of 0.15 mg/kg. The intravenous dose must not exceed 8 mg. Two further intravenous doses may be given in 4-hourly intervals. Oral dosing can commence twelve ondansetron sirup later and may be continued for up to 5 days (Table 2). The total dose over 24 hours (given as divided doses) must not exceed adult dose of 32mg.

Table 2: Weight-based dosing for Chemotherapy - Children aged ≥6 months and adolescents Weight Day 1 (a, b) Days 2 – 6 (b) ≤10kg Up to 3 doses of 0.15 mg/kg every 4 hours 2mg syrup every 12 hours >10kg Up to 3 doses of 0.15 mg/kg every 4 hours 4mg syrup or tablet every 12 hours a The intravenous dose must not exceed 8mg.

b The total dose over 24 hours (given as divided doses) must not exceed adult dose of 32 mg. Elderly: Ondansetron is well tolerated by patients over 65 years. No alteration of oral dose or frequency of administration ondansetron sirup required. Post operative nausea and vomiting (PONV). Adults: For the prevention of PONV: Ondansetron can be administered orally or by intravenous or intramuscular injection. For oral administration: 16mg one hour prior to anaesthesia.

For the treatment of established PONV: Intravenous or intramuscular administration is recommended. Paediatric population PONV in children aged ≥1 month and adolescents Oral formulation: No studies have been conducted on the use of orally administered ondansetron in the prevention or treatment of post-operative nausea and vomiting; slow IV.

injection (not less than 30 seconds) is recommended for this purpose. Injection: For prevention of PONV in paediatric patients having surgery performed under general anaesthesia, a single dose of ondansetron may be administered by slow intravenous injection (not less than 30 seconds) at a dose of 0.1mg/kg up to a maximum of 4mg either prior to, at or after induction of anaesthesia. For the treatment of PONV after surgery in paediatric patients having surgery performed under general anaesthesia, a single dose of Ondansetron may be administered by slow intravenous injection (not less than 30 seconds) at a dose of 0.1mg/kg up to a maximum of 4mg.

There are no data on the use of ondansetron in the treatment of PONV in children below 2 years of age. Elderly: There is limited experience in the use of Ondansetron in the prevention and treatment of PONV in the elderly, however Ondansetron is well tolerated in patients over 65 years receiving chemotherapy.

For both indications Patients with Renal impairment: No alteration of daily dosage or frequency of dosing, or route of administration are required. Patients with Hepatic impairment: Clearance of Ondansetron is significantly reduced and serum half life significantly prolonged in subjects with moderate or severe impairment of hepatic function. In such patients a total daily dose of 8mg should not be exceeded.

Patients with poor Sparteine/Debrisoguine Metabolism: The elimination half-life of ondansetron is not altered in subjects classified as poor metabolisers of sparteine and debrisoquine.

Consequently in such patients repeat dosing will give drug exposure levels no different from those of the general population. No alteration of daily dosage or frequency of dosing are required. Method of administration Oral Hypersensitivity reactions have been reported in patients who have exhibited hypersensitivity to other selective 5HT 3 receptor antagonists. Respiratory events should be treated symptomatically and clinicians should pay particular attention ondansetron sirup them as precursors of hypersensitivity reactions.

Cases of myocardial ischemia have been reported in patients treated with ondansetron. In some patients, especially in the case of intravenous administration, symptoms appeared immediately after administration of ondansetron.

Patients should be alerted to the signs and symptoms of myocardial ischaemia. Ondansetron prolongs the QT interval in a dose-dependent manner (see section 5.1). In addition, post-marketing cases of Torsades de Pointes have been reported in patients using ondansetron. Avoid ondansetron in patients with congenital QT syndrome. Ondansetron should be administered with caution to patients who have or may develop prolongation of QTc, including patients with electrolyte abnormalities, congestive heart failure, bradyarrhythmias or patients taking other medicinal products that lead to QT prolongation or electrolyte abnormalities.

Hypokalemia and hypomagnesaemia should be corrected prior to ondansetron administration. There have been post-marketing reports describing patients with serotonin syndrome (including altered mental status, autonomic instability and neuromuscular abnormalities) following the concomitant use of ondansetron and other serotonergic drugs (including selective serotonin reuptake inhibitors (SSRI) and serotonin noradrenaline reuptake inhibitors (SNRIs)).

If concomitant treatment with ondansetron and other serotonergic drugs is clinically warranted, appropriate observation of the patients is advised. As ondansetron is known to increase large bowel transit time, patients with signs of subacute intestinal obstruction should be monitored following administration.

In patients with adenotonsillar surgery prevention of nausea and vomiting with ondansetron may mask occult bleeding. Therefore, such patients should be followed carefully after ondansetron. Ondansetron Syrup contains sodium benzoate (E211), which may increase jaundice (yellowing of the skin and eyes) in new born babies (up to 4 weeks old). This medicine contains Xylitol (E 967) which may have a laxative effect and has a calorific value of 2.4 kcal/g xylitol.

Paediatric Population: Paediatric patients receiving ondansetron with hepatotoxic chemotherapeutic agents should be monitored closely for impaired hepatic function. CINV: When calculating the dose on an mg/kg basis and administering three doses at 4-hourly intervals, the total daily dose will be higher than if one single dose of 5mg/m 2 followed by an oral dose is given. The comparative efficacy of these two different dosing regimes has not been ondansetron sirup in clinical trials.

Cross-trial comparison indicates similar efficacy for both regimes (section 5.1). There is no evidence that ondansetron either induces or inhibits the metabolism of other drugs commonly co-administered with it. Specific studies have shown that there are no pharmacokinetic interactions when ondansetron is administered with alcohol, temazepam, furosemide, alfentanil, tramadol, morphine, lidocaine, thiopental and propofol.

Ondansetron is metabolised by multiple hepatic cytochrome P-450 enzymes: CYP3A4, CYP2D6 and CYP1A2. Due to the multiplicity of metabolic enzymes capable of metabolising ondansetron, enzyme inhibition or reduced activity of one enzyme (e.g. CYP2D6 genetic deficiency) is normally compensated by other enzymes and should result in little or no significant change in overall ondansetron clearance or dose requirement. Caution should be exercised when ondansetron is co-administered with drugs that prolong the QT interval and/or cause electrolyte abnormalities (see section 4.4).

Use of ondansetron with QT prolonging drugs may result in additional QT prolongation. Concomitant use of ondansetron with cardiotoxic drugs (e.g. anthracyclines (such as doxorubicin, daunorubicin) or trastuzumab), antibiotics (such as erythromycin), antifungals (such as ketoconazole), antiarrhythmics (such as amiodarone) and beta blockers (such as atenolol or timolol) may ondansetron sirup the risk of arrhythmias (see section 4.4).

Serotonergic Drugs (e.g. SSRIs and SNRIs): There have been post-marketing reports describing patients with serotonin syndrome (including altered mental status, ondansetron sirup instability and neuromuscular abnormalities) following the concomitant use of ondansetron and other serotonergic drugs (including SSRIs and SNRIs), (see section 4.4). Apomorphine: based on reports of profound hypotension and loss of consciousness when ondansetron was administered with apomorphine hydrochloride, concomitant use with apomorphone is contraindicated.

Phenytoin, Carbamazepine and Rifampicin: In patients treated with potent inducers of CYP3A4 (i.e. Phenytoin, Carbamazepine and Rifampicin), the oral clearance of ondansetron was increased and ondansetron blood concentrations were decreased. Tramadol: Data from small studies indicate that ondansetron may reduce the analgesic effect of tramadol. Women of childbearing potential Women of childbearing potential should consider the use of contraception.

Pregnancy Based on human experience from epidemiological studies, ondansetron is suspected to cause orofacial malformations when administered during the first trimester of pregnancy. In one cohort study including 1.8 million pregnancies, first trimester ondansetron use was associated with an increased risk of oral clefts (3 additional cases per 10 000 women treated; adjusted relative risk, 1.24, (95% CI 1.03-1.48)).

The available epidemiological studies on cardiac malformations show conflicting results. Animal studies does not indicate direct or indirect harmful effects with respect to reproductive toxicity. Ondansetron should not be used during the first trimester of pregnancy. Breast-feeding Tests have shown that ondansetron passes into the milk of lactating animals.

It is therefore recommended that mothers receiving Ondansetron should not breast-feed their babies. Fertility There is no information on the effects of ondansetron on human fertility.

Adverse events are listed below by system organ class and frequency. Frequencies are defined as: very common (≥1/10), common ondansetron sirup and <1/10), uncommon (≥1/1000 and <1/100), rare (≥1/10,000 and <1/1000) and very rare (<1/10,000). Very common, common and uncommon events were generally determined from clinical trial data.

The incidence in placebo was taken into account. Rare and very rare events were generally determined from post-marketing spontaneous data. The following frequencies are estimated at the standard recommended doses of ondansetron.

System organ class Frequency Undesirable effects Immune system disorders Rare Immediate hypersensitivity reactions sometimes severe, including anaphylaxis. Nervous system disorders Very Common Headache Uncommon Seizures, movement disorders including extrapyramidal reactions such as dystonic reactions, oculogyric crisis and dyskinesia 1 Rare Dizziness during rapid IV administration Eye disorders Rare Transient visual disturbances (e.g.

blurred vision) predominantly during IV administration Very rare Transient blindness predominantly during intravenous administration 2. Cardiac disorders Uncommon Arrhythmias, chest pain with or without ST segment depression, bradycardia Rare QTc prolongation (including Torsades de Pointes) Unknown Myocardial ischemia (see section 4.4) Vascular disorders Common Sensation of warmth or flushing Uncommon Hypotension Respiratory, thoracic ondansetron sirup mediastinal disorders Uncommon Hiccups Gastrointestinal disorders Common Constipation Hepatobiliary disorders Uncommon Asymptomatic increases in liver function tests 3.

1 Observed without definitive evidence of persistent clinical sequelae. 2 The majority of ondansetron sirup blindness cases reported resolved within 20 minutes. Most patients had received chemotherapeutic agents, which included cisplatin. Some cases of transient blindness were reported as cortical in origin 3 These events were observed commonly in patients receiving chemotherapy with cisplatin.

Paediatric population The adverse event profiles in children and adolescents were comparable to that seen in adults. Reporting of suspected adverse reactions Reporting of suspected adverse reactions after authorisation of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. Symptoms There is limited experience of ondansetron overdose. In the majority of cases, symptoms were similar to those already reported in patients receiving recommended doses (see section 4.8).

Manifestations that have been reported include visual disturbances, severe constipation, hypotension and a vasovagal episode with transient second degree AV block.

ondansetron sirup

Ondansetron prolongs the QT interval in a dose-dependent fashion. ECG monitoring is recommended in cases of overdose. Paediatric population Paediatric cases consistent with serotonin syndrome have been reported after inadvertent oral overdoses of ondansetron (exceeded estimated ingestion of 4 mg/kg) in infants and children aged 12 months to 2 years. Management There is no specific antidote for ondansetron, therefore in all cases of suspected overdose, symptomatic and supportive therapy should be given as appropriate.

Further management should be as clinically indicated or as recommended by the national poisons centre, where available. The use of ipecacuanha to treat overdose with ondansetron is not recommended, as patients are unlikely to respond due to the anti-emetic action of ondansetron itself. ATC code: Ondansetron sirup Pharmacotherapeutic group: Serotonin (5HT3) antagonists Mechanism of Action Ondansetron is a potent, highly selective 5HT3 receptor-antagonist.

Its precise mode of action in the control of nausea and ondansetron sirup is not known. Chemotherapeutic agents and radiotherapy may cause release of 5HT in the small intestine initiating a vomiting reflex by activating vagal afferents ondansetron sirup 5HT3 receptors.

Ondansetron blocks the initiation of this reflex. Activation of vagal afferents may also cause a release of 5HT in the area postrema, located on the floor of the fourth ventricle, and this may also promote emesis through a central mechanism. Thus, the effect of ondansetron in the management of the nausea and vomiting induced by cytotoxic chemotherapy and radiotherapy is probably due to antagonism of 5HT3 receptors on neurons located both in the peripheral and central nervous system.

The mechanisms of action in post-operative nausea and vomiting are not known but there may be common pathways with cytotoxic induced nausea and vomiting. Ondansetron does not alter plasma prolactin concentrations.

The role of ondansetron ondansetron sirup opiate-induced emesis is not yet established. QT Prolongation The effect of ondansetron on the QTc interval was evaluated in a double blind, randomised, placebos and positive (moxifloxacin) controlled crossover study in 58 healthy adult men and women.

Ondansetron doses included 8mg and 32mg infused intravenously over 15minutes. At the highest tested dose of 32mg, the maximum mean (upper limit of 90% CI) difference in QTcF from placebo after baseline-correction was 19.6 (21.5) msec. At the lower tested dose of 8mg, the maximum mean (upper limit of 90% CI) difference in QTcF from placebo after baseline-correction was 5.8 (7.8) msec.

In this study, there were no QTcF measurements greater than 480 msec and no QTcF prolongation was greater than 60 msec. Paediatric population CINV The efficacy of ondansetron in the control of emesis and nausea induced by cancer chemotherapy was assessed in a double-blind randomised trial in 415 ondansetron sirup aged 1 to 18 years (S3AB3006). On the days of chemotherapy, patients received either ondansetron 5 mg/m 2 intravenous and ondansetron 4 mg orally after 8 to12 hrs or ondansetron 0.45 mg/kg intravenous and placebo orally after 8 to12 hrs.

Post-chemotherapy both groups received 4 mg ondansetron syrup twice daily for 3 days. Complete control of emesis on worst day of chemotherapy was 49% (5 mg/m 2 intravenous and ondansetron 4 mg orally) and 41% (0.45 mg/kg intravenous and placebo orally).

Post-chemotherapy both groups received 4 mg ondansetron syrup twice daily for 3 days. There was no difference in the overall incidence or nature of adverse events between the two treatment groups. A double-blind randomised placebo-controlled trial (S3AB4003) in 438 patients aged 1 to 17 years demonstrated complete control of emesis on worst day of chemotherapy in: • 73% of ondansetron sirup when ondansetron was administered intravenously at a dose of 5 mg/m2 intravenous together with 2-4 mg dexamethasone orally • 71% of patients when ondansetron was administered as syrup at a dose of 8 mg together with 2 to 4 mg dexamethasone orally on the days of chemotherapy.

Post-chemotherapy both groups received 4 mg ondansetron syrup ondansetron sirup daily for 2 days. There was no difference in the overall incidence or nature of adverse events between the two treatment groups.

The efficacy of ondansetron in 75 children aged 6 to 48 months was investigated in an open-label, non-comparative, single-arm study (S3A40320). All children received three 0.15 mg/kg doses of ondansetron sirup ondansetron, administered 30 minutes before the start of chemotherapy and then at 4 and 8 hours after the first dose.

Complete control of emesis was achieved in 56% of patients. Another open-label, non-comparative, single-arm study (S3A239) investigated the efficacy of one intravenous dose of 0.15 mg/kg ondansetron followed by two oral ondansetron doses of 4 mg for children aged < 12 yrs and 8 mg for children aged ≥12 yrs (total no. of children n= 28). Complete control of emesis was achieved in 42% of patients. PONV The efficacy of a single dose of ondansetron in the prevention of post-operative nausea and vomiting was investigated in a randomised, double-blind, placebo-controlled study in 670 children aged 1 to 24 months (post-conceptual age ≥44 weeks, weight ≥3 kg).

Included subjects were scheduled to undergo elective surgery under general anaesthesia and ondansetron sirup an ASA status ≤III.

A single dose of ondansetron 0.1 mg/kg was administered within five minutes following induction of anaesthesia. The proportion of subjects who experienced at least one emetic episode during the 24-hour assessment period (ITT) was greater for patients on placebo than those receiving ondansetron (28% vs.

11%, p <0.0001). Four double-blind, placebo-controlled studies have been performed in 1469 male and female patients (2 to 12 years of age) undergoing general anaesthesia. Patients were randomised to ondansetron sirup single intravenous doses of ondansetron (0.1 mg/kg for paediatric patients weighing 40 kg or less, 4 mg for paediatric patients weighing more than 40 kg; number of patients = 735)) or placebo (number of patients = 734).

Study drug was administered over at least 30 seconds, immediately prior to or following anaesthesia induction. Ondansetron was significantly more effective than placebo in preventing nausea and vomiting. The results of these studies are summarised in Table 3.

Table 3 Prevention and treatment of PONV in Paediatric Patients – Treatment response over 24 hours Absorption: Following oral administration, ondansetron is passively and completely absorbed from the gastrointestinal tract and undergoes first pass metabolism. Peak plasma concentrations of about 30ng/ml are attained approximately 1.5 hours after an 8mg dose. For doses above 8mg the increase in ondansetron systemic exposure with dose is greater than proportional; this may reflect some reduction in first pass metabolism at higher oral doses.

Ondansetron sirup bioavailability in healthy male subjects, following the oral ondansetron sirup of a single 8mg tablet, is approximately 55 to 60%. Bioavailability, following oral administration, is slightly enhanced by the presence of food but unaffected by antacids. Gender differences were shown in the disposition of ondansetron, with females having a greater rate and extent of absorption following an oral dose and reduced systemic clearance and volume of distribution (adjusted for weight).

The disposition of ondansetron following oral, intramuscular(IM) and intravenous(IV) dosing is similar with a terminal half life of about 3 hours and steady state volume of distribution of about 140L.

Equivalent systemic exposure is achieved after IM and IV administration of ondansetron. A 4mg intravenous infusion of ondansetron sirup given over 5 minutes results in peak plasma concentrations of about 65ng/ml.

Following intramuscular administration of ondansetron, peak plasma concentrations of about 25ng/ml are attained within 10 minutes of injection. Following administration of ondansetron suppository, plasma ondansetron concentrations become detectable between 15 and 60 minutes after dosing. Concentrations rise in an essentially linear fashion, until peak concentrations of 20-30 ng/ml are attained, typically 6 hours after dosing. Plasma concentrations then fall, but at a slower rate than observed following oral dosing due to continued absorption of ondansetron.

ondansetron sirup

The absolute bioavailability of ondansetron from the suppository is approximately 60% and is not affected by gender. Distribution: Ondansetron is not highly protein bound (70-76%) Biotransformation: Ondansetron is cleared from the systemic circulation predominantly by hepatic metabolism through multiple enzymatic pathways Elimination: The half life of the elimination phase following suppository administration is determined by the rate of ondansetron absorption, not systemic clearance and is approximately 6 hours.

Females show a small, clinically insignificant, ondansetron sirup in half-life in comparison with males. Less than 5% of the absorbed dose is excreted unchanged in the urine. Ondansetron sirup absence of the enzyme CYP2D6 (the debrisoquine polymorphism) has no effect on ondansetron's pharmacokinetics. The pharmacokinetic properties of ondansetron are unchanged on repeat dosing. Special Patient Populations Children and Ondansetron sirup (aged 1 month to 17 years) In paediatric patients aged 1 to 4 months (n=19) undergoing surgery, weight normalised clearance was approximately 30% slower than in patients aged 5 to 24 months (n=22) but comparable to the patients aged 3 to 12 years.

The half-life in the patient population aged 1 to 4 month was reported to average 6.7 hours compared to 2.9 hours for patients in the 5 to 24 month and 3 to 12 year age range.

The differences in pharmacokinetic parameters in the 1 to 4 month patient population can be explained in part by the higher percentage of total body water in neonates and infants and a higher volume of distribution for water soluble drugs like ondansetron.

In paediatric patients aged 3 to 12 years undergoing elective surgery with general anaesthesia, the absolute values for both the clearance and volume of distribution of ondansetron were reduced in comparison to values with adult patients. Both parameters increased in a linear fashion with weight and by 12 years of age, the values were approaching those of young adults.

When clearance and volume of distribution values were normalised by body weight, the values for these parameters were similar between the different age group populations.

Use of weight-based dosing compensates for age-related changes and is effective in normalising systemic exposure in ondansetron sirup patients. Population pharmacokinetic analysis was performed on 428 subjects (cancer patients, surgery patients and healthy volunteers) aged 1 month to 44 years following intravenous administration of ondansetron.

Based on this analysis, systemic exposure (AUC) of ondansetron following oral or IV dosing in children and adolescents was comparable to adults, with the exception of infants aged 1 to 4 months. Volume was related to age and was lower in adults than in infants and children. Clearance was related to weight but not to age with the exception of infants aged 1 to 4 months. It is difficult to conclude whether there was an additional reduction in clearance related to age in infants 1 to 4 months or simply inherent variability due ondansetron sirup the low number of subjects studied in this age group.

Since patients less than 6 months of age will only receive a single dose in PONV a decreased clearance is not likely to be clinically relevant. Elderly Early Phase I studies in healthy elderly volunteers showed a slight age-related decrease in clearance, and an increase in half-life of ondansetron.

However, wide inter-subject variability resulted in considerable overlap in pharmacokinetic parameters between young (<65 years of age) and elderly subjects (≥65 years of age) and there was no overall differences in safety or efficacy observed between young and elderly cancer patients enrolled in CINV clinical trials to support a different dosing recommendation for the elderly. Based on more recent ondansetron plasma concentrations and exposure-response modelling, a greater effect on QTcF is predicted in patients ≥75 years of ages compared to young adults.

Specific dosing ondansetron sirup is provided for patients over 65 years of ages and over 75 years of age for intravenous dosing. Renal impairment In patients with renal impairment (creatinine clearance 15-60 ml/min), both systemic clearance and volume of distribution are reduced following IV administration of ondansetron, resulting in a slight, but clinically insignificant, increase in elimination half-life (5.4 hours).

A study in patients with severe renal impairment who required regular haemodialysis (studied between dialyses) showed ondansetron's pharmacokinetics to be essentially unchanged following IV administration. Hepatic impairment Following oral, intravenous or intramuscular dosing in patients with severe hepatic impairment, ondansetron's systemic clearance is markedly reduced with prolonged elimination half-lives (15-32 hours) and an oral bioavailability approaching 100% due to reduced pre-systemic metabolism.

The pharmacokinetics of ondansetron following administration as a suppository have not been evaluated in patients with hepatic impairment. Ondansetron Generic name: ondansetron (oral) [ on-DAN-se-tron ] Brand names: Zofran, Zofran ODT, Zuplenz Drug class: 5HT3 receptor antagonists Medically reviewed by Drugs.com. Last updated on Oct 25, 2021. • Uses • Warnings • Before taking • Side effects • Dosage • Interactions • FAQ What is ondansetron?

Ondansetron sirup blocks the actions of chemicals in the body that can trigger nausea and vomiting. Ondansetron is used to prevent nausea and vomiting that may be caused by surgery, cancer chemotherapy, or radiation treatment.

Ondansetron may be used for purposes not listed in this medication guide. Warnings You should not use ondansetron if you are also ondansetron sirup apomorphine (Apokyn). You should not use ondansetron if you are allergic to it or to similar medicines such as dolasetron (Anzemet), granisetron (Kytril), or palonosetron (Aloxi).

Before ondansetron sirup ondansetron, tell your doctor if you have liver disease, or a personal or family history of Long QT syndrome.

Ondansetron orally disintegrating tablets may contain phenylalanine. Tell your doctor if you have phenylketonuria (PKU). Serious side effects of ondansetron include blurred vision or temporary vision loss (lasting from only a few minutes to several hours), slow heart rate, trouble breathing, anxiety, agitation, shivering, feeling like you might pass out, and urinating less than usual or not at all.

ondansetron sirup

Stop taking this medicine and call your doctor at once if you have any of these side effects. Ondansetron may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Before taking ondansetron You should not use ondansetron if: • ondansetron sirup are also using apomorphine (Apokyn); or • you are allergic to ondansetron or similar medicines (dolasetron, granisetron, palonosetron).

To make sure ondansetron is safe for you, tell your doctor if you have: • liver disease; • an electrolyte imbalance (such as low levels of potassium or magnesium in your blood); • congestive heart failure, slow heartbeats; ondansetron sirup a personal or family history of long QT syndrome; or • a blockage in your digestive tract (stomach or ondansetron sirup.

Ondansetron is not expected to harm an unborn baby. Tell your doctor if you are pregnant. It is not known whether ondansetron passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Ondansetron is not approved for use by anyone younger than 4 years old. Ondansetron orally disintegrating tablets may contain phenylalanine. Tell your doctor if you have phenylketonuria (PKU). How should I take ondansetron? Take ondansetron exactly as prescribed by your doctor.

Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended. Ondansetron can be taken with or without food. The first dose is usually taken before the start of your surgery, chemotherapy, or radiation treatment. Follow your doctor's dosing instructions very carefully. Take the ondansetron regular tablet with a full glass of water. To take the orally disintegrating tablet (Zofran ODT): • Keep the tablet in its blister pack until you are ready to take it.

Open the package and peel back the foil. Do not push a tablet through the foil or you may damage the tablet. • Use dry hands to remove the tablet and place it in your mouth. • Do not swallow the tablet whole. Allow it to dissolve in your mouth without chewing. • Swallow several times as the tablet dissolves.

ondansetron sirup

To use ondansetron oral soluble film (strip) (Zuplenz): • Keep the strip in the foil pouch until you are ready to use the medicine. • Using dry hands, remove the strip and place it on your tongue. It will begin to dissolve right away.

• Do not swallow the strip whole. Allow it to dissolve in your mouth without chewing. • Swallow several times after the strip dissolves. If desired, you may drink liquid to help swallow the dissolved strip.

• Wash your hands after using Zuplenz. Measure liquid medicine with the dosing syringe provided, or with a special dose-measuring spoon or medicine cup. If you do not have ondansetron sirup dose-measuring device, ask your pharmacist for one. Store at room temperature away from moisture, heat, and light.

Store liquid medicine in an upright position. What happens if I miss a dose? Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose. What happens if I overdose? Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Overdose symptoms may include sudden loss of vision, severe constipation, feeling light-headed, or fainting.

What to avoid Ondansetron may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Ondansetron side effects Get emergency medical help if you have signs of an allergic reaction to ondansetron: rash, hives; fever, chills, difficult breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have: • severe constipation, stomach pain, or bloating; • headache with chest pain and severe dizziness, fainting, fast or pounding heartbeats; • fast or pounding heartbeats; • jaundice (yellowing of the skin or eyes); • blurred vision or temporary vision loss (lasting from only a few minutes to several hours); • high levels of serotonin in the body--agitation, hallucinations, fever, fast heart rate, overactive reflexes, nausea, vomiting, diarrhea, loss of coordination, fainting.

Common ondansetron side effects may include: • diarrhea or constipation; • headache; • drowsiness; or • tired feeling. This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. Ondansetron side effects (more detail) Dosing information Usual Adult Dose of Ondansetron for Nausea/Vomiting -- Chemotherapy Induced: Oral: Highly Emetogenic Cancer Chemotherapy (HEC): -Recommended dose: 24 mg orally 30 minutes before the start of single-day HEC (including cisplatin doses of 50 mg/m2 or greater) Moderately Emetogenic Cancer Chemotherapy (MEC): -Recommended dose: 8 mg ondansetron sirup twice a day, with the first dose administered 30 minutes before the start of chemotherapy and the subsequent dose 8 hours later; then 8 mg orally 2 times a day (every 12 hours) for 1 to 2 days after the completion of chemotherapy Parenteral: -Recommended dose: 0.15 mg/kg IV, with the first dose (infused over 15 minutes) 30 minutes before the start of emetogenic chemotherapy and subsequent doses given 4 and 8 hours after the first dose.

-Maximum dose: 16 mg per dose Comments: -Multi-day, single-dose administration of 24 mg orally for HEC has not been studied. -The injection formulation should be diluted prior to IV administration. Uses: -Prevention of nausea and vomiting associated with HEC or MEC -Prevention of nausea and vomiting associated with initial and repeat courses of emetogenic chemotherapy Usual Adult Dose of Ondansetron for Nausea/Vomiting: Oral: Highly Emetogenic Cancer Chemotherapy (HEC): -Recommended dose: 24 mg orally 30 minutes before the start of single-day HEC (including cisplatin doses of 50 mg/m2 or greater) Moderately Emetogenic Cancer Chemotherapy (MEC): -Recommended dose: 8 mg orally twice a day, with the first dose administered 30 minutes before the start of chemotherapy and the subsequent dose 8 hours later; then 8 mg orally 2 times a day (every 12 hours) for 1 to 2 days after the completion of chemotherapy Parenteral: -Recommended dose: 0.15 mg/kg IV, with the first dose (infused over 15 minutes) 30 minutes before the start of emetogenic chemotherapy and subsequent doses given 4 and 8 hours after the first dose.

-Maximum dose: 16 mg per dose Comments: -Multi-day, single-dose administration of 24 mg orally for HEC has not been studied. -The injection formulation should be diluted prior to IV administration. Uses: -Prevention of nausea and vomiting associated with HEC or MEC -Prevention of nausea and vomiting associated with initial and repeat courses of emetogenic chemotherapy Usual Adult Dose of Ondansetron for Nausea/Vomiting -- Postoperative: Oral: -Recommended dose: 16 mg orally 1 hour before the induction of anesthesia Parenteral: -Recommended dose: 4 mg IV (undiluted) immediately before induction of anesthesia or postoperatively (nausea and/or vomiting within 2 hours after surgery) -Alternative route: 4 mg IM (undiluted) Comment: -Administration of a second dose does not provide additional control of nausea and vomiting.

Use: -Prevention of postoperative nausea and vomiting Usual Adult Dose for Nausea/Vomiting--Radiation Induced: Recommended dose: 8 mg orally 3 times a day -Total Body Irradiation: 8 mg orally 1 to 2 hours before each fraction of radiotherapy administered each day -Single High-dose Fraction Radiotherapy to the Abdomen: 8 mg orally 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for 1 to 2 days after the completion of radiotherapy -Daily Fractionated Radiotherapy to the Abdomen: 8 mg orally 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for each day radiotherapy is given Use: -Prevention of nausea and vomiting associated with radiotherapy, either as total body irradiation, single high-dose fraction, or daily fractions to the abdomen Usual Pediatric Dose for Nausea/Vomiting -- Postoperative: Parenteral: 1 month to 12 years: Less than 40 kg: -Recommended dose: 0.1 mg/kg IV over 2 to 5 minutes immediately prior to/following anesthesia induction or postoperatively (nausea and/or vomiting occurring shortly after surgery) 40 kg and greater: -Recommended dose: 4 mg IV over 2 to 5 minutes immediately prior to/following anesthesia induction or postoperatively (nausea and/or vomiting occurring shortly after surgery) Use: -Prevention of postoperative nausea and vomiting Usual Pediatric Dose for Ondansetron sirup -- Chemotherapy Induced: Oral: 4 to 11 years: -Recommended dose: 4 mg orally 3 times a day, with the first dose administered 30 minutes before the start of chemotherapy, and subsequent doses 4 and 8 hours after the first dose; then 4 mg orally 3 times a day (every 8 hours) for 1 to 2 days after the completion of chemotherapy 12 years and older: -Recommended dose: 8 mg orally twice a day, with the first dose administered 30 minutes before the start of chemotherapy and the subsequent dose 8 hours later; then 8 mg orally 2 times ondansetron sirup day ondansetron sirup 12 hours) for 1 to 2 days after the completion of chemotherapy Parenteral: 6 months to 18 years: -Recommended dose: 0.15 mg/kg IV, with the first dose (infused over 15 minutes) 30 minutes before the start of emetogenic chemotherapy, and subsequent doses given 4 and 8 hours after the first dose -Maximum dose: 16 mg (per dose) Comments: -The injection formulation should be diluted in 50 mL prior to IV administration.

-This drug should be used to prevent nausea and vomiting associated with moderately to highly emetogenic chemotherapy. Uses: -Prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy -Prevention of nausea and vomiting associated with initial and repeat courses of emetogenic chemotherapy Detailed Ondansetron dosage information What other drugs will affect ondansetron?

Ondansetron can cause a serious heart problem, especially if you use certain medicines at the same time, including antibiotics, antidepressants, heart rhythm medicine, antipsychotic medicines, and medicines to treat cancer, malaria, HIV or AIDS. Tell your doctor about all medicines you use, and those you start or stop using during your treatment with ondansetron. Taking ondansetron sirup while you are using certain other medicines can cause high levels of serotonin to build up in your body, a condition called "serotonin syndrome," which can be fatal.

Tell your doctor if you also use: • medicine to treat depression; • medicine to treat a psychiatric disorder; • a narcotic (opioid) medication; or • medicine to prevent nausea and vomiting.

This list is not complete and many other drugs can interact with ondansetron. This includes prescription and over-the-counter medicines, vitamins, and herbal products.

Give a list of all your medicines to any healthcare provider who treats you. More about ondansetron • Side effects • Drug interactions • Dosage information • During pregnancy or Breastfeeding • Reviews (440) • Patient tips • Drug images • Compare alternatives • Pricing & coupons • Drug class: 5HT3 receptor antagonists Patient resources • Advanced Reading • Ondansetron Oral, Oromucosal (Advanced Reading) • Ondansetron Orally Disintegrating Tablets • Ondansetron Tablets • Ondansetron Oral Soluble Film • Ondansetron Oral Solution Other brands Zofran, Zofran ODT, Zuplenz Professional resources • Prescribing Information Related treatment guides • Nausea/Vomiting • Alcohol Dependence • Gastroenteritis • Nausea/Vomiting, Chemotherapy Induced Further information Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use ondansetron only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. Medical Disclaimer Copyright 1996-2022 Cerner Multum, Inc. Version: 13.01. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Data sources include IBM Watson Micromedex (updated 3 May 2022), Cerner Multum™ (updated 28 Apr 2022), ASHP (updated 11 Apr 2022) and others.
Expand Indications and Usage for Ondansetron Oral Solution Ondansetron Oral Solution is indicated for the prevention of nausea and vomiting associated with: • highly emetogenic cancer chemotherapy, including cisplatin greater than or equal to 50 mg/m 2 • initial and repeat courses of moderately emetogenic cancer chemotherapy • radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen Ondansetron Oral Solution is also indicated for the prevention of postoperative nausea and/or vomiting.

Ondansetron Oral Solution Dosage and Administration Dosage The recommended dosage regimens for adult and pediatric patients are described in Table 1 and Table 2, respectively. Table 1: Adult Recommended Dosage Regimen for Prevention of Nausea and Vomiting Indication Dosage Regimen Highly Emetogenic Cancer Chemotherapy A single 24-mg dose administered 30 minutes before the start of single-day highly emetogenic chemotherapy, including cisplatin ≥50 mg/m 2 Moderately Emetogenic Cancer Chemotherapy 8 mg administered 30 minutes before the start of chemotherapy, with a subsequent 8-mg dose 8 hours after the first dose.

Then administer 8 mg twice a day (every 12 hours) for 1 to 2 days after completion of chemotherapy. Radiotherapy For total body irradiation: 8 mg administered 1 to 2 ondansetron sirup before each fraction of radiotherapy each day. For single high-dose fraction radiotherapy to the abdomen: 8 mg administered 1 to 2 hours before radiotherapy, with subsequent 8-mg doses every 8 hours after the first dose for 1 to 2 days after completion of radiotherapy.

For daily fractionated radiotherapy to the abdomen: 8 mg administered 1 to 2 hours before radiotherapy, with subsequent 8-mg doses every 8 hours after the first dose for each day radiotherapy is given. Postoperative 16 mg administered 1 hour before induction of anesthesia. Table 2: Pediatric Recommended Dosage Regimen for Prevention of Nausea and Vomiting Indication Dosage Regimen Moderately Emetogenic Ondansetron sirup Chemotherapy 12 to 17 years of ondansetron sirup 8 mg administered 30 minutes before the start of chemotherapy, with a subsequent 8-mg dose 8 hours after the first dose.

Then administer 8 mg twice a day (every 12 hours) for 1 to 2 days after completion of chemotherapy. 4 to 11 years of age: 4 mg administered 30 minutes before the start of chemotherapy, with a subsequent 4-mg dose 4 and 8 hours after the first dose. Then administer 4 mg three times a day for 1 to 2 days after completion of chemotherapy.

Dosage in Hepatic Impairment In patients with severe hepatic impairment (Child-Pugh score of 10 or greater), do not exceed a total daily dose of 8 mg [see Use in Specific Populations (8.6), Clinical Pharmacology (12.3)]. Dosage Forms and Strengths Ondansetron Oral Solution, USP, 4 mg/5 mL, is a clear, colorless liquid with a characteristic strawberry odor available in a 50-mL bottle.

Contraindications Ondansetron is contraindicated in patients: • known to have hypersensitivity (e.g., anaphylaxis) to ondansetron or any of the components of the formulation [see Adverse Reactions (6.2)] • receiving concomitant apomorphine due to the risk of profound hypotension and loss of consciousness Warnings and Precautions Hypersensitivity Reactions Hypersensitivity reactions, including anaphylaxis and bronchospasm, have been reported in patients who have exhibited hypersensitivity to other selective 5-HT 3 receptor antagonists.

If hypersensitivity reactions occur, discontinue use of ondansetron; treat promptly per standard of care and monitor until signs and symptoms resolve [see Contraindications (4)].

QT Prolongation Electrocardiograms (ECG) changes including QT interval prolongation have been seen in patients receiving ondansetron. In addition, postmarketing cases of Torsade de Pointes have been reported in patients using ondansetron. Avoid ondansetron in patients with congenital long QT syndrome.

ECG monitoring is recommended in patients ondansetron sirup electrolyte abnormalities (e.g., hypokalemia or hypomagnesemia), congestive heart failure, bradyarrhythmias, ondansetron sirup patients taking other medicinal products that lead to Ondansetron sirup prolongation [see Clinical Pharmacology (12.2)].

Serotonin Syndrome The development of serotonin syndrome has been reported with 5-HT 3 receptor antagonists alone. Most reports have been associated with concomitant use of serotonergic drugs (e.g., selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), monoamine oxidase inhibitors, mirtazapine, fentanyl, lithium, tramadol, and intravenous methylene blue).

Some of the reported cases were fatal. Serotonin syndrome occurring with overdose of ondansetron alone has also been reported. The majority of reports of serotonin syndrome related to 5-HT 3 receptor antagonist use occurred in a post-anesthesia care unit or an infusion center.

Symptoms associated with serotonin syndrome may include the following combination of signs and symptoms: mental status changes (e.g., agitation, hallucinations, delirium, and coma), autonomic instability (e.g., tachycardia, labile blood pressure, dizziness, diaphoresis, flushing, hyperthermia), neuromuscular symptoms (e.g., tremor, rigidity, myoclonus, hyperreflexia, incoordination), seizures, with or without gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea).

Patients should be monitored ondansetron sirup the emergence of serotonin syndrome, especially with concomitant use of ondansetron and other serotonergic drugs.

If symptoms of serotonin syndrome occur, discontinue ondansetron and initiate supportive treatment. Patients should be informed of the increased risk of serotonin syndrome, especially if ondansetron is used concomitantly with other serotonergic drugs [see Drug Interactions (7.1), Overdosage (10)].

Masking of Progressive Ileus and Gastric Distension The use of ondansetron in patients following abdominal surgery or in patients with chemotherapy-induced nausea and vomiting may mask a progressive ileus and/or gastric distension. Monitor for decreased bowel activity, particularly in patients with risk factors for gastrointestinal obstruction. Ondansetron is not a drug that stimulates gastric ondansetron sirup intestinal peristalsis.

It should not be used instead of nasogastric suction. Adverse Reactions Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice. The following adverse reactions have been reported in clinical trials of patients treated with ondansetron, the active ingredient of ondansetron.

A causal relationship to therapy with ondansetron was unclear in many cases. Prevention of Chemotherapy-Induced Nausea and Vomiting The most common adverse reactions reported in greater than or equal to 4% of 300 adults receiving a single 24-mg dose of ondansetron orally in 2 trials for the prevention of nausea and vomiting associated with highly emetogenic chemotherapy (cisplatin ondansetron sirup than or equal to 50 mg/m 2) were: headache (11%) and diarrhea (4%).

The most common adverse reactions reported in 4 trials in adults for the prevention of nausea and vomiting associated with moderately emetogenic chemotherapy (primarily cyclophosphamide-based regimens) are shown in Table 3. Table 3. Most Common Adverse Reactions in Adults a for the Prevention of Nausea and Vomiting Associated with Moderately Emetogenic Chemotherapy [Primarily Cyclophosphamide-based Regimens] Adverse Reaction Ondansetron 8 mg Twice Daily (n = 242) Placebo (n = 262) Headache 58 (24%) 34 (13%) Malaise/fatigue ondansetron sirup (13%) 6 (2%) Constipation 22 (9%) 1 (<1%) Diarrhea 15 (6%) 10 (4%) Less Common Adverse Reactions Central Nervous System: Ondansetron sirup reactions (less than 1% of patients).

Hepatic: Aspartate transaminase (AST) and/or alanine transaminase (ALT) values exceeded twice the upper limit of normal in approximately 1% to 2% of 723 patients receiving ondansetron and cyclophosphamide-based chemotherapy in US clinical trials. The increases were transient and did not appear to be related to dose or duration of therapy.

On repeat exposure, similar transient elevations in transaminase values occurred in some courses, but symptomatic hepatic disease did not occur. Ondansetron sirup role of cancer chemotherapy in these biochemical changes is unclear. Liver failure and death has been reported in cancer patients receiving concurrent medications, including potentially hepatotoxic cytotoxic chemotherapy and antibiotics. The etiology of the liver failure is unclear. Integumentary: Rash (approximately 1% of patients).

Other (less than 2%): Anaphylaxis, bronchospasm, tachycardia, angina, hypokalemia, electrocardiographic alterations, vascular occlusive events, and grand mal seizures. Except for bronchospasm and anaphylaxis, the relationship to ondansetron is unclear. Prevention of Radiation-Induced Nausea and Vomiting The most common adverse reactions (greater than or equal to 2%) reported in patients receiving ondansetron and concurrent radiotherapy were similar to those reported in patients receiving ondansetron and concurrent chemotherapy and were headache, constipation, and diarrhea.

Prevention of Postoperative Nausea and Vomiting The most common adverse reactions reported in adults in trial(s) of prevention of postoperative nausea and vomiting are shown in Table 4.

In these trial(s), patients were receiving multiple concomitant perioperative and postoperative medications in both treatment groups. Table 4.

Most Common Adverse Reactions in Adults a for the Prevention of Postoperative Nausea and Vomiting Adverse Reaction Ondansetron 16 mg as a Single Dose (n = 550) Placebo (n = 531) Headache 49 (9%) 27 (5%) Hypoxia 49 (9%) 35 (7%) Pyrexia 45 (8%) 34 (6%) Dizziness 36 (7%) 34 (6%) Gynecological disorder 36 (7%) 33 (6%) Anxiety/agitation 33 (6%) 29 (5%) Urinary retention 28 (5%) 18 (3%) Pruritus 27 (5%) 20 (4%) a Reported in greater than or equal to 5% of patients treated with ondansetron and at a rate that exceeded placebo.

In a crossover study with 25 subjects, headache was reported in 6 subjects administered ondansetron ODT with water (24%) as compared with 2 subjects administered ondansetron ODT without water (8%). Postmarketing Experience The following adverse reactions have been identified during post-approval use of ondansetron. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Cardiovascular Arrhythmias (including ventricular and supraventricular tachycardia, premature ventricular contractions, and atrial fibrillation), bradycardia, electrocardiographic alterations (including second-degree heart block, QT/QTc interval prolongation, and ST segment depression), palpitations, and syncope.

Rarely and predominantly with intravenous ondansetron, transient ECG changes including QT interval prolongation have been reported. General Flushing. Rare cases of hypersensitivity reactions, sometimes severe (e.g., anaphylactic reactions, angioedema, bronchospasm, shortness of breath, hypotension, laryngeal edema, stridor) have also been reported.

Laryngospasm, shock, and cardiopulmonary arrest have occurred during allergic reactions in patients receiving injectable ondansetron. Hepatobiliary Liver enzyme abnormalities. Lower Respiratory Hiccups. Neurology Oculogyric crisis, appearing alone, as well as with other dystonic reactions. Skin Urticaria, Stevens-Johnson syndrome, and toxic epidermal necrolysis.

Eye Disorders Cases of transient blindness, predominantly during intravenous administration, have been reported. These cases of transient blindness were reported to resolve within a few minutes up to 48 hours. Drug Interactions Serotonergic Drugs Serotonin syndrome (including altered mental status, autonomic instability, and neuromuscular symptoms) has been described following the concomitant use of 5-HT 3 receptor antagonists and other serotonergic drugs, including selective serotonin reuptake inhibitors (SSRIs) and serotonin and noradrenaline reuptake inhibitors (SNRIs).

Monitor for the emergence of serotonin syndrome. If symptoms occur, discontinue ondansetron and initiate supportive treatment [see Warnings and Precautions (5.3)]. Drugs Affecting Cytochrome P-450 Enzymes Ondansetron does not itself appear to induce or inhibit the cytochrome P-450 drug-metabolizing enzyme system of the liver [see Clinical Pharmacology (12.3)]. Because ondansetron is metabolized by hepatic cytochrome P-450 drug-metabolizing enzymes (CYP3A4, CYP2D6, CYP1A2), inducers or inhibitors of these enzymes may change the clearance and, hence, the half-life of ondansetron.

In patients treated with potent inducers of CYP3A4 (i.e., phenytoin, carbamazepine, and rifampin), the clearance of ondansetron was significantly increased and ondansetron blood concentrations were decreased.

However, on the basis of available data, no dosage adjustment for ondansetron is recommended for patients on these drugs [see Clinical Pharmacology (12.3)]. Tramadol Although no pharmacokinetic drug interaction between ondansetron and tramadol has been observed, data from 2 small trials indicate that when used together, ondansetron may increase patient-controlled administration of tramadol.

Monitor patients to ensure adequate pain control when ondansetron is administered with tramadol. Chemotherapy Carmustine, etoposide, and cisplatin do not affect the pharmacokinetics of ondansetron. In a crossover trial in 76 pediatric patients, intravenous ondansetron did not increase systemic concentrations of high-dose methotrexate.

ondansetron sirup

Alfentanil and Atracurium Ondansetron does not alter the respiratory depressant effects produced by alfentanil or the degree of neuromuscular blockade produced by atracurium. Interactions with general or local anesthetics have not been studied. USE IN SPECIFIC POPULATIONS Pregnancy Risk Summary Available data do not reliably inform ondansetron sirup association of ondansetron and adverse fetal outcomes. Published epidemiological studies on the ondansetron sirup between ondansetron and fetal outcomes have reported inconsistent findings and have important methodological limitations hindering interpretation ( see Data).

Reproductive studies in rats and rabbits did not show evidence of harm to the fetus when ondansetron was administered during organogenesis at approximately ondansetron sirup and 24 times the maximum recommended human oral dose of 24 mg/day, based on body surface area, respectively ( see Data). The background risk of major birth defects and miscarriage for the indicated population is unknown.

In the US general population, the estimated background risk of major birth defects and miscarriages in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Human Data Methodological limitations of the epidemiology studies preclude a reliable evaluation of the potential risk of adverse fetal outcomes with the use of ondansetron in pregnancy. Two large retrospective cohort studies of ondansetron use in pregnancy have been published. In one study with 1,349 infants born to women who reported the use of ondansetron or received an ondansetron prescription in the first trimester, no increased risk for major congenital malformations was seen in aggregate analysis.

ondansetron sirup

In this same study, however, a sub-analysis for specific malformations reported an association between ondansetron exposure and cardiovascular defect (odds ratio (OR) 1.62 [95% CI ondansetron sirup, 2.14)]) and cardiac septal defect (OR 2.05 [95% CI (1.19, 3.28)]). The second study examined 1970 women who received ondansetron prescription during pregnancy and reported no association between ondansetron exposure and major congenital malformations, miscarriage or stillbirth, and infants of low-birth weight or small for gestational age.

Important methodological limitations with these studies include the ondansetron sirup of whether women who filled a prescription actually took the medication, the concomitant use of other medications or treatments, and other unadjusted confounders that may account for the study findings. A case-control study evaluating associations between several common non-cardiac malformations and multiple antiemetic drugs reported an association between maternal use of ondansetron and isolated cleft palate (reported adjusted OR = 2.37 [95% CI (1.18, 4.76)]).

However, this association could be a chance finding, given the large number of drugs-birth defect comparisons in this study. It is unknown whether ondansetron exposure in utero in the cases of cleft palate occurred during the time of palate formation (the palate is formed between the 6th and 9th weeks of pregnancy) or whether mothers of infants with cleft palate used other medications or had other risk factors for cleft palate in the offspring.

In addition, no cases of isolated cleft palate were identified in the aforementioned 2 large retrospective cohort studies. At this time, there is no clear evidence that ondansetron exposure in early pregnancy can cause cleft palate.

Animal Data In embryo-fetal development studies in rats and rabbits, pregnant animals received oral doses of ondansetron up to 15 mg/kg/day and 30 mg/kg/day, respectively, during the period of organogenesis.

With the exception of a slight decrease in maternal body weight gain in the rabbits, there were no significant effects of ondansetron on the maternal animals or the development of the offspring. At doses of 15 mg/kg/day in rats and 30 mg/kg/day in rabbits, the maternal exposure margin was approximately 6 and 24 times the maximum recommended human oral dose of 24 mg/day, respectively, based on body surface area. In a pre-and postnatal developmental toxicity study, pregnant rats received oral doses of ondansetron up to 15 mg/kg/day from Day 17 of pregnancy to litter Day 21.

With the exception of a slight reduction in maternal body weight gain, there were no effects upon the pregnant rats and the pre-and postnatal development of their offspring, including reproductive performance of the mated F1 generation.

At a dose of 15 mg/kg/day in rats, the maternal exposure margin was approximately 6 times the maximum recommended human oral dose of 24 mg/day, based on body surface area. Lactation Risk Summary It is not known whether ondansetron is present in human milk. There are no data on the effects of ondansetron on the breastfed infant or the effects on milk production. However, it has been demonstrated that ondansetron is present in the milk of rats.

The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for ondansetron and any potential adverse effects on the breast fed infant from ondansetron or from the underlying maternal condition. Pediatric Use The safety and effectiveness of orally administered ondansetron have been established in pediatric patients 4 years and older for the prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy.

Use of ondansetron in these age-groups is supported by evidence from adequate and well-controlled studies of ondansetron in adults with additional data from 3 open-label, uncontrolled, non-US trials in 182 pediatric ondansetron sirup aged 4 to 18 years with cancer who were given a variety of cisplatin or noncisplatin regimens [see Dosage and Administration (2.2), Clinical Studies (14.1)].

Additional information on the use of ondansetron in pediatric patients may be found in ondansetron Injection prescribing information. The safety and effectiveness of orally administered ondansetron have not been established in pediatric patients for: • prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy • prevention of nausea and vomiting associated with radiotherapy • prevention of postoperative nausea and/or vomiting Geriatric Use Of the total number of subjects enrolled in cancer chemotherapy-induced and postoperative nausea and vomiting in US-and foreign-controlled clinical trials, for which there were subgroup analyses, 938 (19%) were aged 65 years and older.

No overall differences in safety or effectiveness were observed between subjects 65 years of age and older and younger subjects.

A reduction in clearance ondansetron sirup increase in elimination half-life were seen in patients older than 75 years compared with younger subjects [see Clinical Pharmacology (12.3)].

There were an insufficient number of patients older than 75 years of age and older in the clinical trials to permit safety or efficacy conclusions in this age-group. Other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot ondansetron sirup ruled out. No dosage adjustment is needed in elderly patients.

Hepatic Impairment No dosage adjustment is needed in patients with mild or moderate hepatic impairment. In patients with severe hepatic impairment, clearance is reduced and the apparent volume of distribution is increased, resulting in a significant increase in the half-life of ondansetron.

Ondansetron sirup, do not exceed a total daily dose of 8 mg in patients with severe hepatic impairment (Child-Pugh score of 10 or greater) [see Dosage and Administration (2.2), Clinical Pharmacology (12.3)]. Renal Impairment No dosage ondansetron sirup is recommended for patients with any degree of renal impairment (mild, moderate, or severe).

There is no experience beyond first-day administration of ondansetron [see Clinical Pharmacology (12.3)]. Drug Abuse and Dependence Animal studies have shown that ondansetron is not discriminated as a benzodiazepine nor does it substitute for benzodiazepines in direct addiction studies. Overdosage There is no specific antidote for ondansetron overdose.

Patients should be managed with appropriate supportive therapy. In addition to the adverse reactions listed above, the following adverse reactions have been described in the setting of ondansetron overdose: “Sudden blindness” (amaurosis) of 2 to 3 minutes’ duration plus severe constipation occurred in one patient that was administered 72 mg of ondansetron intravenously as a single dose.

Hypotension (and faintness) occurred in a patient that took 48 mg of ondansetron tablets. Following infusion of 32 mg over only a 4-minute period, a vasovagal episode with transient second-degree heart block was observed.

In all instances, the adverse reactions resolved completely. Pediatric cases consistent with serotonin syndrome have been reported after inadvertent oral overdoses of ondansetron (exceeding estimated ingestion of 5 mg per kg) in young children. Reported symptoms included somnolence, agitation, tachycardia, tachypnea, hypertension, flushing, mydriasis, diaphoresis, myoclonic movements, horizontal nystagmus, hyperreflexia, and seizure.

Patients required supportive care, including intubation in some cases, with complete recovery without sequelae within 1 to 2 days. Ondansetron Oral Solution Description The active ingredient in Ondansetron Oral Solution, USP is ondansetron hydrochloride, USP as the dihydrate, the racemic form of ondansetron and a selective blocking agent of the serotonin 5-HT 3 receptor type.

Chemically it is (±) 1, 2, 3, 9-tetrahydro-9-methyl-3-[(2-methyl-1H-imidazol-1-yl)methyl]-4H-carbazol-4-one, monohydrochloride, dihydrate. It has the following structural formula: The empirical formula is C 18H 19N 3O•HCl•2H 2O, representing a molecular weight of 365.9.

Ondansetron hydrochloride dihydrate is a white to off-white powder that is soluble in water and normal saline. Each 5 mL of Ondansetron Oral Solution, USP contains 5 mg of ondansetron hydrochloride dihydrate equivalent to 4 mg of ondansetron. Ondansetron Oral Solution, USP contains the inactive ingredients citric acid anhydrous, glycerin, purified water, saccharin sodium, sodium benzoate, sodium citrate and strawberry flavor.

Ondansetron Oral Solution - Ondansetron sirup Pharmacology Mechanism of Action Ondansetron is a selective 5-HT 3 receptor antagonist.

While its mechanism of action has not been fully characterized, ondansetron is not a dopamine-receptor antagonist. Serotonin receptors of the 5-HT 3 type are present both peripherally on vagal nerve terminals and centrally in the chemoreceptor trigger zone of the area postrema. It is not certain whether ondansetron’s antiemetic action is mediated centrally, peripherally, or in both sites. However, cytotoxic chemotherapy appears to be associated with release of serotonin from the enterochromaffin cells of the small intestine.

In humans, urinary 5-hydroxyindoleacetic acid (5-HIAA) excretion increases after ondansetron sirup administration in parallel with the onset of emesis. The released serotonin may stimulate the vagal afferents through the 5-HT 3 receptors and initiate the vomiting reflex. Pharmacodynamics In healthy subjects, single intravenous doses of 0.15 mg/kg of ondansetron had no effect on esophageal motility, gastric motility, lower esophageal sphincter pressure, or small intestinal transit time.

Multiday administration of ondansetron has been shown to slow colonic transit in healthy subjects. Ondansetron has no effect on plasma prolactin concentrations. Cardiac Electrophysiology QTc interval prolongation was studied in a double-blind, single-intravenous dose, placebo-and positive-controlled, crossover trial in 58 healthy subjects.

The maximum mean (95% upper confidence bound) difference in QTcF from placebo after baseline correction was 19.5 (21.8) milliseconds and 5.6 (7.4) milliseconds after 15 minute intravenous infusions of ondansetron sirup mg and 8 mg of ondansetron injection, respectively. A significant exposure-response relationship was identified between ondansetron concentration and ΔΔQTcF.

Using the established exposure-response relationship, 24 mg infused intravenously over 15 minutes had a mean predicted (95% upper prediction interval) ΔΔQTcF of 14 (16.3) milliseconds.

In contrast, 16 mg infused intravenously over 15 minutes using the same model had a mean predicted (95% upper prediction interval) ΔΔQTcF of 9.1 (11.2) milliseconds. In this study, the 8-mg dose infused over 15 minutes did not prolong the QT interval to any clinically relevant extent. Pharmacokinetics Absorption Ondansetron is absorbed from the gastrointestinal tract and undergoes some first-pass metabolism.

Mean bioavailability in healthy subjects, following administration of a single 8-mg tablet, is approximately 56%. Ondansetron systemic exposure does not increase proportionately to dose. The area under curve (AUC) from a 16-mg tablet was 24% greater than predicted from an 8-mg tablet dose. This may reflect some reduction of first-pass metabolism at higher oral doses.

Food Effects: Bioavailability is also slightly enhanced by the presence of food. Distribution Plasma protein binding of ondansetron as measured in vitro was 70% to 76% over the concentration range of 10 to 500 ng/mL. Circulating drug also distributes into erythrocytes.

Elimination Metabolism and Excretion: Ondansetron is extensively metabolized in humans, with approximately 5% of a radiolabeled dose recovered as the parent compound from the urine. The metabolites are observed in the urine. The primary metabolic pathway is hydroxylation on the indole ring followed by subsequent glucuronide or sulfate conjugation. In vitro metabolism studies have shown that ondansetron is a substrate for human hepatic cytochrome P-450 enzymes, including CYP1A2, CYP2D6, and CYP3A4.

In terms of overall ondansetron turnover, CYP3A4 played the predominant role. Because of the multiplicity of metabolic enzymes capable of metabolizing ondansetron, it is likely that inhibition or loss of one enzyme (e.g., CYP2D6 genetic deficiency) will be compensated by others and may result in little change in overall rates of ondansetron elimination.

Although some nonconjugated metabolites have pharmacologic activity, these are not found in plasma at concentrations likely to significantly contribute to the biological activity of ondansetron. Specific Populations Age: Ondansetron sirup Population: A reduction in clearance and increase in elimination half-life are seen in patients older than 75 years compared to younger subjects [see Use in Specific Populations (8.5)].

ondansetron sirup

Sex: Gender differences were shown in the disposition of ondansetron given as a single dose. The extent and rate of absorption are greater in women than men. Ondansetron sirup clearance in women, a smaller apparent volume of distribution (adjusted for weight), and higher absolute bioavailability resulted ondansetron sirup higher plasma ondansetron concentrations.

These higher plasma concentrations may in part be explained by differences in body weight between men and women. It is not known whether these sex-related differences were clinically important.

More detailed pharmacokinetic information is contained in Tables 5 and 6. Table 5: Pharmacokinetics in Male and Female Healthy Subjects after a Single Dose of an Ondansetron 8-mg Tablet Age-group (years) Sex (M/F) Mean Weight (kg) N Peak Plasma Concentration (ng/mL) Time of Peak Plasma Concentration (h) Mean Elimination Half-life (h) Systemic Plasma Clearance L/h/kg Absolute Bioavailability 18 to 40 M 69 6 26.2 2 3.1 0.403 0.483 F 62.7 5 42.7 1.7 3.5 0.354 0.663 61 to 74 M 77.5 6 24.1 2.1 4.1 0.384 0.585 F 60.2 6 52.4 1.9 4.9 0.255 0.643 ≥75 M 78 5 37 2.2 4.5 0.277 0.619 F 67.6 6 46.1 2.1 6.2 0.249 0.747 Table 6: Pharmacokinetics in Male and Female Healthy Subjects after a Single Dose of an Ondansetron 24-mg Tablet Age-group (years) Sex (M/F) Mean Weight (kg) N Peak Plasma Concentration (ng/mL) Time of Peak Plasma Concentration (h) Mean Elimination Half-life (h) 18 to 43 M 84.1 8 125.8 1.9 4.7 F 71.8 8 194.4 1.6 5.8 Renal Impairment: Renal impairment is not expected to significantly influence the total clearance of ondansetron as renal clearance represents only 5% of the overall clearance.

However, the mean plasma clearance of ondansetron was reduced by about 50% in patients with severe ondansetron sirup impairment (creatinine clearance less than 30 mL/min). The reduction in clearance was variable and not consistent with an increase in half-life [see Use in Specific Populations (8.7)]. Hepatic Impairment: In patients with mild-to-moderate hepatic impairment, clearance is reduced 2-fold and mean half-life is increased to 11.6 hours compared with 5.7 hours in healthy subjects.

In patients with severe hepatic impairment (Child-Pugh score of 10 or greater), clearance is reduced 2- fold to 3- fold and apparent volume of distribution is increased with a resultant increase in half-life to 20 hours [see Dosage and Administration (2.2), Use in Specific Populations (8.6)].

Drug Interaction Studies CYP 3A4 Inducers: Ondansetron sirup elimination may be affected by cytochrome P-450 inducers. In a pharmacokinetic trial of 16 epileptic patients maintained chronically on CYP3A4 inducers, carbamazepine, or phenytoin, a reduction in AUC, C max, and t ½ of ondansetron was observed. This ondansetron sirup in a significant increase in the clearance of ondansetron. However, this increase is not thought to be clinically relevant [see Drug Interactions (7.2)]. Chemotherapeutic Agents: Carmustine, etoposide, and cisplatin do not affect the pharmacokinetics of ondansetron [see Drug Interactions (7.4)].

Antacids: Concomitant administration of antacids does not alter the absorption of ondansetron. Nonclinical Toxicology Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenic effects were not seen in 2-year studies in rats and mice with oral ondansetron doses up to 10 mg/kg per day and 30 mg/kg per day, respectively (approximately 4 and 6 times the maximum recommended human oral dose of 24 mg per day, based on body surface area).

Ondansetron was not mutagenic in standard tests for mutagenicity. Oral administration of ondansetron up to 15 mg/kg per day (approximately 6 times the maximum recommended human oral dose of 24 mg per day, based on body surface area) did not affect fertility or general reproductive performance of male and female rats.

Clinical Studies Prevention of Chemotherapy-Induced Nausea and Vomiting Highly Emetogenic Chemotherapy In 2 randomized, double-blind, monotherapy trials, a single 24-mg oral dose of ondansetron was superior to a relevant historical placebo control in the prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy, including cisplatin greater than or equal to 50 mg/m 2.

Steroid administration was excluded ondansetron sirup these clinical trials. More than 90% of patients receiving a cisplatin dose greater than or equal to 50 mg/m 2 in the historical placebo comparator, experienced vomiting in the absence of antiemetic therapy. The first trial compared oral doses of ondansetron 24 mg as a single dose, 8 mg every 8 hours for 2 doses, and 32 mg as a single dose in 357 adult cancer patients receiving chemotherapy regimens containing cisplatin greater than or equal to 50 mg/m 2.

The first or single dose was administered 30 minutes prior to chemotherapy. A total of 66% of patients in the ondansetron 24-mg once-a-day group, 55% in the ondansetron 8-mg twice-a-day group, and 55% in the ondansetron 32-mg once-a-day group, completed the 24-hour trial period with 0 emetic episodes and no rescue antiemetic medications, the primary endpoint of efficacy.

Each of the 3 treatment groups was shown to be statistically significantly superior to a historical placebo control. In the same trial, 56% of patients receiving a single 24-mg oral dose of ondansetron experienced no nausea during ondansetron sirup 24-hour trial period, compared with 36% of patients in the oral ondansetron 8-mg twice-a-day group (P = 0.001) and 50% in the oral ondansetron 32-mg once-a-day group.

Dosage regimens of ondansetron 8 mg twice daily and 32 mg once daily are not recommended for the prevention of nausea and vomiting associated with highly emetogenic chemotherapy [see Dosage and Administration (2.1)].

In a second trial, efficacy of a single 24-mg oral dose of ondansetron for the prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy, including cisplatin greater than or ondansetron sirup to 50 mg/m 2, was confirmed.

Moderately Emetogenic Chemotherapy A randomized, placebo-controlled, double-blind trial was conducted in the US in 67 patients receiving a cyclophosphamide-based chemotherapy regimen containing doxorubicin. The first 8-mg dose of ondansetron was administered 30 minutes before the start of chemotherapy, with a subsequent dose 8 hours after the first dose, followed by 8 mg ondansetron sirup ondansetron twice a day for 2 days after the completion of chemotherapy.

Ondansetron was significantly more effective than placebo in preventing vomiting. Treatment response was based on the total number of emetic episodes over the 3-day trial period. The results of this trial are summarized in Table 7. Table 7: Emetic Episodes-Treatment Response in Patients Receiving Moderately Emetogenic Chemotherapy (Cyclophosphamide-based Regimen Containing Doxorubicin) Ondansetron (n = 33) Placebo (n ondansetron sirup 34) P Value Treatment response 0 Emetic episodes 1 to 2 Emetic episodes More than 2 emetic episodes/withdrawn 20 (61%) 6 (18%) 7 (21%) 2 (6%) 8 (24%) 24 (71%) <0.001 <0.001 Median number of emetic episodes 0 Undefined a Median time to first emetic episode (hours) Undefined b 6.5 a Median undefined since at least 50% of the patients were withdrawn or had more than 2 emetic episodes.

b Median undefined since at least 50% of patients did not have any emetic episodes. In a double-blind, US trial in 336 patients receiving a cyclophosphamide-based chemotherapy regimen containing either methotrexate or doxorubicin, ondansetron ondansetron sirup mg administered twice a day, was as effective as ondansetron 8 mg administered 3 times a day in preventing nausea and vomiting.

ondansetron 8 mg three times daily is not a recommended regimen for the treatment of moderately emetogenic chemotherapy [see Dosage and Administration (2.1)]. Treatment response was based on the total number of emetic episodes over the 3-day trial period. See Table 8 for the details of the dosage regimens studied and results of this trial. Table 8: Emetic Episodes-Treatment Response after Ondansetron Tablets Ondansetron sirup Twice a Day and Three Times a Day Ondansetron Tablets 8 mg Twice Daily a (n = 165) 8 mg Three Times a Day b (n = 171) Treatment response 0 Emetic episodes 1-2 Emetic episodes More than 2 emetic episodes/withdrawn 101 (61%) 16 (10%) 48 (29%) 99 (58%) 17 (10%) 55 (32%) Median number of emetic episodes 0 0 Median time to first emetic episode (h) Undefined c Undefined c Median nausea scores (0 to 100) d 6 6 a The first 8-mg dose was administered 30 minutes before the start of emetogenic chemotherapy, with a subsequent 8-mg dose 8 hours after the first dose, followed by 8 mg administered twice a day for 2 days after the completion of chemotherapy.

b The first 8-mg dose was administered 30 minutes before the start of emetogenic chemotherapy, with subsequent 8-mg doses at 4 hours and 8 hours after the first dose, followed by 8 mg administered 3 times a day ondansetron sirup 2 days after the completion of chemotherapy. c Median undefined since at least 50% of patients did not have any emetic episodes. d Visual analog scale assessment: 0 = no nausea, 100 = nausea as bad as it can be. Re-treatment In single-arm trials, 148 patients receiving cyclophosphamide-based chemotherapy were re-treated with ondansetron 8 mg three times daily during subsequent chemotherapy for a total of 396 re-treatment courses.

No emetic episodes occurred in 314 (79%) of the re-treatment courses, and only 1 to 2 emetic episodes occurred in 43 (11%) of the re-treatment courses. Pediatric Trials Three open-label, single-arm, non-US trials have been performed with 182 pediatric patients aged 4 to 18 years with cancer who were given a variety of cisplatin or noncisplatin regimens. The initial dose of ondansetron injection ranged from 0.04 mg to 0.87 mg ondansetron sirup kg (total dose of 2.16 mg to 12 mg) followed by the administration of oral doses of ondansetron ranging from 4 mg to 24 mg daily for ondansetron sirup days.

In these trials, 58% of the 170 evaluable patients had a complete response (no emetic episodes) on Day 1. In 2 trials the response rates to ondansetron 4 mg three times a day in patients younger than 12 years was similar to ondansetron 8 mg three times daily in patients 12 to 18 years. Prevention of emesis in these pediatric ondansetron sirup was essentially the same as for adults.

Radiation-Induced Nausea and Vomiting Total Body Irradiation In a randomized, placebo-controlled, double-blind trial in 20 patients, 8 mg of ondansetron administered 1.5 hours before each fraction of radiotherapy for 4 days was significantly more effective than placebo in preventing vomiting induced by total body irradiation.

Total body irradiation consisted of 11 fractions (120 cGy per fraction) over 4 days for a total of 1,320 cGy. Patients received 3 fractions for 3 days, then 2 fractions on Day 4. Single High-Dose Fraction Radiotherapy In an active-controlled, double-blind trial in 105 patients receiving single high-dose radiotherapy (800 to 1,000 cGy) over an anterior or posterior field size of ≥80 cm2 to the abdomen, ondansetron was significantly more effective than metoclopramide with respect to complete control of emesis (0 emetic episodes).

Patients received the first dose of ondansetron (8 mg) or metoclopramide (10 mg) 1 to 2 hours before radiotherapy. If radiotherapy was given in the morning, 8 mg of ondansetron or 10 mg of metoclopramide was administered in the late afternoon and repeated again before bedtime.

If radiotherapy was given ondansetron sirup the afternoon, patients took 8 mg of ondansetron or 10 mg of metoclopramide only once before bedtime. Patients continued the doses of oral medication three times daily for 3 days. Daily Fractionated Radiotherapy In an active-controlled, double-blind trial in 135 patients receiving a 1- to 4-week course of fractionated radiotherapy (180 cGy doses) over a field size of ≥100 cm2 to the abdomen, ondansetron was significantly more effective than prochlorperazine with respect to complete control of emesis (0 emetic episodes).

Patients received the first dose of ondansetron (8 mg) or prochlorperazine (10 mg) 1 to 2 hours before the first daily radiotherapy fraction, with subsequent 8-mg doses approximately every 8 hours on each day of radiotherapy. Postoperative Nausea and Vomiting In 2 placebo-controlled, double-blind trials (one conducted in the US and the other outside the US) in 865 females undergoing inpatient surgical procedures, ondansetron 16 mg as a single dose or placebo was administered one hour before the induction of general balanced anesthesia (barbiturate, opioid, nitrous oxide, neuromuscular blockade, and supplemental isoflurane or enflurane), ondansetron tablets was significantly more effective than placebo in preventing postoperative nausea and vomiting.

No trials have been performed in males. How Supplied/Storage and Handling • Ondansetron Oral Solution, USP a clear, colorless to light yellow liquid with a characteristic strawberry odor, contains 5 mg of ondansetron hydrochloride dihydrate equivalent to 4 mg of ondansetron per 5 mL : • Available in 5 mL cups with 30 cups per carton NDC 0904-7073-93.

Store at 20º to 25ºC (68º to 77ºF); excursions permitted to 15º to 30º C (59º to 86ºF) [see USP Controlled Room Temperature]. Protect from light. Store bottles upright in cartons. Patient Counseling Information QT Prolongation Inform patients that ondansetron may cause serious cardiac arrhythmias such as QT prolongation. Instruct patients to tell their healthcare provider right away if they perceive a change in their heart rate, if they feel lightheaded, or if they have a syncopal episode.

Hypersensitivity Reactions Inform patients that ondansetron may cause hypersensitivity reactions, some as severe as anaphylaxis and bronchospasm. Instruct patients to immediately report any signs and symptoms of hypersensitivity reactions, including fever, chills, rash, or breathing problems to their healthcare provider.

Masking of Progressive Ileus ondansetron sirup Gastric Distension Inform patients following abdominal surgery or those with chemotherapy-induced nausea and vomiting that ondansetron may mask signs and symptoms of bowel obstruction.

Instruct patients to immediately report any signs or symptoms consistent with a potential bowel obstruction to their healthcare provider. Drug Interactions • Instruct the patient to report the use of all medications, especially apomorphine, to their healthcare provider.

Concomitant use of apomorphine and ondansetron may cause a significant drop in blood pressure and loss of consciousness. • Advise patients of the possibility of serotonin syndrome with concomitant use of ondansetron and another serotonergic agent such as medications to treat depression and migraines.

Advise patients to seek immediate medical attention if the following symptoms occur: changes in mental status, autonomic instability, neuromuscular symptoms with or without gastrointestinal symptoms. Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 Distributed By: MAJOR® PHARMACEUTICALS Livonia, MI 48152 Rev.

10-2017-03 Package/Label Display Panel Ondansetron Oral Solution, USP 4 mg / 5mL Delivers 5mL per cup More about ondansetron • Side effects • Drug interactions • Dosage information • During pregnancy or Breastfeeding • Reviews (440) • Patient tips • Drug images • Compare alternatives • Pricing & coupons • Drug class: 5HT3 receptor antagonists Patient resources • Drug Information Professional resources • Prescribing Information • Ondansetron (FDA) • Ondansetron Injection (FDA) • Ondansetron ODT (FDA) • Ondansetron and Dextrose (FDA) Other brands Zofran, Zuplenz Related treatment guides • Nausea/Vomiting • Alcohol Dependence • Gastroenteritis • Nausea/Vomiting, Chemotherapy Induced Medical Disclaimer Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products.

This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Data sources include IBM Watson Micromedex (updated 3 May 2022), Cerner Multum™ (updated 28 Apr 2022), ASHP (updated 11 Apr 2022) and others.
Show table of contents Hide table of contents • 1. Name of the medicinal product • 2. Qualitative and quantitative composition • 3. Pharmaceutical form • 4. Clinical particulars • 4.1 Therapeutic indications • 4.2 Posology and method of administration • 4.3 Contraindications • 4.4 Special warnings and precautions for use • 4.5 Interaction with other medicinal products and other forms of interaction • 4.6 Fertility, pregnancy and lactation • 4.7 Effects on ability to drive and use machines • 4.8 Undesirable effects • 4.9 Overdose • 5.

Pharmacological properties • 5.1 Pharmacodynamic properties • 5.2 Pharmacokinetic properties • 5.3 Preclinical safety data • 6. Pharmaceutical particulars • 6.1 List of excipients • 6.2 Incompatibilities • 6.3 Shelf life • 6.4 Special precautions for storage • 6.5 Nature and contents of container • 6.6 Special precautions for disposal and other handling • 7.

Marketing authorisation holder • 8. Marketing authorisation number(s) ondansetron sirup 9. Date of first authorisation/renewal of the authorisation • 10. Date of revision ondansetron sirup the text Ondansetron Syrup is indicated for the management of nausea and vomiting induced by cytotoxic chemotherapy and radiotherapy.

Ondansetron Syrup is also indicated for the prevention of post-operative nausea and vomiting (PONV). For treatment of established PONV, administration by injection is recommended. Chemotherapy and radiotherapy induced nausea and vomiting ondansetron sirup and RINV). CINV and RINV in Adults: The emetogenic potential of cancer treatment varies according to the doses and combinations of chemotherapy and radiotherapy regimens used.

The selection of dose regimen should be determined by the severity of the emetogenic challenge. Emetogenic chemotherapy ondansetron sirup radiotherapy: Ondansetron can be given by oral administration. Ondansetron sirup recommended oral dose is ondansetron sirup (8mg) 1-2 hours before treatment, followed by 10ml (8mg) orally 12 hours later. For highly emetogenic chemotherapy: a single dose of up to 30ml (24mg) Ondansetron taken with 12mg oral dexamethasone sodium phosphate, 1 to 2 hours before chemotherapy, may be used.

To protect against delayed or prolonged emesis after the first 24 hours, oral or rectal treatment with Ondansetron may be continued for up to 5 days after a course of treatment. The recommended dose for oral administration is 10ml (8mg) to be taken twice daily. Paediatric Population: CINV in children aged ≥ 6 months and adolescents The dose for CINV can be calculated based on body surface area (BSA) or weight – see below.

In paediatric clinical studies, ondansetron was given by IV infusion diluted in 25 to 50mL of saline or other compatible infusion fluid and infused over not less than 15 minutes.

Weight-based dosing results in higher total daily doses compared to BSA-based dosing (sections 4.4.). There are no data from controlled clinical trials on the use of Ondansetron in the prevention of delayed or prolonged CINV. There are no data from controlled clinical trials on the use of Ondansetron for radiotherapy-induced nausea and vomiting in children. Dosing by BSA: Ondansetron should be administered immediately before chemotherapy as a single intravenous dose of 5mg/m 2.

The single intravenous dose must not exceed 8mg. Oral dosing can commence 12 hours later and may be continued for up to 5 days (Table 1). The total dose over 24 hours (given as divided doses) must not exceed adult dose of 32mg. Table 1: BSA-based dosing for CINV - (aged 6 months to 17 years) BSA Day 1 (a, b) Days 2-6 (b) < 0.6m 2 5mg/m 2 IV plus 2mg syrup after 12 hours 2mg (2.5ml) syrup every 12 hours ≥ 0.6m 2 to ≤ 1.2m 2 5mg/m 2 IV plus 4mg syrup or tablet after 12 hours 4mg syrup (5ml) or tablet every 12 hours a The intravenous dose must not exceed 8mg.

b The total dose over 24 hours must not exceed adult dose of 32 mg Ondansetron sirup by bodyweight: Weight-based dosing results in higher total daily ondansetron sirup compared to BSA-based dosing (sections 4.4.

and 5.1). Ondansetron should be administered immediately before chemotherapy ondansetron sirup a single intravenous dose of 0.15mg/kg. The intravenous dose must not exceed 8mg. Two further intravenous doses may be given in 4-hourly intervals. Oral dosing can commence twelve hours later and may be continued for up to 5 days (Table 2).

The total dose over 24 hours (given as divided doses) must not exceed adult dose of 32mg. Table 2: Weight-based dosing for Chemotherapy - Children aged ≥6 months and adolescents Weight Day 1 (a, b) Days 2-6 (b) ≤ 10kg Up to 3 doses of 0.15mg/kg every 4 hours 2mg (2.5ml) syrup every 12 hours > 10kg Up to 3 doses of 0.15mg/kg every 4 hours 4mg (5ml) syrup every 12 hours a The intravenous dose must not exceed 8mg.

b The total dose over 24 hours must not exceed adult dose of 32mg. Elderly: Ondansetron is well tolerated by patients over 65 years. No alteration of oral dose or frequency of administration is required. Post operative nausea and vomiting (PONV).

Adults: For the prevention of PONV: Ondansetron can be administered orally For oral administration: 20ml (16mg) one hour prior to anaesthesia. For the treatment of established PONV: Intravenous or intramuscular administration is recommended.

Paediatric population: PONV in children aged ≥ 1 month and adolescents Oral formulation: No studies have been conducted on the use of orally administered ondansetron in the prevention or treatment of post-operative nausea and vomiting; slow IV injection (not less than 30 seconds) is recommended for this purpose.

There are no data on the use of ondansetron in the ondansetron sirup of PONV in children below 2 years of age. Elderly: There is limited experience in the use of Ondansetron in the prevention and treatment of PONV in the elderly, however ondansetron is well tolerated in patients over 65 years receiving chemotherapy. For both indications: Patients with Renal impairment: No alteration of daily dosage or frequency of dosing, or route of administration are required.

Patients with Hepatic impairment: Clearance of ondansetron is significantly reduced and serum half life significantly prolonged in subjects with moderate or severe impairment of hepatic function. In such patients a total daily dose of 10ml (8mg) should not be exceeded. Patients with poor Sparteine/Debrisoquine Metabolism: The elimination half-life of ondansetron is not altered in subjects classified as poor metabolisers of sparteine and debrisoquine.

Consequently in such patients repeat dosing will give drug exposure levels no different from those of the general population. No alteration of daily dosage or frequency of dosing is required. Method of administration: ► Use the 2.5-5ml double-ended spoon supplied in the pack (see below) to measure the required dose. ► Swallow the solution. ► Wash the spoon with clean water after taking every dose.

► Once measured, the solution should be consumed within 3 hours Double-ended Spoon Hypersensitivity reactions have been reported in patients who have exhibited hypersensitivity to other selective 5HT 3 receptor antagonists. Respiratory events should be treated symptomatically and clinicians should pay particular attention to them as precursors of hypersensitivity reactions.

ondansetron sirup

Ondansetron prolongs the QT interval in a dose-dependent manner (see section 5.1). In addition, post-marketing cases of Torsade de Pointes have been reported in patients using ondansetron. Avoid ondansetron in patients with congenital long QT syndrome. Ondansetron should be administered with ondansetron sirup to patients who have or may develop prolongation of QTc, including patients with electrolyte abnormalities, congestive heart failure, bradyarrhythmias or patients taking other medicinal products that lead to QT prolongation or electrolyte abnormalities.

Hypokalaemia and hypomagnesaemia should be corrected prior to ondansetron administration. There have been post-marketing reports describing patients with serotonin syndrome (including altered mental status, autonomic instability and neuromuscular abnormalities) following the concomitant use of ondansetron and other serotonergic drugs (including selective serotonin reuptake inhibitors (SSRI) and serotonin noradrenaline reuptake inhibitors (SNRIs)).

If concomitant treatment with ondansetron and other serotonergic drugs is clinically warranted, appropriate observation of the patient is advised. As ondansetron is known to increase large bowel transit time, patients with signs of subacute intestinal obstruction should be monitored following administration.

In patients with adenotonsillar surgery prevention of nausea and vomiting with ondansetron may mask occult bleeding. Therefore, such patients should be followed carefully after ondansetron. Paediatric Population: Paediatric patients receiving ondansetron with hepatotoxic chemotherapeutic agents should be monitored closely for impaired hepatic function. CINV: When calculating the dose on an mg/kg basis and administering ondansetron sirup doses at 4-hour intervals, the total daily dose will be higher than if one single dose of 5mg/m 2 followed by an oral dose is given.

The comparative efficacy of these two different dosing regimens has not been investigated in clinical trials. Cross-trial comparison indicates similar efficacy for both regimens (section 5.1). Excipient warnings: This medicinal product contains: Sorbitol (E420): This medicinal product contains 2100mg sorbitol in each 5ml dose which is equivalent to 420mg/ml. Patients with hereditary fructose intolerance (HFI) should not take/be given this medicinal product.

Sorbitol may cause gastrointestinal discomfort and mild laxative effect. Sodium benzoate (E211): This medicinal product contains 6mg sodium benzoate in each 5ml dose which is equivalent to 1.2mg/ml. Propylene glycol (E1520): This medicinal product contains 14.1mg/5ml propylene glycol in each 5ml dose which is equivalent to 2.82mg/ml.

Sodium: This medicinal product contains less than 1 mmol sodium (23 mg) per 5ml dose, that is to say essentially 'sodium-free'. There is no evidence that ondansetron either induces or inhibits the metabolism of other drugs commonly co-administered with it. Specific studies have shown that there are no interactions when ondansetron is administered with alcohol, temazepam, furosemide, alfentanil, tramadol, morphine, lidocaine, thiopental or propofol.

Ondansetron is metabolised by multiple hepatic cytochrome P-450 enzymes: CYP3A4, CYP2D6 and CYP1A2. Due to the multiplicity of metabolic enzymes capable of metabolising ondansetron, enzyme inhibition or reduced activity of one enzyme (e.g. CYP2D6 genetic deficiency) is normally compensated by other enzymes and should result in little or no significant change in overall ondansetron clearance or dose requirement.

Caution should be exercised when ondansetron is coadministered with drugs that prolong the QT interval and/or cause electrolyte abnormalities (See section 4.4). Use of ondansetron with QT prolonging drugs may result in additional QT prolongation. Concomitant use of ondansetron with ondansetron sirup drugs (e.g.

anthracyclines (such as doxorubicin, daunorubicin) or trastuzumab), antibiotics (such as erythromycin or ketoconazole), antiarrhythmics (such as amiodarone) and beta blockers (such as atenolol or timolol) may increase the risk of arrhythmias (See section 4.4).

Serotonergic Drugs (e.g. SSRIs ondansetron sirup SNRIs): There have been post-marketing reports describing patients with serotonin syndrome (including altered mental status, autonomic instability and neuromuscular abnormalities) following the concomitant use of ondansetron and other serotonergic drugs (including SSRIs and SNRIs) (See section 4.4). Apomorphine: Based on reports of profound hypotension and loss of consciousness ondansetron sirup ondansetron was administered with apomorphine hydrochloride, concomitant use with apomorphine is contraindicated.

ondansetron sirup

Phenytoin, Carbamazepine and Rifampicin: In patients treated with potent inducers of CYP3A4 (i.e. phenytoin, carbamazepine, and rifampicin), the oral clearance of ondansetron was increased and ondansetron blood concentrations were decreased. Tramadol: Data from small studies indicate that ondansetron may reduce the analgesic effect of tramadol. Women ondansetron sirup childbearing potential Women of childbearing potential should consider the use of contraception.

Pregnancy Based on human experience from epidemiological studies, ondansetron is suspected to cause orofacial malformations when administered during the first trimester of pregnancy.

In one cohort study including 1.8 million pregnancies, first trimester ondansetron use was associated with an increased risk of oral clefts (3 additional cases per 10 000 women treated; adjusted relative risk, ondansetron sirup, (95% CI 1.03-1.48)).

The available epidemiological studies on cardiac malformations show conflicting results. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity. Ondansetron should not be used during the first trimester of pregnancy.

Breast-feeding Tests have shown that ondansetron passes into the milk of lactating animals. It is therefore recommended that mothers receiving Ondansetron should not breast-feed their babies. Adverse events are listed below by system organ class and frequency.

Frequencies are defined as: very common (≥1/10), common (≥1/100 and <1/10), uncommon (≥1/1000 and <1/100), rare (≥1/10,000 and <1/1000) and very rare (<1/10,000). Very common, common and uncommon events were generally determined from clinical trial data. The incidence in placebo was taken into account. Rare and very rare events were generally determined from post-marketing spontaneous data.

The following frequencies are estimated at the standard recommended doses of ondansetron. The adverse event profiles in children and adolescents were comparable to that seen in adults. Immune system disorders Rare: Immediate hypersensitivity reactions sometimes severe, including anaphylaxis. Nervous system disorders Very common: Headache.

Uncommon: Seizures, movement disorders (including extrapyramidal reactions such as dystonic reactions, ondansetron sirup crisis and dyskinesia) (1) Rare: Dizziness during rapid IV administration. Eye disorders Rare: Transient visual disturbances (e.g.

blurred vision) predominantly during IV administration. Very rare: Transient blindness predominantly during IV administration. (2) Cardiac disorders Uncommon: Arrhythmias, chest pain with or without ST segment depression, bradycardia. Rare: QTc prolongation (including Torsade de Pointes) Vascular disorders Common: Sensation of warmth or flushing. Uncommon: Hypotension. Respiratory, thoracic and mediastinal disorders Uncommon: Hiccups.

Gastrointestinal disorders Common: Constipation. Hepatobiliary disorders Uncommon: Asymptomatic increases in liver function tests. (3) (1) Observed without definitive evidence of persistent clinical sequelae.

(2) The majority of the blindness cases reported resolved within 20 minutes. Most patients had received chemotherapeutic agents, which included cisplatin. Some cases of transient blindness were reported as cortical in origin. ondansetron sirup These events were observed commonly in patients receiving chemotherapy with cisplatin. Paediatric population The adverse event profile in children and adolescents was comparable to that seen in adults.

Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme Website at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. Ondansetron sirup and Signs There is limited experience of ondansetron overdose.

In the majority of cases, symptoms were similar to those already reported in patients receiving recommended doses (see section 4.8). Manifestations that have been reported include visual disturbances, ondansetron sirup constipation, hypotension and a vasovagal episode with transient second-degree AV block Ondansetron prolongs the QT interval in a dose-dependent fashion.

ECG monitoring is recommended in cases of overdose. Treatment There is no specific antidote for ondansetron, therefore in all cases of suspected overdose, symptomatic and supportive therapy should be given as appropriate. The use of ipecacuanha to treat overdose with ondansetron is not recommended, as patients are unlikely to respond due to the anti-emetic action of ondansetron itself.

Paediatric population Paediatric cases consistent with serotonin syndrome have been reported after inadvertent oral overdoses of ondansetron (exceeded estimated ingestion of 4 mg/kg) in infants and children aged 12 months to 2 years. ATC code: A04AA01, Pharmacotherapeutic group: Antiemetics and antinauseants, Serotonin (5HT 3) antagonist Mechanism of Action Ondansetron is a potent, highly selective 5HT 3 receptor-antagonist. Its precise mode of action in the control of nausea and vomiting is ondansetron sirup known.

Chemotherapeutic agents and radiotherapy may cause release of 5HT in the small intestine initiating a vomiting reflex by activating vagal afferents via 5HT3 receptors. Ondansetron blocks the initiation of this reflex.

Activation of vagal afferents may also cause a release of 5HT in the area postrema, located on the floor of the fourth ventricle, and this may also promote emesis through a central mechanism.

Ondansetron sirup, the effect of ondansetron in the management of the nausea and vomiting induced by cytotoxic chemotherapy and radiotherapy is probably due to antagonism of 5HT3 receptors on neurons located both in the peripheral and central nervous system.

The mechanisms of action in post-operative nausea and vomiting are not known but there may be common pathways with cytotoxic induced nausea and vomiting. Ondansetron does ondansetron sirup alter plasma prolactin concentrations. The role of ondansetron in opiate-induced emesis is not yet established. QT Prolongation The effect of ondansetron on the QTc interval was evaluated in a double blind, randomized, placebo and positive (moxifloxacin) controlled, crossover study in 58 healthy adult men and women.

Ondansetron doses included 8 mg and 32 mg infused intravenously over 15 minutes. At the highest tested dose of 32 mg, the maximum mean (upper limit of 90% CI) difference in QTcF from placebo after baseline-correction was 19.6 (21.5) msec. At the lower tested dose of 8 mg, the maximum mean (upper limit of 90% CI) difference in QTcF from placebo after baseline-correction was 5.8 (7.8) msec.

In this study, there were no QTcF measurements greater than 480 msec and no QTcF prolongation was greater than 60 msec. Paediatric population CINV The efficacy of ondansetron in the control of emesis and nausea induced by cancer chemotherapy was assessed in a ondansetron sirup randomised trial in 415 patients aged 1 to 18 years (S3AB3006).

On the days of chemotherapy, patients received either ondansetron 5 mg/m 2 intravenous and ondansetron 4 mg orally after 8 to 12 hours or ondansetron 0.45 mg/kg intravenous and placebo orally after 8 to 12 hrs. Post-chemotherapy both groups received 4 mg ondansetron syrup twice daily for 3 days. Complete control of emesis on worst day of chemotherapy was 49% (5 mg/m 2 intravenous and ondansetron 4 mg orally) and 41% (0.45 mg/kg intravenous and placebo orally).

Post-chemotherapy both groups received 4 mg ondansetron syrup twice daily for 3 days. There was no difference in the overall incidence or nature of adverse events between the two treatment groups. A double-blind randomised placebo-controlled trial (S3AB4003) in 438 patients aged 1 to 17 years demonstrated complete control of emesis on worst day of chemotherapy in: • 73% of patients when ondansetron was administered intravenously at a dose of 5 mg/m 2 intravenous together with 2 to 4 mg dexamethasone ondansetron sirup • 71% of patients when ondansetron was administered as syrup at a dose of 8 mg together with 2 to 4 mg dexamethasone orally on the days of chemotherapy.

Post-chemotherapy both groups received 4 mg ondansetron syrup twice daily for 2 days. There was no difference in the overall incidence or nature of adverse events between the two treatment groups. The efficacy of ondansetron in 75 children aged 6 to 48 months was investigated in an open-label, non-comparative, single-arm study (S3A40320).

All children received three 0.15 mg/kg doses of intravenous ondansetron, administered 30 minutes before the start of chemotherapy and then at 4 and 8 hours after the first dose. Complete control of emesis was achieved in 56% of patients. Another open-label, non-comparative, single-arm study (S3A239) investigated the efficacy of one intravenous dose of 0.15 mg/kg ondansetron followed by two oral ondansetron doses of 4 mg for children aged < 12 years and 8 mg for children aged ≥ 12 years (total no.

of children n= 28). Complete control of emesis was achieved in 42% of patients. PONV The efficacy of a single dose of ondansetron in the prevention of post-operative nausea and vomiting was investigated in a randomised, double-blind, placebo-controlled study in 670 children aged 1 to 24 months (post-conceptual age ≥44 weeks, weight ≥ 3 kg). Included subjects were scheduled to undergo elective surgery under general anaesthesia and had an ASA status ≤ III.

A single dose of ondansetron 0.1 mg/kg was administered within five minutes following induction of anaesthesia. The proportion of subjects who experienced at least one emetic episode during the 24-hour assessment period (ITT) was greater for patients on placebo than those receiving ondansetron (28% vs.

11%, p <0.0001). Following oral administration, ondansetron is passively and completely absorbed from the gastrointestinal tract and undergoes first pass metabolism. Peak plasma concentrations of about 30ng/mL are attained approximately 1.5 hours after an 8mg dose. For doses above 8mg the increase in ondansetron systemic exposure with dose is greater than proportional; this may reflect some reduction in first pass metabolism at higher oral doses.

Mean bioavailability in healthy male subjects, following the oral administration of a single 8 mg tablet, is approximately 55 to 60%. Bioavailability, following oral administration, is slightly enhanced by the presence of food but unaffected by antacids. The disposition of ondansetron following oral, intramuscular(IM) and intravenous(IV) dosing is similar with a terminal half life of about 3 hours and steady state volume of distribution of about 140L.

Equivalent systemic exposure is achieved after IM and IV administration of ondansetron. A ondansetron sirup intravenous infusion of ondansetron given over 5 minutes results in peak plasma concentrations of about 65ng/mL.

Following intramuscular administration of ondansetron, peak plasma concentrations of about 25ng/mL are attained within 10 minutes of injection. Following administration of ondansetron suppository, plasma ondansetron concentrations become detectable between 15 ondansetron sirup 60 minutes after dosing.

Concentrations rise in an essentially linear fashion, until peak concentrations of 20-30 ng/mL are attained, typically 6 hours after dosing. Plasma concentrations then fall, but at a slower rate than observed following oral dosing due to continued absorption of ondansetron. The absolute bioavailability of ondansetron from the suppository is approximately 60% and is not affected by gender.

The half life of the elimination phase following suppository administration is determined by the rate of ondansetron absorption, not systemic clearance and is approximately 6 hours. Females show a small, clinically insignificant, increase in half-life in comparison with males.

Ondansetron is not highly protein bound (70-76%). Ondansetron is cleared from the systemic circulation predominantly by hepatic metabolism through multiple enzymatic pathways. Less than 5% of the absorbed dose is excreted unchanged in the urine. The absence of the enzyme CYP2D6 (the debrisoquine polymorphism) has no effect on ondansetron's pharmacokinetics. The pharmacokinetic properties of ondansetron are unchanged on repeat dosing.

Studies in healthy elderly volunteers have shown slight, but clinically insignificant, age-related increases in both oral bioavailability (65%) and half-life (5 h) of ondansetron. Gender differences were shown in the disposition of ondansetron, with females having a greater rate and extent of absorption following an oral dose and reduced systemic clearance and volume of distribution (adjusted for weight).

In a study of 21 paediatric patients aged between 3 and 12 years undergoing elective surgery with general anaesthesia, the absolute values for both the clearance and volume of distribution of ondansetron following a single intravenous dose of 2mg (3-7 years old) or 4mg (8-12 years old) were reduced.

The magnitude of the change was age-related, with clearance falling from about 300mL/min at 12 years of age to 100mL/min at 3 years.

Volume of distribution fell from about 75L at 12 years to 17L at 3 years. Use of weight-based dosing (0.1mg/kg up to 4mg maximum) compensates for these changes and is effective ondansetron sirup normalising systemic exposure in paediatric patients. Special Patient Populations Gender Gender differences were shown in the disposition of ondansetron, with females having a greater rate and extent of absorption following an oral dose and reduced systemic clearance and volume of distribution (adjusted for weight).

Children and Adolescents (aged 1 month to 17 years) In paediatric patients aged 1 to 4 months (n=19) undergoing surgery, weight normalised clearance was approximately 30% slower than in patients aged 5 to 24 months (n=22) but comparable to the patients aged 3 to 12 years. The half-life in the patient population aged 1 to 4 month was reported to average 6.7 hours compared to 2.9 hours for patients in the 5 to 24 month and 3 to 12 year age range. The differences in pharmacokinetic parameters in the 1 to 4 month patient population can be explained in part by the higher percentage of total body water in neonates and infants and a higher volume of distribution for water soluble drugs like ondansetron.

In paediatric patients aged 3 to 12 years undergoing elective surgery with general anaesthesia, the absolute values for both the clearance and volume of distribution of ondansetron were reduced in comparison to values with adult patients. Both parameters increased in a linear fashion with weight and by 12 years of age, the values were approaching those of ondansetron sirup adults.

When clearance and volume of distribution values were normalised by body weight, the values for these parameters were similar between the different age group populations. Use of weight-based dosing compensates for age-related changes and is effective in normalising systemic exposure in paediatric patients.

Population pharmacokinetic analysis was performed on 428 subjects (cancer patients, surgery patients and healthy volunteers) aged 1 month to 44 years following intravenous administration of ondansetron. Based on this analysis, systemic exposure (AUC) of ondansetron following oral or IV dosing in children and adolescents was comparable to adults, with the exception of infants aged 1 to 4 months.

Volume was related to age and was lower in adults than in infants and children. Clearance was related to weight but not to age with the exception of infants aged 1 to 4 months. It is difficult to conclude whether there was an additional reduction in clearance related to age in infants 1 to 4 months or simply inherent variability due to the low number of subjects studied in this age group. Since patients less than 6 months of age will only receive a single dose in PONV a decreased clearance is not likely ondansetron sirup be clinically relevant.

Elderly Early Phase I studies in healthy elderly volunteers showed a slight age-related decrease in clearance, and an increase in half-life of ondansetron. However, wide inter-subject variability resulted in considerable overlap in pharmacokinetic parameters between young (< 65 years of age) and elderly subjects (≥ 65 years of age) and there were no overall differences in safety or efficacy observed between young and elderly cancer patients enrolled in CINV clinical trials to support a different dosing recommendation for the elderly.

Based on more recent ondansetron plasma concentrations and exposure-response modelling, a greater effect on QTcF is predicted in patients ≥75 years of age compared to young adults. Specific dosing information is provided for patients over 65 years of age and over 75 years of age for intravenous dosing.

Renal impairment In patients with renal impairment (creatinine clearance 15-60 mL/min), both systemic clearance and volume of distribution are reduced following IV administration of ondansetron, resulting in a slight, but clinically insignificant, increase in elimination half-life (5.4 hours). A study in patients with severe renal impairment who required regular haemodialysis (studied between dialyses) showed ondansetron's pharmacokinetics to be essentially unchanged following IV administration.

Hepatic impairment Following oral, intravenous or intramuscular dosing in patients with severe hepatic impairment, ondansetron's systemic clearance is markedly reduced with prolonged elimination half-lives (15-32 hours) and an oral bioavailability approaching 100% due to reduced pre-systemic metabolism. The pharmacokinetics of ondansetron following administration as a suppository have not been evaluated in patients with hepatic impairment.Ondansetron Oral Solution Generic name: Ondansetron Oral Solution [ on-DAN-se-tron ] Brand name: Zofran Drug class: 5HT3 receptor antagonists Medically reviewed by Drugs.com.

Last updated on Mar 6, 2022. • Uses • Before taking • Warnings • Dosage • Side effects • Storage • FAQ Uses of Ondansetron Oral Solution: • It is used to treat or prevent upset stomach and throwing up. What do I need to tell my doctor BEFORE I take Ondansetron Oral Solution?

• If you ondansetron sirup an allergy to ondansetron or any other part of ondansetron oral solution. • If you are allergic to ondansetron oral solution; any part of ondansetron oral solution; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had. • If you have a long QT on ECG. • If you are taking apomorphine.

ondansetron sirup

This is not a list of all drugs or health problems that interact with ondansetron oral solution. Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, ondansetron sirup and health problems.

You must check to make sure that it is safe for you to take ondansetron oral solution with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor. What are some things I need to know or do while I take Ondansetron Oral Solution? • Tell all of your health care providers that you take ondansetron oral solution.

This includes your doctors, nurses, pharmacists, and dentists. • Tell your doctor if you are pregnant, plan on getting pregnant, or are breast-feeding. You will need to talk about the benefits and risks to you and the baby.

How is this medicine (Ondansetron Oral Solution) best taken? Use ondansetron oral solution as ordered by your doctor. Read all information given to you. Follow all instructions closely. • Take with or ondansetron sirup food. • Measure liquid doses carefully. Use the measuring device that comes with ondansetron oral solution. If there is none, ask the pharmacist for a device to measure ondansetron oral solution. What do I do if I miss a dose? • If you take ondansetron oral solution on a regular basis, take a missed dose as soon as you think about it.

• If it is close to the time for your next dose, skip the missed dose and go back to your normal time. • Do not take 2 doses at the same time or extra doses.

• Many times ondansetron oral solution ondansetron sirup taken on an as needed basis. Do not take more often than told by the doctor. Detailed Ondansetron dosage information What are some side effects that I need to call my doctor about right away? WARNING/CAUTION: Even though it may be rare, ondansetron sirup people may have very bad and sometimes deadly side effects when taking a drug.

Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect: • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.

• Stomach pain. • Trouble passing urine. • Dizziness. • A type of abnormal heartbeat (prolonged QT interval) ondansetron sirup happened with ondansetron oral solution. Sometimes, this has led to another type of unsafe abnormal heartbeat (torsades de pointes). Call your doctor right away if you have a fast or abnormal heartbeat, or if you pass out. • A severe and sometimes deadly problem called serotonin syndrome may happen.

The risk may be greater if you also take certain other drugs. Call your doctor right away if you have agitation; change in balance; confusion; hallucinations; fever; fast or abnormal heartbeat; flushing; muscle twitching or stiffness; seizures; shivering or shaking; sweating a lot; severe diarrhea, upset stomach, or throwing up; or very bad headache. Ondansetron side effects (more detail) What are some other side effects of Ondansetron Oral Solution?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects.

Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away: • Headache. • Feeling tired or weak. • Diarrhea or constipation. • Feeling sleepy. • Anxiety. These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-332-1088.

You may also report side effects at https://www.fda.gov/medwatch. If OVERDOSE is suspected: If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Ondansetron Oral Solution? • Store at room temperature. • Store in a dry place. Do not store in a bathroom. • Protect from light. • Store upright with the cap on. • Store in original container. • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets. • Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs.

There may be drug take-back programs in your area. Consumer information use • If your symptoms or health problems do not get better or if they become worse, call your doctor. • Do not share your drugs with others and do not take anyone else's drugs. • Some drugs may have another patient information leaflet. Check with your pharmacist. If you ondansetron sirup any questions about ondansetron oral solution, please talk with your doctor, nurse, pharmacist, or other health care provider.

• If you think ondansetron sirup has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened. Frequently asked questions • How long before a meal should you take ondansetron? More about ondansetron • Side effects • Drug interactions • Dosage information • During pregnancy or Breastfeeding • Reviews (440) • Patient tips • Drug images • Compare alternatives • Pricing & coupons • Drug class: 5HT3 receptor antagonists Patient resources • Drug Information • Ondansetron injection • Ondansetron Oral, Injection, Intravenous (Advanced Reading) • Ondansetron Oral, Oromucosal (Advanced Reading) • Ondansetron Orally Disintegrating Tablets Other brands Zofran, Zofran ODT, Zuplenz Professional resources • Prescribing Information Related treatment guides • Nausea/Vomiting • Alcohol Dependence • Gastroenteritis • Nausea/Vomiting, Chemotherapy Induced Further information Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Data sources include IBM Ondansetron sirup Micromedex (updated 3 May 2022), Cerner Multum™ (updated 28 Apr 2022), ASHP (updated 11 Apr 2022) and others.

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