Ország: Egyesült Államok
Nyelv: angol
Forrás: NLM (National Library of Medicine)
Ondansetron Hydrochloride (UNII: NMH84OZK2B) (Ondansetron - UNII:4AF302ESOS)
Taro Pharmaceuticals U.S.A., Inc.
Ondansetron Hydrochloride
Ondansetron 4 mg
ORAL
PRESCRIPTION DRUG
Ondansetron is indicated for the prevention of nausea and vomiting associated with: - highly emetogenic cancer chemotherapy, including cisplatin greater than or equal to 50 mg/m2 . - 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 is also indicated for the prevention of postoperative nausea and/or vomiting. 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. Risk Summary Available data do not reliably inform the association of ondansetron and adverse fetal outcomes. Published epidemiological studies on the association between ondansetron and fetal outcomes have reported inconsistent findings and
Ondansetron Tablets USP, 4 mg (ondansetron hydrochloride USP dihydrate equivalent to 4 mg of ondansetron), are yellow, film coated oval convex tablets debossed with "TARO" on one side and "OND4" on the other side. Ondansetron Tablets USP, 8 mg (ondansetron hydrochloride USP dihydrate equivalent to 8 mg of ondansetron), are white, film coated oval convex tablets debossed with "TARO" on one side and "OND8" on the other side. Ondansetron Tablets USP, 24 mg (ondansetron hydrochloride USP dihydrate equivalent to 24 mg of ondansetron), are pink, film coated oval convex tablets debossed with "TARO" on one side and "OND24" on the other side. Bottles: Store at 20˚ to 25˚C (68˚ to 77˚F) [see USP Controlled Room Temperature]. Protect from light. Dispense in tight, light-resistant container as defined in the USP. Unit Dose Packs: Store at 20˚ to 25˚C (68˚ to 77˚F) [see USP Controlled Room Temperature]. Protect from light. Store blisters in cartons.
Abbreviated New Drug Application
ONDANSETRON HYDROCHLORIDE- ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED TARO PHARMACEUTICALS U.S.A., INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE ONDANSETRON TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ONDANSETRON TABLETS ONDANSETRON TABLETS, FOR ORAL USE INITIAL U.S. APPROVAL: 1991 INDICATIONS AND USAGE Ondansetron is a 5-HT receptor antagonist indicated for the prevention of: nausea and vomiting associated with highly emetogenic cancer chemotherapy, including cisplatin greater than or equal to 50 mg/m . (1) nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy. (1) nausea and vomiting associated with radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen. (1) postoperative nausea and/or vomiting. (1) DOSAGE AND ADMINISTRATION See full prescribing information for the recommended dosage in adults and pediatrics. (2) Patients with severe hepatic impairment: do not exceed a total daily dose of 8 mg. (2.2, 8.6) DOSAGE FORMS AND STRENGTHS Tablets: 4 mg, 8 mg and 24 mg (3) CONTRAINDICATIONS Patients known to have hypersensitivity (e.g., anaphylaxis) to ondansetron or any components of the formulation. (4) Concomitant use of apomorphine. (4) WARNINGS AND PRECAUTIONS Hypersensitivity reactions including anaphylaxis and bronchospasm: Discontinue ondansetron if suspected. Monitor and treat promptly per standard of care until signs and symptoms resolve. (5.1) QT interval prolongation and Torsade de Pointes: Avoid in patients with congenital long QT syndrome; monitor with electrocardiograms (ECGs) if concomitant electrolyte abnormalities, cardiac failure or arrhythmias, or use of other QT prolonging drugs. (5.2) Serotonin syndrome: Reported with 5-HT receptor antagonists alone but particularly with concomitant use of serotonergic drugs. If such symptoms occur, discontinue ondansetron an Olvassa el a teljes dokumentumot