ONDANSETRON HYDROCHLORIDE tablet, film coated

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

Ondansetron Hydrochloride (UNII: NMH84OZK2B) (Ondansetron - UNII:4AF302ESOS)

متاح من:

Taro Pharmaceuticals U.S.A., Inc.

INN (الاسم الدولي):

Ondansetron Hydrochloride

تركيب:

Ondansetron 4 mg

طريقة التعاطي:

ORAL

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الخصائص العلاجية:

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

ملخص المنتج:

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.

الوضع إذن:

Abbreviated New Drug Application

خصائص المنتج

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