ONDANSETRON- ondansetron tablet, film coated

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

ONDANSETRON HYDROCHLORIDE (UNII: NMH84OZK2B) (ONDANSETRON - UNII:4AF302ESOS)

제공처:

Sandoz Inc

INN (International Name):

ONDANSETRON HYDROCHLORIDE

구성:

ONDANSETRON 4 mg

관리 경로:

ORAL

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

Ondansetron tablets are indicated for the prevention of nausea and vomiting associated with: Ondansetron tablets are also indicated for the prevention of postoperative nausea and/or vomiting. Ondansetron tablets are contraindicated in patients: 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 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 6 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 def

제품 요약:

Ondansetron Tablets, USP, for oral administration, are available as: 4 mg (ondansetron hydrochloride USP equivalent to 4 mg of ondansetron) are round, white, film-coated tablets, debossed GG on one side and 927 on the reverse side. They are supplied as follows: NDC 0781-1679-31 in bottles of 30 NDC 0781-1679-33 in unit of use package of 3 8 mg (ondansetron hydrochloride USP equivalent to 8 mg of ondansetron) are round, yellow, film-coated tablets, debossed GG on one side and 928 on the reverse side. They are supplied as follows: NDC 0781-1681-31 in bottles of 30 NDC 0781-1681-33 in unit of use package of 3 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light. Store unit of use blisters in carton. Dispense in tight, light-resistant container as defined in the USP.

승인 상태:

Abbreviated New Drug Application

제품 특성 요약

ONDANSETRON- ONDANSETRON TABLET, FILM COATED
SANDOZ INC
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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:
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DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
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CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
The most common adverse reactions in adults for the:
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3
nausea and vomiting associated with highly emetogenic cancer
chemotherapy, including cisplatin greater than or
equal to 50 mg/m . (1)
2
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)
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)
Tablets: 4 mg and 8 mg (3)
Patients known to have hypersensitivity (e.g., anaphylaxis) to
ondansetron or any components of the formulation. (4)
Concomitant use of apomorphine. (4)
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 concom