ONDANSETRON- ondansetron tablet, film coated

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

REMEDYREPACK INC.

INN (International Name):

ONDANSETRON HYDROCHLORIDE

Sammensetning:

ONDANSETRON 8 mg

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Ondansetron tablets are 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 tablets are also indicated for the prevention of postoperative nausea and/or vomiting. Ondansetron tablets are 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 tablets and adverse fetal outcomes. Published epidemiological studies on the association between ondansetron and

Produkt oppsummering:

Ondansetron Tablets Ondansetron Tablets USP, 4 mg (ondansetron hydrochloride dihydrate equivalent to 4 mg of ondansetron), are white, oval, film-coated tablets engraved with “4” on one side and “NO” on another side. They are supplied as follows: NDC 45963-538-30 Bottles of 30 Ondansetron Tablets USP, 8 mg (ondansetron hydrochloride dihydrate equivalent to 8 mg of ondansetron), are yellow, oval, film-coated tablets engraved with “8” on one side and “NO” on the other side. They are supplied as follows: NDC 45963-539-30 Bottles of 30 Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature].

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

ONDANSETRON- ONDANSETRON TABLET, FILM COATED
REMEDYREPACK INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ONDANSETRON TABLETS, USP SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ONDANSETRON TABLETS,
USP.
ONDANSETRON TABLETS USP, FOR ORAL USE
INITIAL U.S. APPROVAL: 1991
INDICATIONS AND USAGE
Ondansetron tablets are a 5-HT
receptor antagonist indicated for the prevention of:
• nausea and vomiting associated with highly emetogenic cancer
chemotherapy, including cisplatin ≥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 and 8 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 tablets 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