ONDANSETRON HYDROCHLORIDE tablet, film coated

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

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

Disponível em:

Unit Dose Services

DCI (Denominação Comum Internacional):

ONDANSETRON HYDROCHLORIDE

Composição:

ONDANSETRON 8 mg

Via de administração:

ORAL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

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 an

Resumo do produto:

Product: 50436-0131 NDC: 50436-0131-1 30 TABLET, FILM COATED in a BOTTLE

Status de autorização:

Abbreviated New Drug Application

Características técnicas

ONDANSETRON HYDROCHLORIDE- ONDANSETRON HYDROCHLORIDE TABLET, FILM
COATED
UNIT DOSE SERVICES
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ONDANSETRON HYDROCHLORIDE
TABLETS, AND ONDANSETRON ORALLY DISINTEGRATING TABLETS SAFELY AND
EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR ONDANSETRON HYDROCHLORIDE TABLETS, AND
ONDANSETRON ORALLY
DISINTEGRATING TABLETS.
ONDANSETRON HYDROCHLORIDE TABLETS, FOR ORAL USE
ONDANSETRON ORALLY DISINTEGRATING TABLETS
INITIAL U.S. APPROVAL: 1991
INDICATIONS AND USAGE
Ondansetronis a 5-HT receptor antagonist indicated for the prevention
of: (1)
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. (2.1)
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)
Orally Disintegrating 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 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