ONDANSETRON- ondansetron hydrochloride solution

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

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

Disponible desde:

NuCare Pharmaceuticals, Inc.

Designación común internacional (DCI):

ONDANSETRON HYDROCHLORIDE

Composición:

ONDANSETRON 4 mg in 5 mL

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Ondansetron oral solution, USP is 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 . highly emetogenic cancer chemotherapy, including cisplatin greater than or equal to 50 mg/m 2 . - initial and repeat courses of moderately emetogenic cancer chemotherapy. 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. radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen. Ondansetron oral solution, USP is also indicated for the prevention of postoperative nausea and/or vomiting. Ondansetron oral solution, USP is contraindicated in patients: - known to have hypersensitivity (e.g., anaphylaxis) to ondansetron or any of the components of the formulation

Resumen del producto:

Ondansetron oral solution, USP a clear, colorless liquid with a characteristic strawberry odor, contains 5 mg of ondansetron hydrochloride dihydrate equivalent to 4 mg of ondansetron per 5 mL in brown bottles of 50 mL NDC 68071-3275-5 resistant closures. Store at 20° to 25°C (68° to 77°F), [See USP Controlled Room Temperature]. Protect from light. Store bottles upright in cartons.

Estado de Autorización:

Abbreviated New Drug Application

Ficha técnica

ONDANSETRON- ONDANSETRON HYDROCHLORIDE SOLUTION
NUCARE PHARMACEUTICALS, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ONDANSETRON HYDROCHLORIDE ORAL
SOLUTION, USP SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION
FOR ONDANSETRON
HYDROCHLORIDE ORAL SOLUTION, USP.
ONDANSETRON HYDROCHLORIDE SOLUTION, 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
Oral Solution: 4 mg/5 mL ( 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 oral solution, USP 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
serotoner