ONDANSETRON- ondansetron hydrochloride solution

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

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

Disponible depuis:

Lannett Company, Inc.

DCI (Dénomination commune internationale):

ONDANSETRON HYDROCHLORIDE

Composition:

ONDANSETRON 4 mg in 5 mL

Mode d'administration:

ORAL

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

Ondansetron oral solution 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 highly emetogenic cancer chemotherapy, including cisplatin greater than or equal to 50 mg/m2 - 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 is also indicated for the prevention of postoperative nausea and/or vomiting. Ondansetron oral solution is contraindicated in patients: - known to have hypersensitivity (e.g., anaphylaxis) to ondansetron or any of the components of the formulation [see Adverse Reactions (

Descriptif du produit:

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 54838-555-50) with child-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.

Statut de autorisation:

Abbreviated New Drug Application

Résumé des caractéristiques du produit

ONDANSETRON- ONDANSETRON HYDROCHLORIDE SOLUTION
LANNETT COMPANY, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ONDANSETRON
HYDROCHLORIDE ORAL SOLUTION SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION
FOR ONDANSETRON HYDROCHLORIDE ORAL SOLUTION.
ONDANSETRON HYDROCHLORIDE SOLUTION, FOR ORAL USE
INITIAL U.S. APPROVAL: 1991
RECENT MAJOR CHANGES
Warnings and Precautions, Myocardial Ischemia (5.4) 10/2021
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 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 ondansetron
oral solution 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 r