ZOFRAN ondansetron hydrochloride injection

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

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

Disponible des:

GlaxoSmithKline LLC

Designació comuna internacional (DCI):

ONDANSETRON HYDROCHLORIDE

Composición:

ONDANSETRON 2 mg in 1 mL

tipo de receta:

PRESCRIPTION DRUG

Estat d'Autorització:

New Drug Application

Fitxa tècnica

ZOFRAN- ONDANSETRON HYDROCHLORIDE INJECTION
GLAXOSMITHKLINE LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ZOFRAN SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR ZOFRAN.
ZOFRAN (ONDANSETRON HYDROCHLORIDE) INJECTION, FOR INTRAVENOUS OR
INTRAMUSCULAR USE
INITIAL U.S. APPROVAL: 1991
INDICATIONS AND USAGE
ZOFRAN Injection is a 5-HT receptor antagonist indicated for the
prevention of:
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DOSAGE AND ADMINISTRATION
Prevention of nausea and vomiting associated with initial and repeat
courses of emetogenic cancer chemotherapy (2.1):
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Prevention of postoperative nausea and/or vomiting (2.2):
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Patients with severe hepatic impairment (2.3):
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DOSAGE FORMS AND STRENGTHS
Injection: 40 mg/20 mL multiple-dose vial. (3)
CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
Chemotherapy-Induced Nausea and Vomiting –
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Postoperative Nausea and Vomiting –
3
nausea and vomiting associated with initial and repeat courses of
emetogenic cancer chemotherapy. (1.1)
postoperative nausea and/or vomiting. (1.2)
Dilution of ZOFRAN Injection in 50 mL of 5% Dextrose Injection or 0.9%
Sodium Chloride Injection is required
before administration to adult and pediatric patients.
Adults and pediatric patients 6 months of age and older: The
recommended dosage is 0.15 mg/kg per dose for 3
doses (maximum of 16 mg per dose), infused intravenously over 15
minutes.
Administer the first dose 30 minutes before the start of chemotherapy
and subsequent doses 4 and 8 hours after the
first dose.
Dilution of ZOFRAN Injection is not required before administration to
adult and pediatric patients.
See full prescribing information for the recommended dosage and
administration instructions for adult and pediatric
patients 1 month of age and older.
Do not exceed a total daily dose of 8 mg.
Patients known to have hypersensitivity (e.g., anaphylaxis) to this
product or any of its components. (4)
Concomitant use of apomorphine