GRANISETRON HYDROCHLORIDE injection

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

GRANISETRON HYDROCHLORIDE (UNII: 318F6L70J8) (GRANISETRON - UNII:WZG3J2MCOL)

Available from:

WOCKHARDT LIMITED

INN (International Name):

GRANISETRON HYDROCHLORIDE

Composition:

GRANISETRON 1 mg in 1 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

- The prevention of nausea and/or vomiting associated with initial and repeat courses of emetogenic cancer therapy, including high-dose cisplatin. It is not known whether granisetron is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when granisetron hydrochloride injection is administered to a nursing woman. Chemotherapy-Induced Nausea and Vomiting [See Dosage and Administration (2)]  for use in chemotherapy-induced nausea and vomiting in pediatric patients 2 to 16 years of age. Safety and effectiveness in pediatric patients under 2 years of age have not been established.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

GRANISETRON HYDROCHLORIDE - GRANISETRON HYDROCHLORIDE INJECTION
WOCKHARDT LIMITED
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
GRANISETRON HYDROCHLORIDE INJECTION SAFELY
AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR GRANISETRON
HYDROCHLORIDE INJECTION.
GRANISETRON HYDROCHLORIDE INJECTION, USP, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 1993
INDICATIONS AND USAGE
Granisetron hydrochloride injection, USP is a serotonin-3 (5-HT )
receptor antagonist indicated for:
Prevention of nausea and/or vomiting associated with initial and
repeat courses of emetogenic cancer therapy, including
high-dose cisplatin. (1)
DOSAGE AND ADMINISTRATION
Prevention of chemotherapy-induced nausea and vomiting (2.1):
Recommended dosage is 10 mcg/kg intravenously within 30 minutes before
initiation of chemotherapy
Pediatric patients (2 to 16 years): Recommended dosage is 10 mcg/kg
DOSAGE FORMS AND STRENGTHS
Injection 1 mg/mL (free base). (3)
CONTRAINDICATIONS
Hypersensitivity to granisetron or to any of its components. (4)
WARNINGS AND PRECAUTIONS
Granisetron hydrochloride injection does not stimulate gastric or
intestinal peristalsis and should not be used instead of
nasogastric suction. (5.1)
QT prolongation has been reported with granisetron hydrochloride
injection. Use with caution in patients with pre-
existing arrhythmias or cardiac conduction disorders. (5.2)
Hypersensitivity reactions, such as anaphylaxis, shortness of breath,
hypotension, and urticaria, may occur in patients
with known hypersensitivity to other selective 5-HT receptor
antagonists. (5.3)
ADVERSE REACTIONS
Most common adverse reactions:
Chemotherapy-induced nausea and vomiting (≥3%): Headache, and
constipation (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT WOCKHARDT USA LLC. AT
1-800-346-6854 OR FDA AT 1-
800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
Granisetron hydrochloride injection has been administered safely with
benzodiazepines, neuroleptics, and anti-ulcer
medicatio