Land: USA
Språk: engelska
Källa: NLM (National Library of Medicine)
GRANISETRON HYDROCHLORIDE (UNII: 318F6L70J8) (GRANISETRON - UNII:WZG3J2MCOL)
Wockhardt USA LLC.
GRANISETRON HYDROCHLORIDE
GRANISETRON 1 mg in 1 mL
INTRAVENOUS
PRESCRIPTION DRUG
Granisetron hydrochloride injection is a serotonin-3 (5-HT3 ) receptor antagonist indicated for: - The prevention of nausea and/or vomiting associated with initial and repeat courses of emetogenic cancer therapy, including high-dose cisplatin. Granisetron hydrochloride injection is contraindicated in patients with known hypersensitivity (eg. anaphylaxis, shortness of breath, hypotension, urticaria) to the drug or to any of its components. Pregnancy Category B Reproduction studies have been performed in pregnant rats at intravenous doses up to 9 mg/kg/day (54 mg/m2 /day, 146 times the recommended human dose based on body surface area) and pregnant rabbits at intravenous doses up to 3 mg/kg/day (35.4 mg/m2 /day, 96 times the recommended human dose based on body surface area) and have revealed no evidence of impaired fertility or harm to the fetus due to granisetron. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predi
Granisetron hydrochloride injection USP, 1 mg/mL (free base), is supplied in 4 mL Multi-Use Vials. Contains preservative. NDC 64679-841-01 (package of 1 Multi-Use Vial) Store at 20°-25°C (68°-77°F). [See USP Controlled Room Temperature] Once the multi-use vial is penetrated, its contents should be used within 30 days. Do not freeze. Protect from light.
Abbreviated New Drug Application
GRANISETRON HYDROCHLORIDE- GRANISETRON HYDROCHLORIDE INJECTION WOCKHARDT USA LLC. ---------- 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 RECENT MAJOR CHANGES Warnings and Precautions Serotonin Syndrome (5.4) 08/2014 INDICATIONS AND USAGE Granisetron hydrochloride injection 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) Serotonin syndrome has been reported with other granisetron products, alone but particularly with concomitant use of serotonergic drugs. (5.4) 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 Läs hela dokumentet