GRANISETRON HYDROCHLORIDE- granisetron hydrochloride injection

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

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

Tillgänglig från:

Cipla USA Inc.

INN (International namn):

GRANISETRON HYDROCHLORIDE

Sammansättning:

GRANISETRON 0.1 mg in 1 mL

Administreringssätt:

INTRAVENOUS

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

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. Teratogenic Effects 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 alw

Produktsammanfattning:

Granisetron Hydrochloride Injection, 0.1 mg/mL (free base), is supplied in 1 mL Single-Use Vials. CONTAINS NO PRESERVATIVES. NDC 69097-195-67 (package of 1 Single-Use Vial) NDC 69097-195-68 (package of 5 Single-Use Vials) Storage Store single-use vials at 20° to 25° C (68° to 77° F). [See USP Controlled Room Temperature.] Do not freeze. Protect from light. Retain in carton until time of use.

Bemyndigande status:

Abbreviated New Drug Application

Produktens egenskaper

GRANISETRON HYDROCHLORIDE- GRANISETRON HYDROCHLORIDE INJECTION
CIPLA USA INC.
----------
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, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 1993
RECENT MAJOR CHANGES
Warnings and Precautions (5.5) 08/2014
INDICATIONS AND USAGE
Granisetron Hydrochloride Injection is a serotonin-3 (5-HT ) 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. (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 0.1 mg/mL (free base). (3)
CONTRAINDICATIONS
Hypersensitivity to granisetron or to any of its components. (4)
WARNINGS AND PRECAUTIONS
Granisetron hydrochloride 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. 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 granisetron, 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 CIPLA LIMITED AT
1-866-604-3268 OR FDA AT 1-800-
FDA-1088 OR WWW.FDA.GOV