GRANISETRON HYDROCHLORIDE injection

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

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

Dostopno od:

Wockhardt USA LLC.

INN (mednarodno ime):

GRANISETRON HYDROCHLORIDE

Sestava:

GRANISETRON 1 mg in 1 mL

Pot uporabe:

INTRAVENOUS

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

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

Povzetek izdelek:

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.

Status dovoljenje:

Abbreviated New Drug Application

Lastnosti izdelka

GRANISETRON HYDROCHLORIDE- GRANISETRON HYDROCHLORIDE INJECTION
WOCKHARDT USA LLC.
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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
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