GRANISETRON HYDROCHLORIDE injection

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

Granisetron Hydrochloride (UNII: 318F6L70J8) (Granisetron - UNII:WZG3J2MCOL)

Dostupné s:

Akorn

INN (Mezinárodní Name):

Granisetron Hydrochloride

Složení:

Granisetron 0.1 mg in 1 mL

Podání:

INTRAVENOUS

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

Granisetron Hydrochloride Injection, USP 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 (e.g., 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 predictive

Přehled produktů:

Granisetron Hydrochloride Injection, USP, 1 mg/mL (free base), is supplied in 1 mL Single-dose vials and 4 mL Multi-dose vials. CONTAINS BENZYL ALCOHOL. NDC 17478-546-02 (package of 1 Single-dose Vial) NDC 17478-546-05 (package of 1 Multi-dose Vial) Granisetron Hydrochloride Injection, USP 0.1 mg/mL (free base), is supplied in 1 mL Single-dose Vials. CONTAINS NO PRESERVATIVE. NDC 17478-547-01 (package of 10 Single-dose Vial) Storage: Store single-dose vials and multiple-dose vials at 20º to 25°C (68º to 77°F) [see USP Controlled Room Temperature]. Protect from light. Do not freeze. Retain in carton until time of use. Once the multiple-dose vial is penetrated, its contents should be used within 30 days.

Stav Autorizace:

Abbreviated New Drug Application

Charakteristika produktu

GRANISETRON HYDROCHLORIDE- GRANISETRON HYDROCHLORIDE INJECTION
AKORN
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
GRANISETRON
HYDROCHLORIDE INJECTION, USP SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR
GRANISETRON HYDROCHLORIDE INJECTION, USP.
GRANISETRON HYDROCHLORIDE INJECTION USP, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 1993
RECENT MAJOR CHANGES
Warnings and Precautions (5.4)
08/2014
INDICATIONS AND USAGE
Granisetron Hydrochloride Injection, USP 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 1 mg/mL (free base). (3)
Injection 0.1 mg/mL (free base). (3)
CONTRAINDICATIONS
Hypersensitivity to granisetron hydrochloride injection 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)
Contains benzyl alcohol (5.5)
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
serotogenic drugs. (5.4)
ADVERSE REACTIONS
Most common adverse reactions:
Chemotherapy-induced nausea and vomiting (≥3%): Headache, and
constipation (6.1)
TO REPORT SUSPECTED