GRANISETRON HYDROCHLORIDE- granisetron hydrochloride injection, solution

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

granisetron hydrochloride (UNII: 318F6L70J8) (granisetron - UNII:WZG3J2MCOL)

Disponível em:

Sagent Pharmaceuticals

DCI (Denominação Comum Internacional):

granisetron hydrochloride

Composição:

granisetron 1 mg in 1 mL

Via de administração:

INTRAVENOUS

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

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 (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

Resumo do produto:

Granisetron Hydrochloride Injection, USP is supplied as follows: Storage Conditions Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F). [See USP Controlled Room Temperature.] Discard unused portion for the single-use vials. Once the multi-dose vial is penetrated, its contents should be used within 30 days. Do not freeze. Protect from light. Retain vial in carton until time of use. Sterile, Nonpyrogenic. The container closure is not made with natural rubber latex.

Status de autorização:

Abbreviated New Drug Application

Características técnicas

GRANISETRON HYDROCHLORIDE- GRANISETRON HYDROCHLORIDE INJECTION,
SOLUTION
SAGENT PHARMACEUTICALS
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
GRANISETRON HYDROCHLORIDE SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR GRANISETRON
HYDROCHLORIDE.
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:
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 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 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 SAGENT PHARMACEUTI