Drug Catalog - Product Detail
GRANISETRON HCL FOR INJECTION INJECT. 1MG/ML 1X2ML
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 00143-9744-10 | HIKMA | 1 | 1MG/ML | SOLUTION |
PACKAGE FILES
Generic Name
GRANISETRON HYDROCHLORIDE
Substance Name
GRANISETRON HYDROCHLORIDE
Product Type
HUMAN PRESCRIPTION DRUG
Route
INTRAVENOUS
Application Number
ANDA078629
Description
11 DESCRIPTION Granisetron Hydrochloride Injection, USP is a serotonin-3 (5-HT 3 ) receptor antagonist. Chemically it is endo -N-(9-methyl-9-azabicyclo [3.3.1] non-3-yl)-1-methyl-1H-indazole-3-carboxamide hydrochloride with a molecular weight of 348.9 (312.4 free base). Its empirical formula is C18H24N4O•HCl, while its chemical structure is: Granisetron hydrochloride is a white to off-white solid that is readily soluble in water and normal saline at 20°C. Granisetron Hydrochloride Injection, USP is a clear, colorless, sterile, nonpyrogenic, aqueous solution for intravenous administration. Granisetron Hydrochloride Injection, USP 1 mg/mL is available in 1 mL single dose and 4 mL multiple dose vials. 1 mg/mL: Each mL contains 1.12 mg granisetron hydrochloride equivalent to granisetron, 1 mg; sodium chloride, 9 mg; citric acid anhydrous, 2 mg; and benzyl alcohol, 10 mg, as a preservative. The solution’s pH ranges from 4.0 to 6.0; pH adjusted with sodium hydroxide/hydrochloric acid. chemical structure
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING Granisetron Hydrochloride Injection, USP 1 mg/mL (free base), is supplied in 1 mL Single Dose Vials and 4 mL Multiple Dose Vials. CONTAINS BENZYL ALCOHOL. NDC 0143-9744-10 (Carton of 10 x 1 mL Single Dose Vials) NDC 0143-9745-10 (Carton of 10 x 4 mL Multiple Dose Vials) NDC 0143-9745-05 (Carton of 5 x 4 mL Multiple Dose Vials) Store single dose vials and multiple dose vials at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature] Discard unused portion for the single dose vials. Once the multiple dose vial is penetrated, its contents should be used within 30 days. Do not freeze. Protect from light. Retain in carton until time of use.
Indications & Usage
1 INDICATIONS AND USAGE Granisetron Hydrochloride Injection, USP is a serotonin-3 (5-HT 3 ) 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, USP is a serotonin-3 (5-HT 3 ) 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
2 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 2.1 Prevention of Chemotherapy-Induced Nausea and Vomiting Adult Patients The recommended dosage for Granisetron Hydrochloride Injection is 10 mcg/kg administered intravenously within 30 minutes before initiation of chemotherapy, and only on the day(s) chemotherapy is given. Infusion Preparation Granisetron Hydrochloride Injection may be administered intravenously either undiluted over 30 seconds or diluted with 0.9% Sodium Chloride or 5% Dextrose and infused over 5 minutes. Stability Intravenous infusion of Granisetron Hydrochloride Injection should be prepared at the time of administration. However, Granisetron Hydrochloride Injection has been shown to be stable for at least 24 hours when diluted in 0.9% Sodium Chloride or 5% Dextrose and stored at room temperature under normal lighting conditions. As a general precaution, Granisetron Hydrochloride Injection should not be mixed in solution with other drugs. Parenteral drug products should be inspected visually for particulate matter and discoloration before administration whenever solution and container permit. Pediatric Patients The recommended dose in pediatric patients 2 to 16 years of age is 10 mcg/kg [see Clinical Studies ( 14 )] . Pediatric patients under 2 years of age have not been studied.