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Side Effects & Adverse Reactions
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Legal Issues
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Manufacturer Warnings
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FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
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.
History
There is currently no drug history available for this drug.
Other Information
Granisetron Hydrochloride Injection, USP is a serotonin-3 (5-HT3) 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, USP is a white to off-white solid that is readily soluble in water and normal saline at 20ºC. Granisetron Hydrochloride Injection, USP is a clear, colorless, sterile, nonpyrogenic, aqueous solution for intravenous administration.
Granisetron Hydrochloride Injection, USP 1 mg per mL is available in 1 mL single-use and 4 mL multi-dose vials.
Granisetron Hydrochloride Injection, USP 0.1 mg per mL is available in 1 mL single-use vials.
1 mg per mL (multi-dose): Each 1 mL contains granisetron hydrochloride, USP, 1.12 mg equivalent to granisetron, 1 mg; sodium chloride, 9 mg; citric acid, 2 mg; and methylparaben, 1.8 mg; propylparaben, 0.2 mg as preservative. Sodium hydroxide and/or hydrochloric acid may be added to adjust the pH.
0.1 mg per mL (single-use): Each 1 mL contains granisetron hydrochloride, USP, 0.112 mg equivalent to granisetron, 0.1 mg; sodium chloride, 9 mg; and citric acid, 2 mg. Contains no preservative. Sodium hydroxide and/or hydrochloric acid may be added to adjust the pH.
1 mg per mL (single-use): Each 1 mL contains granisetron hydrochloride, USP, 1.12 mg equivalent to granisetron, 1 mg; sodium chloride, 9 mg; and citric acid, 2 mg. Contains no preservative. Sodium hydroxide and/or hydrochloric acid may be added to adjust the pH.
Sources
Merrem Iv Manufacturers
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Astrazeneca Pharmaceuticals Lp
Merrem Iv | Sagent Pharmaceuticals
2.1 Prevention of Chemotherapy-Induced Nausea and VomitingAdult 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.
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