Gentamicin Sulfate
in 0.9% Sodium Chloride Injection
60, 70, 80, 90 and 100 mg Gentamicin in 50 mL or 100 mL
FOR INTRAVENOUS INFUSION ONLY
Flexible Container
Rx only
To reduce the development of drug-resistant bacteria and maintain the effectiveness of gentamicin and other antibacterial drugs, gentamicin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.
DESCRIPTION
Gentamicin Sulfate in 0.9% Sodium Chloride Injection is a sterile, nonpyrogenic solution of gentamicin sulfate in 0.9% sodium chloride injection. It is administered by the intravenous route as an antibiotic infusion.
Each milliliter (mL) of the 50 mL size contains gentamicin sulfate equivalent to 1.2, 1.4, 1.6 or 2 mg gentamicin base with sodium chloride 9 mg in water for injection.
Each milliliter (mL) of the 100 mL size contains gentamicin sulfate equivalent to 0.6, 0.8, 0.9 or 1 mg gentamicin base with sodium chloride 9 mg in water for injection.
For the 50 and 100 mL sizes, the osmolar concentration is 317 mOsmol/liter (calc.); pH is 3.8 (3.0 to 5.5). May contain sulfuric acid and/or sodium hydroxide for pH adjustment.
The solutions contain no bacteriostat, antimicrobial agent (except gentamicin) or buffer and are intended only for use as a single-dose injection. When smaller doses are required the unused portion should be discarded.
Gentamicin is classified as an aminoglycoside antibiotic and is derived from Micromonospora purpurea, an actinomycete.
The chemical name for gentamicin C1A is: 0-3-Deoxy-4-C-methyl-3-(methylamino)-β-L-arabinopyranosyl-(1→ 6)-0-[2,6-diamino-2,3,4,6-tetradeoxy-α-D-erythro-hexopyranosyl-(1→ 4)]-2-deoxy-D-streptamine.
Gentamicin Sulfate, USP is chemically designated gentamicin sulfate, a white to buff powder soluble in water. It has the following structural formula:
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