SUMMARY
Gentamicin Sulfate
in 0.9% Sodium Chloride Injection
Gentamicin Sulfate in 0.9% Sodium Chloride Injections are sterile, nonpyrogenic solutions of gentamicin sulfate in 0.9% sodium chloride injection. They are administered by the intravenous route as antibiotic infusions. They are premixed and require no further dilution. Each milliliter (mL) of the 50 mL size contains gentamicin sulfate equivalent to 1.2, or 1.6 mg gentamicin base with Sodium Chloride USP 9 mg in Water for Injection USP. Each milliliter (mL) of the 100 mL size contains gentamicin sulfate equivalent to 0.6, 0.8, or 1.0 mg gentamicin base with Sodium Chloride USP 9 mg in Water for Injection USP. Gentamicin Sulfate in 0.9% Sodium Chloride Injections have a calculated osmolarity of 290 mOsmol/liter; pH: 4.0 (3.0–5.5). May contain Sulfuric Acid NF and/or Sodium Hydroxide NF 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 a aminoglycoside antibiotic and is derived from Micromonospora purpurea, an actinomycete.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Gentamicin Sulfate in 0.9% Sodium Chloride Injection and other antibacterial drugs, Gentamicin Sulfate in 0.9% Sodium Chloride Injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
Gentamicin Sulfate in 0.9% Sodium Chloride Injection is indicated in the treatment of serious infections caused by susceptible strains of the following microorganisms: Pseudomonas aeruginosa, Proteus species (indole-positive and indole-negative), Escherichia coli, Klebsiella - Enterobacter - Serratia species, Citrobacter species, and Staphylococcus species (coagulase-positive and coagulase-negative).
Clinical studies have shown gentamicin sulfate to be effective in bacterial neonatal sepsis; bacterial septicemia, and serious bacterial infections of the central nervous system (meningitis), urinary tract, respiratory tract, gastrointestinal tract (including peritonitis), skin, bone and soft tissue (including burns).
Aminoglycosides, including gentamicin, are not indicated in uncomplicated initial episodes of urinary tract infections unless the causative organisms are susceptible to these antibiotics and are not susceptible to antibiotics having less potential for toxicity.
Specimens for bacterial culture should be obtained to isolate and identify causative organisms and to determine their susceptibility to gentamicin.
Gentamicin may be considered as initial therapy in suspected or confirmed gram-negative infections, and therapy may be instituted before obtaining results of susceptibility testing. The decision to continue therapy with this drug should be based on the results of susceptibility tests, the severity of the infection, and the important additional concepts contained in the boxed WARNINGS. If the causative organisms are resistant to gentamicin, other appropriate therapy should be instituted.
In serious infections when the causative organisms are unknown, gentamicin may be administered as initial therapy in conjunction with a penicillin-type or cephalosporin-type drug before obtaining results of susceptibility testing. If anaerobic organisms are suspected as etiologic agents, consideration should be given to using other suitable antimicrobial therapy in conjunction with gentamicin. Following identification of the organism and its susceptibility, appropriate antibiotic therapy should then be continued.
Gentamicin has been used effectively in combination with carbenicillin for the treatment of life-threatening infections caused by Pseudomonas aeruginosa. It has also been found effective when used in conjunction with a penicillin-type drug for the treatment of endocarditis caused by group D streptococci.
Gentamicin has also been shown to be effective in the treatment of serious staphylococcal infections. While not the antibiotic of first choice, gentamicin may be considered when penicillins or other less potentially toxic drugs are contraindicated and bacterial susceptibility tests and clinical judgement indicate its use. It may also be considered in mixed infections caused by susceptible strains of staphylococci and gram-negative organisms.
In the neonate with suspected bacterial sepsis or staphylococcal pneumonia, a penicillin-type drug is also usually indicated as concomitant therapy with gentamicin.
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