PrGentamicin Injection USP - Gentamicin base (as sulfate) USP - 10 mg/mL and 40 mg/mL - Antibiotic - Actions and Clinical Pharmacology

Sep 8, 2026

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Gentamicin is a bactericidal antibiotic that inhibits normal protein synthesis in susceptible bacteria, making it effective for serious Gram-negative and Gram-positive infections. Indications include bacteremia, respiratory tract and urinary tract infections, infected wounds, and bone or soft-tissue infections such as peritonitis and sepsis-complicated burns. Initial cultures and sensitivity testing guide therapy and help manage risk of resistance, including possible cross-resistance with aminoglycosides.

LanguageEnglish

CategoryHealthcare

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Pages21

Reading Time53 min

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Actions and Clinical Pharmacology

Indications

Contraindications

Pregnancy and Lactation

Precautions

Ototoxicity

PRODUCT MONOGRAPH PrGENTAMICIN INJECTION USP Gentamicin base (as sulfate) USP 10 mg/mL and 40 mg/mL Antibiotic Sandoz Canada Inc. 145, Jules-Léger Date of Revision: August 29, 2017 Boucherville, QC, Canada J4B 7K8 Control: 203909 PrGentamicin Injection USP Gentamicin base (as sulfate) USP 10 mg/mL and 40 mg/mL THERAPEUTIC CLASSIFICATION Antibiotic ACTIONS AND CLINICAL PHARMACOLOGY Gentamicin is a bactericidal antibiotic which affects bacterial growth by specific inhibition of normal protein synthesis in susceptible bacteria. INDICATIONS Gentamicin is clinically effective in serious infections due to susceptible Gram-negative and Gram-positive bacteria, including: Pseudomonas aeruginosa, indole-negative and indole-positive Proteus species, Escherichia coli, Klebsiella pneumoniæ, Enterobacter ærogenes, Serratia marcescens and Staphylococcus species (including strains resistant to other antibiotics) . The use of gentamicin is indicated in the treatment of serious infections caused by laboratory determined susceptible bacteria, with due regard for relative antibiotic toxicity. Therefore, the drug should be considered for treatment of: 􀁸 bacteremia 􀁸 respiratory tract infections 􀁸 urinary tract infections 􀁸 infected wounds: surgical and traumatic 􀁸 bone and soft tissue infections, including peritonitis and burns complicated by sepsis. In the majority of cases bacteriologic cultures should be obtained initially to identify the causative organism and to determine its sensitivity to gentamicin. Sensitivity discs of 10 mcg and 2 mcg are available for this purpose. In suspected or documented Gram-negative septicemia, particularly when shock or hypotension are present, gentamicin should be considered for initial antimicrobial therapy. Gentamicin should also be considered in serious Staphylococcus infections when other conventional antimicrobial therapy is inappropriate or when bacterial susceptibility testing and clinical judgment indicate its use. If anærobic organisms are suspected, additional antimicrobial therapy should be added to the gentamicin regimen. The decision to continue therapy with gentamicin should be based on results of the sensitivity tests, clinical response of the patient, and consideration of relative antibiotic toxicity. Clinical studies have shown that organisms previously sensitive to gentamicin have become resistant during therapy. Although this has occurred infrequently, the possibility should nevertheless be considered. There is evidence that cross resistance between gentamicin and aminoglycoside antibiotics may occur since bacteria made resistant to aminoglycoside antibiotics artificially in the laboratory are also resistant to gentamicin. However, gentamicin may be active against clinical isolates of bacteria resistant to other aminoglycosides. Conversely, organisms resistant to gentamicin may be sensitive to other aminoglycoside antibiotics. If susceptibility tests indicate the causative organism is resistant to gentamicin, other tests or additional antimicrobial therapy should be instituted. Combined therapy with gentamicin and a penicillin type of drug has been used in suspected sepsis until bacteriological studies have identified the etiological organism. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Gentamicin Injection USP and other antibacterial drugs, Gentamicin Injection USP should be used only to treat 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 antimicrobial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. CONTRAINDICATIONS A history of hypersensitivity or toxic reactions to gentamicin are contraindications to its use. Pregnancy and Lactation Although st

FAQs

What infections is gentamicin indicated to treat?

Gentamicin is indicated for serious infections caused by susceptible Gram-negative and Gram-positive bacteria, including bacteremia, respiratory and urinary tract infections, infected wounds, and bone or soft-tissue infections such as peritonitis and sepsis-complicated burns.

Why are cultures and sensitivity tests important before using gentamicin?

Bacteriologic cultures should be obtained initially to identify the causative organism and determine its sensitivity to gentamicin, supporting appropriate selection or modification of therapy and accounting for antibiotic toxicity.

What precautions are emphasized regarding gentamicin’s ototoxicity?

Gentamicin can cause ototoxicity that may be delayed, primarily affecting vestibular function. Early recognition is critical, and tinnitus, dizziness, or hearing loss should prompt strong consideration of discontinuing the antibiotic unless gentamicin is the only proven therapy.

Sep 8, 2026

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