Gentamicin

Indications

INDICATIONS AND USAGE: 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 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 Injection, USP 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 injection to be effective in bacterial neonatal sepsis.

Dosage and administration (summary)

DOSAGE AND ADMINISTRATION: Gentamicin injection may be given IM or IV. The patient’s pretreatment body weight should be obtained for calculation of correct dosage. The dosage of aminoglycosides in obese patients should be based on an estimate of the lean body mass. It is desirable to limit the duration of treatment with aminoglycosides to short term. PATIENTS WITH NORMAL RENAL FUNCTION Adults The recommended dosage of gentamicin injection for patients with serious infections and normal renal function is 3 mg/kg/day, administered in three equal doses every eight hours (Table 3) .

Contraindications

CONTRAINDICATIONS: Hypersensitivity to gentamicin is a contraindication to its use. A history of hypersensitivity or serious toxic reactions to other aminoglycosides may contraindicate use of gentamicin because of the known cross-sensitivity of patients to drugs in this class.

Warnings and precautions

WARNINGS: (See BOXED WARNINGS .) Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in non-asthmatic people. Aminoglycosides can cause fetal harm when administered to a pregnant woman.

Storage and supply

HOW SUPPLIED: Gentamicin Injection, USP, containing gentamicin 40 mg per mL is supplied as follows: Product Code Unit of Sale Strength Each 1002 NDC 63323-010-02 Unit of 25 80 mg per 2 mL (40 mg per mL) NDC 63323-010-01 2 mL Multiple Dose Vial 1020 NDC 63323-010-20 Unit of 25 800 mg per 20 mL (40 mg per mL) NDC 63323-010-03 20 mL Multiple Dose Vial…

Source: Gentamicin Sulfate (Gentamicin) — US FDA prescribing information, 2023-11-10, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.