Gentamicin

Indications

Gentamicin sulfate solution is recommended for the control of bacterial infections of the uterus (metritis) in horses and as an aid in improving conception in mares with uterine infections caused by bacteria sensitive to gentamicin. Bacteriologic studies should be conducted to identify the causative organism and to determine its sensitivity to gentamicin sulfate. Sensitivity discs of the drug are available for this purpose.

Dosage and Administration

The recommended dose is 20 to 25 mL (2.0 - 2.5 grams) gentamicin sulfate solution per day for 3 to 5 days during estrus. Each dose should be diluted with 200-500 mL of sterile physiological saline before aseptic uterine infusion.

Contraindications

There are no known contraindications to this drug when used as directed.

Precautions

If hypersensitivity to any of the components develops, or if overgrowth of nonsusceptible bacteria, fungi, or yeasts occurs, treatment with Gentamicin Sulfate Solution should be discontinued and appropriate therapy instituted. Although Gentamicin Sulfate Solution is not spermicidal, treatment should not be given the day of breeding. Warning : Do not use for horses intended for human consumption. SIDE EFFECTS There have been no reports of drug hypersensitivity or adverse side effects following the recommended intrauterine infusion of gentamicin sulfate solution combined with sterile physiological saline in mares.

Description

Each mL of Gentamicin Sulfate Solution contains gentamicin sulfate solution veterinary equivalent to 100 mg gentamicin base; 2.4 mg sodium metabisulfite; 0.8 mg sodium sulfite, anhydrous; 0.1 mg edetate disodium; 10 mg benzyl alcohol as preservative; water for injection q.s. CHEMISTRY: Gentamicin is a mixture of aminglycoside antibiotics derived from the fermentation of Micromonospora purpurea . Gentamicin sulfate is a mixture of sulfate salts of the antibiotics produced in this fermentation. The salts are weakly acidic, freely soluble in water, and stable in solution. ANTIBACTERIAL ACTIVITY : In Vitro antibacterial activity has shown that gentamicin is active against most gram-negative and gram-positive bacteria isolated from domestic animals. 1 Gentamicin is active against Pseudomonas aeruginosa , indole-positive and -negative Proteus species, Escherichia coli , Klebsiella species, Enterobacter species, Alcaligenes species, Staphylococcus species, and Streptococcus species. PHARMACOLOGY : Studies in man indicate that recommended doses of gentamicin produce serum concentrations bactericidal for most bacteria sensitive to gentamicin within an hour after intramuscular injection; these concentrations last for 6 to 12 hours. 2 Some 30% of the administered dose of gentamicin is bound by serum proteins and released as the drug is excreted. Gentamicin is excreted almost entirely by glomerular filtration. High concentrations of the active form are found in the urine. Fifty to 100% of the gentamicin injected can be recovered unchanged within 24 hours from the urine of patients with normal renal function. A small amount is excreted into the bile. TOXICITY STUDIES : No toxic effects were observed in rats given gentamicin sulfate 20 mg/kg/day for 24 days; in cats given 10 mg/kg/day for 40 days. Gentamicin sulfate given to dogs at 6 mg/lb/day, 6 days weekly for 3 weeks, caused no detectable kidney damage. At higher doses, impairment of equilibrium and renal function were observed in these species.

Other labels for this ingredient

These labels are also stored for the same active ingredient. They are not identical to the one reprinted above, and each is listed by product and set id rather than merged with it.

• GENTAMICIN SULFATE SOLUTION Sterile Multi Dose Vial 100 mg/mL, Sparhawk Laboratories, Inc.. Set id 2a120c74-bc49-4249-9d06-8dd1ee37b3e3.
• GENTAMAX® 100 (GENTAMICIN SULFATE SOLUTION) 100 mg/mL, Clipper Distributing Company, LLC.. Set id 4940fa85-0201-4d71-9ff9-5ee3ac725036.
• GENTAMICIN SULFATE SOLUTION 100 mg/mL, VetTek. Set id 92f9e76b-7498-43f7-88ba-192016125bed.
• GENTAMICIN SULFATE SOLUTION 100 mg/mL, MWI/VetOne. Set id cde9d2ad-7844-4e48-af95-bd1fafc23031.
• GENTAMICIN SULFATE SOLUTION 100 mg/mL, Aspen Veterinary Resources, Ltd.. Set id f95c1810-28f2-4507-b58e-0cfa30efea1d.

FDA adverse event reports

The FDA Center for Veterinary Medicine publishes the adverse event reports it receives through openFDA. The counts below are the reports naming gentamicin as an active ingredient for each species this label names, as returned on 2026-09-16, coded by the VeDDRA reaction term the reporter chose. Reactions are counted per report, so one report can appear under several terms.

These are counts, not rates. Reporting is voluntary, the number of animals treated is not known, and a widely used product accumulates reports for that reason alone. A report records that an event followed a dose; it does not establish that the product caused it. The counts say nothing about how one product compares with another.