LEGACY

Company: Huvepharma

Gentamicin Sulfate Solution

100 mg/mL

Approved by FDA under ANADA # 200-395

LEGACY Caution

Federal law restricts this drug to use by or on the order of a licensed veterinarian.

For Use in Horses Only

Not for Use in Humans

Description

Each mL of LEGACY^® Gentamicin Sulfate Solution contains gentamicin sulfate 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 aminoglycoside 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.

LEGACY Indications

LEGACY^® 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.

PRECAUTION: If hypersensitivity to any of the components develops, or if overgrowth of nonsusceptible bacteria, fungi, or yeasts occurs, treatment with LEGACY^® Gentamicin Sulfate Solution should be discontinued and appropriate therapy instituted.

Although LEGACY^® 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.

CONTACT INFORMATION: To report suspected adverse events, for technical assistance or to obtain a copy of the Safety Data sheet, contact Sparhawk Laboratories Inc at 1-800-255-6388 or 1-913-888-7500. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or http://www.fda.gov/reportanimalae.

How Supplied

LEGACY^® Gentamicin Sulfate Solution, 100 mg per mL for intrauterine use, is available in 100 and 250 mL multiple dose vials.

Store between 2° and 30°C (36° and 86°F). Protect from freezing.

Keep Out of Reach of Children

References

1. Hennessey, PW, et al. In vitro activity of gentamicin against bacteria isolated from domestic animals. Veterinary Medicine/Small Animal Clinician. Nov. 1971; 1118-1122.

2. Black, J, et al. Pharmacology of gentamicin, a new broad spectrum antibiotic. Antimicrob Agents and Chemother. 1963; 138-147.

For intra-uterine use in horses only.

Read accompanying directions carefully.

Manufactured for Huvepharma, Inc., Peachtree City, GA 30269

^® Registered trademark of Huvepharma, Inc.

CPN: 1309087.0