Label: GENTAMICIN SULFATE - gentamicin sulfate solution
- NDC Code(s): 58005-633-04, 58005-633-05
- Packager: Sparhawk Laboratories, Inc.
- Category: PRESCRIPTION ANIMAL DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Animal Drug Application
Updated December 26, 2012
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- GENERAL PRECAUTIONS
For Use In Horses Only
Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian.Close
Each mL of 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.Close
- CLINICAL STUDIES
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 getnamicin 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.Close
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.Close
- 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.
There are no known contraindications to this drug when used as directed.Close
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.Close
- 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.
- HOW SUPPLIED
Gentamicin Sulfate Solution, 100 mg per mL for intrauterine use, is available in 100 mL and 250 mL multiple dose vials.
- STORAGE AND HANDLING
Store between 2oand 30oC (36o and 86oF).Close
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.Close
For intra-uterine use in horses only.
Each mL 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.
Store between 2o and 30oC (36o and 86oF).
Protect from freezing.
TAKE TIME OBSERVE LABEL DIRECTIONS
- PRINCIPAL DISPLAY PANEL
Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian.
ANADA 200-395, Approved by FDA
- INGREDIENTS AND APPEARANCE
gentamicin sulfate solution
Product Information Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:58005-633 Route of Administration INTRAUTERINE Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GENTAMICIN SULFATE (UNII: 8X7386QRLV) (GENTAMICIN - UNII:T6Z9V48IKG) GENTAMICIN 100 mg in 1 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58005-633-04 100 mL in 1 VIAL 2 NDC:58005-633-05 250 mL in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANADA ANADA200395 08/21/2008 Labeler - Sparhawk Laboratories, Inc. (147979082)