AmTech GentaMax 100

Manufacturer: IVX Animal Health

(gentamicin Sulfate Solution)

100 Mg/ml

For Use In Horses Only

ANADA 200-137, Approved by FDA

AmTech GentaMax 100 Caution

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

Description

Each mL of GentaMax^® 100 (Gentamicin Sulfate Solution) contains: gentamicin sulfate equivalent to 100 mg gentamicin base; 3.2 mg sodium metabisulfite; 0.1 mg edetate disodium; 1.8 mg methylparaben and 0.2 mg propylparaben as preservatives; 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.

AmTech GentaMax 100 Indications

GentaMax^® 100 (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.

AmTech GentaMax 100 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 an overgrowth of nonsusceptible bacteria, fungi, or yeast occurs, treatment with GentaMax^® 100 (Gentamicin Sulfate Solution) should be discontinued and appropriate therapy instituted.

Although GentaMax^® 100 (Gentamicin Sulfate Solution) is not spermicidal, treatment should not be given the day of breeding.

Warning

Not for use in horses intended for food.

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

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

For intrauterine use in horses only.

Store At Controlled Room Temperature 20°-25°c (68°-77°f).

Do Not Refrigerate.

Protect From Freezing.

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

AmTech^® and GentaMax^® are registered trademarks of IVX Animal Health, Inc.

Manufactured by IVX Animal Health, Inc., St. Joseph, MO 64503

Net Contents:	NDC
100 mL	59130-667-01	600040-01 Rev0806
250 mL	59130-667-02	600040-02 Rev0806

Nac No.

10740205