GENTAMICIN SULFATE description, usages, side effects, indications, overdosage, supplying and lots more!

GENTAMICIN SULFATE

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GENTAMICIN SULFATE SOLUTION 100 mg/mL

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

For Use In Horses Only

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

DESCRIPTION

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.

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.

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



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 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



HOW SUPPLIED



Store between 2o and 30oC (36o and 86oF).

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.
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



Sterile Multiple Dose Vial

CAUTION





GENTAMICIN SULFATE

GENTAMICIN SOLUTION

Product Information

Product Type Prescription animal drug label Item Code (Source) NDC:60270-338
Route of Administration INTRAUTERINE DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Gentamicin Sulfate GENTAMICIN 100 mg

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:60270-338-10 100 in 1 VIAL
2 NDC:60270-338-13 250 in 1 VIAL

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANADA ANADA200395 2008-08-21


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Be sure to consult your doctor before taking any medication!
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