Animal NDC 58005-633-05 Gentamicin Sulfate

Animal Product Information

Field Name Field Value
Animal NDC Code 58005-633-05
Proprietary Name Gentamicin Sulfate What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Non-Proprietary Name Gentamicin Sulfate What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Labeler Name Sparhawk Laboratories, Inc.
Product Type Prescription Animal Drug
Usage Information
    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.
Active Ingredient(s)
  • Gentamicin Sulfate
Marketing Category ANADA - ABBREVIATED NEW ANIMAL DRUG APPLICATION What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
FDA Application Number ANADA200395 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Gentamicin Sulfate Images

Gentamicin Sulfate Animal Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



General Precautions



Not For Use in Humans

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


Description



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


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 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.


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.


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



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).


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.


Other



CONTACT INFORMATION: To report suspected adverse drug events, for technical assistance or to obtain a copy of the Safety Data Sheet, contact Sparhawk Laboratories, Inc. at 1-800-255-6368 or 1-913-888-7500. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or www.fda.gov/reportanimalae


Package Label.Principal Display Panel



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

Approved by FDA under ANADA # 200-395


* The information on this page is for an ANIMAL PRODUCT, please review the complete disclaimer below.