GENTAMICIN SULFATE- gentamicin sulfate and betamethasone valerate spray 
FIRST PRIORITY INCORPORATED

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Gentamicin Sulfate Topical Spray


Gentamicin Sulfate, USP With Betamethasone Valerate, USP

Veterinary

For Topical Use in Dogs Only

For Animal Use Only

CAUTION:

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

DESCRIPTION:

Each mL contains: gentamicin sulfate, USP equivalent to 0.57 mg gentamicin base, betamethasone valerate, USP equivalent to 0.284 mg betamethasone, 163 mg isopropyl alcohol, propylene glycol, methylparaben and propylparaben as preservatives, purified water q.s. Hydrochloric acid may be added to adjust pH.

CHEMISTRY:

Gentamicin is a mixture of aminoglycoside antibiotics derived from the fermentation of Micromonospora purpurea. Gentamicin sulfate veterinary is a mixture of sulfate salts of the antibiotics produced in this fermentation. The salts are weakly acidic and freely soluble in water.

Gentamicin sulfate veterinary contains not less than 500 micrograms of gentamicin base per milligram.

Betamethasone valerate is a synthetic glucocorticoid.

PHARMACOLOGY:

Gentamicin, a broad-spectrum antibiotic, is a highly effective topical treatment for bacterial infections of the skin. In vitro, gentamicin is bactericidal against a wide variety of gram-positive and gram-negative bacteria isolated from domestic animals.1,2 Specifically, gentamicin is active against the following organisms isolated from canine skin: Alcaligenes sp., Citrobacter sp., Klebsiella sp., Pseudomonas aeruginosa, indole-positive and -negative Proteus sp., Escherichia coli, Enterobacter sp., Staphylococcus sp., and Streptococcus sp. Betamethasone valerate emerged from intensive research as the most promising of some 50 newly synthesized corticosteroids in the experimental model described by McKenzie,3 et al.

This human bioassay technique has been found reliable for evaluating the vasoconstrictor properties of new topical corticosteroids and is useful in predicting clinical efficacy.

Betamethasone valerate in veterinary medicine has been shown to provide anti-inflammatory and antipruritic activity in the topical management of corticosteroid-responsive infected superficial lesions in dogs.

WARNING:

Clinical and experimental data have demonstrated that corticosteroids administered orally or parenterally to animals may induce the first stage of parturition when administered during the last trimester of pregnancy and may precipitate premature parturition followed by dystocia, fetal death, retained placenta, and metritis.

Additionally, corticosteroids administered to dogs, rabbits, and rodents during pregnancy have produced cleft palate. Other congential anomalies including deformed forelegs, phocomelia, and anasarca have been reported in offspring of dogs that received corticosteroids during pregnancy.

INDICATIONS:

For the treatment of infected superficial lesions in dogs caused by bacteria susceptible to gentamicin.

Keep Out of Reach of Children.

CONTRAINDICATIONS:

If hypersensitivity to any of the components occurs, discontinue treatment and institute appropriate therapy.

DOSAGE AND ADMINISTRATION:

Prior to treatment, remove excessive hair and clean the lesion and adjacent area. Hold bottle upright 3 to 6 inches from the lesion and depress the sprayer head twice. Administer 2 to 4 times daily for 7 days.

Each depression of the sprayer head delivers 0.7 mL of Gentamicin Sulfate Topical Spray.

TOXICITY:

Gentamicin Sulfate Topical Spray was well-tolerated in an abraded skin study in dogs. No treatment-related toxicological changes in the skin were observed.

Systemic effects directly related to treatment were confined to histological changes in the adrenals, liver, and kidney and to organ-to-body weight ratios of adrenals. All were dose related, were typical for or not unexpected with corticosteroid therapy, and were considered reversible with cessation of treatment.

SIDE EFFECTS:

Side effects such as SAP and SGPT enzyme elevations, weight loss, anorexia, polydipsia, and polyuria have occurred following parenteral or systemic use of synthetic corticosteroids in dogs. Vomiting and diarrhea (occasionally bloody) have been observed in dogs.

Cushing’s syndrome in dogs has been reported in association with prolonged or repeated steroid therapy.

PRECAUTIONS:

Antibiotic susceptibility of the pathogenic organism(s) should be determined prior to use of this preparation. Use of topical antibiotics may permit overgrowth of nonsusceptible bacteria, fungi, or yeasts. If this occurs, treatment should be instituted with other appropriate agents as indicated.

Administration of recommended dose beyond 7 days may result in delayed wound healing. Animals treated longer than 7 days should be monitored closely.

Avoid ingestion. Oral or parenteral use of corticosteroids, depending on dose, duration, and specific steroid may result in inhibition of endogenous steroid production following drug withdrawal.

In patients presently receiving or recently withdrawn from systemic corticosteroid treatments, therapy with a rapidly acting corticosteroid should be considered in especially stressful situations.

If ingestion should occur, patients should be closely observed for the usual signs of adrenocorticoid overdosage that include sodium retention, potassium loss, fluid retension, weight gains, polydipsia, and/or polyuria. Prolonged use or overdosage may produce adverse immunosuppressive effects.

HOW SUPPLIED:

Plastic spray bottles containing 60 mL, 120 mL and 240 mL of Gentamicin Sulfate Topical Spray

Store upright between 2° and 30°C (36° and 86°F).

REFERENCES:

  1. Hennessy PW, et al. In vitro activity of gentamicin against bacteria isolated from domestic animals. Veterinary Medicine/SmallAnimalClinician. November 1971; 1118-1122.
  2. Bachmann HJ, et al. Comparative in vitro activity of gentamicin and other antibiotics against bacteria isolated from clinical samples from dogs, cats, horses, and cattle. Veterinary Medicine/Small Animal Clinician.  October 1975; 1218-1222.
  3. McKenzie HW, Atkinson RM. Topical activities of betamethasone esters in man. Arch Derm. May 1964; 741-746.

Rev. 04-08

Priority Care is a registered trademark of First Priority, Inc.

Manufactured by: First Priority, Inc. Elgin, IL 60123-1146

ANADA# 200-415, Approved by FDA

image of 60 mL bottle/case label

image of 60 mL bottle/case label (iss. 10-08)

image of 120 mL bottle/case label

image of 120 mL bottle/case label (iss. 10-08)

image of 240 mL bottle/case label

image of 240 mL bottle/case label (iss. 10-08)

GENTAMICIN SULFATE 
gentamicin sulfate spray
Product Information
Product TypePRESCRIPTION ANIMAL DRUG LABELItem Code (Source)NDC:58829-337
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GENTAMICIN SULFATE (GENTAMICIN) GENTAMICIN0.0599 g  in 100 mL
BETAMETHASONE VALERATE (BETAMETHASONE) BETAMETHASONE0.0352 g  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58829-337-6012 in 1 CASE
160 mL in 1 BOTTLE, SPRAY
2NDC:58829-337-1212 in 1 CASE
2120 mL in 1 BOTTLE, SPRAY
3NDC:58829-337-2412 in 1 CASE
3240 mL in 1 BOTTLE, SPRAY
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANADAANADA20041508/31/2013
Labeler - FIRST PRIORITY INCORPORATED (179925722)
Establishment
NameAddressID/FEIBusiness Operations
FIRST PRIORITY INCORPORATED179925722manufacture

Revised: 8/2013
Document Id: f4cff860-3454-4b60-a646-6aab79e025f1
Set id: 9e62cd03-9f18-4385-bf51-cf3912bf5568
Version: 1
Effective Time: 20130822
 
FIRST PRIORITY INCORPORATED