GENTAMICIN SULFATE spray

Gentamicin Sulfate by

Drug Labeling and Warnings

Gentamicin Sulfate by is a Animal medication manufactured, distributed, or labeled by Covetrus North America. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DESCRIPTION

GENTAMICIN SULFATE WITH BETAMETHASONE VALERATE TOPICAL SPRAY

Approved by FDA under ANADA # 200-416

For Topical Use in Dogs Only

For Animal Use Only

Keep Out of Reach of Children

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 equivalent to 0.284 mg betamethasone, 163 mg isopropyl alcohol, isopropyl alcohol, propylene glycol, methylparaben and propylparaben as preservatives, purified water q.s. Hydrochloric acid may be added to adjust pH.

CLINICAL PHARMACOLOGY

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 and freely soluble in water.  

Gentamicin sulfate 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 McKenzie3, 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.

WARNINGS

Clinical and experimental data have demonstrated that corticosteriods administrated 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 congenital abnormalities including deformed forelegs, phocomelia, and anasarca have been reported in offspring of dogs which received corticosteroids during pregnancy.

INDICATIONS

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

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, USP with betamethasone valerate, USP.

TOXICITY

Gentamicin Sulfate with betamethasone valerate topical spray was well tolerated in a 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 corticosteroids 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.

Cushings 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 the use of this preparation. Use of topical antibiotics may permit overgrowth of non-susceptible 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 parental 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 system 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 overdose which includes sodium retention, potassium loss, fluid retention, weight gains, polydipsia, and/or polyuria. Prolonged use or overdose may produce adverse immunosuppressive effects.

HOW SUPPLIED

Plastic spray bottle containing 60 mL, 120 mL, or 240 mL of Gentamicin Topical Spray.

STORAGE AND HANDLING

Store upright between 20o-25oC (68o-77oF), excursions permitted between 15o and 30o (between 59o and 86oF).

TAKE TIME OBSERVE LABEL DIRECTIONS.

REFERENCES

1.  Hennessy PW, et al. In vitro activity of gentamicin against bacteria isolated from domestic animals. Veterinary Medicine/Small Animal Clinician. 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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

GENTAMICIN SULFATE 
gentamicin sulfate spray

Product Information
Product Type	PRESCRIPTION ANIMAL DRUG	Item Code (Source)	NDC: 11695-7009
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GENTAMICIN SULFATE (UNII: 8X7386QRLV) (GENTAMICIN - UNII:T6Z9V48IKG)	GENTAMICIN	0.57 mg  in 1 mL
BETAMETHASONE VALERATE (UNII: 9IFA5XM7R2) (BETAMETHASONE - UNII:9842X06Q6M)	BETAMETHASONE VALERATE	0.284 mg  in 1 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11695-7009-1	60 mL in 1 BOTTLE, SPRAY
2	NDC: 11695-7009-2	120 mL in 1 BOTTLE, SPRAY
3	NDC: 11695-7009-3	240 mL in 1 BOTTLE, SPRAY

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANADA	ANADA200416	08/31/2022

Labeler - Covetrus North America (603750329)