Label: GENTAVED- gentamicin sulfate spray
- NDC Code(s): 50989-433-19, 50989-433-74, 50989-433-75
- Packager: Vedco, Inc.
- Category: PRESCRIPTION ANIMAL DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Animal Drug Application
Updated November 29, 2017
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GENTAMICIN SULFATE WITH BETAMETHASONE VALERATE TOPICAL SPRAY
ANADA 200-416, Approved by FDA
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.
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.
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.
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.
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.
- DOSAGE AND ADMINISTRATION
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 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.
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 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 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
- STORAGE AND HANDLING
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 spray
Product Information Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:50989-433 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:50989-433-19 60 mL in 1 BOTTLE, PUMP 2 NDC:50989-433-75 120 mL in 1 BOTTLE, PUMP 3 NDC:50989-433-74 240 mL in 1 BOTTLE, PUMP Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANADA ANADA200416 06/15/2013 Labeler - Vedco, Inc. (021634266)