Gentamicin and betamethasone

Indications

For topical use in dogs only. For the treatment of infected superficial lesions in dogs caused by bacteria susceptible to gentamicin. Read accompanying directions carefully. DIRECTIONS FOR USE: Usual Dosage: Two depressions of the sprayer head 2 to 4 times daily for 7 days. Manufactured for: Dechra Veterinary Products Overland Park, KS 66211 USA Rev. January 2023 GENTACALM is a registered trademark of Dechra Veterinary Products, LLC. image of eye clock

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 GENTACALM ® Topical Spray. TOXICITY: GENTACALM ® 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. 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.

Contraindications

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

Warnings

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 congenital anomalies including deformed forelegs, phocomelia, and anasarca have been reported in offspring of dogs that received corticosteroids during pregnancy.

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 retention, weight gains, polydipsia, and/or polyuria. Prolonged use or overdosage may produce adverse immunosuppressive effects.

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., Staphylococcu s 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.

Storage

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

Other labels for this ingredient

These labels are also stored for the same active ingredient. They are not identical to the one reprinted above, and each is listed by product and set id rather than merged with it.

• Gentamicin Sulfate With Betamethasone Valerate TOPICAL SPRAY, Covetrus North America. Set id e732e591-fe4e-4fef-a9ea-ba3a0495995e.
• GentaVed Topical Spray Gentamicin Sulfate With Betamethasone Valerate TOPICAL SPRAY, Vedco, Inc.. Set id f65a673e-a374-462b-a5fd-8cf1ebc9561f.
• GenOne ™ Spray, MWI. Set id 83e23b7f-9007-487f-b519-65fb4707fbbc.

FDA adverse event reports

The FDA Center for Veterinary Medicine publishes the adverse event reports it receives through openFDA. The counts below are the reports naming gentamicin and betamethasone as an active ingredient for each species this label names, as returned on 2026-09-16, coded by the VeDDRA reaction term the reporter chose. Reactions are counted per report, so one report can appear under several terms.

These are counts, not rates. Reporting is voluntary, the number of animals treated is not known, and a widely used product accumulates reports for that reason alone. A report records that an event followed a dose; it does not establish that the product caused it. The counts say nothing about how one product compares with another.