Topagen Spray (Canada)

Company: Merck Animal Health

Betamethasone valerate and Gentamicin sulfate Spray

DIN 00602841

Glucocorticoid / Antibiotic

For Topical Use Only In Dogs

CONTAINS ANTIMICROBIAL

USE RESPONSIBLY

VETERINARY USE ONLY

Active Ingredients

Each mL contains: 0.57 mg gentamicin (as sulfate) Ph.Eur. and 0.284 mg betamethasone (as valerate) Ph.Eur.

Description

Gentamicin, as sulfate, is a water soluble (bactericidal) antibiotic of the aminoglycoside group, derived from Micromonospora, an actinomycete.

Betamethasone valerate is a synthetic glucocorticoid derivative of prednisolone.

Action

Gentamicin, a broad spectrum antibiotic, is a highly effective topical treatment for bacterial infections. Gentamicin is bactericidal in vitro against a wide variety of gram-positive and gram-negative bacteria isolated from domestic animals. Specifically gentamicin is active against the following organisms: Alcaligenes sp., Citrobacter sp., Klebsiella sp., Pseudomonas aeruginosa, Proteus sp. (indole positive and negative), Escherichia coli, Enterobacter sp., Staphylococcus sp., and Streptococcus sp.

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

Topagen Spray Indications

TOPAGEN spray is indicated for the treatment, in dogs, of superficial skin lesions infected by the bacteria: Alcaligenes sp., Citrobacter sp., Klebsiella sp., Pseudomonas aeruginosa, indole positive and negative Proteus sp., Escherichia coli, Enterobacter sp., Staphylococcus sp., and Streptococcus sp. which are susceptible to gentamicin.

Topagen Spray 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 four times daily for 7 days.

Each depression of the sprayer head delivers 0.7 mL of TOPAGEN, containing 0.4 mg gentamicin and 0.2 mg betamethasone.

Contraindications

If hypersensitivity to any of the components occurs, treatment should be discontinued and appropriate therapy instituted. TOPAGEN spray is not indicated for the treatment of fungal infections of the skin of dogs.

Topagen Spray Cautions

Antibiotic susceptibility of the pathogenic organism(s) should be determined prior to 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 the other appropriate agents as indicated.

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

WARNINGS

Keep out of reach of children.

Adverse Reactions

The possibility of delayed wound healing and sensitivity should be kept under consideration.

Adverse systemic reactions have been observed following the oral ingestion of some topical corticosteroid preparations. Although topical steroids have not been reported to have an adverse effect on pregnancy, the safety of their use in pregnancy has not been established. Therefore, TOPAGEN spray should not be used extensively on pregnant dogs, in large amounts, or for prolonged periods of time.

Overdose

Dogs should be closely observed for clinical signs associated with adrenocorticoid overdosage which include sodium retention, potassium loss, fluid retention, weight gains, polydipsia and/or polyuria. Prolonged use or overdosage may produce adverse immunosuppressive effects.

Toxicology

TOPAGEN 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.

Storage

Store upright between 2°C and 30°C.

How Supplied

TOPAGEN spray is available in a plastic bottle containing 70 mL.

^® Intervet Canada Corp.

INTERVET CANADA CORP., subsidiary of Merck & Co., Inc., 16750, route Transcanadienne, Kirkland, QC H9H 4M7

1 866 683-7838

Version: March 20, 2019

CPN: 1208084.8