Animal NDC 54925-028-06 Betagen
Gentamicin Sulfate With Betamethasone Valerate
Animal Product Information
Betagen Animal Product Labeling Information
The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.
Table of Contents
Description
For Topical Use in Dogs Only.
Approved by FDA under ANADA # 200-188
CAUTION: Federal law restricts this drug to use by or on the order of a licensed veterinarian.
DESCRIPTION: Each mL contains: gentamicin sulfate equivalent to 0.57 mg gentamicin base, betamethasone valerate 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 purpures. 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.
Animal Pharmacology & Or Toxicology
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 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.
TOXICITY: Gentamicin sulfate with betamethasone valerate 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.
Warnings
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 congenital anomalies,
including deformed forelegs, phocomelia and anasarca, have been reported in offspring of dogs which received corticosteroids during pregnancy.
Indications & Usage
INDICATIONS: For the treatment of infected superficial lesions in dogs caused by bacteria susceptible to gentamicin.
Contraindications
CONTRAINDICATIONS: If hypersensitivity of any of the components occurs, treatment with this product should be discontinued and appropriate therapy instituted.
Dosage & Administration
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 BetagenTM Topical Spray.
Adverse Reactions
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.
CONTACT INFORMATION:
To report suspected adverse drug events, for technical assistance or to obtain a copy of the Safety Data Sheet (SDS), contact Med-Pharmex at (800) 587-4306. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or online at http://www.fda.gov/reportanimalae
Precautions
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 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 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 corticosteroids 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, which include sodium
retention, potassium loss, fluid retention, weight gains, polydipsia and/or polyuria. Prolonged use or overdosage may produce adverse
immunosuppressive effects.
How Supplied
HOW SUPPLIED: Plastic spray bottle containing either 60 mL, 120 mL or 240 mL of BetagenTM Topical Spray.
Storage And Handling
STORAGE: Store upright between 2° and 30°C (36°F and 86°F).
References
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 clincial samples from
dogs, cats, horses and cattle. Veterinary Medicine/Small Animal Clinician. October 1975; 1218-1222.
3. McKenzie, HW and Atkinson, RM. Topical activities of betamethasone esters in man. Arch Derm. May 1964; 741-746.
Manufactured by:
Med-Pharmex, Inc.
Pomona, CA 91767
Rev. April 2023
* The information on this page is for an ANIMAL PRODUCT, please review the complete disclaimer below.