Label: BETAGEN- gentamicin sulfate with betamethasone valerate spray
- NDC Code(s): 57319-551-54, 57319-551-69, 57319-551-70
- Packager: Clipper Distributing Company LLC
- Category: PRESCRIPTION ANIMAL DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Animal Drug Application
Updated April 1, 1999
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ANADA #200-188, Approved by FDA
For Topical Use in Dogs Only.
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 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.
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 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.
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
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 Gentamicin Sulfate with Betamethasone Valerate Topical Spray.
ANIMAL PHARMACOLOGY & OR TOXICOLOGY
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.
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 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
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
- 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 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. 1964; 19:741-746.
Pomona, CA 91767
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
gentamicin sulfate with betamethasone valerate spray
Product Information Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:57319-551 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 0.284 mg in 1 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:57319-551-54 60 mL in 1 BOTTLE, SPRAY 2 NDC:57319-551-70 120 mL in 1 BOTTLE, SPRAY 3 NDC:57319-551-69 240 mL in 1 BOTTLE, SPRAY Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANADA ANADA200188 04/01/1999 Labeler - Clipper Distributing Company LLC (150711039) Registrant - Med-Pharmex, Inc (025353699) Establishment Name Address ID/FEI Business Operations Med-Pharmex, Inc 025353699 manufacture