Label: BETAGEN- gentamicin sulfate with betamethasone valerate spray

  • NDC Code(s): 54925-028-06, 54925-028-12, 54925-028-24
  • Packager: Med-Pharmex, Inc
  • Category: PRESCRIPTION ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Animal Drug Application

Drug Label Information

Updated April 1, 1999

If you are a consumer or patient please visit this version.

  • DESCRIPTION

    ANADA #200-188, Approved by FDA
    Veterinary

    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 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.

  • 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 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.

  • 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.

  • 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 60 mL, 120 mL and 240 mL of Gentamicin Sulfate with Betamethasone Valerate Topical Spray.

  • STORAGE AND HANDLING

    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.

    April 1999
    Manufactured by
    Med-Pharmex, Inc
    Pomona, CA 91767

  • PRINCIPAL DISPLAY PANEL

    Betagen Topical Spray 60mL

    Betagen Topical Spray 120mL

    Betagen Topical Spray 240 mL

  • INGREDIENTS AND APPEARANCE
    BETAGEN  
    gentamicin sulfate with betamethasone valerate spray
    Product Information
    Product TypePRESCRIPTION ANIMAL DRUGItem Code (Source)NDC:54925-028
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GENTAMICIN SULFATE (UNII: 8X7386QRLV) (GENTAMICIN - UNII:T6Z9V48IKG) GENTAMICIN0.57 mg  in 1 mL
    BETAMETHASONE VALERATE (UNII: 9IFA5XM7R2) (BETAMETHASONE - UNII:9842X06Q6M) BETAMETHASONE 0.284 mg  in 1 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54925-028-0660 mL in 1 BOTTLE, SPRAY
    2NDC:54925-028-12120 mL in 1 BOTTLE, SPRAY
    3NDC:54925-028-24240 mL in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANADAANADA20018804/01/1999
    Labeler - Med-Pharmex, Inc (025353699)