Label: GENTACALM - gentamicin sulfate, betamethasone valerate and isopropyl alcohol spray

  • NDC Code(s): 17033-335-12, 17033-335-24, 17033-335-60
  • Packager: Dechra Veterinary Products
  • Category: PRESCRIPTION ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Animal Drug Application

Drug Label Information

Updated 02/13

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  • Front Panel Label

    GENTACALM
    Topical Spray

    (Gentamicin Sulfate With
    Betamethasone Valerate)

    Veterinary

    CAUTION: Federal Law restricts this drug
    to use by or on the order of a
    licensed veterinarian

    ANADA 200-388, Approved by FDA

    NDC 17033-335-12

    Net Contents: 60 mL, 120 mL, or 240 mL Bottles

    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.

    For topical use in dogs only.
    For animal use only.
    Keep out of Reach of Children.

    Usual dose:
    Two depressions of the
    sprayer head 2 to 4 times daily for 7 days.

    Read accompanying directions carefully.

    Store upright between 2 0C and 30 0C
    (36 0F and 86 0F)

    Manufactured For       
    Dechra Veterinary Products
    Overland Park, KS 662211

    Lot No.
    Exp. Date

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  • ANIMAL PHARMACOLOGY & OR TOXICOLOGY

    PRODUCT INFORMATION
    ANADA 200-388, Approved by FDA
    GENTAMICIN SULFATE WITH BETAMETHASONE
    VALERATE TOPICAL SPRAY

    (Gentamicin Sulfate, USP With Betamethasone
    Valerate, USP Topical Spray)

             Veterinary
    For Topical Use in Dogs Only
    For Animal Use 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.

    PHARMACOLOGY: Gentamicin, a broad-spectrum antibiotic, is a highly
    effective topical treatment for bacterial infection 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.,  Staphlyococcus 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.


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  • 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. Close
  • INDICATIONS & USAGE

    INDICATIONS: For the treatment of infected superficial lesions in dogs
    caused by bacteria susceptible to gentamicin.

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

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  • 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.

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  • 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.

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  • GENERAL PRECAUTIONS


    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.

    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 includes sodium
    retention, potassium loss, fluid retention, weight gains, polydipsia and/or
    polyuria. Prolonged use or overdosage may produce adverse
    immunosuppressive effects.

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  • STORAGE AND HANDLING


    HOW SUPPLIED:
    Plastic spray bottles containing 60 mL, 120 mL
    and 240 mL of Gentamicin Sulfate with Betamethasone Valerate Topical Spray.

    Store upright between 20C and 300C (360F and 860F). Close
  • 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.

    June 2009

    Manufactured For:                                         

    Dechra Veterinary Products

    Overland Park, KS 66211
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  • Gentacalm 60 mL Bottle Label

    60 mL Bottle Label

    60 mL bottle label image

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  • SPL UNCLASSIFIED SECTION

    60 mL box image

    60 mL box image

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  • PRINCIPAL DISPLAY PANEL

    120 mL bottle label image

    120 mL bottle label image

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  • SPL UNCLASSIFIED SECTION

    120 mL box image

    120 mL box image

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  • PRINCIPAL DISPLAY PANEL

    240 mL bottle image label

    240 mL bottle image label

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  • SPL UNCLASSIFIED SECTION

    240 mL box image

    240 mL box image

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  • Outcert Front Panel

    Outcert front panel

    Outcert front panel

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  • Outcert Back Panel

    Outcert back panel

    Outcert back panel

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  • INGREDIENTS AND APPEARANCE
    GENTACALM 
    gentamicin sulfate and betamethasone valerate spray
    Product Information
    Product Type PRESCRIPTION ANIMAL DRUG LABEL Item Code (Source) NDC:17033-335
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    GENTAMICIN SULFATE (GENTAMICIN) GENTAMICIN 0.57 mg  in 1 mL
    BETAMETHASONE VALERATE (BETAMETHASONE) BETAMETHASONE VALERATE 0.284 mg  in 1 mL
    ISOPROPYL ALCOHOL (ISOPROPYL ALCOHOL) ISOPROPYL ALCOHOL 163 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    PROPYLENE GLYCOL  
    METHYLPARABEN  
    PROPYLPARABEN  
    WATER  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:17033-335-60 12 in 1 BOX
    1 60 mL in 1 BOTTLE, SPRAY
    2 NDC:17033-335-12 12 in 1 BOX
    2 120 mL in 1 BOTTLE, SPRAY
    3 NDC:17033-335-24 12 in 1 BOX
    3 240 mL in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANADA ANADA200388 01/24/2013
    Labeler - Dechra Veterinary Products (362142734)
    Registrant - American Pharmaceuticals and Cosmetics, Inc. (038023805)
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