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GENTACALM Dailymed


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GENTACALM Topical Spray

(Gentamicin Sulfate WithBetamethasone Valerate)

Veterinary

CAUTION: Federal Law restricts this drugto 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 sulfateequivalent to 0.57 mg gentamicin base,betamethasone valerate equivalent to0.284 mg betamethasone, 163 mgisopropyl alcohol, propylene glycol,methylparaben and propylparaben aspreservatives, 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 thesprayer head 2 to 4 times daily for 7 days. Read accompanying directions carefully. Store upright between 20C and 300C(360F and 860F) Manufactured For        Dechra Veterinary ProductsOverland Park, KS 662211 Lot No.Exp. Date

Animal Pharmacology & Or Toxicology Section


PRODUCT INFORMATION ANADA 200-388, Approved by FDAGENTAMICIN SULFATE WITH BETAMETHASONEVALERATE TOPICAL SPRAY (Gentamicin Sulfate, USP With BetamethasoneValerate, USP Topical Spray)

         VeterinaryFor Topical Use in Dogs OnlyFor Animal Use Only



CAUTION: Federal Law restricts this drugto use by or on the order of a licensed veterinarian DESCRIPTION: Each mL contains: gentamicin sulfateequivalent to 0.57 mg gentamicin base,betamethasone valerate equivalent to 0.284 mgbetamethasone, 163 mg isopropyl alcohol, propyleneglycol, methylparaben and propylparaben aspreservatives, purified water q.s.Hydrochloric acid may be added to adjust pH.

CHEMISTRY: Gentamicin is a mixture of aminoglycoside antibiotics derived from thefermentation of Micromonospora purpurea. Gentamicin sulfate is a mixture of sulfatesalts of the antibiotics produced in this fermentation. The salts are weakly acidicand freely soluble in water.

Gentamicin sulfate contains not less than 500 micrograms of gentamicin base permilligram.

Betamethasone valerate is a synthetic glucocorticoid.

PHARMACOLOGY: Gentamicin, a broad-spectrum antibiotic, is a highlyeffective 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 isactive against the following organisms isolated from canine skin: Alcaligenes sp., Citrobacter sp., Klebsiella sp., Pseudomonas aeruginosa, indole-positiveand -negative Proteus sp., Escherichia coli, Enterobacter sp.,  Staphlyococcus sp.and Streptococcus sp.

Betamethasone valerate emerged from intensive research as the mostpromising of some 50 newly synthesized corticosteroids in theexperimental model described by McKenzie,3 et al. This human bioassaytechnique has been found reliable for evaluating vasoconstrictorproperties of new topical corticosteroids and is useful in predicting clinicalefficacy.

Betamethasone valerate in veterinary medicine has been shown to provideanti-inflammatory and antipruritic activity in the topical management ofcorticosteroid-responsive infected superficial lesions in dogs.

Warnings Section


WARNING: Clinical and experimental data have demonstrated thatcorticosteroids administered orally or parenterally to animals may induce thefirst stage of parturition when administered during the last trimester ofpregnancy and may precipitate premature parturition followed by dystocia,fetal death, retained placenta and metritis. Additionally, corticosteroids administered to dogs, rabbits and rodentsduring pregnancy have produced cleft palate. Other congenital anomalies,including deformed forelegs, phocomelia and anasarca, have beenreported in offspring of dogs which received corticosteroids duringpregnancy.

Indications & Usage Section


INDICATIONS: For the treatment of infected superficial lesions in dogscaused by bacteria susceptible to gentamicin. CONTRAINDICATIONS: If hypersensitivity of any of the componentsoccurs, discontinue treatment and institute appropriate therapy.

Dosage & Administration Section


DOSAGE AND ADMINISTRATION: Prior to treatment, remove excessivehair and clean the lesion and adjacent area. Hold bottle upright 3 to 6inches from the lesion and depress the sprayer head twice. Administer 2to 4 times daily for 7 days. Each depression of the sprayer head delivers 0.7 mL of GentamicinSulfate With Betamethasone Valerate Topical Spray.

Animal Pharmacology & Or Toxicology Section


TOXICITY: Gentamicin sulfate with betamethasone valerate topical spraywas well-tolerated in an abraded skin study in dogs. No treatment-relatedtoxicological changes in the skin were observed. Systemic effects directly related to treatment were confined to histologicalchanges in the adrenals, liver and kidney and to organ-to-bodyweight ratios of adrenals. All were dose related, were typical for or notunexpected with corticosteroid therapy and were considered reversiblewith cessation of treatment.

General Precautions Section


SIDE EFFECTS: Side effects such as SAP and SGPT enzymeelevations, weight loss, anorexia, polydipsia and polyuria have occurredfollowing 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 withprolonged or repeated steroid therapy. PRECAUTIONS: Antibiotic susceptibility of the pathogenic organism(s)should be determined prior to use of this preparation. Use of topicalantibiotics may permit overgrowth of non-susceptible bacteria, fungi oryeasts. If this occurs, treatment should be instituted with otherappropriate agents as indicated. Administration of recommended dose beyond 7 days may result indelayed wound healing. Animals treated longer than 7 days should bemonitored closely. Avoid ingestion. Oral or parenteral use of corticosteroids, depending ondose, duration and specific steroid may result in inhibition of endogenoussteroid production following drug withdrawal. In patients presently receiving or recently withdrawn from systemiccorticosteroids treatments, therapy with a rapidly acting corticosteroidshould be considered in especially stressful situations. If ingestion should occur, patients should be closely observed for theusual signs of adrenocorticoid overdosage, which includes sodiumretention, potassium loss, fluid retention, weight gains, polydipsia and/orpolyuria. Prolonged use or overdosage may produce adverseimmunosuppressive effects.

Storage And Handling Section


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).

References Section


REFERENCES: 1. Hennessy, PW, et al. In vitro activity of gentamicin against bacteriaisolated from domestic animals.  Veterinary Medicine/Small AnimalClinician. November 1971; 1118-1122. 2. Bachmann, HJ, et al. Comparative in vitro activity of gentamicin andother antibiotics against bacteria isolated from clincial samples fromdogs, cats, horses and cattle. Veterinary Medicine/Small AnimalClinician. October 1975; 1218-1222. 3. McKenzie, HW and Atkinson, RM. Topical activities of betamethasoneesters in Man. Arch Derm. May 1964;741-746. June 2009 Manufactured For:                                          Dechra Veterinary Products Overland Park, KS 66211

Gentacalm 60 Ml Bottle Label


60 mL Bottle Label



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120 mL bottle label image



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120 mL box image



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240 mL bottle image label



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240 mL box image



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