GENTACALM- gentamicin sulfate and betamethasone valerate spray

GENTACALM by

Drug Labeling and Warnings

GENTACALM by is a Animal medication manufactured, distributed, or labeled by Dechra Veterinary Products. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 20C and 300C
(360F and 860F)

Manufactured For       
Dechra Veterinary Products
Overland Park, KS 662211

Lot No.
Exp. Date

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.

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

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.

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.

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).

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

Gentacalm 60 mL Bottle Label

60 mL Bottle Label

PRINCIPAL DISPLAY PANEL

60 mL box image

PRINCIPAL DISPLAY PANEL

120 mL bottle label image

PRINCIPAL DISPLAY PANEL

120 mL box image

PRINCIPAL DISPLAY PANEL

240 mL bottle image label

PRINCIPAL DISPLAY PANEL

240 mL box image

Outcert Front Panel

Outcert front panel

Outcert Back Panel

Outcert back panel

INGREDIENTS AND APPEARANCE

GENTACALM 
gentamicin sulfate and betamethasone valerate spray

Product Information
Product Type	PRESCRIPTION ANIMAL DRUG	Item Code (Source)	NDC: 17033-335
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 VALERATE	0.284 mg  in 1 mL
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	163 mg  in 1 mL

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)