(GENTAMICIN SULFATE WITH
Net Contents: 60 mL
Caution: Federal law restricts this
drug to use by or on the order of
a licensed veterinarian.
ANADA 200-388, Approved by FDA
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.
Usual dose: Two depressions of the
sprayer head 2 to 4 times daily for 7 days.
Keep out of Reach of Children.
For animal use only.
Read accompanying directions carefully.
Store upright between 2oC and 30oC
(36oF and 86oF)
St. Joseph, MO 64507
DESCRIPTION: Each mL contains: gentamicin sulfate equivalent to 0.57
gentamicin base, betamethasone valerate equivalent to 0.284 mg
163 mg isopropyl alcohol, propylene glycol, methylparaben and
preservatives, purified water q.s. Hydrochloric acid may be added to
Chemistry, Pharmacology and Toxicity
CHEMISTRY: Gentamicin is a mixture of aminoglycoside antibiotics
derived from the
fermentation of Micromonospora purpurea. Gentamicin sulfate is a mixture
salts of the antibiotics produced in this fermentation. The salts are
and freely soluble in water.
Gentamicin sulfate contains not less than 500 micrograms of
gentamicin base per
Betamethasone valerate is a synthetic glucocorticoid.
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
negative bacteria isolated from domestic animals. 1,2
Specifically, gentamicin is
active against the following organisms isolated from canine skin:
sp., Citrobacter sp., Klebsiella sp., Pseudomonas aeruginosa,
and -negative Proteus sp., Escherichia coli, Enterobacter sp.,
Betamethasone valerate emerged from intensive research as the most
promising of some 50 newly synthesized corticosteroids in
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
Betamethasone valerate in veterinary medicine has been shown to
anti-inflammatory and antipruritic activity in the topical management of
corticosteroid-responsive infected superficial lesions in dogs.
TOXICITY: Gentamicin sulfate with betamethasone valerate topical
Systemic effects directly related to treatment were confined to
was well-tolerated in an abraded skin study in dogs. No
toxicological changes in the skin were observed.
changes in the adrenals, liver and kidney and to organ-to-body
weight ratios of adrenals. All were dose related, were typical for or
unexpected with corticosteroid therapy and were considered reversible
with cessation of treatment.
WARNING: Clinical and experimental data have demonstrated that
corticosteroids administered orally or parenterally to animals may
first stage of parturition when administered during the last trimester
pregnancy and may precipitate premature parturition followed by
fetal death, retained placenta and metritis.
Additionally, corticosteroids administered to dogs, rabbits and
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
Indications and contraindications
INDICATIONS: For the treatment of infected superficial lesions in
caused by bacteria susceptible to gentamicin.
CONTRAINDICATIONS: If hypersensitivity of any of the components
occurs, discontinue treatment and institute appropriate therapy.
Dosage and 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.
Side Effects and 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
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
Avoid ingestion. Oral or parenteral use of corticosteroids, depending
dose, duration and specific steroid may result in inhibition of
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
usual signs of adrenocorticoid overdosage, which includes sodium
retention, potassium loss, fluid retention, weight gains, polydipsia
polyuria. Prolonged use or overdosage may produce adverse
How Supplied and Storage
HOW SUPPLIED: Plastic spray bottles containing 60 mL, 120 mL and
Store upright between 2oC and 30oC (36oF and 86oF).
240 mL of Gentamicin Sulfate with Betamethasone Valerate Topical Spray.
1. Hennessy, PW, et al. In vitro activity of gentamicin against
isolated from domestic animals. Veterinary Medicine/Small Animal
Clinician. November 1971; 1118-1122.
2. Bachmann, HJ, et al. Comparative in vitro activity of gentamicin
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.
Manufactured for: VEDCO INC.
St. Joseph, MO 64507