Relifor
Gentamicin Sulfate with Betamethasone Valerate Topical Spray
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:
Ear 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 infections of the skin. In vitro, gentamicin is
bactericidal against a wide variety of gram-positive and gram-negative bacteria
isolated from domestic animals. Specifically, gentamicin is active against the
following organisms isolated from canine skin: Alcaligenes sp., Citrobacter
sp., Kiebsiella 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 McKenzi, et al. This human bioassay technique has been found reliable for
evaluating the 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.
Warning:
Clinical and experimental data have demonstrated that corticosteroids
administered orally or parenterally to animals may induce the first stage of
parturition which 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, phocornelia and anasarca have been reported in offspring of
dogs which received corticosteroids during pregnancy.
Indications:
For the treatment of infected superficial lesions in dogs caused by bacteria
sensitive to gentamicin.
Contraindictions:
If hypersensitivity to any of the components occurs, treatment with this
product should be discontinued and appropriate therapy instituted.
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.
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 the cessation of
treatment.
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 the 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 then 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
corticosteroid 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 effecs.
How Supplied:
Plastic spray bottle containing 60 mL, 120 mL or 240 mL of Gentamicin Sulfate
with Betamethasone Valerate Topical Spray.
Store upright between 2° and 30°C (36° and 86°F).
References:
1. Hennessey 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 clinical samples from dogs, cats,
horses and cattle. Veterinary Medicine/Small Animal Clinician. October 1975:
1218-1222.
3. McKenzi, HW., Atkinson, RM: Topical activities of betamethasone esters in
man. Arch Derm. 1964; 19:741-746.
April 1999
Manufactured MED-PHARMEX,
Inc. Pomona,
CA 91767