Gentamicin Sulfate with Betamethasone Valerate
Compare to GentaVed
Veterinary: For Topical Use in Dogs Only
INDICATIONS: For the treatment of
infected superficial lesions in dogs caused by bacteria sensitive to
gentamicin.
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 infections 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.,
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 McKenzie3, 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 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. |
CONTRAINDICATIONS: 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
GenOne™ Spray.
TOXICITY: GenOne™ 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.
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 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 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 effects.
HOW SUPPLIED: Plastic spray bottle
containing 60 mL, 120 mL or 240 mL of GenOne™ Spray.
Store upright between 2° and 30°C (36°F and 86°F).
CAUTION: Federal law restricts this drug
to use by or on the order of a licensed veterinarian.