Description:
(GENTAMICIN
SULFATE WITH BETAMETHASONE VALERATE)
For Use in Dogs
and Cats Only
ANADA #200-183,
approved by FDA.
CAUTION:
Federal law restricts this drug to use by or on the order of a licensed
veterinarian.
DESCRIPTION:
GentaVed Otic Solution is packaged in a convenient plastic squeeze bottle
for easy application. Each mL of GentaVed Otic Solution contains gentamicin
sulfate equivalent to 3 mg gentamicin base, betamethasone valerate
equivalent to 1 mg betamethasone, 1.0 mg hydroxyethylcellulose, 2.5 mg
glacial acetic acid, 200 mg purified water, 19% ethanol, 9.4 mg benzyl
alcohol as preservative, 300 mg glycerin and propylene glycol q.s.
CHEMISTRY:
Gentamicin is a bactericidal antibiotic of the aminoglycoside group derived
from Micromonospora purpurea of the Actinomyces group. It is a
powder, white to buff in color, basic in nature, readily soluble in water
and highly stable in solution.
Betamethasone
valerate is a synthetic corticosteroid derivative of prednisolone.
ACTION:
GentaVed Otic Solution combines the broad-spectrum activity of gentamicin
sulfate with the anti-inflammatory and antipruritic activity of
betamethasone valerate. In vitro antibacterial activity1
has shown that gentamicin is active against most gram-negative bacteria
including Pseudomonas aeruginosa, indole-positive and negative
Proteus sp., Escherichia coli, Klebsiella pneumoniae, Aerobacter
aerogenes and Neisseria. Gentamicin is also active against
strains of gram-positive bacteria including Staphylococcus species
and some Streptococcus species.
Betamethasone
valerate has emerged from intensive research as the most promising of some
50 newly synthesized corticosteroids in the experimental model described by
McKenzie2 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 human medicine has been shown to provide anti-inflammatory and
antipruritic activity in the topical management of corticosteroid-responsive
dermatoses. In the response cases, the local anti-inflammatory activity is
sustained by the vasoconstrictor properties of the steroid.
TOXICITY
STUDIES: Parenterally, no
toxic effects were observed in rats given gentamicin sulfate 20 mg/kg/day
for twenty-four days; in cats given 10 mg/kg/day for forty days. Gentamicin
sulfate given to dogs at 6 mg/lb/day, 6 days weekly for three weeks, caused
no detectable kidney damage. At higher doses, impairment of equilibrium and
of renal function were observed in these species.
Subacute otic
toxicity in dogs showed gentamicin sulfate with betamethasone valerate
solution to be well tolerated locally with no adverse systemic effects when
administered at 5 drops twice a day for 21 consecutive days.
Gentamicin sulfate
in a 21-day subacute dermal toxicity study in dogs was shown to be well
tolerated when applied topically to abraded skin. There were no meaningful
findings except a reduction in eosinophil count attributable to absorption
of the corticosteroid component.
INDICATIONS:
GentaVed Otic Solution is
indicated for the treatment of acute and chronic canine otitis externa and
canine and feline superficial infected lesions caused by bacteria sensitive
to gentamicin.
DOSAGE AND
ADMINISTRATION: Duration of
treatment will depend upon the severity of the condition and the response
obtained. The duration of treatment and/or frequency of the dosage may be
reduced, but care should be taken not to discontinue therapy prematurely.
Otitis externa:
The external ear and ear canal should be properly cleaned and dried before
treatment. Remove foreign material, debris, crusted exudates, etc., with
suitable nonirritating solutions. Excessive hair should be clipped from the
treatment area of the external ear. Instill 3 to 8 drops of GentaVed Otic
Solution (approximately room temperature) into the ear canal twice daily for
seven to fourteen days.
Superficial
infected lesions: The lesion and adjacent area should be properly cleaned
before treatment. Excessive hair should be removed. Apply a sufficient
amount of GentaVed Otic Solution to cover the treatment area twice daily for
seven to fourteen days.
CONTRAINDICATIONS:
If hypersensitivity to any of the
components occurs, treatment with this product should be discontinued and
appropriate therapy instituted.
Concomitant use of
drugs known to induce ototoxicity should be avoided.
This preparation
should not be used in conditions where corticosteroids are contraindicated.
Do not administer
parenteral corticosteroids during treatment with GentaVed Otic Solution.
PRECAUTIONS:
The antibiotic sensitivity of the pathogenic organism should be determined
prior to the use of this preparation. Use of topical antibiotics
occasionally allows overgrowth of non-susceptible bacteria, fungi, or
yeasts. In these cases, treatment should be instituted with other
appropriate agents as indicated.
Adverse systemic
reactions have been observed following the oral ingestion of some topical
corticosteroid preparations. 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.
Experimentally it
has been demonstrated that corticosteroids, especially at high dosage
levels, may result in delayed wound healing. An increase in the incidence of
osteoporosis may be noted, mainly in the elderly, with prolonged use of
these compounds. Their use in older dogs during the healing stages of bone
fracture is not indicated for the reason listed above.
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 unusually stressful situations.
CAUTION:
Before instilling any medication into the ear, examine the external ear
canal thoroughly to be certain the tympanic membrane is not ruptured in
order to avoid the possibility of transmitting infection to the middle ear
as well as damaging the cochlea or vestibular apparatus from prolonged
contact. If hearing or vestibular dysfunction in noted during the course of
treatment, discontinue use of GentaVed Otic Solution.
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 can induce
cleft palates in offspring when given to pregnant animals during the period
of palate closure of the embryos. Other congenital anomalies including
deformed forelegs, phocomelia, and anasarca have been reported in offspring
of dogs which received corticosteroids during pregnancy.
Avoid ingestion.
SIDE EFFECTS:
Side effects such as SAP and SGPT enzyme elevations, weight loss, anorexia,
polydipsia, and polyuria have occurred following the use of parenteral or
systemic synthetic corticosteroids in dogs. Vomiting and diarrhea
(occasionally bloody) have been observed in cats and dogs.
Cushing's Syndrome
in dogs has been reported in association with prolonged or repeated steroid
therapy.
HOW SUPPLIED:
GentaVed Otic Solution, squeeze bottles of 7.5 mL, 15 mL, and 240 mL
(8 fl oz).
Store between 2°C
and 25°C (36°F and 77°F).
Manufactured for
VEDCO, INC.
St. Joseph, MO
64504
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