Otibiotic Ointment [gentamicin-betamethasone-clotrimazole
ointment] is indicated for the treatment of canine acute and chronic otitis
externa associated with yeast [Malassezia pachydermatis] and/or bacteria
susceptible to gentamicin.
Otobiotic is a generic Otomax Ointment.
For Otic [Ear] Use in Dogs Only
Gentamicin: Gentamicin sulfate is an
aminoglycoside antibiotic active against a wide variety of pathogenic
gram-negative and gram-positive bacteria. In vitro tests have determined
that gentamicin is bactericidal and acts by inhibiting normal protein synthesis
in susceptible microorganisms. Specifically, gentamicin is active against the
following organisms commonly isolated from canine ears: Staphylococcus aureus,
other Staphylococcus spp., Pseudomonas aeruginosa, Proteus
spp., and Escherichia coli.
Betamethasone: Betamethasone valerate is a
synthetic adrenocorticoid for dermatologic use. Betamethasone, an analog of
prednisolone, has a high degree of corticosteroid activity and a slight degree
of mineralocorticosteroid activity. Betamethasone valerate, the 17-valerate
ester of betamethasone, has been shown to provide anti-inflammatory and anti-pruritic
activity in the topical management of corticosteroid-responsive otitis externa.
Topical corticosteroids can be absorbed from normal, intact skin. Inflammation
can increase percutaneous absorption. Once absorbed through the skin, topical
corticosteroids are handled through pharmacokinetic pathways similar to
systemically administered corticosteroids.
Clotrimazole: Clotrimazole is a broad-spectrum
antifungal agent that is used for the treatment of dermal infections caused by
various species of pathogenic dermatophytes and yeasts. The primary action of
clotrimazole is against dividing and growing organisms.
In vitro, clotrimazole exhibits fungistatic and
fungicidal activity against isolates of Trichophyton rubrum, Trichophyton
mentagrophytes, Epidermophyton floccosum, Microsporum canis, Candida spp.
and Malassezia pachydermatis [Pityrosporum canis]. Resistance to
clotrimazole is very rare among the fungi that cause superficial mycoses. In an
induced otitis externa infected with Malassezia pachydermatis, 1%
clotrimazole in the gentamicin-betamethasone-clotrimazole ointment vehicle was
effective both microbiologically and clinically in terms of reduction of exudate
odor and swelling.
In studies of the mechanism of action, the minimum
fungicidal concentration of clotrimazole caused leakage of intracellular
phosphorus compounds into the ambient medium with concomitant breakdown of
cellular nucleic acids and accelerated potassium efflux. These events began
rapidly and extensively after addition of the drug. Clotrimazole is very poorly
absorbed following dermal application.
Gentamicin-Betamethasone-Clotrimazole: By virtue
of its three active ingredients, Otibiotic Ointment [gentamicin-betamethasone-clotrimazole]
has antibacterial, anti-inflammatory, and antifungal activity. In component
efficacy studies, the compatibility and additive effect of each of the
components were demonstrated. In clinical field trials,
gentamicin-betamethasone-clotrimazole was effective in the treatment of otitis
externa associated with bacteria and Malassezia pachydermatis. Otibiotic
Ointment [gentamicin sulfate USP, betamethasone valerate, USP and clotrimazole,
USP ointment] reduced discomfort, redness, swelling, exudate, and odor, and
exerted a strong antimicrobial effect.
CONTRAINDICATIONS: If hypersensitivity to any of
the components occurs, treatment should be discontinued and appropriate therapy
instituted. Concomitant use of drugs known to induce ototoxicity should be
avoided. Do not use in dogs with known perforation of eardrums.
WARNINGS: The use of Otibiotic Ointment [gentamicin-betamethasone-clotrimazole
ointment] has been associated with deafness or partial hearing loss in a small
number of sensitive dogs [eg. geriatric]. The hearing deficit is usually
temporary. If hearing or vestibular dysfunction is noted during the course of
treatment, discontinue use of Otibiotic Ointment [gentamicin-betamethasone-clotrimazole
ointment] immediately and flush the ear canal thoroughly with a non-ototoxic
solution. Corticosteroids administered to dogs, rabbits, and rodents during
pregnancy have resulted in cleft palate in offspring. Other congenital anomalies
including deformed forelegs, phocomelia, and anasarca have been reported in
offspring of dogs which received corticosteroids during pregnancy.
Clinical and experimental data have demonstrated that
corticosteroids administered orally or parenterally to animals may induce the
first stage of parturition if used during the last trimester of pregnancy and
may precipitate premature parturition followed by dystocia, fetal death,
retained placenta and metritis.
PRECAUTIONS: Identification of infecting
organisms should be made either by microscopic roll smear evaluation or by
culture as appropriate. Antibiotic susceptibility of the pathogenic organism[s]
should be determined prior to use of this preparation.
If overgrowth of nonsusceptible bacteria, fungi, or
yeasts occur, or if hypersensitivity develops, treatment should be discontinued
and appropriate therapy instituted.
Administration of recommended doses of Otibiotic
Ointment [gentamicin-betamethasone-clotrimazole ointment] beyond 7 days may
result in delayed wound healing.
Avoid ingestion. 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 gain, polydipsia and/or polyuria. Prolonged use or overdosage
may produce adverse immunosuppressive effects.
Use of corticosteroids, depending on dose, duration, and
specific steroid, may result in endogenous steroid production inhibition
following drug withdrawal. In patients presently receiving or recently withdrawn
from corticosteroid treatments, therapy with a rapidly acting corticosteroid
should be considered in especially stressful situations.
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
TOXICOLOGY: Clinical and safety studies with
Otibiotic Ointment [gentamicin sulfate USP, betamethasone valerate, USP and
clotrimazole, USP ointment] have shown a wide safety margin at the recommended
dose level in dogs [see PRECAUTIONS/SIDE EFFECTS].
Gentamicin: While aminoglycosides are absorbed
poorly from skin, intoxication may occur when aminoglycosides are applied
topically for prolonged periods of time to large wounds, burns, or any denuded
skin, particularly if there is renal insufficiency. All aminoglycosides have the
potential to produce reversible and irreversible vestibular, cochlear, and renal
Betamethasone: 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 dogs and cats.
Cushing's syndrome in dogs has been reported in
association with prolonged or repeated steroid therapy.
Clotrimazole: The following have been reported
occasionally in humans in connection with the use of clotrimazole: erythema,
stinging, blistering, peeling, edema, pruritus, urticaria, and general
irritation of the skin not present before therapy.
DOSAGE AND ADMINISTRATION: The external ear
should be thoroughly cleaned and dried before treatment. Remove foreign
material, debris, crusted exudates, etc., with suitable non-irritating
solutions. Excessive hair should be clipped from the treatment area. After
verifying that the eardrum is intact, instill 4 drops [2 drops from the 215 g
bottle] of Otibiotic Ointment [gentamicin-betamethasone-clotrimazole ointment]
twice daily into the ear canal of dogs weighing less than 30 lbs. Instill 8
drops [4 drops from the 215 g bottle] twice daily into the ear canal of dogs
weighing 30 lbs or more. Therapy should continue for 7 consecutive days.
DESCRIPTION: Each gram of Otibiotic Ointment [gentamicin-betamethasone-clotrimazole
ointment] contains gentamicin sulfate USP equivalent to 3 mg gentamicin base;
betamethasone valerate, USP equivalent to 1 mg betamethasone; and 10 mg
clotrimazole, USP in a mineral oil-based system containing a plasticized
HOW SUPPLIED: Otibiotic Ointment [gentamicin-betamethasone-clotrimazole
ointment] is available in 7.5 mL, 10 gram, 15 mL and 25 gram tubes as well as in
a 15 gram and 215 mL plastic bottles.
Federal law restricts this drug to use by or
on the order of a licensed veterinarian
Store between 2° and 25°C [36° and 77°F].
Shake well before use when using the 215 gram bottle.
Keep this and all drugs out of the reach of children.
Butler Schein Animal Health
Rx Medication Sold Only To Licensed Veterinarians & Pharmacies. Current License Must Be On File Prior To Shipping.