what is otibiotic ointment used for

what is otibiotic ointment used for

Firm: Henry Schein® Animal Well being


You're reading: what is otibiotic ointment used for

ANADA #200-229, Authorized by FDA


For Otic Use in Canine Solely

CAUTION: Federal legislation restricts this drug to make use of by or on the order of a licensed veterinarian.

Hold this and all medication out of the attain of kids.


Every gram of gentamicin-betamethasone-clotrimazole ointment comprises gentamicin sulfate USP equal to three mg gentamicin base; betamethasone valerate USP equal to 1 mg betamethasone; and 10 mg clotrimazole USP in a mineral oil-based system containing a plasticized hydrocarbon gel.


Gentamicin: Gentamicin sulfate is an aminoglycoside antibiotic energetic in opposition to all kinds of pathogenic gram-negative and gram-positive micro organism. In vitro assessments have decided that gentamicin is bactericidal and acts by inhibiting regular protein synthesis in prone microorganisms. Particularly, gentamicin is energetic in opposition to the next organisms generally remoted from canine ears: Staphylococcus aureus, different Staphylococcus spp., Pseudomonas aeruginosa, Proteus spp., and Escherichia coli.

Betamethasone: Betamethasone valerate is an artificial adrenocorticoid for dermatologic use. Betamethasone, an analog of prednisolone, has a excessive diploma of corticosteroid exercise and a slight diploma of mineralocorticosteroid exercise. Betamethasone valerate, the 17-valerate ester of betamethasone, has been proven to supply anti-inflammatory and anti-pruritic exercise within the topical administration of corticosteroid-responsive otitis externa. Topical corticosteroids may be absorbed from regular, intact pores and skin. Irritation can improve percutaneous absorption. As soon as absorbed via the pores and skin, topical corticosteroids are dealt with via pharmacokinetic pathways much like systemically administered corticosteroids.

Clotrimazole: Clotrimazole is a broad-spectrum antifungal agent that’s used for the remedy of dermal infections brought on by varied species of pathogenic dermatophytes and yeasts. The first motion of clotrimazole is in opposition to dividing and rising organisms.

In vitro, clotrimazole reveals fungistatic and fungicidal exercise in opposition to isolates of Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum, Microsporum canis, Candida spp. and Malassezia pachydermatis (Pityrosporum canis). Resistance to clotrimazole may be very uncommon among the many fungi that trigger superficial mycoses.

In an induced otitis externa contaminated with Malassezia pachydermatis, 1% clotrimazole within the gentamicin-betamethasone-clotrimazole ointment car was efficient each microbiologically and clinically when it comes to discount of exudate odor and swelling.

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In research of the mechanism of motion, the minimal fungicidal focus of clotrimazole prompted leakage of intracellular phosphorus compounds into the ambient medium with concomitant breakdown of mobile nucleic acids and accelerated potassium efflux. These occasions started quickly and extensively after addition of the drug. Clotrimazole may be very poorly absorbed following dermal utility.

Gentamicin-Betamethasone-Clotrimazole: By advantage of its three energetic components, gentamicin-betamethasone-clotrimazole ointment has antibacterial, anti-inflammatory, and antifungal exercise. In element efficacy research, the compatibility and additive impact of every of the elements had been demonstrated. In medical area trials, gentamicin-betamethasone-clotrimazole was efficient within the remedy of otitis externa related to micro organism and Malassezia pachydermatis. Gentamicin sulfate USP, Betamethasone valerate, USP and Clotrimazole, USP ointment diminished discomfort, redness, swelling, exudate, and odor, and exerted a powerful antimicrobial impact.

Otibiotic Ointment Indications

Gentamicin-betamethasone-clotrimazole ointment is indicated for the remedy of canine acute and continual otitis externa related to yeast (Malassezia pachydermatis, previously Pityrosporum canis) and/or micro organism prone to gentamicin.


If hypersensitivity to any of the elements happens, remedy ought to be discontinued and applicable remedy instituted. Concomitant use of medication identified to induce ototoxicity ought to be averted. Don’t use in canines with identified perforation of eardrums.


Using gentamicin-betamethasone-clotrimazole ointment has been related to deafness or partial listening to loss in a small variety of delicate canines (e.g. geriatric). The listening to deficit is often non permanent. If listening to or vestibular dysfunction is famous through the course of remedy, discontinue use of gentamicin-betamethasone-clotrimazole ointment instantly and flush the ear canal totally with a non-ototoxic answer. Corticosteroids administered to canines, rabbits, and rodents throughout being pregnant have resulted in cleft palate in offspring. Different congenital anomalies together with deformed forelegs, phocomelia, and anasarca have been reported in offspring of canines which obtained corticosteroids throughout being pregnant.

Medical and experimental knowledge have demonstrated that corticosteroids administered orally or parenterally to animals could induce the primary stage of parturition if used over the past trimester of being pregnant and should precipitate untimely parturition adopted by dystocia, fetal dying, retained placenta, and metritis.


Identification of infecting organisms ought to be made both by microscopic roll smear analysis or by tradition as applicable. Antibiotic susceptibility of the pathogenic organism(s) ought to be decided prior to make use of of this preparation.

If overgrowth of nonsusceptible micro organism, fungi, or yeasts happen, or if hypersensitivity develops, remedy ought to be discontinued and applicable remedy instituted.

Administration of advisable doses of gentamicin-betamethasone-clotrimazole ointment past 7 days could lead to delayed wound-healing.

Keep away from ingestion. Antagonistic systemic reactions have been noticed following the oral ingestion of some topical corticosteroid preparations. Sufferers ought to be intently noticed for the standard indicators of adrenocorticoid overdosage which embody sodium retention, potassium loss, fluid retention, weight acquire, polydipsia, and/or polyuria. Extended use or overdosage could produce antagonistic immunosuppressive results.

Use of corticosteroids, relying on dose, period, and particular steroid, could lead to endogenous steroid manufacturing inhibition following drug withdrawal. In sufferers presently receiving or lately withdrawn from corticosteroid remedies, remedy with a quickly appearing corticosteroid ought to be thought of in particularly irritating conditions.

Earlier than instilling any treatment into the ear, look at the exterior ear canal totally to make certain the tympanic membrane just isn’t ruptured with the intention to keep away from the opportunity of transmitting an infection to the center ear in addition to damaging the cochlea or vestibular equipment from extended contact.

TOXICOLOGY: Medical and security research with Gentamicin sulfate USP, Betamethasone valerate, USP and Clotrimazole USP ointment have proven a large security margin on the advisable dose degree in canines (see PRECAUTIONS/SIDE EFFECTS).

Facet Results

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Gentamicin: Whereas aminoglycosides are absorbed poorly from pores and skin, intoxication could happen when aminoglycosides are utilized topically for extended durations of time to giant wounds, burns, or any denuded pores and skin, notably if there may be renal insufficiency. All aminoglycosides have the potential to provide reversible and irreversible vestibular, cochlear and renal toxicity.

Betamethasone: Negative effects akin to SAP and SGPT enzyme elevations, weight reduction, anorexia, polydipsia, and polyuria have occurred following using parenteral or systemic artificial corticosteroids in canines. Vomiting and diarrhea (sometimes bloody) have been noticed in canines and cats.

Cushing’s syndrome in canines has been reported in affiliation with extended or repeated steroid remedy.

Clotrimazole: The next have been reported sometimes in people in reference to using clotrimazole: erythema, stinging, blistering, peeling, edema, pruritus, urticaria, and common irritation of the pores and skin not current earlier than remedy.

Dosage and Administration

The exterior ear ought to be totally cleaned and dried earlier than remedy. Take away international materials, particles, crusted exudates, and so forth., with appropriate non-irritating options. Extreme hair ought to be clipped from the remedy space. After verifying that the eardrum is undamaged, instill 4 drops (2 drops from the 215 g. bottle) of gentamicin-betamethasone-clotrimazole ointment twice each day into the ear canal of canines weighing lower than 30 lbs. Instill 8 drops (4 drops from the 215 g. bottle) twice each day into the ear canal of canines weighing 30 lbs. or extra. Remedy ought to proceed for 7 consecutive days.

How Provided

Gentamicin-betamethasone-clotrimazole ointment is accessible in 7.5 gram and 15 gram tubes in addition to in 10 gram, 15 gram, 25 gram and 215 gram plastic bottles.

Retailer between 2° and 25°C (36° and 77°F).

Shake effectively earlier than use when utilizing the 215 gram bottle.

January 2001


Distributed Solely by Henry Schein Animal Well being, Dublin, OH 43017



CPN: 1082283.3

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