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Otomax Otic for Dogs

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Description

Otomax is indicated for the treatment of canine acute and chronic otitis externa associated with yeast (Malassezia pachydermatis) and/or bacteria susceptible to gentamicin. Otomax contains gentamicin sulfate, betamethasone valerate and clotrimazole in a mineral oil-based system containing a plasticized hydrocarbon gel.

Key Benefits

  • Treats both acute and chronic ear infections
  • Easy to administer has the consistency of a solution with the prolonged contact time of an ointment

How it works

By virtue of its three active ingredients Gentamicin, Betamethasone, and Clotrimazole, Otomax ointment provides antibacterial, anti-inflammatory, and antifungal activity to combat infections of the outer ear accompanied by inflammation.

Indications

Otomax Otic Ointment is indicated for the treatment of canine acute and chronic otitis externa associated with yeast (Malassezia pachydermatis) and/or bacteria susceptible to gentamicin.

  • Gentamicin is an antibiotic with broad spectrum activity.
  • Betamethasone is a highly effective and safe corticosteroid that reduces inflammation.
  • Clotrimazole is an antifungal proven effective for the most common ear yeast isolate- Malassezia pachydermatis.

Directions

View Otomax Drug Facts Sheet.

The external ear should be thoroughly cleaned and dried before treatment. Remove foreign material,debris, crusted exudates, etc., with suitable nonirritating solutions. Excessive hair should be clippedfrom the treatment area. After verifying that the eardrum is intact, instill 4 drops from the 7.5 g and 15 gtube, and 15 g and 30 g bottle (2 drops from the 215 g bottle) of Otomax ointment twice daily into theear canal of dogs weighing less than 30 lbs. Instill 8 drops from the 7.5 g and 15 g tube, and 15 g and 30g bottle (4 drops from the 215 g bottle) twice daily into the ear canal of dogs weighing 30 lbs or more.Massage external ear canal carefully after instillation to ensure appropriate distribution of medication. Therapy should continue for 7 consecutive days.

Caution:

Federal law restricts this drug to use by or on the order of a licensed veterinarian. Keep this and all drugs out of the reach of children.

Precautions:

Identification of infecting organisms should be made either by microscopic roll smear evaluation or byculture 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 Otomax 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, weightgain, 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 endogenoussteroid production inhibition following drug withdrawal. In patients presently receiving or recently withdrawn from corticosteroid treatments, therapy with a rapidly-acting corticosteroid should beconsidered in especially stressful situations.

Before instilling any medication into the ear, examine the external ear canal thoroughly to be certain thetympanic membrane is not ruptured in order to avoid the possibility of transmitting infection to themiddle ear as well as damaging the cochlea or vestibular apparatus from prolonged contact.

Contraindications

If hypersensitivity to any of the components occurs, treatment should be discontinued and appropriatetherapy instituted. Concomitant use of drugs known to induce ototoxicity should be avoided. Do not usein dogs with known perforation of eardrums.

Warnings

The use of Otomax ointment has been associated with deafness or partial hearing loss in a smallnumber of sensitive dogs (eg, geriatric). The hearing deficit is usually temporary. If hearing orvestibular dysfunction is noted during the course of treatment, discontinue use of Otomax ointment immediately and flush the ear canal thoroughly with a nonototoxic solution.

Corticosteroids administered to dogs, rabbits, and rodents during pregnancy have resulted in cleft palatein offspring. Other congenital anomalies including deformed forelegs, phocomelia, and anasarca havebeen reported in offspring of dogs which received corticosteroids during pregnancy.

Clinical and experimental data have demonstrated that corticosteroids administered orally orparenterally to animals may induce the first stage of parturition if used during the last trimester ofpregnancy and may precipitate premature parturition followed by dystocia, fetal death, retained placenta,and metritis.

Toxicology

Clinical and safety studies with Otomax ointment have shown a wide safety margin at the recommended dose level in dogs (see Precautions/Side Effects).

Side Effects:

Gentamicin: While aminoglycosides are absorbed poorly from skin, intoxication may occur whenaminoglycosides are applied topically for prolonged periods of time to large wounds, burns, or anydenuded skin, particularly if there is renal insufficiency. All aminoglycosides have the potential toproduce reversible and irreversible vestibular, cochlear, and renal toxicity.

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 andcats.

Cushing's syndrome in dogs has been reported in association with prolonged or repeated steroidtherapy.

Clotrimazole: The following have been reported occasionally in humans in connection with the use ofclotrimazole: erythema, stinging, blistering, peeling, edema, pruritus, urticaria, and general irritation ofthe skin not present before therapy.

Pharmacology

Gentamicin: Gentamicin sulfate is an aminoglycoside antibiotic active against a wide variety ofpathogenic gram-negative and gram-positive bacteria. In vitro tests have determined that gentamicin isbactericidal 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 ofbetamethasone, has been shown to provide anti-inflammatory and antipruritic 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 Trichophytonrubrum, 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 Otomaxvehicle was effective both microbiologically and clinically in terms of reduction of exudate, odor, andswelling.

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 ofcellular 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.

FAQ

Otomax is a prescription medicine FDA approved for veterinary use in dogs. Otomax is available in 7.5 gm and 15 gm tubes and 15 gm, 30 gm, and 215 gm bottles. Each gm contains gentamicin sulfate equivalent to 3mg gentamicin base, betamethasone valerate equivalent to 1mg betamethasone and clotrimazole 10 mg. Prior to use the external ear should be cleaned and dried and excessive hair should be clipped from the treatment area. Otomax should not be used in pets with perforated eardrums.
Do not use Otomax if your pet has a viral or fungal infection. Tell your veterinarian if your pet is pregnant or lactating.
Use this medication exactly as directed by your veterinarian. If you do not understand the directions ask the pharmacist or veterinarian to explain them to you. The usual dose for dogs less than 30 lbs is 4 drops into the ear canal twice a day, and for dogs over 30 lbs use 8 drops into the ear canal twice a day.
Side effects associated with this medication are related to the individual ingredients. Gentamicin, while absorbed poorly from the skin, when applied topically to large wounds, burns, or denuded skin for prolonged periods of time has a potential for reversible or irreversible ear and kidney toxicity. Hearing loss (usually temporary) may occur. Discontinue this medication and consult with your veterinarian if hearing loss, head tilting or dizziness are noticed. In humans, clotrimazole has been observed to occasionally cause redness of the skin, stinging, blistering, peeling, fluid retention, itching, hives and general irritation of the skin. Discontinue the medication and talk to your veterinarian about any side effect that seems unusual or bothersome to your pet.
Apply the missed dose as soon as you remember. However, if it is almost time for the next regularly scheduled dose, skip the missed dose and apply the next one as directed. Do not give a double dose of the medication.
An overdose of this medication is unlikely. If an overdose is suspected, seek emergency veterinary medical treatment.
Do not use this medication in pets allergic to it or any of the individual ingredients. Do not use in dogs with perforated eardrums. Discontinue use of this medication and contact your veterinarian if hearing loss is noted during treatment. Treatment beyond 7 days may lead to prolonged wound healing.
Before using Otomax, tell your veterinarian if your pet is using other antibiotic, antifungal or corticosteroid medications either topically or by mouth. Talk to your veterinarian or pharmacist before giving any prescription or over the counter medicines.

Reviews

Review Summary
5.0
3 Reviews
5
100% (3)
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100% Recommend this product (3 of 3 responses)
By Susan D.
Ohio
Otomax Ointment
May 9, 2020
Thus far, I'm very happy with this medication. My pup isn't scratching her ear voraciously anymore. She doesn't mind me putting it in her ears because it's so liquid that it quickly slides into her ear canal. A little massage, which she likes, and it's done.
Even more, I'm so pleased with Entirely Pets service and diligent follow up with my vet in order to provide what I was needing.
By Mark
Boynton Beach, FL.
Otomax
February 6, 2020
Been using it for 2 years plus
By UDF
Tazewell VA
Great stuff
October 30, 2019
This stuff is awesome.
It's the only thing that helps my fur babies angry ears..
Thank You

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