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Otomax Ear Drops for Dogs

  • 14ml Dropper Bottle £7.47
  • 34ml Dropper Bottle £15.98

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£7.47 to £15.98

Description

Otomax Ear Drops Suspension is a carefully formulated mixture of ingredients designed to treat all the common causes of acute otitis in dogs. It is also effective to treat the periodic flare-ups of acute symptoms which tend to occur in dogs with mild, on-going otitis. Otomax Ear Drops Suspension contains gentamycin to kill bacteria and clotrimazole to kill yeasts and fungi (especially including Malassezia). The third active ingredient is betamethasone which has a powerful anti-inflammatory effect on the skin lining the ear canal. This helps to reduce the discomfort and itching dogs experience, as well as reducing any swelling and discharge formation. Otomax should be applied twice daily for 7 days. between 4 and 8 drops should be placed into the ear canal, which is then massaged gently from the outside to distribute the drops through the ear canal. Any excess discharge should be wiped away from the surface as required. If the discharge is excessive, a mild, water-based ear cleaner should be used before applying Otomax.
Betamethasone is a steroid which can be absorbed through the skin. Otomax drops should not be overdosed or Otomax side effects can occur systemically. For full information, see the datasheet below.

Presentation

Each ml of the product contains Gentamicin base (as sulfate) 2640 IU, Betamethasone (as valerate) 0.88 mg and Clotrimazole 8.80 mg. The product is a smooth, uniform, white to off-white viscous suspension.

Uses

For the treatment of acute external otitis in the dog. Also for treatment of short term exacerbation of the acute signs of chronic external otitis of bacterial and fungal origin due to bacteria susceptible to gentamicin, such as Staphylococcus intermedius, and fungi susceptible to clotrimazole, in particular Malassezia pachydermatis.

Dosage and administration

For otic use only.

Shake the product well before administration

Dogs weighing less than 15 kg: apply 4 drops to the ear twice a day.

Dogs weighing more than 15 kg: apply 8 drops to the ear twice a day. The duration of treatment is 7 days.

After application the base of the ear may be massaged briefly and gently to allow the preparation to penetrate to the lower part of the ear canal.

1 drop of the product corresponds to 66.9 IU gentamicin, 22.3μg betamethasone and 223 μg clotrimazole.

Contra-indications, warnings, etc

This product should not be used in the following instances:

Do not administer to pregnant or lactating bitches.

Do not administer to dogs with a perforated ear drum.

Do not administer in the case of known hypersensitivity to any of the ingredients.

Do not administer the product concurrently with other substances which are known to cause ototoxicity

Erythematous papules may appear locally; these lesions regress when treatment is discontinued.

Temporary impairment of hearing and extremely rare cases of irreversible loss of hearing have been observed, especially in elderly animals.

In the event of auditory or vestibular dysfunction, treatment must be discontinued immediately and the auditory canal cleaned carefully using a non-ototoxic solution.

Prolonged and extensive use of topical corticosteroid preparations have been known to induce local and systemic side-effects. These include suppression of adrenal function, epidermal thinning, and delayed wound healing.

If you notice any serious effects or other effects not mentioned in this datasheet, please inform your veterinary surgeon.

Contact with eyes should be avoided. In case of accidental contact, flush with plenty water.

Before the product is applied, the external auditory canal must be examined thoroughly to ensure that the eardrum is not perforated in order to avoid the risk of transmission of the infection to the middle ear and to prevent damage to the cochlear and vestibular apparatus.

The outer ear should be cleaned meticulously and dried before treatment. Excess hair around the treatment area should be cut.

Bacterial and fungal otitis is often secondary in nature. The underlying cause should be identified and treated.

Use of the product should be based on susceptibility of isolated bacteria and/or other appropriate diagnostic tests. If this is not possible, therapy should be based on local (regional, farm level) epidemiological information about susceptibility of the target bacteria.

Use of the product deviating from the instructions given in the data sheet may increase the prevalence of bacteria resistant to gentamicin and may decrease the effectiveness of treatment with other aminoglycosides, due to the potential for cross resistance.

Prolonged and intensive use of topical corticosteroids preparation is known to trigger local and systemic effects, including suppression of adrenal function, thinning of the epidermis and delayed healing.

User warnings:

Avoid contact with the product.

Wash hands carefully after applying the product. In case of accidental contact with the eyes, rinse with copious amounts of water.

Do not handle the product if you have known hypersensitivity against compounds in the product.

For animal treatment only.

Keep out of the reach and sight of children.

Pharmaceutical precautions

Do not store above 25°C. Keep the container in the outer carton.

Shelf-life after first opening the immediate packaging: 14 days.

Do not use after the expiry date stated on the bottle or carton (EXP end of: Use by MM/YY).

When the container is broached (opened) for the first time, using the in-use shelf-life which is specified on this package leaflet, the date on which any product remaining in the container should be discarded should be worked out. This discard date should be written in the space provided on the label.

Any unused product or waste materials should be disposed of in accordance with national requirements.

Legal category

POM-V

Packaging Quantities

Box containing 1 plastic bottle of 14 ml.

Box containing 1 plastic bottle of 34 ml.

Further information

Gentamicin sulphate is an aminoglycoside bactericidal antibiotic which acts by inhibiting protein synthesis.

Its spectrum of activity includes Gram-positive and Gram-negative bacteria, such as the following pathogenic organisms isolated from the ears of dogs: Staphylococcus intermedius, coagulase-positive Staphylococcus spp. and Proteus mirabilis.

Betamethasone valerate is a synthetic dexamethasone-analogue corticosteroid with an anti-inflammatory, anti-pruritic activity when applied topically. It has mild mineralo-corticoid properties. Betamethasone valerate is absorbed after topical application. Absorption may be increased if there is inflammation of the skin.

Clotrimazole is an antifungal agent which acts by causing changes in the cell membrane, which lead to a loss of intracellular components and consequently to a cessation of molecular synthesis. Clotrimazole has a broad spectrum of activity and is used in the treatment of skin conditions caused by various species of pathogenic dermatophytes and by moulds, in particular Malassezia pachydermatis.

Marketing authorisation number

Vm 01708/4588.

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Deafness

8th Dec 2014
susan

My english bull terrier was given otomax ear drops for a mild ear infection.he is 12 years olad and in very good health but ia now completely deaf as a result of using these eardrops. It is one of the side effects with those drops and we werent told about. It seemingly only in older dogs. Should be took off the market or not used on dogs of 8 years old and over. Im heartbroken

John Cousins
  • Veterinary Surgeon

Deafness is occasionally caused by adding medication to the ear canal. This usually only happens when the ear drum is already perforated (which can be difficult to ascertain in some dogs). Your vet should check the state of the ear drums if possible before using drops of a type known to be potentially damaging. Many of the ear drops commonly used in dogs can have this effect, but it is in fact rare. The vast majority of dogs are not so sensitive to the ingredients and do not show this sort of adverse reaction. I would suggest you report this event to the VMD who collate all such data and decide if veterinary medications should be withdrawn from the market. You can report this online yourself easily by following this link. (When it asks how the drug was administered, you should choose "Auricular use"). The information you provide will be used along with any other reports to decide how safe it is.