Oridermyl (Canada)

Company: Vetoquinol

Ointment

VETERINARY USE ONLY

DIN 02364166

Permethrin, nystatin, triamcinolone acetonide and neomycin sulphate ear ointment

Antiparasitic, antibacterial, antifungal and anti-inflammatory

Active Ingredients

Each gram contains 10 mg of permethrin, 100,000 IU of nystatin, 1 mg of triamcinolone acetonide, and 3500 IU of neomycin sulphate.

Indication: For the treatment of otitis externa caused by Otodectes cynotis and its associated secondary bacterial (Staphylococcus spp) and/or yeast infections in cats and kittens over 8 weeks of age and 1 kg of bodyweight.

Dosage and Administration

The external ear canals should be cleaned before treatment. Attach the flexible cannula to the tube of ointment. The cannula must be vertically positioned to ensure accurate dosing. In adult cats instil exactly 8 drops of ointment (≈ 0.3 ml) into each ear. In kittens instil exactly 4 drops of ointment (≈ 0.15 ml) into each ear. Gently massage the base of the ears to uniformly disperse the ointment. Administer once daily for 10 consecutive days. Care should be taken to avoid staining the fur. Since otoacariasis is very contagious, both ears should be treated even if only one seems to be infested. Following 10 days of treatment, a veterinarian should re-evaluate the ears. If repeated treatment is required, an alternative treatment should be considered.

Contraindications

Do not use in animals with a perforated tympanic membrane. Do not use in cats with known hypersensitivity to any of the ingredients. Do not use in pregnant or lactating animals. Do not use in kittens less than 8 weeks of age or 1 kg of bodyweight. Do not administer to sick or debilitated cats.

Cautions: Do not apply more than the recommended dose or more frequently as it could result in signs of permethrin toxicity. If signs of permethrin toxicity develop, stop the treatment. The safety of this product has not been established in breeding animals.

Warnings

Keep out of reach of children. Wash hands carefully after applying the product. If the product splashed the eye accidentally, rinse with copious amounts of water.

Adverse Reactions

Ear canal ulceration and irritation may occur following administration in some animals. If irritation persists or worsens, administration should be stopped. Some cats may be predisposed to developing localized dermatophytosis (ringworm) infection following treatment. Additional treatment for the dermatophyte infection may be required.

Mild neurological signs may be observed, especially in kittens. If clinical signs are observed, treatment should be stopped and a veterinarian consulted.

Cats that lick a significant quantity of ointment when grooming can also develop signs of permethrin toxicity, such as mydriasis, muscle tremors, seizures, depression, vocalization, hyperexcitability, ataxia, vomiting, and/or anorexia. If signs of permethrin toxicity are observed, administration should be stopped and a veterinarian consulted for symptomatic treatment.

The use of otic preparations has been associated with deafness or partial hearing loss in a small number of animals. Hearing loss may be transient or permanent. If signs of hearing loss are observed administration should be stopped and a veterinarian consulted.

Information for pet owners: If the ears become redder and/or more painful after applying the ointment, stop administration and consult your veterinarian. This ointment contains an ingredient which can cause nervous system signs if absorbed in significant quantity, such as tremors, seizures, awkward gait, abnormal behaviour (meowing excessively, restless, depression) or dilated pupils. Vomiting and/or lack of appetite could also indicate an over- dose. If you observe any such sign, stop treatment and consult your veterinarian immediately. Do not apply more than the recommended dose. Avoid staining the fur of your cat with the ointment as your cat could ingest it when grooming.

Overdose: Wash all ointment off the fur with warm soapy water. Remove as much ointment as possible from the ears. Administer crystalloid fluids to maintain hydration, electrolyte balance and urine output. Monitor body temperature. It is important to ensure normal body temperature. Tremors and seizures should be controlled with a centrally acting muscle relaxant, methocarbamol, a benzodiazepine, diazepam, barbiturates or inhalant anesthesia depending on the severity of the situation.

Safety information: A safety study was conducted on 18 kittens aged 8 to 9 weeks and weighing 0.85 to 1.17 kg. They were divided into 3 treatment groups. The kittens were treated once daily with Oridermyl at 1, 2 or 3 times the label dose of 0.15 ml/ear instilled into both ears for 10 days (30 days for the 1X group). All kittens tolerated the study procedures well and completed the study. There were isolated reports of depression in all three groups. The incidence of these reports was 0.8%, 3.1%, and 3.9% in the 1X, 2X, and 3X group of kittens respectively. Mild tail tremors were occasionally observed. The tremors increased in frequency with increasing dose (once in 1 kitten in the 1X group - incidence rate 2.9%; once in each of 2 kittens in the 2X group - incidence rate 16.7%; 4 times in 3 kittens in the 3X group - incidence rate 33.3%). Mydriasis was observed in 1/6 kittens in the 2X group and in 3/6 kittens in the 3X group.

Efficacy studies: Twenty-four adult cats with otitis caused by Otodectes cynotis and associated secondary bacterial and yeast infections from an animal shelter were enrolled. The cats were randomly assigned to one of 4 groups. Two groups of 8 cats were treated once daily for 10 days with 0.3 ml of Oridermyl instilled into each ear. One group of 4 cats served as the negative control and was not treated. The fourth group of 4 cats received treatment with a placebo ointment of Oridermyl’s excipients. On days 0 and 10 ear swabs were evaluated for mean counts of bacteria and yeast. A swab was also taken for bacteriological culture and sensitivity testing. The ears were examined otoscopically and scored for the degree of clinical otitis. On day 10 all ear secretions were removed for mite counts, except from one group of 8 cats treated with Oridermyl whose ear secretions were removed on day 30. The most frequently isolated bacteria were Staphylococcus spps. The number of bacteria and yeast decreased significantly after Oridermyl treatment. No live mites were found in the cats treated with Oridermyl or the placebo ointment. Bruising of the ear was observed in one treated cat and excessive salivation in another one. These events may or may not have been related to Oridermyl administration.

A second efficacy study was conducted in 16 younger cats aged 16 to 28 weeks of age. These cats were experimentally infested with live Otodectes cynotis. The cats were treated with 0.15 ml of Oridermyl instilled into each ear daily for 10 days. There was no control group. All ear secretions were collected from 8 cats on day 10 and from the other 8 cats 20 days later. No live mites were observed at either time. Treatment with Oridermyl resulted in a dramatic decrease of the otoscopic score used to assess clinical signs of otitis. Of the 8 cats that had secondary bacterial infections prior to treatment all resolved with treatment. Of the 3 cats that had secondary yeast infections prior to treatment 2 resolved with treatment. No drug related adverse reactions were observed and Oridermyl was well tolerated.

Storage

Store between 15°C and 25°C.

Vetoquinol N.-A. Inc., 2000, ch. Georges, Lavaltrie, QC, Canada J5T 3S5

0518B

CPN: 1234358.4