OTIZOLE SUSPENSION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

MICONAZOLE NITRATE; POLYMYXIN B SULFATE; PREDNISOLONE ACETATE

Available from:

CAN-VET ANIMAL HEALTH SUPPLIES LTD.

Dosage:

23MG; 0.5293MG; 5MG

Pharmaceutical form:

SUSPENSION

Composition:

MICONAZOLE NITRATE 23MG; POLYMYXIN B SULFATE 0.5293MG; PREDNISOLONE ACETATE 5MG

Administration route:

OTIC

Units in package:

15/30/100ML

Prescription type:

Prescription

Therapeutic group:

CATS; DOGS

Product summary:

Active ingredient group (AIG) number: 0318442003

Authorization status:

APPROVED

Authorization date:

2020-07-03

Patient Information leaflet

Can-Vet Version 29MAY2020
[PACKAGE INSERT – ENGLISH]
FOR VETERINARY USE ONLY
DIN: 02458888
PR
OTIZOLE (MICONAZOLE NITRATE, POLYMYXIN B SULFATE, PREDNISOLONE ACETATE
SUSPENSION)
TOPICAL AND OTIC ANTIFUNGAL, ANTIBACTERIAL AND ANTI-INFLAMMATORY FOR
DOGS AND CATS.
ACTIVE INGREDIENTS: Each mL of Otizole contains: miconazole nitrate 23
mg, polymyxin B sulfate 0.5293
mg, prednisolone acetate 5 mg.
INDICATIONS: Otizole is indicated for treating dogs and cats with
otitic and dermal infections when
caused by pathogens sensitive to miconazole nitrate or polymyxin B
sulfate, and for the inflammation
which often accompanies these conditions.
Otizole is appropriate for treating disease conditions such as:
- otitis externa in dogs
- _Otodectes cynotis_ (ear mite) infestation and associated otitis in
cats
- allergic dermatitis in dogs
- fungal infections when caused by _M. canis _in dogs and cats
- bacterial dermatitis in dogs and cats
- non-specific dermatitis in dogs and cats
DOSAGE AND ADMINISTRATION
Roll the Otizole bottle between both hands and shake well before use.
Skin conditions: Clipping of hair around and over appropriate sites of
infection should be done at the
start of treatment and again as necessary. Administer sufficient drops
to cover the affected area and
rub in well. Treat twice daily until symptoms subside, or until
infecting organism is completely
eradicated as indicated by appropriate clinical or laboratory
examination. If a satisfactory response is
not achieved within three weeks, re-evaluate the diagnosis. Otizole is
best applied using a cotton swab
or finger cot. General hygienic measures aid in the control of
infection and prevent reinfection.
Otitis externa: The ear should be thoroughly cleaned and dried before
the initiation of treatment, and
examined to ensure the eardrum is intact. Instill 3-5 drops twice
daily for 7 consecutive days. After 7
days, the veterinarian should evaluate the necessity to extend the
treatment. In the majority of cases,
clinical resolution will be achieved in 7 to 14 days.