Otizole (Canada)

Company: Pro Concepts Animal Health

(miconazole nitrate, polymyxin B sulfate, prednisolone acetate suspension)

Topical and otic antifungal, antibacterial and anti-inflammatory for dogs and cats.

FOR VETERINARY USE ONLY

DIN: 02458888

Active Ingredients

Each mL of Otizole contains: miconazole nitrate 23 mg, polymyxin B sulfate 0.5293 mg, prednisolone acetate 5 mg.

Otizole 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. Massage the ear and the auditory canal gently but thoroughly to ensure proper distribution.

Otoacariasis (cats): Excess debris should be removed from the ear canals and the ears treated with 2-3 drops of Otizole twice daily. To prevent reinfestation, treatment should be continued for the entire life cycle of the mite (approximately 21 days). Massage the ear and the auditory canal gently but thoroughly to ensure proper distribution.

Contraindications

Otizole is contraindicated in animals with suspected or known hypersensitivity to miconazole nitrate, polymyxin B sulfate, or prednisolone acetate.

Do not use in animals with known perforated tympanum. Do not use with drugs known to induce ototoxicity.

Cautions: Before instilling any medication into the ear, examine the external ear canal thoroughly to be certain the tympanic membranes are not ruptured. If overgrowth of non-susceptible bacteria or fungi occurs, treatment with Otizole should be discontinued and appropriate therapy instituted. Avoid contact with eyes since irritation may result. If Otizole is to be applied to extensive areas of the animal’s body surface, care should be exercised to avoid excessive oral ingestion. If hypersensitivity to any of the components occurs, treatment should be discontinued.

Long-term use of topical and otic corticosteroids has been associated with adrenocortical suppression and iatrogenic hypoadrenocorticism in dogs. The safe use of Otizole in animals used for breeding purposes, during pregnancy, or in lactating animals, has not been evaluated.

Warnings

Keep out of reach of children. Care should be taken as some canine and feline fungal infections are transmissible to humans.

Adverse Reactions

The post-marketing adverse reports for a suspension of miconazole nitrate, polymyxin B sulfate and prednisolone acetate for otic and topical use have shown that deafness and reduced hearing, usually of a transient nature, and topical hypersensitivity reactions such as erythema (or redness) and blisters on pinna, are very rarely reported (reported in less than 1 in 10,000 animals).

For technical support or to report a suspected adverse drug reaction, contact Can-Vet Animal Health Supplies Ltd. at 519-822-5333.

Actions: Otizole combines the antifungal and antibacterial activity of miconazole nitrate with the antibacterial activity of polymyxin B sulfate and the anti-inflammatory and antipruritic properties of prednisolone.

Miconazole nitrate has been demonstrated to be effective in the treatment of canine and feline dermatomycoses when caused by Microsporum canis and has demonstrated in-vitro efficacy against a number of pathogenic fungi including M. gypseum, Trichophyton mentagrophytes, and T. interdigitale¹. Miconazole nitrate has also demonstrated in vitro efficacy against several species of yeast¹ including Malassezia pachydermatis isolated from cases of canine otitis externa². Miconazole nitrate has also been shown to possess antibacterial activity against Gram-positive bacteria, including Staphylococcus aureus^1,3.

The bactericidal properties of polymyxin B sulfate against Gram-negative bacteria, such as Escherichia coli⁴ and Pseudomonas aeruginosa⁵, are well established. Moreover, a synergistic interaction has been shown to exist between miconazole nitrate and polymyxin B sulfate against E. coli and S. aureus⁴.

The anti-inflammatory and antipruritic properties of prednisolone are well known.

Studies have also indicated that a suspension of miconazole nitrate, polymyxin B sulfate and prednisolone acetate for otic and topical use is effective in treating otoacariasis caused by Otodectes cynotis (ear mites) in cats.

Storage

Store between 15 - 30°C. Protect from light and freezing.

How Supplied

Otizole is available in 15 mL, 30 mL and 100 mL bottles.

References

¹ Van Cutsem JM, Thienpont D. Miconazole, a broad spectrum antimycotic agent with antibacterial activity. Chemotherapy 1972; 17:392-404

² Uchida Y, Nakade T, Kitazawa K. In vitro activity of five antifungal agents against Malassezia pachydermatis. Jpn J Vet Sci 1990;52(4):851-3

³ Sud IJ, Feingold DS. Action of antifungal imidazoles on Staphylococcus aureus. Antimicrob Agents Chemother 1982;22(3):470-474

⁴ Cornelissen F, Van den Bossche H. Synergism of the antimicrobial agents miconazole, bacitracin and polymyxin B. Chemotherapy 1983; 29:419-27

⁵ Hariharan H, McPhee L, Heaney S, Bryenton J. Antimicrobial drug susceptibility of clinical isolates of Pseudomonas aeruginosa. Can Vet J 1995; 36:166-167

Manufactured By:

Can-Vet Animal Health Supplies Ltd., 61 Malcolm Rd., Guelph, ON N1K 1A7

519-822-5333

CPN: 1445032.0