Aurimic (Canada)

Company: Rafter 8

Miconazole nitrate, polymyxin B sulfate, prednisolone acetate suspension

VETERINARY USE ONLY

DIN 02509725

Description

Aurimic^® is a topical and otic antifungal, antibacterial and anti-inflammatory suspension for dogs and cats. Each mL contains miconazole nitrate 23 mg, polymyxin B sulfate 0.5293 mg and prednisolone acetate 5 mg.

Aurimic Indications

Aurimic^® 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.

Aurimic^® 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 Microsporum canis in dogs and cats

- bacterial dermatitis in dogs and cats

- non-specific dermatitis in dogs and cats

Dosage and Administration

Roll the Aurimic^® 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. Aurimic^® 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 Aurimic^® 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

Aurimic^® 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 Aurimic^® should be discontinued and appropriate therapy instituted. Avoid contact with eyes since irritation may result. If Aurimic^® 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 Aurimic^® 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 event reports from the use of 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).

ACTIONS:

Aurimic^® 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 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.

Discard unused product 90 days after first opening. Do not freeze.

PRESENTATION:

Aurimic^® is available in 20 mL bottles.

Richter Pharma AG, Feldgasse 19, 4600 Wels, Austria

Aurimic^® is a registered trademark of Richter Pharma.

Imported and distributed by:

Rafter 8 Products Inc., 87 Skyline Crescent NE, Calgary AB T2K 5X2

1-800-461-8615

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.

Revision date: November, 2020

61558/A

CPN: 1219050.0