Surolan (Canada)

Company: Elanco

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

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

CA0813

DIN 00755753

FOR VETERINARY USE ONLY

Active Ingredients

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

Surolan Indications

Surolan 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.

Surolan 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 Surolan 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. Surolan 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 Surolan 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

Surolan 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 Surolan should be discontinued and appropriate therapy instituted. Avoid contact with eyes since irritation may result. If Surolan 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 Surolan 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 for Surolan 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 Elanco Canada Limited at 1-800-265-5475.

Actions:

Surolan 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. interdigitale.¹ Miconazole nitrate has also demonstrated in vitro efficacy against several species of yeast¹ including Malassezia pachydermatis isolated from cases of canine otitis externa.² 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 aeruginosa,⁵ are well-established. Moreover, a synergistic interaction has been shown to exist between miconazole nitrate and polymyxin B sulfate against E. coli and S. aureus.⁴

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

Studies have also indicated that Surolan is effective in treating otoacariasis caused by Otodectes cynotis (ear mites) in cats.

Storage

Store between 15-25°C.

How Supplied

Surolan is available in 15 and 30 mL bottles.

Date: May 2022

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.

Surolan, Elanco and the diagonal bar logo are trademarks of Elanco or affiliates.

© 2022 Elanco or its affiliates.

Manufactured by: Elanco Canada Limited, 1919 Minnesota Court, Suite 401, Mississauga, Ontario L5N 0C9

24May2022

CPN: 1231137.2