Surolan Drops (Canada)

(miconazole nitrate, polymyxin B sulfate, prednisolone acetate)

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

CA0813

DIN 00755753

FOR VETERINARY USE ONLY

Active Ingredients

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

Actions:

SUROLAN Drops combine 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 Drops are effective in treating otoacariasis caused by Otodectes cynotis (ear mites) in cats.

Surolan Drops Indications

SUROLAN Drops are 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 Drops are 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

Precautions

Roll the bottle between both hands and shake well before use. Avoid contact with eyes, since irritation may result. No data have been collected as to the safety of SUROLAN Drops in pregnant queens and bitches and, therefore, it should not be used in pregnant animals. If SUROLAN Drops are to be applied to extensive areas of the animal’s body surface, care should be exercised to avoid excessive oral ingestion.

Warning

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

Dosage and Administration

Administer sufficient SUROLAN Drops to cover the affected area. 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 satisfactory response is not achieved within three weeks, re-evaluate the disease. Medication is best accomplished using a cotton swab or finger cot. Clipping of hair around and over appropriate sites of infection should be done at the start of treatment and again as necessary. General hygienic measures aid in the control of infection and prevent reinfection.

For treatment of otoacariasis in cats it is recommended that excess debris 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).

How Supplied

SUROLAN Drops are available in 15, 30 and 100 mL bottles.

Storage

Store at or below 25°C.

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.

Elanco and Surolan are trademarks owned or licensed by Eli Lilly and Company, its subsidiaries or affiliates.

Manufactured by: Elanco, Division Eli Lilly Canada Inc., 150 Research Lane, Suite 120, Guelph, ON, N1G 4T2, Canada

Revised 15-Jul-13

NAC No.: 1184059.0