Surolan

Generic name: miconazole nitrate, polymyxin b sulfate, and prednisolone acetate
Dosage form: FOR ANIMAL USE ONLY

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

Rx

Antifungal, antibacterial and anti-inflammatory
For otic use in dogs only

CAUTION

Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian.

Surolan Description

Surolan contains 23 mg/mL miconazole nitrate, 0.5293 mg/mL polymyxin B sulfate and 5 mg/mL prednisolone acetate. Inactive ingredients are colloidal silicon dioxide and liquid paraffin.

INDICATIONS

Surolan is indicated for the treatment of canine otitis externa associated with susceptible strains of yeast (Malassezia pachydermatis) and bacteria (Staphylococcus pseudintermedius).

Surolan Dosage and Administration

Shake well before use.

The external ear should be thoroughly cleaned and dried before the initiation of treatment. Verify that the eardrum is intact. Instill 5 drops of Surolan in the ear canal twice daily and massage the ear. Therapy should continue for 7 consecutive days.

Contraindications

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

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

Warnings

Not for use in humans. Keep this and all drugs out of reach of children.

ANIMAL WARNINGS

Do not administer orally.

For otic use only.

Precautions

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 should be discontinued and appropriate therapy instituted.

Long-term use of topical otic corticosteroids has been associated with adrenocortical suppression and iatrogenic hypoadrenalcorticism in dogs.

The safe use of Surolan in dogs used for breeding purposes, during pregnancy, or in lactating bitches, has not been evaluated.

Adverse Reactions

In the field study, 161 dogs treated with Surolan were included in the safety database. Two dogs experienced reduced hearing at the end of treatment; on follow-up one dog had normal hearing capacity while the other case was lost for follow-up. The owner of another dog reported that on day 4 of treatment, build-up of the medication decreased the dog's hearing. At th..