Miconazole, polymyxin b and prednisolone

Indications

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

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 the end of treatment, this dog had normal hearing as assessed by the investigator. Residue build-up was reported in 1 dog and pain upon drug application in another dog. A total of 161 dogs treated with the active control was included in the safety database and adverse reactions were reported in 8 dogs treated with the active control. One dog experienced reduced hearing at the end of treatment. Residue build-up was noted in 1 dog. Four dogs vomited during treatment, 1 dog showed red pustules on the pinna and head shaking was observed in another dog. Foreign market experience: the following adverse events were reported voluntarily during post-approval use of the product in foreign markets: deafness, reduced hearing, topical hypersensitivity reactions and red blisters on pinna. For a copy of the Safety Data Sheet (SDS), for technical assistance or to report a suspected adverse drug reaction, contact Elanco Animal Health at 1-888-545-5973. Alternatively, suspected adverse drug reactions may be reported to FDA at 1-888-FDA-VETS or www.fda.gov/reportanimalae PHARMACOLOGY By virtue of its 3 active ingredients, SUROLAN has antibacterial, antifungal, and anti-inflammatory activity. Polymyxin B sulfate is a broad-spectrum polypeptide antibiotic with activity against both Gram-positive and Gram-negative species. Miconazole nitrate is a synthetic imidazole derivative with antifungal activity and antibacterial activity against Gram-positive bacteria. Moreover, synergistic effects between miconazole nitrate and polymyxin B sulfate have been demonstrated in an in vitro study (1) . Prednisolone acetate is a glucocorticoid with anti-inflammatory activity. A study performed using an experimentally-induced model of ear inflammation in mice demonstrated the effectiveness of prednisolone acetate in treating ear inflammation either alone or in combination with the other active ingredients of SUROLAN (2) . MICROBIOLOGY The compatibility and additive effect of each of the components in SUROLAN was demonstrated in a component effectiveness and non-interference study. An in vitro study of organisms collected from clinical cases of otitis externa at a veterinary teaching hospital and from dogs enrolled in the clinical effectiveness study for SUROLAN determined that polymyxin B sulfate and miconazole nitrate inhibit the growth of bacteria and yeast commonly associated with canine otitis externa. Furthermore, a synergistic effect of the two antimicrobials was demonstrated. The addition of prednisolone acetate to the combination did not impair antimicrobial activity to any clinically-significant extent.

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.

Storage

Store at or below 25 °C (77 °F). Approved by FDA under NADA # 141-298 Manufactured for Elanco US, Inc., Greenfield, IN 46140 Product of Portugal Surolan, Elanco and the diagonal bar logo are trademarks of Elanco or its affiliates. © 2021 Elanco or its affiliates CA081315HAM CA081330HAM March 2021

FDA adverse event reports

The FDA Center for Veterinary Medicine publishes the adverse event reports it receives through openFDA. The counts below are the reports naming miconazole and polymyxin b and prednisolone as an active ingredient for each species this label names, as returned on 2026-09-16, coded by the VeDDRA reaction term the reporter chose. Reactions are counted per report, so one report can appear under several terms.

These are counts, not rates. Reporting is voluntary, the number of animals treated is not known, and a widely used product accumulates reports for that reason alone. A report records that an event followed a dose; it does not establish that the product caused it. The counts say nothing about how one product compares with another.