Product Description

Surolan is indicated for the topical treatment of otitis externa and skin infections caused by susceptible pathogens, and for the topical treatment of otitis externa caused by the ear mite Otodectes cynotis. Bacteriological sampling and sensitivity testing are recommended prior to initiating treatment, particularly where polymyxin B resistance is a concern. The product also has anti-inflammatory and anti-pruritic activity through its prednisolone acetate component.

For Dogs:

Topical treatment of otitis externa and skin infections caused by Gram-positive bacteria (Staphylococcus aureus, Streptococcus spp.) and Gram-negative bacteria (Escherichia coli, Pseudomonas aeruginosa)

Topical treatment of otitis externa and skin infections caused by fungi and yeasts (Trichophyton spp., Microsporum spp., Malassezia pachydermatis, Candida spp.)

Topical treatment of otitis externa caused by the ear mite Otodectes cynotis

For Cats:

Topical treatment of otitis externa and skin infections caused by Gram-positive bacteria (Staphylococcus aureus, Streptococcus spp.) and Gram-negative bacteria (Escherichia coli, Pseudomonas aeruginosa)

Topical treatment of otitis externa and skin infections caused by fungi and yeasts (Trichophyton spp., Microsporum spp., Malassezia pachydermatis, Candida spp.)

Topical treatment of otitis externa caused by the ear mite Otodectes cynotis

Which Animals Can Use Surolan Ear Drops?

Surolan Ear Drops are licensed for use in dogs and cats only. They must not be used in any animal with a perforated eardrum, as polymyxin B is a known potential ototoxic agent. They must not be used in animals with known hypersensitivity to any of the active ingredients or excipients. Corticosteroids are not recommended for use in pregnant animals. All use must be under the direction of your vet and in accordance with a valid veterinary prescription.

Available Strengths & Sizes

Please order the specific pack size as directed on your veterinary prescription.

Not all pack sizes may be marketed.

Directions for Use

This is a prescription medication and must be used exactly as directed by your veterinary surgeon. The product is for topical (external) use only — in the ear canal or applied directly to the skin. Shake the bottle vigorously before each use to ensure the suspension is fully resuspended. Hair surrounding or covering any skin lesions should be clipped before starting treatment, and repeated during treatment if necessary. Dosage and treatment duration will depend on the condition being treated and the animal's response. Refer to the dispensing label or product datasheet for full instructions. Do not exceed the prescribed dose or duration of treatment.

Contraindications

Source: SPC Section 4.3

Do not use in animals with a perforated eardrum — polymyxin B is a known potential ototoxic agent

Do not use in cases of known hypersensitivity to any of the active substances (miconazole nitrate, prednisolone acetate, polymyxin B sulfate) or to any of the excipients

Storage & Handling

Store below 25°C. Keep out of the sight and reach of children and animals at all times. Once opened, use within 3 months. No withdrawal period applies — this product is for companion animal use only.

Important Warnings

Source: SPC Sections 4.4 & 4.5

As a prescription-only medicine, treatment must be closely supervised by a veterinary practitioner throughout the course of therapy

For external use only — do not administer internally

Bacteriological sampling and sensitivity testing (antibiogram) are recommended prior to use due to likely variability in the emergence of polymyxin B resistance; if overgrowth of resistant bacteria or fungi occurs, treatment should be discontinued and an appropriate alternative initiated

Deafness and impaired hearing have been reported very rarely — mainly in elderly dogs; if this occurs, treatment should be stopped; decreased hearing or deafness is generally temporary in nature

Prolonged use of topical corticosteroids can cause skin discolouration and delayed wound healing; conventional adverse effects of corticosteroids may also occur (including disturbance of biochemical parameters such as increased cortisol and hepatic enzyme levels)

Corticosteroids are not recommended for use in pregnant animals

Do not use concomitantly with medicines that may induce ototoxicity

Do not handle this product if you are allergic to any of the ingredients

Corticosteroids contained in this product may produce irreversible effects in the skin, can be absorbed systemically, and may have harmful effects — especially with frequent and extensive contact or during pregnancy; always wear single-use disposable gloves when applying the product to animals

Accidental spillage on skin should be washed off immediately with soap and water; wash hands thoroughly after use

In case of accidental ingestion by licking, no toxic effects have been observed; however, seek veterinary or medical advice if concerned

POM-V Prescription Notice

This product is a Prescription Only Medicine — Veterinary (POM-V). It may only be supplied by a veterinary surgeon or, when prescribed by a veterinary surgeon, by a pharmacist or SQP. A valid veterinary prescription is required before this product can be dispensed.

MA Number: Vm 52127/5083 (MA source: VMD Product Information Database — SPC_97091.PDF, revised April 2025, AN: 04322/2024)