Surolan Ear Drops and Cutaneous Suspension

Composition

Each ml contains:

Active substances:

Miconazole Nitrate 23 mg

Prednisolone Acetate 5 mg

Polymyxin B Sulfate 0.5293 mg

Excipients:

Qualitative composition of excipients and other constituents

Silica colloidal anhydrous

Liquid paraffin

White suspension

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Pharmacological properties

4.1 ATCvet code: QS02CA01

4.2 Pharmacodynamics

Miconazole nitrate is a synthetic imidazole derivative with a pronounced antifungal activity and a potent activity against Gram-positive bacteria. Miconazole selectively inhibits the synthesis of ergosterol, which is an essential component of the membrane of yeasts and fungi.

Polymyxin B sulfate is a polypeptide antibiotic with bactericidal activity against Gram-negative bacteria. It binds to phospholipids in the cytoplasmic membrane, whereby the membrane permeability is disturbed. This results in lysis of the bacteria.

Prednisolone acetate is a glucocorticoid with strong anti-inflammatory activity which results from its reduction of the permeability of capillaries and vascular proliferation and from the inhibition of fibroblast action.

4.3 Pharmacokinetics

After topical application of miconazole nitrate, virtually no systemic absorption takes place through the skin or mucus membranes.

Systemic absorption of prednisolone on normal or abraded skin is minimal. Absorption of polymyxin B via the skin is also negligible. Excretion is almost completely via the kidneys.

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Target species

Dogs and cats

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Indications

For the topical treatment of otitis externa and skin infections caused by Gram-positive bacteria e.g. Staphylococcus aureus and Streptococcus spp. and Gram-negative bacteria Escherichia coli and Pseudomonas aeruginosa.

For the topical treatment of otitis externa and skin infections caused by fungi and yeasts: Trichophyton spp., Microsporum spp., Malassezia pachydermatis, Candida spp.

For the topical treatment of otitis externa caused by the ear mite Otodectes cynotis. The product also has anti-inflammatory and anti-pruritic activity.

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Dosage

This product is for topical administration. Shake the bottle vigorously and ensure the product is fully resuspended before use.

At the beginning of treatment, hair surrounding or covering the lesions must be clipped; this should be repeated during treatment if necessary.

Ears: Clean the auditory canal and place a few drops of the product into the ear twice daily. For infections caused by Otodectes cynotis, instill five drops twice daily for 14 days.

Massage the ear and the auditory canal gently but thoroughly to ensure proper distribution.

Skin: Having ensured the area to be treated is clean, apply a few drops of the product (depending on lesion size) twice a day and rub well.

Treatment should be continued until a few days after complete disappearance of the clinical symptoms. In some obstinate cases, treatment may be required for 2 to 3 weeks (see also 3.6).

Where ear mite infestation is present, consideration should be given to treating both ears even if infestation is only apparent in one ear.

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Contraindications

Do not use in animals with perforated ear drums since Polymyxin B is known to be a potential ototoxic agent.

Do not use in cases of hypersensitivity to the active substances or to any of the excipients.

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Adverse reactions

Dogs and cats:

Very rare (<1 animal / 10,000 animals treated, including isolated reports): Deafness1, Impaired hearing1

1Mainly in elderly dogs.If this occurs, treatment should be stopped. Decreased hearing or deafness is generally temporary in nature.

Prolonged use of topical steroids can cause skin discoloration and delay wound healing.

The conventional adverse effects of corticosteroids can occur (disturbance of biochemical parameters, such as increased cortisol and hepatic enzyme levels).

Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or the national competent authority via the national reporting system. See the package leaflet for respective contact details.

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Warnings

Special precautions for safe use in the target species:

For external use only.

Due to the likely variability (temporal, geographical) in the emergence of bacterial resistance to polymyxin B, bacteriological sampling and sensitivity testing (antibiogram) is recommended.

If there is overgrowth of resistance bacteria and/or fungi, treatment with this product should be discontinued and treatment with an appropriate alternative should be initiated.

Special precautions to be taken by the person administering the veterinary medicinal product to animals

Do not handle the product if you are allergic to the ingredients in the product. Accidental spillage on the skin should be washed off immediately with soap and water. Wash hands after use.

Corticosteroids may produce irreversible effects in the skin. They can be absorbed and may have harmful effects, especially with frequent and extensive contact or in pregnancy. Personal protective equipment consisting of single use disposable gloves should always be worn when applying the product to animals.

Special precautions for the protection of the environment:

Not applicable.

3.11 Special restrictions for use and special conditions for use, including restrictions on the use of antimicrobial and antiparasitic veterinary medicinal products in order to limit the risk of development of resistance

Not applicable.

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Use during pregnancy, lactation or lay

Corticosteroids are not recommended for use in pregnant animals.

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Interactions

Do not use concomitantly with medicines that induce ototoxicity.

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Overdose

Topical use. In case of accidental ingestion by licking, no toxic effects were observed.

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Special warnings

As the product is a prescription only medicine, treatment should be closely supervised by a veterinary practitioner.

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Withdrawal period

Not applicable

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Incompatibilities

None known.

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Immediate packaging

Bottle: 15 ml or 30 ml white, opaque low-density polyethylene squeeze dropper bottle.

Closure: White, opaque high-density polyethylene child resistant cap (screwfit) with tamper evident ring or white, opaque high-density polyethylene tamper evident (screw fit) cap.

Dropper (Dosing Device): White, low-density polyethylene and thermoplastic elastomer or white, low density polyethylene.

Not all pack sizes may be marketed.

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Storage

Do not store above 25 °C

Keep the dropper bottle in the outer carton.

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Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 2 years.

Shelf life after first opening the immediate packaging: 3 months.

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Disposal of unused product

Medicines should not be disposed of via wastewater.

Use take-back schemes for the disposal of any unused veterinary medicinal product or waste materials derived thereof in accordance with local requirements and with any national collection systems applicable to the veterinary medicinal product concerned.

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Additional information

7 MARKETING AUTHORISATION NUMBERS

UK(GB) – Vm 52127/5083

UK(NI) - Vm 52127/3018

8 DATE OF FIRST AUTHORISATION

05 September 1985

9 DATE OF THE LAST REVISION OF THE SUMMARY OF THE PRODUCT CHARACTERISTICS

July 2026

10 CLASSIFICATION OF VETERINARY MEDICINAL PRODUCT

Veterinary medicinal product subject to prescription.

Find more product information by searching for the ‘Product Information Database’ on www.gov.uk.

Approved: 30 July 2026

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Registration holder

Elanco GmbH

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