Surolan Otic Suspension is an effective treatment for common and recurring cases of otitis externa and dermatitis in dogs. Surolan is a combination of antibiotic, antifungal and anti-inflammatory medications, including polymyxin B, miconazole and prednisolone. This formulation gives Surolan broad effectiveness against the pathogens that cause ear infections and make it less likely to develop into resistant cases. Surolan is dispensed as drops to provide a rapid, penetrating action. Additionally, it can be administered more comfortably and precisely to infected ears because it is stable and fluid at room temperature.
Surolan is used in dogs for the therapeutic treatment of otitis externa and dermatitis caused by:
Surolan also has anti-inflammatory and antipruritic activity.
The ingredients in Surolan are a combination of antifungal, antibiotic, and anti-inflammatory agents including polymyxin B, miconazole and prednisolone to help treat otitis externa.
Surolan is indicated for the treatment of canine otitis externa associated with susceptible strains of yeast (Malassezia pachydermatis) and bacteria (Staphylococcus pseudintermedius).
|Active Ingredients (per ml)||Amount|
|Miconazole nitrate||23 mg|
|Polymyxin B sulfate||0.5293 mg|
|Prednisolone acetate||5 mg|
Colloidal silicone dioxide and liquid paraffin
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.
Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian.
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.
Not for use in humans. Keep this and all drugs out of reach of children.
Do not administer orally. For otic use only.
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.
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.
The following adverse reactions were reported in a study when Surolan was administered at 1X, 3X and 5X for 42 consecutive days (6 times the recommended treatment duration) in laboratory Beagles: hypersensitivity reactions which included mild erythema and hyperemia, painful and sensitive ear canals on examination, changes in hematology, clinical chemistry and urinalysis values consistent with the systemic absorption of topical corticosteroids, and veterinary observations of pale ear canals.
Store at or below 25°C (77°F).