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Surolan Otic Suspension

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  • FAQ
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Description

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:

  • Yeasts and fungi
    • Microsporum spp.
    • Trichophyton spp.
    • Candida spp.
    • Malassezia pachydermatis
  • Gram-positive bacteria
    • Staphylococcus spp. (sensitive strains)
    • Streptococcus spp. (sensitive strains)
  • Gram-negative bacteria
    • Pseudomona spp. (sensitive strains)
    • Escherichia coli
  • Ear mites
    • Otodectes cynotis

Surolan also has anti-inflammatory and antipruritic activity.

How It Works

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.

Indications

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

Ingredients

Active Ingredients (per ml) Amount
Miconazole nitrate 23 mg
Polymyxin B sulfate 0.5293 mg
Prednisolone acetate 5 mg

Other Ingredients:

Colloidal silicone dioxide and liquid paraffin

Directions

View Surolan Drug Facts Sheet.

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.

Caution:

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

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.

Animal Safety:

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.

Storage:

Store at or below 25°C (77°F).

FAQ

Surolan Otic Suspension is a prescription medication FDA approved for use in dogs only. It is available in a 15 ml plastic dropper bottle. Use this medication for the full amount of time prescribed by your veterinarian, even if your pet appears to be better. Symptoms may improve before the infection is completely healed. Shake well before use. The usual dose for dogs of any weight is 5 drops placed into the ear canal 2 times a day and massage the ear. Therapy should continue for 7 consecutive days. Avoid getting this medication in your pet's eyes, nose or mouth.
Tell your veterinarian if your pet has ever had an allergic reaction to this medication or any of the individual ingredients. Do not use in dogs with a perforated ear drum. Do not use with other drugs known to cause ear damage (ototoxicity).
The external ear should be thoroughly cleaned and dried before treatment. Apply this medication exactly as directed by your veterinarian. If you do not understand these directions ask your pharmacist or veterinarian to explain them to you. Avoid getting Surolan Otic Suspension in your dog's eyes, nose or mouth. Store Surolan Otic Suspension at or below 77 F.
Apply the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the dose you missed and apply the next regularly scheduled dose. Do not use a double dose of this medication unless otherwise directed by your veterinarian.
An overdose of Surolan Otic Suspension is unlikely to occur. If you suspect that a much larger than normal dose has been used, or that the medication has been swallowed, contact your veterinarian or veterinary emergency room.
Avoid using any other medications in your pet's ear unless instructed to by your veterinarian. Do not use Surolan Otic Suspension in dogs allergic to it or any of the individual ingredients. Do not use in dogs with perforated ear drums. Discontinue use of this medication if hearing loss is noted during treatment. Use of this product beyond the recommended dose of 7 days may result in delayed wound healing.
Side effects that may occur include topical sensitivity and reduced hearing or deafness. Other side effects may also occur. Talk to your veterinarian about any side effect that seems unusual or bothersome to your pet.
Avoid using other ear medications without first talking to your veterinarian. Drugs other than those listed may also interact with Surolan Otic Suspension. Talk to your veterinarian or pharmacist before taking or using any other prescription or over the counter medicines, including vitamins, minerals, and herbal products.

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