Otitis externa relief requires the right mix of active ingredients

Three active ingredients.

One proven product. One©2014 trustedElanco SUR00105 company.

With three active ingredients, Surolan® otic suspension (miconazole nitrate, polymyxin B sulfate and prednisolone acetate), has antibacterial, antifungal and anti-infl ammatory benefi ts. It is indicated for the treatment of canine otitis externa associated with susceptible strains of yeast (Malassezia pachydermatis) and bacteria (Staphylococcus pseudintermedius).

Surolan has been used successfully and effectively around the world as a treatment for otitis externa for more than three decades — without documented resistance.*, 1

Now from Elanco, Surolan is proven to show a synergistic effect between miconazole nitrate and polymyxin B sulfate resulting in enhanced fungicidal and bactericidal activity.*, 2

Potent antifungal and antibacterial 100% of Malassezia isolates showed sensitivity to Surolan in a peer-reviewed field trial*, 3 Polymyxin B sulfate is proven to be effective against Gram-positive and Gram-negative bacteria3

Synergistic effect In an in vitro study, when used in combination, the antimicrobial activity of polymyxin B and miconazole was enhanced in all strains tested.*, 2 The amount of each active ingredient required can be reduced while maximizing efficacy against susceptible strains of yeast and bacteria*, 2 Combining miconazole nitrate with polymyxin B sulfate reduces the minimum inhibitory concentration (MIC) for Malassezia pachydermatis by 75%*, 2

* The clinical relevance of this in vitro data has not been demonstrated. Can help prevent resistance in fungal and bacterial pathogens2 In a 2012 peer-reviewed study, resistance to miconazole nitrate and polymyxin B sulfate was either low or could not be detected in canine methicillin-resistant Staphylococcus pseudintermedius (MRSP).1 When combined, miconazole nitrate and polymyxin B sulfate were effective in inhibiting the growth of MRSP at a concentration 1000x less than the concentration in Surolan.1

Provides relief In clinical trials, dogs showing an improvement: in a high number of patients 94% 89% 91%

in pain in swelling in erythema

94%94% 89% 89% 91%91%

Standardized dosing: Apply 5 drops into clean, dry ear twice a day for 7 days for any size dog.

Surolan has been used with confidence for more than 35 years and is one of the best known and most used small animal otitis brands in Europe.4 It is now fully supported by Elanco Animal Health, a global leader in the development of innovative solutions that enable veterinarians to help pets live longer, healthier higher-quality lives.

To learn more contact your Elanco or distributor representative, call 888-545-5973 or visit Surolan.com

Important Safety Information The most common adverse reaction was reduced hearing. Do not use Surolan in dogs with known perforated tympanum or with drugs known to induce ototoxicity. 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 hypoadrenocorticism in dogs. The safe use of Surolan in breeding animals has not been evaluated. For product label, including complete safety information see back.

1 Boyen F, Verstappen K M H W, De Bock M, Duim B, Weese J S, Schwarz S, Haesebrouck F and Wagenaar J A. In vitro antimicrobial activity of miconazole and polymyxin B against canine meticillin-resistant Staphylococcus aureus and meticillin-resistant Staphylococcus pseudintermedius isolates. Vet Derm, Aug 2012 23(4): 381 e-70. 2 Pietschmann S, Hoffmann K, Voget M, Pison U. Synergistic effects of Miconazole and Polymyxin B on microbial pathogens. Vet Res Commun, Aug 2009; 33(6): 489-505. 3 Engelen M, De Bock M, Hare J, Goossens L. Effectiveness of an Otic Product Containing Miconazole, Polymyxin B and Prednisolone in the Treatment of Canine Otitis Externa: Multisite Field Trial in the US and Canada. Intern J Appl Res Vet Med, 2010 8(1): 21-30. 4 Ipsos Agriculture and Animal Health Research, Surolan Outcomes Veterinarian Qualitative Study, July 2013. 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 e£ects between miconazole nitrate and polymyxin B sulfate have been demonstrated in otic suspension an in vitro study(1). Prednisolone acetate is a glucocorticoid with (miconazole nitrate, polymyxin B sulfate, anti-inflammatory activity. A study performed using an experimentally-induced model of ear inflammation in mice demonstrated the e£ectiveness of prednisolone prednisolone acetate) acetate in treating ear inflammation either alone or in combination with the other ℞ active ingredients of SUROLAN(2). Antifungal, antibacterial and anti-inflammatory MICROBIOLOGY For otic use in dogs only The compatibility and additive e£ect of each of the components in SUROLAN CAUTION was demonstrated in a component e£ectiveness and non-interference study. Federal (USA) law restricts this drug to use by or on the order of a licensed An in vitro study of organisms collected from clinical cases of otitis externa at a veterinarian. veterinary teaching hospital and from dogs enrolled in the clinical e£ectiveness study for SUROLAN determined that polymyxin B sulfate and miconazole nitrate DESCRIPTION inhibit the growth of bacteria and yeast commonly associated with canine otitis SUROLAN contains 23 mg/mL miconazole nitrate, 0.5293 mg/mL polymyxin B externa. Furthermore, a synergistic e£ect of the two antimicrobials was sulfate and 5 mg/mL prednisolone acetate. Inactive ingredients are colloidal silicon demonstrated. The addition of prednisolone acetate to the combination did dioxide and liquid para‰n. not impair antimicrobial activity to any clinically-significant extent. INDICATIONS ANIMAL SAFETY SUROLAN is indicated for the treatment of canine otitis externa associated The following adverse reactions were reported in a study when SUROLAN was with susceptible strains of yeast (Malassezia pachydermatis) and bacteria administered at 1X, 3X and 5X for 42 consecutive days (6 times the recommended (Staphylococcus pseudintermedius). treatment duration) in laboratory Beagles: hypersensitivity reactions which DOSAGE AND ADMINISTRATION included mild erythema and hyperemia, painful and sensitive ear canals on Shake well before use. examination, changes in hematology, clinical chemistry and urinalysis values The external ear should be thoroughly cleaned and dried before the initiation consistent with the systemic absorption of topical corticosteroids, and veterinary of treatment. Verify that the eardrum is intact. Instill 5 drops of SUROLAN in the observations of pale ear canals. ear canal twice daily and massage the ear. Therapy should continue for 7 EFFECTIVENESS consecutive days. Of 337 dogs enrolled in the field study, 176 dogs were included in the CONTRAINDICATIONS e£ectiveness database; 91 were treated with SUROLAN and 85 were treated with SUROLAN is contraindicated in dogs with suspected or known hypersensitivity an FDA-approved active control. Clinical evaluations of otitis externa included to miconazole nitrate, polymyxin B sulfate, or prednisolone acetate. pain/discomfort, swelling, redness, and exudate. A non-inferiority evaluation was used to compare SUROLAN with the active control with respect to each clinical Do not use in dogs with known perforated tympanum. Do not use with drugs sign of otitis externa and overall clinical improvement. SUROLAN was determined known to induce ototoxicity. to be non-inferior to treatment with the active control for otitis externa. Malassezia WARNINGS pachydermatis and Staphylococcus pseudintermedius were identified Not for use in humans. Keep this and all drugs out of reach of children. pre-treatment in at least 10 cases that were clinically responsive to SUROLAN. ANIMAL WARNINGS Table 1. Mean Percentage of Improvement in Clinical Signs of Otitis Externa Do not administer orally. SUROLAN Active control For otic use only. Clinical sign N=91 N=85 PRECAUTIONS Pain/discomfort 94.4% 91.7% Before instilling any medication into the ear, examine the external ear canal thoroughly to be certain the tympanic membranes are not ruptured. Swelling 89.1% 90.5% If overgrowth of non-susceptible bacteria or fungi occurs, treatment should be Redness 91.2% 86.1% discontinued and appropriate therapy instituted. Exudate 83.1% 82.1% Long-term use of topical otic corticosteroids has been associated with Overall 96.7% 95.2% adrenocortical suppression and iatrogenic hypoadrenalcorticism in dogs. HOW SUPPLIED The safe use of SUROLAN in dogs used for breeding purposes, during pregnancy, SUROLAN is available in 15 mL and 30 mL plastic dispensing bottles with or in lactating bitches, has not been evaluated. applicator tip for otic use. ADVERSE REACTIONS STORAGE AND HANDLING In the field study, 161 dogs treated with SUROLAN were included in the safety Store at or below 25 °C (77 °F). database. Two dogs experienced reduced hearing at the end of treatment; on NADA 141-298, Approved by FDA. 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 Manufactured for Elanco Animal Health, of the medication decreased the dog’s hearing. At the end of treatment, this dog A Division of Eli Lilly & Company had normal hearing as assessed by the investigator. Residue build-up was Indianapolis, IN 46285 reported in 1 dog and pain upon drug application in another dog. Elanco and Surolan are trademarks owned or licensed by Eli Lilly and Company, A total of 161 dogs treated with the active control was included in the safety its subsidiaries or a‰liates database and adverse reactions were reported in 8 dogs treated with the active NDC 0986-0813-15 control. One dog experienced reduced hearing at the end of treatment. Residue NDC 0986-0813-30 build-up was noted in 1 dog. Four dogs vomited during treatment, 1 dog showed CA081315HAM red pustules on the pinna and head shaking was observed in another dog. CA081330HAM Foreign market experience: the following adverse events were reported voluntarily July 2013 during postapproval use of the product in foreign markets: deafness, reduced REFERENCES hearing, topical hypersensitivity reactions and red blisters on pinna. 1. Pietschmann S. et al. (2009) For a copy of the Material Safety Data Sheet (MSDS), for technical assistance or Synergistic e£ects of miconazole and polymyxin B on microbial pathogens. to report a suspected adverse drug reaction, contact Elanco Animal Health at Veterinary Research Communications 33(6), 489-505 1-888-545-5973. Alternatively, suspected adverse drug reactions may be reported 2. Bolinder A. et al. (2006) to FDA at 1-888-FDA-VETS or http://www.fda.gov/AnimalVeterinary/SafetyHealth/ In vivo e‰cacy study of the anti-inflammatory properties of Surolan ReportaProblem/ucm055305.htm The Canadian Journal of Veterinary Research 70, 234-236

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