Label: SUROLAN- miconazole nitrate, polymyxin b sulfate, prednisolone acetate solution/ drops

  • NDC Code(s): 0986-0813-15, 0986-0813-30
  • Packager: Elanco Animal Health Co
  • Category: PRESCRIPTION ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Animal Drug Application

Drug Label Information

Updated November 5, 2019

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  • SPL UNCLASSIFIED SECTION

    Rx

    otic suspension

    (miconazole nitrate, polymyxin B sulfate, prednisolone acetate)

    Antifungal, antibacterial and anti-inflammatory

    For otic use in dogs only

    CAUTION

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

  • DESCRIPTION

    SUROLAN contains 23 mg/mL miconazole nitrate, 0.5293 mg/mL polymyxin B sulfate and 5 mg/mL prednisolone acetate. Inactive ingredients are colloidal silicon dioxide and liquid paraffin.

  • INDICATIONS

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

  • DOSAGE AND ADMINISTRATION

    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.

  • 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 Material Safety Data Sheet (MSDS), 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 http://www.fda.gov/AnimalVeterinary/SafetyHealth/ReportaProblem/ucm055305.htm

  • 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 effects between miconazole nitrate and polymyxin B sulfate have been demonstrated in an in vitro study(1). Prednisolone acetate is a glucocorticoid with anti-inflammatory activity. A study performed using an experimentally-induced model of ear inflammation in mice demonstrated the effectiveness of prednisolone acetate in treating ear inflammation either alone or in combination with the other active ingredients of SUROLAN(2).

  • MICROBIOLOGY

    The compatibility and additive effect of each of the components in SUROLAN was demonstrated in a component effectiveness and non-interference study. An in vitro study of organisms collected from clinical cases of otitis externa at a veterinary teaching hospital and from dogs enrolled in the clinical effectiveness study for SUROLAN determined that polymyxin B sulfate and miconazole nitrate inhibit the growth of bacteria and yeast commonly associated with canine otitis externa. Furthermore, a synergistic effect of the two antimicrobials was demonstrated. The addition of prednisolone acetate to the combination did not impair antimicrobial activity to any clinically-significant extent.

  • 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.

  • EFFECTIVENESS

    Of 337 dogs enrolled in the field study, 176 dogs were included in the effectiveness database; 91 were treated with SUROLAN and 85 were treated with an FDA-approved active control. Clinical evaluations of otitis externa included pain/discomfort, swelling, redness, and exudate.

    A non‑inferiority evaluation was used to compare SUROLAN with the active control with respect to each clinical sign of otitis externa and overall clinical improvement. SUROLAN was determined to be non-inferior to treatment with the active control for otitis externa. Malassezia pachydermatis and Staphylococcus pseudintermedius were identified pre-treatment in at least 10 cases that were clinically responsive to SUROLAN.

    Table 1. Mean Percentage of Improvement in Clinical Signs of Otitis Externa
    Clinical signSUROLAN
    N=91
    Active control
    N=85
    Pain/discomfort 94.4% 91.7%
    Swelling 89.1% 90.5%
    Redness 91.2% 86.1%
    Exudate 83.1% 82.1%
    Overall 96.7% 95.2%
  • HOW SUPPLIED

    SUROLAN is available in 15 mL and 30 mL plastic dispensing bottles with applicator tip for otic use.

  • STORAGE AND HANDLING

    Store at or below 25 °C (77 °F).

    NADA 141-298, Approved by FDA.

    Manufactured for Elanco US, Inc.,

    Greenfield, IN 46140

    Product of Portugal

    Surolan, Elanco and the diagonal bar logo are trademarks of Elanco or its affiliates.

    NDC 0986-0813-15

    NDC 0986-0813-30

    CA081315HAM

    CA081330HAM

    February 2018

  • REFERENCES

    1. Pietschmann S. et al. (2009) Synergistic effects of miconazole and polymyxin B on microbial pathogens. Veterinary Research Communications 33(6), 489-505
    2. Bolinder A. et al. (2006) In vivo efficacy study of the anti-inflammatory properties of Surolan The Canadian Journal of Veterinary Research 70, 234-236
  • Principal Display Panel - 15 mL Carton Label

    NDC 0986-0813-15

    15 mL

    CA0813

    Surolan™

    otic suspension
    (miconazole nitrate,
    polymyxin B sulfate,
    prednisolone acetate)

    For otic use in dogs only.

    CAUTION:

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

    NADA 141-298

    Approved by FDA

    Elanco

    Principal Display Panel - 15 mL Carton Label
  • Principal Display Panel - 15 mL Bottle Label

    NDC 0986-0813-15

    Surolan

    otic suspension
    (miconazole nitrate, polymyxin B sulfate, prednisolone acetate)

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

    15 mL

    Elanco

    Principal Display Panel - 15 mL Bottle Label
  • Principal Display Panel - 30 mL Carton Label

    NDC 0986-0813-30

    30 mL

    Surolan

    otic suspension
    (miconazole nitrate,
    polymyxin B sulfate,
    prednisolone acetate)

    For otic use in dogs only.

    CAUTION:

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

    Approved by
    FDA under
    NADA# 141-298

    Elanco

    Principal Display Panel - 30 mL Carton Label
  • Principal Display Panel - 30 mL Bottle Label

    NDC 0986-0813-30

    Surolan

    otic suspension (miconazole nitrate, polymyxin B sulfate, prednisolone acetate)

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

    30 mL

    Elanco

    Principal Display Panel - 30 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    SUROLAN 
    miconazole nitrate, polymyxin b sulfate, prednisolone acetate solution/ drops
    Product Information
    Product TypePRESCRIPTION ANIMAL DRUGItem Code (Source)NDC:0986-0813
    Route of AdministrationAURICULAR (OTIC)
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE23 mg  in 1 mL
    POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B.05293 mg  in 1 mL
    PREDNISOLONE ACETATE (UNII: 8B2807733D) (PREDNISOLONE - UNII:9PHQ9Y1OLM) PREDNISOLONE ACETATE5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0986-0813-151 in 1 CARTON
    115 mL in 1 BOTTLE, WITH APPLICATOR
    2NDC:0986-0813-301 in 1 CARTON
    230 mL in 1 BOTTLE, WITH APPLICATOR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NADANADA14129812/30/2009
    Labeler - Elanco Animal Health Co (807447169)
    Establishment
    NameAddressID/FEIBusiness Operations
    Janssen Pharmaceutica NV370005019API MANUFACTURE
    Establishment
    NameAddressID/FEIBusiness Operations
    Lusomedicamenta Sociedade Tecnica Farmaceutica, S.A.,450630343MANUFACTURE, PACK, LABEL