Surolan

Name: Surolan

Surolan Drug Class

Surolan is part of the drug classes:

  • Antiinfectives and antiseptics for local oral treatment

  • Imidazole and triazole derivatives

  • Polymyxins

  • Corticosteroids acting locally

  • Antiinflammatory Corticosteroids

  • Corticosteroids, weak group I

  • Corticosteroids, weak, other combinations

  • Corticosteroids/antiinfectives/mydriatics in combination

  • Glucocorticoids

Surolan®

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

Rx

Antifungal, antibacterial and anti-inflammatory
For otic use in dogs only

Indications

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

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.

PRINCIPAL DISPLAY PANEL - 15 mL Box

NDC 17030-947-15

Surolan®

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

15mL

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

Vétoquinol

Surolan 
miconazole nitrate, polymyxin b sulfate, and prednisolone acetate suspension/ drops
Product Information
Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:17030-947
Route of Administration AURICULAR (OTIC) DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
miconazole nitrate (miconazole) miconazole nitrate 23 mg  in 1 mL
polymyxin B sulfate (polymyxin B) polymyxin B sulfate 0.5293 mg  in 1 mL
prednisolone acetate (prednisolone) prednisolone acetate 5 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
paraffin  
Product Characteristics
Color WHITE (opaque) Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description
1 NDC:17030-947-15 1 BOTTLE, WITH APPLICATOR (BOTTLE) in 1 BOX
1 15 mL in 1 BOTTLE, WITH APPLICATOR
2 NDC:17030-947-30 1 BOTTLE, WITH APPLICATOR (BOTTLE) in 1 BOX
2 30 mL in 1 BOTTLE, WITH APPLICATOR
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NADA NADA141298 12/30/2009
Labeler - Vetoquinol USA Inc (106824209)
Establishment
Name Address ID/FEI Operations
Jansen Pharmaceutica NV 370005019 MANUFACTURE
Revised: 12/2009   Vetoquinol USA Inc
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