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 | |||||||||||||||||||
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Labeler - Vetoquinol USA Inc (106824209) |
Establishment | |||
Name | Address | ID/FEI | Operations |
Jansen Pharmaceutica NV | 370005019 | MANUFACTURE |