CORTISPORIN-TC- colistin sulfate, neomycin sulfate, thonzonium bromide and hydrocortisone acetate suspension
Par Pharmaceutical, Inc.
DESCRIPTION
Cortisporin� -TC Otic Suspension with Neomycin and Hydrocortisone (colistin sulfate�neomycin sulfate�thonzonium bromide�hydrocortisone acetate otic suspension) is a sterile antibacterial and anti-inflammatory aqueous suspension containing in each mL: Colistin base activity, 3 mg (as the sulfate); Neomycin base activity, 3.3 mg (as the sulfate); Hydrocortisone acetate, 10 mg (1%); Thonzonium bromide,
0.5 mg (0.05%); Polysorbate 80, acetic acid, and sodium acetate in a buffered aqueous vehicle. Thimerosal (mercury derivative), 0.002%, is added as a preservative. It is a nonviscous liquid, buffered at pH 5, for instillation into the canal of the external ear or direct application to the affected aural skin.
The structural formulas of colistin sulfate (mixture of Colistin A & B), neomycin sulfate (mixture of neomycin A, B & C), hydrocortisone acetate ((11?)-21-(acetyloxy)-11,17-dihydroxypregn) methyl]-2 pyrimidinylamino] ethyl]-N,N-dimethyl-1-hexadecanaminium, bromide) are represented below:
Chemical Structure
Thonzonium Bromide
Chemical Structure
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Colistin sulfate
Chemical Structure
Neomycin A
Chemical Structure
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Neomycin B Sulfate
Chemical Structure
Hydrocortisone Acetate
Chemical Structure
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Neomycin C Sulfate
CLINICAL PHARMACOLOGY
Colistin sulfate is a polypeptide antibiotic which penetrates into and disrupts the bacterial cell membrane. Neomycin sulfate is an aminoglycoside antibiotic which inhibits protein synthesis, disrupting the normal cycle of ribosomal function. Hydrocortisone acetate is a corticosteroid hormone which is thought to act by regulating the rate of protein synthesis; it controls inflammation, edema, pruritus and other dermal reactions. Cortiscosteroids suppress the inflammatory response to a variety of agents and they may delay healing. Since corticoids may inhibit the body�s defense mechanism against infection, a concomitant antimicrobial drug may be used when this inhibition is considered to be clinically significant in a particular case.
The relative potency of corticosteroids depends on the molecular structure, concentration, and release from the vehicle.
Thonzonium bromide is a surface-active agent that promotes tissue contact by dispersion and penetration of the cellular debris and exudate.
