Ország: Egyesült Államok
Nyelv: angol
Forrás: NLM (National Library of Medicine)
COLISTIN SULFATE (UNII: WP15DXU577) (COLISTIN - UNII:Z67X93HJG1), NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297), THONZONIUM BROMIDE (UNII: JI2B19CR0R) (THONZONIUM BROMIDE - UNII:JI2B19CR0R), HYDROCORTISONE ACETATE (UNII: 3X7931PO74) (HYDROCORTISONE - UNII:WI4X0X7BPJ)
Physicians Total Care, Inc.
COLISTIN SULFATE
COLISTIN 3 mg in 1 mL
AURICULAR (OTIC)
PRESCRIPTION DRUG
Cortisporin® -TC Otic Suspension is indicated for the treatment of superficial bacterial infections of the external auditory canal, caused by organisms susceptible to the action of the antibiotics; and for the treatment of infections of mastoidectomy and fenestration cavities, caused by organisms susceptible to the antibiotics. This product is contraindicated in those individuals who have shown hypersensitivity to any of its components. This product should not be used if the external auditory canal disorder is suspected or known to be due to cutaneous viral infection (e.g., herpes simplex virus or varicella zoster virus).
Cortisporin® -TC Otic Suspension is supplied as: NDC 54868-0564-0 ............... 10 mL bottle with dropper Each mL contains: Colistin sulfate equivalent to 3 mg of colistin base activity, Neomycin sulfate equivalent to 3.3 mg neomycin base activity, Hydrocortisone acetate 10 mg (1%), Thonzonium bromide 0.5 mg (0.05%), and Polysorbate 80 in an aqueous vehicle buffered with acetic acid and sodium acetate. Thimerosal (mercury derivative) 0.002% is added as a preservative. A sterilized dropper-cap assembly for use on the bottle of suspension is included in the package. Shake well before using. Store at 20°–25°C (68°–77°F). Rx only.
New Drug Application
CORTISPORIN-TC - COLISTIN SULFATE, NEOMYCIN SULFATE, THONZONIUM BROMIDE, AND HYDROCORTISONE ACETATE SUSPENSION PHYSICIANS TOTAL CARE, INC. ---------- CORTISPORIN -TC OTIC SUSPENSION WITH NEOMYCIN AND HYDROCORTISONE (COLISTIN SULFATE—NEOMYCIN SULFATE—THONZONIUM BROMIDE—HYDROCORTISONE ACETATE OTIC SUSPENSION) 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 ((11β)-21-(acetyloxy)-11,17-dihydroxypregn) methyl]-2 pyrimidinylamino] ethyl]-N,N-dimethyl-1-hexadecanaminium, bromide) are represented below: _Thonzonium Bromide_ _Colistin sulfate_ ® ® _Neomycin A_ _Neomycin B Sulfate_ _Hydrocortisone Acetate_ _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 Olvassa el a teljes dokumentumot