Страна: Соединенные Штаты
Язык: английский
Источник: NLM (National Library of Medicine)
NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297), POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K), HYDROCORTISONE ACETATE (UNII: 3X7931PO74) (HYDROCORTISONE - UNII:WI4X0X7BPJ)
Pfizer Laboratories Div Pfizer Inc
NEOMYCIN SULFATE
NEOMYCIN 3.5 mg in 1 g
TOPICAL
PRESCRIPTION DRUG
For the treatment of corticosteroid-responsive dermatoses with secondary infection. It has not been demonstrated that this steroid-antibiotic combination provides greater benefit than the steroid component alone after 7 days of treatment (see WARNINGS). Not for use in the eyes or in the external ear canal if the eardrum is perforated. This product is contraindicated in tuberculous, fungal, or viral lesions of the skin (herpes simplex, vaccinia, and varicella). This product is contraindicated in those individuals who have shown hypersensitivity to any of its components.
Tube of 7.5 g (NDC 61570-032-75). Store at 15° to 25°C (59° to 77°F).
New Drug Application
CORTISPORIN- NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND HYDROCORTISONE ACETATE CREAM PFIZER LABORATORIES DIV PFIZER INC ---------- CORTISPORIN CREAM (NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE ACETATE CREAM, USP) DESCRIPTION CORTISPORIN Cream (neomycin and polymyxin B sulfates and hydrocortisone acetate cream, USP) is a topical antibacterial cream. Each gram contains: neomycin sulfate equivalent to 3.5 mg neomycin base, polymyxin B sulfate equivalent to 10,000 polymyxin B units, and hydrocortisone acetate 5 mg (0.5%). The inactive ingredients are liquid petrolatum, white petrolatum, propylene glycol, polyoxyethylene polyoxypropylene compound, emulsifying wax, purified water, and 0.25% methylparaben added as a preservative. Sodium hydroxide or sulfuric acid may be added to adjust pH. Neomycin sulfate is the sulfate salt of neomycin B and C, which are produced by the growth of _Streptomyces fradiae_ Waksman (Fam. Streptomycetaceae). It has a potency equivalent of not less than 600 µg of neomycin standard per mg, calculated on an anhydrous basis. The structural formulae are: Polymyxin B sulfate is the sulfate salt of polymyxin B and B , which are produced by the growth of _Bacillus polymyxa_ (Prazmowski) Migula (Fam. Bacillaceae). It has a potency of not less than 6,000 polymyxin B units per mg, calculated on an anhydrous basis. The structural formulae are: ® 1 2 Hydrocortisone acetate is the acetate ester of hydrocortisone, an anti-inflammatory hormone. Its chemical name is 21-(acetyloxy)- 11β,17-dihydroxypregn-4-ene-3,20-dione. Its structural formula is: The base is a smooth vanishing cream with a pH of approximately 5.0. CLINICAL PHARMACOLOGY Corticoids 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 anti-infective components in the combination are includ Прочитать полный документ