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), Bacitracin Zinc (UNII: 89Y4M234ES) (Bacitracin - UNII:58H6RWO52I), Hydrocortisone (UNII: WI4X0X7BPJ) (Hydrocortisone - UNII:WI4X0X7BPJ)
MWI
Neomycin Sulfate
Neomycin 3.5 mg in 1 g
OPHTHALMIC
PRESCRIPTION DRUG
Neomycin and Polymyxin B Sulfates, Bacitracin Zinc, and Hydrocortisone Ophthalmic Ointment is indicated for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where bacterial infection or a risk of bacterial infection exists. Ocular corticosteroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe where the inherent risk of corticosteroid use in certain infective conjunctivitides is accepted to obtain a diminution in edema and inflammation. They are also indicated in chronic anterior uveitis and corneal injury from chemical, radiation, or thermal burns, or penetration of foreign bodies. The use of a combination drug with an anti-infective component is indicated where the risk of infection is high or where there is an expectation that potentially dangerous numbers of bacteria will be present in the eye (see CLINICAL PHARMACOLOGY: Microbiology). The particular anti-infective drugs in this product
Neomycin and Polymyxin B Sulfates, Bacitracin Zinc, and Hydrocortisone Ophthalmic Ointment, USP is supplied in a tube with ophthalmic applicator tip in the following size: NDC 13985-608-03 1/8 oz (3.5 g) tube FOR OPHTHALMIC USE ONLY.
Abbreviated New Drug Application
NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC, AND HYDROCORTISONE- NEOMYCIN SULFATE, POLYMYXIN B SULFATE, BACITRACIN ZINC AND HYDROCORTISONE OINTMENT MWI ---------- APEXA™ NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE Ophthalmic Ointment, USP STERILE Rx Only DESCRIPTION: Neomycin and Polymyxin B Sulfates, Bacitracin Zinc, and Hydrocortisone Ophthalmic Ointment, USP is a sterile antimicrobial and anti-inflammatory ointment for ophthalmic use. The color of the product is colorless to light yellowish. EACH GRAM CONTAINS: ACTIVES: Neomycin Sulfate equivalent to 3.5 mg neomycin base, Polymyxin B Sulfate equal to 10,000 polymyxin B units, Bacitracin Zinc equivalent to 400 bacitracin units, and Hydrocortisone 10 mg (1%); INACTIVE: White Petrolatum q.s. 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 mcg 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: Bacitracin zinc is the zinc salt of bacitracin, a mixture of related cyclic polypeptides (mainly bacitracin A) produced by the growth of an organism of the _licheniformis_ group 1 2 of _Bacillus subtilis_ var Tracy. It has a potency of not less then 40 bacitracin units per mg. The structural formula is: Hydrocortisone, 11β 17, 21-trihydroxypregn-4-ene-3, 20-dione, is an anti-inflammatory hormone. The structural formula is: CLINICAL PHARMACOLOGY: Corticosteroids suppress the inflammatory response to a variety of agents and they probably delay or slow healing. Since corticosteroids may inhibit the body's defense mechanism against infection, a concomitant antimicrobial dru Прочитать полный документ