国家: 美国
语言: 英文
来源: NLM (National Library of Medicine)
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I), POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K)
RPK Pharmaceuticals, Inc.
OPHTHALMIC
PRESCRIPTION DRUG
For the treatment of superficial ocular infections involving the conjunctiva and/or cornea caused by organisms susceptible to bacitracin zinc and polymyxin B sulfate. This product is contraindicated in those individuals who have shown hypersensitivity to any of its components.
Product: 53002-9271 NDC: 53002-9271-1 3.5 g in a BOTTLE, DROPPER
Abbreviated New Drug Application
BACITRACIN ZINC AND POLYMYXIN B SULFATE- BACITRACIN ZINC AND POLYMYXIN B SULFATE OINTMENT RPK PHARMACEUTICALS, INC. ---------- BACITRACIN ZINC AND POLYMYXIN B SULFATE OPHTHALMIC OINTMENT, USP (STERILE) RX ONLY DESCRIPTION Bacitracin zinc and polymyxin B sulfate ophthalmic ointment, USP is a sterile antimicrobial ointment formulated for ophthalmic use. 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 of _Bacillus subtilis _var Tracy. It has a potency of not less than 40 bacitracin units/mg. The structural formula for bacitracin A is: 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/mg, calculated on an anhydrous basis. The structural formulae are: 1 2 EACH GRAM CONTAINS: ACTIVES: bacitracin zinc equal to 500 bacitracin units and polymyxin B sulfate equal to 10,000 polymyxin B units; INACTIVES: mineral oil and white petrolatum. CLINICAL PHARMACOLOGY Polymyxin B sulfate attacks gram-negative bacilli, including virtually all strains of _Pseudomonas aeruginosa _and _Haemophilus influenzae _species. Bacitracin is active against most gram-positive bacilli and cocci including hemolytic streptococci. INDICATIONS AND USAGE For the treatment of superficial ocular infections involving the conjunctiva and/or cornea caused by organisms susceptible to bacitracin zinc and polymyxin B sulfate. CONTRAINDICATIONS This product is contraindicated in those individuals who have shown hypersensitivity to any of its components. WARNINGS Ophthalmic ointments may retard corneal healing. PRECAUTIONS As with other antibiotic preparations, prolonged use may result in overgrowth of nonsusceptible organisms, including fungi. Appropriate measures should be taken if this occurs. ADVERSE REACTIONS TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT BAUSCH & LOMB 阅读完整的文件