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)
NuCare Pharmaceuticals,Inc.
OPHTHALMIC
PRESCRIPTION DRUG
This product is contraindicated in those individuals who have shown hypersensitivity to any of its components.
Bacitracin Zinc and Polymyxin B Sulfate Ophthalmic Ointment, USP is available in tubes with an ophthalmic tip applicator in the following size: Box of 3.5g NDC 68071-5267-3 Store between 15° to 25°C (59° to 77°F). KEEP TIGHTLY CLOSED Keep out of reach of children. Distributed by: Bausch + Lomb, a division of Bausch Health US, LLC Bridgewater, NJ 08807 USA Manufactured by: Bausch & Lomb Incorporated Tampa, FL 33637 USA © 2020 Bausch & Lomb Incorporated or its affiliates Revised: February 2020 9130703 (Folded) 9130603 (Flat)
Abbreviated New Drug Application
BACITRACIN ZINC AND POLYMYXIN B SULFATE- BACITRACIN ZINC AND POLYMYXIN B SULFATE OINTMENT NUCARE 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: 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. 1 2 Bacitracin is active against most gram-positive bacilli and cocci including hemolytic streptococci. INDLCATLONS 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 阅读完整的文件