Riik: Ameerika Ühendriigid
keel: inglise
Allikas: 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)
MWI
NEOMYCIN SULFATE
NEOMYCIN 3.5 mg in 1 g
OPHTHALMIC
PRESCRIPTION DRUG
Neomycin and polymyxin B sulfates and bacitracin zinc ophthalmic ointment is indicated for the topical treatment of superficial infections of the external eye and its adnexa caused by susceptible bacteria. Such infections encompass conjunctivitis, keratitis and keratoconjunctivitis, blepharitis and blepharoconjunctivitis. Neomycin and polymyxin B sulfates and bacitracin zinc ophthalmic ointment is contraindicated in those individuals who have shown hypersensitivity to any of its components.
Neomycin and Polymyxin B Sulfates and Bacitracin Zinc Ophthalmic Ointment USP is supplied in a 3.5 g tube with an ophthalmic tip. NDC 13985-746-35 – 3.5 g tube DO NOT USE IF CAP AND NECKRING ARE NOT INTACT. FOR OPHTHALMIC USE ONLY Store between 15° - 25°C (59°- 77°F). Keep tightly closed when not in use. KEEP OUT OF REACH OF CHILDREN. Revised 10/2016 Manufactured by: Bausch + Lomb, a division of Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807 USA Distributed by: MWI Boise, ID 83705 9563900 (Folded) 9562700 (Flat)
Abbreviated New Drug Application
NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC- NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND BACITRACIN ZINC OINTMENT MWI ---------- NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC OPHTHALMIC OINTMENT, USP (STERILE) RX ONLY DESCRIPTION Neomycin and Polymyxin B Sulfates and Bacitracin Zinc Ophthalmic Ointment USP is a sterile antimicrobial ointment for ophthalmic use. EACH GRAM CONTAINS ACTIVES: Neomycin Sulfate (equivalent to 3.5 mg neomycin base), Polymyxin B Sulfate equivalent to 10,000 polymyxin B units, and Bacitracin Zinc equivalent to 400 bacitracin units; INACTIVES: White Petrolatum, Mineral Oil. 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 micrograms of neomycin standard per milligram, 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 milligram, 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 of _Bacillus subtilis _var Tracy. It has 1 2 a potency of not less than 40 bacitracin units per milligram. The structural formula for bacitracin A is: CLINICAL PHARMACOLOGY A wide range of antibacterial action is provided by the overlapping spectra of neomycin, polymyxin B sulfate, and bacitracin. Neomycin is bactericidal for many gram-positive and gram-negative organisms. It is an aminoglycoside antibiotic which inhibits protein synthesis by binding with ribosomal RNA and causing misreading of the bacterial genetic code. Polymyxin B is bactericidal for a variety of gram-negative organisms. It increases the permeability of the bacterial c Lugege kogu dokumenti