Country: United States
Language: English
Source: NLM (National Library of Medicine)
POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K), TRIMETHOPRIM SULFATE (UNII: E377MF8EQ8) (TRIMETHOPRIM - UNII:AN164J8Y0X)
Physicians Total Care, Inc.
POLYMYXIN B SULFATE
POLYMYXIN B 10000 [USP'U] in 1 mL
OPHTHALMIC
PRESCRIPTION DRUG
Polymyxin B sulfate and trimethoprim ophthalmic solution is indicated in the treatment of surface ocular bacterial infections, including acute bacterial conjunctivitis, and blepharoconjunctivitis, caused by susceptible strains of the following microorganisms: Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pneumoniae, Streptococcus viridans, Haemophilus influenzae and Pseudomonas aeruginosa .** **Efficacy for this organism in this organ system was studied in fewer than 10 infections. Polymyxin B sulfate and trimethoprim ophthalmic solution is contraindicated in patients with known hypersensitivity to any of its components.
Polymyxin B Sulfate and Trimethoprim Ophthalmic Solution USP*, containing 10,000 polymyxin B units and 1 mg trimethoprim per mL, is supplied in a plastic bottle with a controlled drop tip in the following size: 10 mL - NDC 54868-4335-0 DO NOT USE IF IMPRINTED NECKBAND IS NOT INTACT. Storage: Store at 15°-25°C (59°-77°F). PROTECT FROM LIGHT. *Does not meet USP packaging specification for light resistance. RETAIN IN CARTON UNTIL TIME OF USE. Revised: November 2012 Bausch & Lomb Incorporated Tampa, Florida 33637 ©Bausch & Lomb Incorporated 9117801 (Folded) 9117901(Flat) Distributed by: Physicians Total Care, Inc. Tulsa, OK 74146
Abbreviated New Drug Application
POLYMYXIN B SULFATE AND TRIMETHOPRIM - POLYMYXIN B SULFATE AND TRIMETHOPRIM SULFATE SOLUTION/ DROPS PHYSICIANS TOTAL CARE, INC. ---------- POLYMYXIN B SULFATE AND TRIMETHOPRIM OPHTHALMIC SOLUTION USP* (Sterile) Rx only FOR USE IN THE EYES ONLY *Does not meet USP packaging specification for light resistance. DESCRIPTION Polymyxin B Sulfate and Trimethoprim Ophthalmic Solution USP* is a sterile antimicrobial solution for topical ophthalmic use. It has a pH of 4.0 to 6.2 and osmolality of 270 to 310 mOsm/kg. Trimethoprim sulfate, a white, odorless, crystalline powder, is represented by the following structural formula: C H N O S Mol. Wt. 678.72 Chemical Name: Trimethoprim sulfate, 2,4-diamino-5-(3,4 5-trimethoxybenzyl)pyrimidine sulfate (2:1) 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 formula is: EACH ML CONTAINS: ACTIVES: Polymyxin B Sulfate equal to 10,000 polymyxin B units, Trimethoprim Sulfate (equivalent to trimethoprim 1 mg); INACTIVES: Purified Water, Sodium Chloride. Sulfuric acid and, if necessary, sodium hydroxide may be added to adjust pH (4.0 – 6.2). PRESERVATIVE ADDED: Benzalkonium Chloride 0.004%. CLINICAL PHARMACOLOGY Trimethoprim is a synthetic antibacterial drug active against a wide variety of aerobic gram-positive and gram-negative ophthalmic pathogens. Trimethoprim blocks the production of tetrahydrofolic acid from dihydrofolic acid by binding to and reversibly inhibiting the enzyme dihydrofolate reductase. This binding is stronger for the bacterial enzyme than for the corresponding mammalian enzyme and therefore 28 38 8 10 1 2 selectively interferes with bacterial biosynthesis of nucleic acids and proteins. Polymyxin B, a cyclic lipopeptide antibiotic, is bactericidal for a variety of gram-negative organisms, especially _Pseudomonas aeruginosa_. It increases the perme Read the complete document