国: アメリカ合衆国
言語: 英語
ソース: NLM (National Library of Medicine)
POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K), TRIMETHOPRIM SULFATE (UNII: E377MF8EQ8) (TRIMETHOPRIM - UNII:AN164J8Y0X)
DIRECT RX
POLYMYXIN B SULFATE
POLYMYXIN B 10000 [USP'U] in 1 mL
OPHTHALMIC
PRESCRIPTION DRUG
Polymyxin B sulfate and trimethoprim ophthalmic solution, USP 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, USP is contraindicated in patients with known hypersensivitity to any of its components.
Polymyxin B sulfate and trimethoprim ophthalmic solution, USP is supplied sterile in opaque white low density polyethylene ophthalmic dispenser bottles and tips with white high impact polystyrene (HIPS) caps as follows: 10 mL in 10 mL bottle - NDC 60758-908-10 Storage: Store at 15°-25°C (59°-77°F) and protect from light. Revised: 11/2013 © 2013 Allergan, Inc. Irvine, CA 92612, U.S.A. ® mark owned by Allergan, Inc. Made in the U.S.A.
New Drug Application Authorized Generic
POLYMYXIN B SULFATE AND TRIMETHOPRIM SULFATE- POLYMYXIN B SULFATE AND TRIMETHOPRIM SULFATE SOLUTION/ DROPS DIRECT RX ---------- POLYMYXIN B SULFATE AND TRIMETHOPRIM SULFATE CLINICAL PHARMACOLOGY SECTION 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, 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 permeability of the bacterial cell membrane by interacting with the phospholipid components of the membrane. Blood samples were obtained from 11 human volunteers at 20 minutes, 1 hour and 3 hours following instillation in the eye of 2 drops of ophthalmic solution containing 1 mg trimethoprim and 10,000 units polymyxin B per mL. Peak serum concentrations were approximately 0.03 mcg/mL trimethoprim and 1 unit/mL polymyxin B. Microbiology In vitro studies have demonstrated that the anti-infective components of polymyxin B sulfate and trimethoprim ophthalmic solution, USP are active against the following bacterial pathogens that are capable of causing external infections of the eye: Trimethoprim: Staphylococcus aureus and Staphylococcus epidermidis, Streptococcus pyogenes, Streptococcus faecalis, Streptococcus pneumoniae, Haemophilus influenzae, Haemophilus aegyptius, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis (indole- negative), Proteus vulgaris (indole-positive), Enterobacter aerogenes and Serratia marcescens. Polymyxin B: Pseudomonas aeruginosa, Escherichia coli, Klebsiella pneumoniae, Enterobacter aerogenes and Haemophilus influenzae. INDICATIONS & USAGE SECTION 完全なドキュメントを読む