Country: Stati Uniti
Lingwa: Ingliż
Sors: NLM (National Library of Medicine)
TRIMETHOPRIM SULFATE (UNII: E377MF8EQ8) (TRIMETHOPRIM - UNII:AN164J8Y0X), POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K)
REMEDYREPACK INC.
OPHTHALMIC
PRESCRIPTION DRUG
Trimethoprim Sulfate and Polymyxin B Sulfate 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 influenza and Pseudomonas aeruginosa. * *Efficacy for this organism in this organ system was studied in fewer than 10 infections. Trimethoprim Sulfate and Polymyxin B Sulfate Ophthalmic Solution is contraindicated in patients with known hypersensitivity to any of its components.
Trimethoprim Sulfate and Polymyxin B Sulfate Ophthalmic Solution is supplied as a sterile solution in plastic dropper bottles in the following size: 10 mL in a 10 mL bottle NDC 17478-703-11 STORAGE: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light. WARNING – KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. Akorn Manufactured by: Akorn, Inc. Lake Forest, IL 60045 ATP00N Rev. 10/16
Abbreviated New Drug Application
TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE- TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE SOLUTION REMEDYREPACK INC. ---------- TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE OPHTHALMIC SOLUTION RX ONLY DESCRIPTION Trimethoprim Sulfate and Polymyxin B Sulfate Ophthalmic Solution is a sterile antimicrobial solution for topical ophthalmic use. Trimethoprim sulfate, 2,4-diamino-5-(3,4,5-trimethoxybenzyl)pyrimidine sulfate (2:1), occurs as a white, odorless, crystalline powder with a molecular weight of 678.72. The structural formula is as follows: Polymyxin B sulfate is the sulfate salt of polymyxin B1 and B2 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 as follows: EACH ML CONTAINS: ACTIVES: Trimethoprim Sulfate equivalent to Trimethoprim 1 mg (0.1%) and Polymyxin B Sulfate 10,000 units. Preservative: Benzalkonium Chloride 0.04 mg (0.004%). INACTIVES: Sodium Chloride, Sulfuric Acid and Sodium Hydroxide may be added to adjust pH (3.0 to 5.5), and Water for Injection. 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 very much stronger for the bacterial enzyme than for the corresponding mammalian enzyme. For that reason, trimethoprim selectively interferes with bacterial biosynthesis of nucleic acids and proteins. Polymyxin B, a cyclic lipopeptide antibiotic, is rapidly 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. When used topically, trimethoprim and polymyxin B absorption through intact skin a Aqra d-dokument sħiħ