국가: 미국
언어: 영어
출처: NLM (National Library of Medicine)
GENTAMICIN SULFATE (UNII: 8X7386QRLV) (GENTAMICIN - UNII:T6Z9V48IKG)
RPK Pharmaceuticals, Inc.
OPHTHALMIC
PRESCRIPTION DRUG
Gentamicin sulfate ophthalmic solution, USP is indicated in the topical treatment of ocular bacterial infections including conjunctivitis, keratitis, keratoconjunctivitis, corneal ulcers, blepharitis, blepharoconjunctivitis, acute meibomianitis, and dacryocystitis, caused by susceptible strains of the following microorganisms: Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pyogenes, Streptococcus pneumoniae, Enterobacter aerogenes, Escherichia coli, Haemophilus influenzae, Klebsiella pneumoniae, Neisseria gonorrhoeae, Pseudomonas aeruginosa, and Serratia marcescens . Gentamicin sulfate ophthalmic solution, USP is contraindicated in patients with known hypersensitivity to any of its components.
Product: 53002-9292 NDC: 53002-9292-1 5 mL in a BOTTLE, DROPPER
Abbreviated New Drug Application
GENTAMICIN SULFATE- GENTAMICIN SULFATE SOLUTION/ DROPS RPK PHARMACEUTICALS, INC. ---------- GENTAMICIN SULFATE OPHTHALMIC SOLUTION, USP 0.3% STERILE DESCRIPTION Gentamicin sulfate ophthalmic solution, USP is a sterile, topical anti-infective agent for ophthalmic use. Gentamicin is obtained from cultures of _Micromonospora purpurea_. It is a mixture of the sulfate salts of gentamicin C , C , and C . All three components appear to have similar antimicrobial activity. Gentamicin sulfate occurs as a white to buff powder and is soluble in water and insoluble in alcohol. The structural formula is as follows: EACH ML CONTAINS: ACTIVE: gentamicin sulfate equivalent to 3 mg (0.3%) gentamicin base. PRESERVATIVE: benzalkonium chloride. INACTIVES: edetate disodium; polyvinyl alcohol 1.4%; purified water; sodium chloride; sodium phosphate, dibasic; and hydrochloric acid and/or sodium hydroxide may be added to adjust pH. The solution is an aqueous, buffered solution with a shelf life pH range of 6.5 to 7.5. CLINICAL PHARMACOLOGY MICROBIOLOGY Gentamicin sulfate is active _in vitro_ against many strains of the following microorganisms: _Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus_ _pyogenes, Streptococcus pneumoniae, Enterobacter aerogenes, Escherichia coli,_ _Haemophilus influenzae, Klebsiella pneumoniae, Neisseria gonorrhoeae, Pseudomonas_ _aeruginosa, _and _Serratia marcescens_. INDICATIONS AND USAGE Gentamicin sulfate ophthalmic solution, USP is indicated in the topical treatment of ocular bacterial infections including conjunctivitis, keratitis, keratoconjunctivitis, corneal ulcers, blepharitis, blepharoconjunctivitis, acute meibomianitis, and dacryocystitis, caused by 1 2 1A susceptible strains of the following microorganisms: _Staphylococcus aureus,_ _Staphylococcus epidermidis, Streptococcus pyogenes, Streptococcus pneumoniae,_ _Enterobacter aerogenes, Escherichia coli, Haemophilus influenzae, Klebsiella pneumoniae,_ _Neisseria gonorrhoeae, Pseudomonas aeruginosa,_ and _Serratia marcescens_. CONTRAIN 전체 문서 읽기