Země: Spojené státy
Jazyk: angličtina
Zdroj: NLM (National Library of Medicine)
gentamicin sulfate (UNII: 8X7386QRLV) (gentamicin - UNII:T6Z9V48IKG)
Lake Erie Medical & Surgical Suppy DBA Quality Care Products LLC
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 the components.
GENTAMICIN SULFATE OPHTHALMIC SOLUTION, USP 0.3% is supplied sterile in white opaque LDPE plastic bottles and tips with white high impact polystyrene (HIPS) caps as follows: Note : Store at or below 25°C (77°F). Avoid exposure to excessive heat (40°C/104°F or above). Rx only Revised January 2003 © 2004 PACIFIC PHARMA Irvine, CA 92612 U.S.A. 71759PY10P
Abbreviated New Drug Application
GENTAMICIN SULFATE- GENTAMICIN SULFATE SOLUTION/ DROPS LAKE ERIE MEDICAL & SURGICAL SUPPY DBA QUALITY CARE PRODUCTS LLC ---------- GENTAMICIN SULFATE OPHTHALMIC SOLUTION, USP 0.3% Sterile DESCRIPTION GENTAMICIN SULFATE OPHTHALMIC SOLUTION, USP is a sterile, topical anti-infective agent for ophthalmic use. The active ingredient, gentamicin sulfate, is a water-soluble antibiotic of the aminoglycoside group. 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 activities. Gentamicin sulfate occurs as a white to buff powder and is soluble in water but 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 to adjust the 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 micro- organisms: _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 susceptible strains of the following microorganisms: _Staphylococcus aureus, Staphylococcus epidermidis,_ _Streptococcus pyogenes, Streptococcus pneumoniae, Enterobacter aerogenes, Escherichia coli,_ 1 2 1 Přečtěte si celý dokument