Држава: Сједињене Америчке Државе
Језик: Енглески
Извор: NLM (National Library of Medicine)
GENTAMICIN SULFATE (UNII: 8X7386QRLV) (GENTAMICIN - UNII:T6Z9V48IKG)
Aidarex Pharmaceuticals 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 its 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: Storage: Store at or below 25°C (77°F). Avoid exposure to excessive heat (40°C/104°F or above). Revised: 08/2013 © 2013 Allergan, Inc. Irvine, CA 92612, U.S.A. ® mark owned by Allergan, Inc. Made in the U.S.A. Repackaged By : Aidarex Pharmaceuticals LLC, Corona, CA 92880 71759PY11
Abbreviated New Drug Application
GENTAMICIN SULFATE- GENTAMICIN SULFATE SOLUTION/ DROPS AIDAREX PHARMACEUTICALS LLC ---------- GENTAMICIN SULFATE OPHTHALMIC SOLUTION, USP 0.3% S TERILE 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 susceptible strains of the following microorganisms: _Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pyogenes,_ _Streptococcus pneumoniae, Enterobacter aerogenes, Escherichia coli, Haemophilus influenzae, Klebsiella_ 1 2 1A _pneumoniae, Neisseria gonorrhoeae, Pseudomonas aeruginosa,_ and _Serratia marcescens_. CONTRAIND Прочитајте комплетан документ