Nchi: Marekani
Lugha: Kiingereza
Chanzo: NLM (National Library of Medicine)
gentamicin sulfate (UNII: 8X7386QRLV) (gentamicin - UNII:T6Z9V48IKG)
Rebel Distributors Corp
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 Rev January 2003 © 2004 PACIFIC PHARMA Irvine, CA 92612 U.S.A. 6622X 71759PY10P Repackaged by: Rebel Distributors Corp Thousand Oaks, CA 91320
Abbreviated New Drug Application
GENTAMICIN SULFATE- GENTAMICIN SULFATE SOLUTION REBEL DISTRIBUTORS CORP ---------- 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 1A _Haemophilus influenzae, Klebsiella pneumoniae, Neisseri Soma hati kamili