Land: USA
Språk: engelsk
Kilde: NLM (National Library of Medicine)
GENTAMICIN SULFATE (UNII: 8X7386QRLV) (GENTAMICIN - UNII:T6Z9V48IKG)
Physicians Total Care, Inc.
GENTAMICIN SULFATE
GENTAMICIN 3 mg in 1 g
OPHTHALMIC
PRESCRIPTION DRUG
Gentamicin Sulfate Ophthalmic Ointment 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: Gentamicin Sulfate Ophthalmic Ointment is contraindicated in patients with known hypersensitivity to any of the components.
Gentamicin Sulfate Ophthalmic Ointment USP (equivalent to 3 mg gentamicin) is supplied as follows: Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. E. FOUGERA & CO. a division of Altana Inc. MELVILLE, NEW YORK 11747 I24438A R4/03 #82
Abbreviated New Drug Application
GENTAMICIN SULFATE - GENTAMICIN SULFATE OINTMENT PHYSICIANS TOTAL CARE, INC. ---------- RX ONLY DESCRIPTION Gentamicin sulfate is a water soluble antibiotic of the aminoglycoside group. Gentamicin Sulfate Ophthalmic Ointment USP is a sterile ointment for topical ophthalmic use. Each gram contains gentamicin sulfate (equivalent to 3 mg gentamicin) in a base of white petrolatum and mineral oil. Gentamicin is obtained from cultures of _Micromonospora purpurea_. Gentamicin sulfate 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 powder and is soluble in water and insoluble in alcohol. The structural formula is as follows: 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 Ointment 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._ CONTRAINDICATIONS Gentamicin Sulfate Ophthalmic Ointment is contraindicated in patients with known hypersensitivity to any of the components. 1 2 1A WARNINGS NOT FOR INJECTION INTO THE EYE. Gentamicin Sulfate Ophthalmic Ointment is not for injection. It should never be injected subconjun read_full_document