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 Sterile Ophthalmic Solution 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 Sterile Ophthalmic Solution is contraindicated in patients with known hypersensitivity to any of the components.
Gentamicin Sulfate ophthalmic solution - Sterile, 5-mL plastic dropper bottle, box of one. 5 MILLILITER in a BOTTLE, DROPPER/1 BOTTLE in a CARTON (53217-229-01) STORAGE: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Avoid exposure to excessive heat. Repackaged By: Aidarex Pharmaceuticals, LLC Corona, CA 92880
Abbreviated New Drug Application
GENTAMICIN SULFATE- GENTAMICIN SULFATE SOLUTION/ DROPS AIDAREX PHARMACEUTICALS LLC ---------- GENTAMICIN SULFATE OPHTHALMIC SOLUTION USP, 0.3% Sterile Rx only DESCRIPTION Gentamicin sulfate is a water-soluble antibiotic of the aminoglycoside group. Gentamicin Sulfate Ophthalmic Solution is a sterile, aqueous solution for ophthalmic use. EACH ML CONTAINS: ACTIVE: Gentamicin Sulfate USP (equivalent to 3 mg gentamicin base) PRESERVATIVE: Benzalkonium Chloride INACTIVES: Disodium Phosphate, Monosodium Phosphate, and Sodium Chloride. The pH range is from 6.8 to 7.3. 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 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._ 1 2 1A INDICATIONS AND USAGE Gentamicin Sulfate Sterile Ophthalmic Solution 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 Sterile Ophthalmic Solution is contraindicated in patients with known hyperse Прочитајте комплетан документ