Land: USA
Språk: engelska
Källa: NLM (National Library of Medicine)
GENTAMICIN SULFATE (UNII: 8X7386QRLV) (GENTAMICIN - UNII:T6Z9V48IKG)
NuCare Pharmaceuticals, Inc.
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. (NDC 66267-971-05) STORAGE: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Avoid exposure to excessive heat.
Abbreviated New Drug Application
GENTAMICIN SULFATE- GENTAMICIN SULFATE SOLUTION/ DROPS NUCARE PHARMACEUTICALS, INC. ---------- 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: 1 2 1A _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 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 hypers Läs hela dokumentet