Land: Bandaríkin
Tungumál: enska
Heimild: NLM (National Library of Medicine)
GENTAMICIN SULFATE (UNII: 8X7386QRLV) (GENTAMICIN - UNII:T6Z9V48IKG)
Medsource Pharmaceuticals
OPHTHALMIC
PRESCRIPTION DRUG
Gentamicin sulfate 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 ophthalmic solution is contraindicated in patients with known hypersensitivity to any of its components.
Gentamicin Sulfate Ophthalmic Solution USP, 0.3% is supplied in a plastic bottle with a controlled drop tip in the following sizes: 5 mL - NDC 24208-580-60 15 mL - NDC 24208-580-64 NOT FOR INJECTION FOR OPHTHALMIC USE ONLY DO NOT USE IF IMPRINTED NECKBAND IS NOT INTACT.
Abbreviated New Drug Application
GENTAMICIN SULFATE- GENTAMICIN SULFATE SOLUTION/ DROPS MEDSOURCE PHARMACEUTICALS ---------- GENTAMICIN SULFATE OPHTHALMIC SOLUTION USP, 0.3% (STERILE) RX ONLY DESCRIPTION Gentamicin Sulfate Ophthalmic Solution, is a sterile, aqueous solution buffered to approximately pH 7.0 and formulated for ophthalmic use. EACH ML CONTAINS: ACTIVE: Gentamicin Sulfate (equivalent to 3 mg gentamicin). INACTIVES: Dibasic Sodium Phosphate, Sodium Chloride, Monobasic Sodium Phosphate, Purified Water. Hydrochloric Acid and/or Sodium Hydroxide may be added to adjust pH (6.5 - 7.5). PRESERVATIVE ADDED: Benzalkonium Chloride 0.01%. Gentamicin is an aminoglycoside antibiotic obtained from cultures of _Micromonospora purpurea_. It is a mixture of the sulfate salts of Gentamicin C , 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: CLINICAL PHARMACOLOGY MICROBIOLOGY Gentamicin sulfate is active _in vitro _against many strains of the following microorganisms: 1 2 1a 2a _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 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 sulfat Lestu allt skjalið