GENTAMICIN SULFATE solution/ drops GENTAMICIN SULFATE solution/ drops

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

GENTAMICIN SULFATE (UNII: 8X7386QRLV) (GENTAMICIN - UNII:T6Z9V48IKG)

Disponibil de la:

DIRECT RX

Calea de administrare:

OPHTHALMIC

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

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 its components.

Rezumat produs:

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:             5 mL in 10 mL bottle – NDC 60758-188-05 Storage: Store at or below 25°C (77°F). Avoid exposure to excessive heat (40°C/104°F or above). Revised: 08/2013 © 2013 Allergan, Inc. Irvine, CA 92612, U.S.A. ® mark owned by Allergan, Inc. Made in the U.S.A.

Statutul autorizaţiei:

Abbreviated New Drug Application

Caracteristicilor produsului

GENTAMICIN SULFATE- GENTAMICIN SULFATE SOLUTION/ DROPS
GENTAMICIN SULFATE- GENTAMICIN SULFATE SOLUTION/ DROPS
DIRECT RX
----------
GENTAMICIN SULFATE
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 C1, C2, and C1A. 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 SECTION
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 & USAGE SECTION
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.
CONTRAINDICATIONS SECTION
Gentamicin sulfate ophthalmic solution, USP is contraindicated in
patients with known
hypersensitivity to any of its compone