GENTAMICIN SULFATE solution/ drops

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

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

Prieinama:

Aidarex Pharmaceuticals LLC

Vartojimo būdas:

OPHTHALMIC

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

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.

Produkto santrauka:

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

Autorizacija statusas:

Abbreviated New Drug Application

Prekės savybės

GENTAMICIN SULFATE- GENTAMICIN SULFATE SOLUTION/ DROPS
AIDAREX PHARMACEUTICALS LLC
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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