GENTAMICIN SULFATE solution

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

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

Dostupno od:

Proficient Rx LP

Administracija rute:

OPHTHALMIC

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

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 Sulfate Ophthalmic Solution is contraindicated in patients with known hypersensitivity to any of the components.

Proizvod sažetak:

HOW SUPPLIED: Gentamicin Sulfate Ophthalmic Solution: 5 mL in plastic DROP-TAINER* dispenser. NDC 71205-333-05 STORAGE: Protect from light and store away from heat. Store at controlled room temperature 15°-25°C (59°-77°F). To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc., at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. *DROP-TAINER is a registered trademark of Alcon Research, Ltd. Rx Only

Status autorizacije:

Abbreviated New Drug Application

Svojstava lijeka

GENTAMICIN SULFATE- GENTAMICIN SULFATE SOLUTION
PROFICIENT RX LP
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GENTAMICIN SULFATE
OPHTHALMIC SOLUTION USP
STERILE
DESCRIPTION: Gentamicin Sulfate is a water-soluble antibiotic of the
aminoglycoside group.
Gentamicin Sulfate Ophthalmic Solution is a sterile, aqueous solution
buffered to approximately pH 7
for ophthalmic use. 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 white powder
and is soluble in water and
insoluble in alcohol. The structure is as follows:
Established name: Gentamicin Sulfate
Chemical name:
0-3-Deoxy-4-C-methyl-3-(methylamino)-β-L-arabinopyranosyl-(1→6)-0-[2,6-diamino-
2,3,4,6-tetradeoxy-α-D-erythro-hexopyranosyl-(1→4)]-2-deoxy-D-streptamine.
INGREDIENTS: EACH ML CONTAINS: ACTIVE: Gentamicin Sulfate USP
(equivalent to 3 mg gentamicin).
PRESERVATIVE: Benzalkonium Chloride 0.1 mg (0.01%). INACTIVES: Sodium
Chloride, Dried Sodium
Phosphate, Tyloxapol, Sodium Hydroxide and/or Hydrochloric Acid (to
adjust pH) and Purified
Water.
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._
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,_
1
2
1A
_Streptococcus pyogenes, Streptococcus pneumoniae, Enterobacter
aerogenes, E