GENTAMICIN SULFATE solution/ drops

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

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

Dostupno od:

Bausch & Lomb Incorporated

Administracija rute:

OPHTHALMIC

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

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.

Proizvod sažetak:

Gentamicin sulfate ophthalmic solution USP, 0.3% is supplied sterile in a white LDPE plastic bottle, with a white LLDPE extended controlled drop tip and white polypropylene cap in the following size: NDC 24208-580-60 - 5 mL NOT FOR INJECTION INTO THE EYE FOR OPHTHALMIC USE ONLY Storage: Store between 2°C to 25°C (36°F to 77°F). Avoid exposure to excessive heat. KEEP OUT OF REACH OF CHILDREN. Distributed by: Bausch & Lomb Americas Inc. Bridgewater, NJ 08807 USA Manufactured by: Bausch & Lomb Incorporated Tampa, FL 33637 USA © 2022 Bausch & Lomb Incorporated or its affiliates Revised: September 2022 9116006 (Folded) 9116106 (Flat)

Status autorizacije:

Abbreviated New Drug Application

Svojstava lijeka

GENTAMICIN SULFATE- GENTAMICIN SULFATE SOLUTION/ DROPS
BAUSCH & LOMB INCORPORATED
----------
GENTAMICIN SULFATE
OPHTHALMIC SOLUTION, USP
0.3%
(STERILE)
RX ONLY
DESCRIPTION
Gentamicin sulfate ophthalmic solution, USP is a sterile, aqueous
solution buffered to
approximately pH 7.0 and formulated for ophthalmic use.
EACH ML CONTAINS:
ACTIVE: gentamicin sulfate, USP (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: 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 C1, C2,
C1a and C2a. 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:
_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