GENTAMICIN SULFATE solution/ drops

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

gentamicin sulfate (UNII: 8X7386QRLV) (gentamicin - UNII:T6Z9V48IKG)

Commercializzato da:

Proficient Rx LP

Via di somministrazione:

OPHTHALMIC

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

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.

Dettagli prodotto:

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: Storage: Store at or below 25°C (77°F). Avoid exposure to excessive heat (40°C/104°F or above). Revised: 08/2013 Distributed for: Allegan USA, Inc. Madison, NJ 07940 Made in the U.S.A. © 2013 Allergan, Inc. Irvine, CA 92612, U.S.A. ® mark owned by Allergan, Inc. 71759PY11 Relabeled by: Proficient Rx LP Thousand Oaks, CA 91320

Stato dell'autorizzazione:

Abbreviated New Drug Application

Scheda tecnica

GENTAMICIN SULFATE- GENTAMICIN SULFATE SOLUTION/ DROPS
PROFICIENT RX LP
----------
GENTAMICIN SULFATE
OPHTHALMIC SOLUTION, USP 0.3%
STERILE
DESCRIPTION
Gentamicin sulfate ophthalmic solution, USP is a sterile, topical
anti-infective agent 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 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:
EACH ML CONTAINS: ACTIVE: gentamicin sulfate equivalent to 3 mg (0.3%)
gentamicin
base. PRESERVATIVE: benzalkonium chloride. INACTIVES: edetate
disodium; polyvinyl
alcohol 1.4%; purified water; sodium chloride; sodium phosphate,
dibasic; and
hydrochloric acid and/or sodium hydroxide may be added to adjust pH.
The solution is
an aqueous, buffered solution with a shelf life pH range of 6.5 to
7.5.
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 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