GENTAMICIN SULFATE solution/ drops

Pajjiż: Stati Uniti

Lingwa: Ingliż

Sors: NLM (National Library of Medicine)

Ingredjent attiv:

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

Disponibbli minn:

Proficient Rx LP

Rotta amministrattiva:

OPHTHALMIC

Tip ta 'preskrizzjoni:

PRESCRIPTION DRUG

Indikazzjonijiet terapewtiċi:

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.

Sommarju tal-prodott:

Gentamicin Sulfate Ophthalmic Solution USP, 0.3% is supplied in a plastic bottle with a controlled drop tip in the following sizes: 5 mL - NDC 63187-560-05 NOT FOR INJECTION FOR OPHTHALMIC USE ONLY DO NOT USE IF IMPRINTED NECKBAND IS NOT INTACT.

L-istatus ta 'awtorizzazzjoni:

Abbreviated New Drug Application

Karatteristiċi tal-prodott

GENTAMICIN SULFATE- GENTAMICIN SULFATE SOLUTION/ DROPS
PROFICIENT RX LP
----------
GENTAMICIN SULFATE
OPHTHALMIC SOLUTION USP,
0.3% (STERILE)
RX ONLY
DESCRIPTION
Gentamicin Sulfate Ophthalmic Solution, is a sterile, aqueous solution
buffered to
approximately pH 7.0 and formulated for ophthalmic use.
EACH ML CONTAINS:
ACTIVE: Gentamicin Sulfate (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 ADDED: 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 C , 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:
CLINICAL PHARMACOLOGY
1
2
1a
2a
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 sulfate ophth