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:

Unit Dose Services

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: and Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pyogenes, Streptococcus pneumoniae, Enterobacter aerogenes, Escherichia coli; Haemophilus influenzae, Klebsiella pneumoniae, Neisseria gonorrhoeae, Pseudomonas aeruginosa, Serratia marcescens. Gentamicin sulfate ophthalmic solution is contraindicated in patients with known hypersensitivity to any of its components.

Sommarju tal-prodott:

NDC:50436-6752-1 in a BOTTLE, DROPPER of 15 SOLUTION/ DROPSS

L-istatus ta 'awtorizzazzjoni:

Abbreviated New Drug Application

Karatteristiċi tal-prodott

GENTAMICIN SULFATE- GENTAMICIN SULFATE SOLUTION/ DROPS
UNIT DOSE SERVICES
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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 .
It is a mixture of the sulfate salts
of Gentamicin C , C , C and C . All three components appear to have
similar antimicrobial activity.
_Micromonospora purpurea_
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 against many strains of the following
microorganisms: _in vitro_
and _Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus
pyogenes, Streptococcus_
_pneumoniae,Enterobacter aerogenes Escherichia coli; Haemophilus
influenzae, Klebsiella pneumoniae,_
_Neisseriagonorrhoeae, Pseudomonas aeruginosa,Serratia marcescens._
121a2a
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:
and _Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus
pyogenes, Streptococcus_
_pneumoniae,Enterobacter aerogenes, Escherichia coli; Haemophilus
influenzae, Klebsiella pneumoniae,_
_Neisseriagonorrhoeae, Pseudomonas aeruginosa,Serratia marcescens._
CONTRAINDICATIONS
Gentamicin sulfate ophthalmic soluti