GENTAMICIN SULFATE solution/ drops

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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

Tilgængelig fra:

Physicians Total Care, Inc.

Indgivelsesvej:

OPHTHALMIC

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

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.

Produkt oversigt:

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 54868-6745-1 15 mL -   NDC 54868-6745-2 NOT FOR INJECTION FOR OPHTHALMIC USE ONLY DO NOT USE IF IMPRINTED NECKBAND IS NOT INTACT.

Autorisation status:

Abbreviated New Drug Application

Produktets egenskaber

GENTAMICIN SULFATE - GENTAMICIN SULFATE SOLUTION/ DROPS
PHYSICIANS TOTAL CARE, INC.
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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
_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:
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_
1
2
1a
2a
_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