GENTAMICIN SULFATE solution/ drops

Land: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

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

Fáanlegur frá:

Asclemed USA, Inc.

Stjórnsýsluleið:

OPHTHALMIC

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

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.

Vörulýsing:

Gentamicin Sulfate Ophthalmic Solution, USP 0.3% is supplied in a plastic bottle with a controlled drop tip and a white polypropylene cap in the following sizes: NDC 76420-254-05 (relabeled from NDC 24208-580-60) - 5 mL NOT FOR INJECTION INTO THE EYE FOR OPHTHALMIC USE ONLY DO NOT USE IF IMPRINTED NECKBAND IS NOT INTACT.

Leyfisstaða:

Abbreviated New Drug Application

Vara einkenni

GENTAMICIN SULFATE- GENTAMICIN SULFATE SOLUTION/ DROPS
ASCLEMED USA, INC.
----------
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 op