GENTAMICIN SULFATE- gentamicin sulfate solution/ drops

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

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

זמין מ:

Unit Dose Services

מסלול נתינה (של תרופות):

OPHTHALMIC

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

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.

leaflet_short:

Product: 50436-6754 NDC: 50436-6754-1 5 mL in a CARTON

מצב אישור:

Abbreviated New Drug Application

מאפייני מוצר

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
_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 sulfate o