GENTAMICIN SULFATE- gentamicin sulfate solution

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

A-S Medication Solutions

Οδός χορήγησης:

OPHTHALMIC

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

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 the components.

Περίληψη προϊόντος:

Product: 50090-1883 NDC: 50090-1883-0 5 mL in a BOTTLE, PLASTIC

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Αρχείο Π.Χ.Π.

GENTAMICIN SULFATE- GENTAMICIN SULFATE SOLUTION
A-S MEDICATION SOLUTIONS
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GENTAMICIN SULFATE
OPHTHALMIC SOLUTION USP
DESCRIPTION
Gentamicin Sulfate is a water-soluble antibiotic of the aminoglycoside
group. Gentamicin Sulfate
Ophthalmic Solution is a sterile, aqueous solution buffered to
approximately pH 7 for ophthalmic use.
Gentamicin is obtained from cultures of _Micromonosporapurpurea_. It
is a mixture of the sulfate salts of
gentamicin C , C , and C
. All three components appear to have similar antimicrobial
activities.
Gentamicin sulfate occurs as white powder and is soluble in water and
insoluble in alcohol. The
structure is as follows:
Established name: Gentamicin Sulfate
Chemical name:
0-3-Deoxy-4-C-methyl-3-(methylamino)-β-L-arabinopyranosyl-(1→6)-0-[2,6-diamino-
2,3,4,6-tetradeoxy-α-D-erythro-hexopyranosyl-(1→4)]-2-deoxy-D-streptamine.
INGREDIENTS: EACH ML CONTAINS: ACTIVE: Gentamicin Sulfate USP
(equivalent to 3 mg gentamicin).
PRESERVATIVE: Benzalkonium Chloride 0.1 mg (0.01%). INACTIVES: Sodium
Chloride, Dried Sodium
Phosphate, Tyloxapol, Sodium Hydroxide and/or Hydrochloric Acid (to
adjust pH) and Purified
Water.
CLINICAL PHARMACOLOGY
Microbiology: Gentamicin sulfate is active _in vitro _against many
strains of the following
microorganisms:
_Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus
pyogenes, Streptococcus pneumoniae,_
_Enterobacteraerogenes, Escherichia coli, Haemophilusinfluenzae,
Klebsiellapneumoniae, Neisseria_
1
2
1A
_gonorrhoeae, Pseudomonas aeruginosa, and Serratiamarcescens._
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, Enterobacteraerogenes, Escherichia