GENTAMICIN SULFATE ointment

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

Paddock Laboratories, LLC

INN (Διεθνής Όνομα):

GENTAMICIN SULFATE

Σύνθεση:

GENTAMICIN 3 mg in 1 g

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Αρχείο Π.Χ.Π.

GENTAMICIN SULFATE- GENTAMICIN SULFATE OINTMENT
PADDOCK LABORATORIES, LLC
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GENTAMICIN SULFATE OPHTHALMIC OINTMENT USP
GENTAMICIN SULFATE OPHTHALMIC OINTMENT USP
STERILE
RX ONLY
DESCRIPTION:
Gentamicin sulfate is a water soluble antibiotic of the aminoglycoside
group.
Gentamicin Sulfate Ophthalmic Ointment USP is a sterile ointment for
topical ophthalmic use. Each gram
contains gentamicin sulfate (equivalent to 3 mg gentamicin base) in a
base of white petrolatum and
mineral oil.
Gentamicin is obtained from cultures of _Micromonosporapurpurea_.
Gentamicin sulfate 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 a white 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,_
_Enterobacteraerogenes, Escherichia coli, Haemophilusinfluenzae,
Klebsiellapneumoniae, Neisseria_
_gonorrhoeae, Pseudomonas aeruginosa, and Serratiamarcescens._
1
2
1A
INDICATIONS AND USAGE:
Gentamicin Ophthalmic Ointment 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 coli, Haemophilusinfluenzae,
Klebsiellapneumoniae, Neisseria_
_gonorrhoeae, Pseudomonas aeruginosa, and Serratiamarcescens._
CONTRAINDICATIONS:
Gentamicin Ophthalmic Ointment is contraindicated in patients with
known hypersensitivity to any of the
components.
WARNINGS:
NOT FOR INJECTION INTO THE EYE. Gentamicin Sulfate Ophth