GENTAMICIN SULFATE ointment

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Nusipirk tai dabar

Parsisiųsti Prekės savybės (SPC)
30-10-2017

Veiklioji medžiaga:

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

Prieinama:

Paddock Laboratories, LLC

INN (Tarptautinis Pavadinimas):

GENTAMICIN SULFATE

Sudėtis:

GENTAMICIN 3 mg in 1 g

Recepto tipas:

PRESCRIPTION DRUG

Autorizacija statusas:

Abbreviated New Drug Application

Prekės savybės

                                GENTAMICIN SULFATE- GENTAMICIN SULFATE OINTMENT
PADDOCK LABORATORIES, LLC
----------
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
                                
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