GENTAMICIN SULFATE ointment

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

Gentamicin Sulfate (UNII: 8X7386QRLV) (Gentamicin - UNII:T6Z9V48IKG)

Disponível em:

MWI

DCI (Denominação Comum Internacional):

Gentamicin Sulfate

Composição:

Gentamicin 3 mg in 1 g

Via de administração:

OPHTHALMIC

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

Gentamicin sulfate ophthalmic ointment is indicated in the topical treatment of ocular bacterial infections including conjunctivitis, keratitis, keratoconjunctivitis, corneal ulcers, blepharitis, blepharonconjunctivitis, acute meibomianitis, and dacryocystitis, caused by susceptible strains of the following microorganisms: Gentamicin sulfate ophthalmic ointment is contraindicated in patients with known hypersensitivity to any of the components.

Resumo do produto:

Gentamicin sulfate ophthalmic ointment USP, 0.3% is supplied in 3.5 g tube, box of one. (NDC 13985-603-03)

Status de autorização:

Abbreviated New Drug Application

Características técnicas

GENTAMICIN SULFATE- GENTAMICIN SULFATE OINTMENT
MWI
----------
APEXA™
GENTAMICIN SULFATE
Ophthalmic Ointment USP, 0.3%
STERILE
Rx Only
DESCRIPTION:
Gentamicin sulfate is a water soluble antibiotic of the aminoglycoside
group.
Gentamicin sulfate ophthalmic ointment is a sterile ointment for
ophthalmic use. Each
gram contains gentamicin sulfate equivalent to 3 mg gentamicin in a
base of white
petrolatum and mineral oil, with methylparaben and propylparaben as
preservatives.
Gentamicin is obtained from cultures of _Micromonospora purpurea._ 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 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 gonorrhoeae, Pseudomonas
aeruginosa, and_
_Serratia marcescens._
INDICATIONS AND USAGE:
Gentamicin sulfate ophthalmic ointment is indicated in the topical
treatment of ocular
bacterial infections including conjunctivitis, keratitis,
keratoconjunctivitis, corneal ulcers,
blepharitis, blepharonconjunctivitis, acute meibomianitis, and
dacryocystitis, caused by
susceptible strains of the following microorganisms:
1
2
1A
_Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus
pyogenes,_
_Streptococcus pneumoniae, Enterobacter aerogenes, Escherichia coli,
Haemophilus_
CONTRAINDICATIONS:
Gentamicin sulfate ophthalmic ointment is contraindicated in patients
with known
hypersensitivity to any of the components.
WARNINGS:
NOT FOR INJECTION INTO THE EYE.
Gentamicin sulfate ophthalmic ointment is not for injection. It should
never be injected
subconjunctivally, nor should it be