GENTAMICIN SULFATE ointment

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

MWI

INN (International Name):

Gentamicin Sulfate

Composition:

Gentamicin 3 mg in 1 g

Administration route:

OPHTHALMIC

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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.

Product summary:

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

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

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