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:

Physicians Total Care, Inc.

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, blepharoconjunctivitis, 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 (equivalent to 3 mg gentamicin) is supplied as follows: Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. E. FOUGERA & CO. a division of Altana Inc. MELVILLE, NEW YORK 11747 I24438A R4/03 #82

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

GENTAMICIN SULFATE - GENTAMICIN SULFATE OINTMENT
PHYSICIANS TOTAL CARE, INC.
----------
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) in a base
of white petrolatum and mineral oil.
Gentamicin is obtained from cultures of _Micromonospora purpurea_.
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,_
_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,
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._
CONTRAINDICATIONS
Gentamicin Sulfate Ophthalmic Ointment is contraindicated in patients
with known hypersensitivity to any
of the components.
1
2
1A
WARNINGS
NOT FOR INJECTION INTO THE EYE. Gentamicin Sulfate Ophthalmic Ointment
is not for injection.
It should never be injected subconjun