GENTAK- 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:

Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC

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 con-traindicated in patients with known hypersensitivity to any of the components.

Product summary:

GENTAK® Gentamicin sulfate ophthalmic ointment USP, 0.3% is supplied in 3.5 g tube, box of one. (NDC 17478-284-35) STORAGE: Store at 2° to 30°C (36° to 86°F). Akorn Manufactured by: Akorn, Inc. Lake Forest, IL 60045 GKO00N Rev. 09/08

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

GENTAK- GENTAMICIN SULFATE OINTMENT
LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC
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GENTAK
GENTAMICIN SULFATE
OPHTHALMIC OINTMENT USP,03%
STERILE
Rx only
DESCRIPTION
GENTAK 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:
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
influenzae, Klebsiella_
_pneumoniae, Neisseria gonorrhoeae, Pseudomonas aeruginosa, and
Serratia marcescens._
_Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus
pyogenes, Streptococcus_
CONTRAINDICATIONS
Gentamicin sulfate ophthalmic ointment is con-traindicated 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 directly introduc