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:

Preferred Pharmaceuticals, 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, 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 68788-9732-3) STORAGE: Store at 2° to 30°C (36° to 86°F). Akorn Manufactured by: Akorn, Inc. Lake Forest, IL 60045 GKO00N Rev. 06/16 Relabeled By: Preferred Pharmaceuticals Inc.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

GENTAK- GENTAMICIN SULFATE OINTMENT
PREFERRED PHARMACEUTICALS, INC.
----------
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_
_pneumoniae, Enterobacter aerogenes, Escherichia coli, Haemophilus
influenzae, Klebsiella_
_pneumoniae, Neisseria gonorrhoeae, Pseudomonas aeruginosa, and
Serratia marcescens._
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.