GENTAMICIN SULFATE solution/ drops

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Akorn

Administration route:

OPHTHALMIC

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Gentamicin Sulfate Sterile Ophthalmic Solution 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 Sterile Ophthalmic Solution is contraindicated in patients with known hypersensitivity to any of the components.

Product summary:

Gentamicin Sulfate ophthalmic solution - Sterile, 5-mL plastic dropper bottle, box of one. (NDC 17478-826-05) STORAGE: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Avoid exposure to excessive heat. PREMIERProRx® Manufactured by: Akorn, Inc. Lake Forest, IL 60045 PremierProRx® is a registered trademark of Premier Inc., used under license. PGK00N Rev. 10/15

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

GENTAMICIN SULFATE- GENTAMICIN SULFATE SOLUTION/ DROPS
AKORN
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GENTAMICIN SULFATE OPHTHALMIC SOLUTION
USP,0.3%
STERILE
Rx only
DESCRIPTION
Gentamicin sulfate is a water-soluble antibiotic of the aminoglycoside
group.
Gentamicin Sulfate Ophthalmic Solution is a sterile, aqueous solution
for ophthalmic use.
EACH ML CONTAINS:
ACTIVE: Gentamicin Sulfate USP (equivalent to 3 mg gentamicin base)
PRESERVATIVE:
Benzalkonium Chloride
INACTIVES: Disodium Phosphate, Monosodium Phosphate, and Sodium
Chloride. The pH
range is from 6.8 to 7.3.
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 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 Sterile Ophthalmic Solution is indicated in the
topical treatment of
ocular bacterial infections, including conjunctivitis, keratitis,
keratoconjunctivitis, corneal
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._
ulcers, blepharitis, blepharoconjunctivitis, acute meibomianitis, and
dacryocystitis caused
by susceptible strains of the following microorganisms:
CONTRAINDICATIONS
Gentamicin Sulfate Sterile Ophthalmic Solution is contraindicated in
patients with known
hypersensitivity to any of the components.
WARNINGS
NOT FOR INJECTION INTO THE EYE. Gentamicin Sulfate Ophthalmic Solution
is not for
injection. It should never be injected subconjunctivally, nor should
it be directly
introduced into the anterior chamber of the eye.
PRECAUTIONS
GENERAL: Prolonged u