GENTAMICIN SULFATE- 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:

Preferred Pharmaceuticals, Inc.

Administration route:

OPHTHALMIC

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Gentamicin sulfate ophthalmic solution, USP 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 . Gentamicin sulfate ophthalmic solution, USP is contraindicated in patients with known hypersensitivity to any of its components.

Product summary:

Gentamicin sulfate ophthalmic solution, USP 0.3% is supplied sterile in white opaque LDPE plastic bottles and tips with white high impact polystyrene (HIPS) caps as follows: 5 mL - 68788-9921-5 Storage: Store at or below 25°C (77°F). Avoid exposure to excessive heat (40°C/104°F or above). Revised: 08/2013 © 2013 Allergan, Inc. Irvine, CA 92612, U.S.A. ® mark owned by Allergan, Inc. Made in the U.S.A. 71759PY11 Relabeled By: Preferred Pharmaceuticals Inc .

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

GENTAMICIN SULFATE- GENTAMICIN SULFATE SOLUTION/ DROPS
PREFERRED PHARMACEUTICALS, INC.
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GENTAMICIN SULFATE
OPHTHALMIC SOLUTION, USP 0.3%
S TERILE
DESCRIPTION
Gentamicin sulfate ophthalmic solution, USP is a sterile, topical
anti-infective agent for ophthalmic use.
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 activity.
Gentamicin sulfate occurs as a white to buff powder and is soluble in
water and insoluble in alcohol.
The structural formula is as follows:
EACH ML CONTAINS: ACTIVE: gentamicin sulfate equivalent to 3 mg (0.3%)
gentamicin base.
PRESERVATIVE: benzalkonium chloride. INACTIVES: edetate disodium;
polyvinyl alcohol 1.4%; purified
water; sodium chloride; sodium phosphate, dibasic; and hydrochloric
acid and/or sodium hydroxide may
be added to adjust pH. The solution is an aqueous, buffered solution
with a shelf life pH range of 6.5 to
7.5.
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 solution, USP 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_
1
2
1A
_pneumoniae, Neisseria gonorrhoeae, Pseudomonas aeruginosa,_ and
_Serratia marcescens_.
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