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:

Lake Erie Medical & Surgical Suppy DBA Quality Care Products LLC

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 the 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: Note : Store at or below 25°C (77°F). Avoid exposure to excessive heat (40°C/104°F or above). Rx only Revised January 2003 © 2004 PACIFIC PHARMA Irvine, CA 92612 U.S.A. 71759PY10P

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

GENTAMICIN SULFATE- GENTAMICIN SULFATE SOLUTION/ DROPS
LAKE ERIE MEDICAL & SURGICAL SUPPY DBA QUALITY CARE PRODUCTS LLC
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GENTAMICIN SULFATE
OPHTHALMIC SOLUTION, USP 0.3%
Sterile
DESCRIPTION
GENTAMICIN SULFATE OPHTHALMIC SOLUTION, USP is a sterile, topical
anti-infective agent
for ophthalmic use. The active ingredient, gentamicin sulfate, is a
water-soluble antibiotic of the
aminoglycoside group.
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 but 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 to
adjust the 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 micro-
organisms: _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,_
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