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:

Medsource Pharmaceuticals

Administration route:

OPHTHALMIC

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Gentamicin sulfate 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: 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 is contraindicated in patients with known hypersensitivity to any of its components.

Product summary:

Gentamicin Sulfate Ophthalmic Solution USP, 0.3% is supplied in a plastic bottle with a controlled drop tip in the following sizes: 5 mL - NDC 24208-580-60 15 mL - NDC 24208-580-64 NOT FOR INJECTION FOR OPHTHALMIC USE ONLY DO NOT USE IF IMPRINTED NECKBAND IS NOT INTACT.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

GENTAMICIN SULFATE- GENTAMICIN SULFATE SOLUTION/ DROPS
MEDSOURCE PHARMACEUTICALS
----------
GENTAMICIN SULFATE
OPHTHALMIC SOLUTION USP,
0.3% (STERILE)
RX ONLY
DESCRIPTION
Gentamicin Sulfate Ophthalmic Solution, is a sterile, aqueous solution
buffered to approximately pH 7.0
and formulated for ophthalmic use.
EACH ML CONTAINS:
ACTIVE: Gentamicin Sulfate (equivalent to 3 mg gentamicin).
INACTIVES: Dibasic Sodium Phosphate, Sodium Chloride, Monobasic Sodium
Phosphate, Purified
Water. Hydrochloric Acid and/or Sodium Hydroxide may be added to
adjust pH (6.5 - 7.5).
PRESERVATIVE ADDED: Benzalkonium Chloride 0.01%.
Gentamicin is an aminoglycoside antibiotic obtained from cultures of
_Micromonospora purpurea_. It is a
mixture of the sulfate salts of Gentamicin C
, 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:
CLINICAL PHARMACOLOGY
MICROBIOLOGY
Gentamicin sulfate is active _in vitro _against many strains of the
following microorganisms:
1
2
1a
2a
_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 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._
CONTRAINDICATIONS
Gentamicin sulfat