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:

Proficient Rx LP

INN (International Name):

Gentamicin Sulfate

Composition:

Gentamicin 3 mg in 1 mL

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 63187-764-05) STORAGE: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Avoid exposure to excessive heat.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

GENTAMICIN SULFATE- GENTAMICIN SULFATE SOLUTION/ DROPS
PROFICIENT RX LP
----------
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.
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
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.
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._
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:
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
P