GENTAMICIN SULFATE solution/ drops

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

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

Disponible depuis:

Akorn

Mode d'administration:

OPHTHALMIC

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

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.

Descriptif du produit:

Gentamicin Sulfate ophthalmic solution - Sterile, 5-mL plastic dropper bottle, box of one. (NDC 17478-283-10) STORAGE: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Avoid exposure to excessive heat.

Statut de autorisation:

Abbreviated New Drug Application

Résumé des caractéristiques du produit

GENTAMICIN SULFATE- GENTAMICIN SULFATE SOLUTION/ DROPS
AKORN
----------
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 us