FLAREX- fluorometholone acetate suspension/ drops

Country: Stati Uniti

Lingwa: Ingliż

Sors: NLM (National Library of Medicine)

Ingredjent attiv:

FLUOROMETHOLONE ACETATE (UNII: 9I50C3I3OK) (FLUOROMETHOLONE - UNII:SV0CSG527L)

Disponibbli minn:

Alcon Laboratories, Inc.

INN (Isem Internazzjonali):

FLUOROMETHOLONE ACETATE

Kompożizzjoni:

FLUOROMETHOLONE ACETATE 1 mg in 1 mL

Rotta amministrattiva:

OPHTHALMIC

Tip ta 'preskrizzjoni:

PRESCRIPTION DRUG

Indikazzjonijiet terapewtiċi:

FLAREX (fluorometholone acetate ophthalmic suspension) is indicated for use in the treatment of steroid responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the eye. Contraindicated in acute superficial herpes simplex keratitis, vaccinia, varicella, and most other viral diseases of cornea and conjunctiva; mycobacterial infection of the eye; fungal diseases; acute purulent untreated infections, which like other diseases caused by microorganisms, may be masked or enhanced by the presence of the steroid; and in those persons who have known hypersensitivity to any component of this preparation.

Sommarju tal-prodott:

FLAREX (fluorometholone acetate ophthalmic suspension) is supplied in white low density polyethylene (LDPE) bottles, with natural LDPE dispensing plugs and pink polypropylene closures. The product is supplied as 5mL in an 8 mL bottle. 5 mL: NDC 0065-0096-05 STORAGE: Store upright between 2°-25°C (36°-77°F). Protect from freezing. Protect from freezing.

L-istatus ta 'awtorizzazzjoni:

New Drug Application

Karatteristiċi tal-prodott

FLAREX - FLUOROMETHOLONE ACETATE SUSPENSION/ DROPS
ALCON LABORATORIES, INC.
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FLAREX
(FLUOROMETHOLONE ACETATE OPHTHALMIC SUSPENSION) 0.1%
STERILE
DESCRIPTION
FLAREX® (fluorometholone acetate ophthalmic suspension) is a
corticosteroid prepared as a sterile
topical ophthalmic suspension. The active ingredient, fluorometholone
acetate, is a white to creamy
white powder with an empirical formula of C
H FO and a molecular weight of 418.5. Its chemical
name is 9-fluoro-11 , 17-dihydroxy-6 -methylpregna-1, 4-diene-3,
20-dione 17-acetate. The chemical
structure of Fluorometholone Acetate is presented below:
EACH ML CONTAINS: ACTIVE: fluorometholone acetate 1 mg (0.1%).
PRESERVATIVE: benzalkonium
chloride 0.01%. INACTIVES: sodium chloride, monobasic sodium
phosphate, edetate disodium,
hydroxyethyl cellulose, tyloxapol, hydrochloric acid and/or sodium
hydroxide (to adjust pH), and
purified water. The pH of the suspension is approximately 7.3, with an
osmolality of approximately 300
mOsm/kg.
CLINICAL PHARMACOLOGY
Corticosteroids suppress the inflammatory response to inciting agents
of mechanical, chemical or
immunological nature. No generally accepted explanation of this
steroid property has been advanced.
Corticosteroids cause a rise in intraocular pressure in susceptible
individuals. In a small study,
®
24
31
5
β
α
FLAREX (fluorometholone acetate ophthalmic suspension) demonstrated a
significantly longer average
time to produce a rise in intraocular pressure than did dexamethasone
phosphate; however, the ultimate
magnitude of the rise was equivalent for both drugs and in a small
percentage of individuals a
significant rise in intraocular pressure occurred within three days.
INDICATIONS AND USAGE
FLAREX (fluorometholone acetate ophthalmic suspension) is indicated
for use in the treatment of
steroid responsive inflammatory conditions of the palpebral and bulbar
conjunctiva, cornea, and anterior
segment of the eye.
CONTRAINDICATIONS
Contraindicated in acute superficial herpes simplex keratitis,
vaccinia, varicel