FLAREX- fluorometholone acetate suspension/ drops

Riik: Ameerika Ühendriigid

keel: inglise

Allikas: NLM (National Library of Medicine)

Toimeaine:

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

Saadav alates:

Eyevance Pharmaceuticals

Manustamisviis:

OPHTHALMIC

Retsepti tüüp:

PRESCRIPTION DRUG

Näidustused:

FLAREX (fluorometholone acetate ophthalmic suspension) 0.1% 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.

Toote kokkuvõte:

FLAREX (fluorometholone acetate ophthalmic suspension) 0.1% is supplied in white low density polyethylene (LDPE) bottles, with natural LDPE dispensing plugs and pink polypropylene closures. The product is supplied as 5 mL in an 8 mL bottle. Store upright between 2°C to 25°C (36°F to 77°F). After opening, FLAREX can be used until the expiration date on the bottle. Protect from freezing.

Volitamisolek:

New Drug Application

Toote omadused

FLAREX- FLUOROMETHOLONE ACETATE SUSPENSION/ DROPS
EYEVANCE PHARMACEUTICALS
----------
FLAREX (FLUOROMETHOLONE ACETATE OPHTHALMIC SUSPENSION) 0.1%
STERILE
DESCRIPTION
FLAREX
(fluorometholone acetate ophthalmic suspension) 0.1% 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-11β,
17-
dihydroxy-6α-methylpregna-1, 4-diene-3, 20-dione 17-acetate. The
chemical structure
of Fluorometholone Acetate is presented below:
EACH ML OF FLAREX (FLUOROMETHOLONE ACETATE OPHTHALMIC SUSPENSION) 0.1%
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 (IOP)
in susceptible individuals. In a small study, FLAREX (fluorometholone
acetate ophthalmic
suspension) 0.1% demonstrated a significantly longer average time to
produce a rise in
IOP 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
IOP occurred within three days.
®
®
24
31
5
INDICATIONS AND USAGE
FLAREX (fluorometholone acetate ophthalmic suspension) 0.1% 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 superfic