FML- fluorometholone suspension/ drops

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

FLUOROMETHOLONE (UNII: SV0CSG527L) (FLUOROMETHOLONE - UNII:SV0CSG527L)

Saatavilla:

Allergan, Inc.

Antoreitti:

OPHTHALMIC

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

FML ® suspension is indicated for the treatment of corticosteroid-responsive inflammation of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe. FML ® suspension is contraindicated in most viral diseases of the cornea and conjunctiva, including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, and also in mycobacterial infection of the eye, and fungal diseases of ocular structures. FML ® suspension is also contraindicated in individuals with known or suspected hypersensitivity to any of the ingredients of this preparation and to other corticosteroids.

Tuoteyhteenveto:

FML ® (fluorometholone ophthalmic suspension, USP) 0.1% is supplied sterile in opaque white LDPE plastic bottles with white high impact polystyrene (HIPS) caps as follows:       5 mL in 10 mL bottle NDC 11980-211-05       10 mL in 15 mL bottle NDC 11980-211-10 Storage : Store at 2°-25°C (36°-77°F); protect from freezing. Store in an upright position. Revised :   12/2023 Distributed by: AbbVie Inc. North Chicago, IL 60064  © 2024 AbbVie. All rights reserved. FML and its design are trademarks of Allergan, Inc., an AbbVie company.  v2.0USPI211

Valtuutuksen tilan:

New Drug Application

Valmisteyhteenveto

FML- FLUOROMETHOLONE SUSPENSION/ DROPS
ALLERGAN, INC.
----------
FML
(FLUOROMETHOLONE OPHTHALMIC SUSPENSION, USP) 0.1%
STERILE
DESCRIPTION
FML (fluorometholone ophthalmic suspension, USP) 0.1% is a sterile,
topical anti-
inflammatory agent for ophthalmic use.
CHEMICAL NAME
Fluorometholone:
9-Fluoro-11β,17-dihydroxy-6α-methylpregna-1,4-diene-3,20-dione.
STRUCTURAL FORMULA
CONTAINS
ACTIVE: fluorometholone 0.1%. PRESERVATIVE: benzalkonium chloride
0.004%.
INACTIVES: edetate disodium; polysorbate 80; polyvinyl alcohol 1.4%;
purified water;
sodium chloride; sodium phosphate, dibasic; sodium phosphate,
monobasic; and
sodium hydroxide to adjust pH. FML suspension is formulated with a pH
from 6.2 to
7.5. It has an osmolality range of 290-350 mOsm/kg.
CLINICAL PHARMACOLOGY
Corticosteroids inhibit the inflammatory response to a variety of
inciting agents and
probably delay or slow healing. They inhibit the edema, fibrin
deposition, capillary dilation,
leukocyte migration, capillary proliferation, fibroblast
proliferation, deposition of collagen,
and scar formation associated with inflammation.
There is no generally accepted explanation for the mechanism of action
of ocular
corticosteroids. However, corticosteroids are thought to act by the
induction of
phospholipase A inhibitory proteins, collectively called lipocortins.
It is postulated that
these proteins control the biosynthesis of potent mediators of
inflammation such as
prostaglandins and leukotrienes by inhibiting the release of their
common precursor,
arachidonic acid. Arachidonic acid is released from membrane
phospholipids by
®
®
®
2
phospholipase A .
Corticosteroids are capable of producing a rise in intraocular
pressure. In clinical studies
of documented steroid-responders, fluorometholone demonstrated a
significantly longer
average time to produce a rise in intraocular pressure than
dexamethasone phosphate;
however, in a small percentage of individuals, a significant rise in
intraocular pressure
occurred within one week. The ultimate magnitude of the rise