FML FORTE- fluorometholone suspension/ drops

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Allergan, Inc.

Administration route:

OPHTHALMIC

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

FML FORTE ® suspension is indicated for the treatment of corticosteroid-responsive inflammation of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe. FML FORTE ® 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 FORTE ® suspension is also contraindicated in individuals with known or suspected hypersensitivity to any of the ingredients of this preparation and to other corticosteroids.

Product summary:

FML FORTE ® (fluorometholone ophthalmic suspension, USP) 0.25% is supplied sterile in opaque white LDPE plastic bottles with droppers with white high impact polystyrene (HIPS) caps as follows:       5 mL in 10 mL bottle NDC 11980-228-05       10 mL in 15 mL bottle NDC 11980-228-10 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  © 2023 AbbVie. All rights reserved. FML FORTE and its design are trademarks of Allergan, Inc., an AbbVie company. V2.0USPI228

Authorization status:

New Drug Application

Summary of Product characteristics

FML FORTE- FLUOROMETHOLONE SUSPENSION/ DROPS
ALLERGAN, INC.
----------
FML FORTE
(FLUOROMETHOLONE OPHTHALMIC SUSPENSION, USP) 0.25%
STERILE
RX ONLY
DESCRIPTION
FML FORTE (fluorometholone ophthalmic suspension, USP) 0.25% is a
sterile, topical
anti-inflammatory agent for ophthalmic use.
CHEMICAL NAME
Fluorometholone: 9-Fluoro-11ß,
17-dihydroxy-6α-methylpregna-1,4-diene-3,20-dione
STRUCTURAL FORMULA
CONTAINS
ACTIVE: fluorometholone 0.25%. PRESERVATIVE: benzalkonium chloride
0.005%.
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 FORTE suspension is formulated with
a pH from
6.2 to 7.5.
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 was
equivalen