FML- fluorometholone ointment

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 ® ointment is indicated for the treatment of corticosteroid-responsive inflammation of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe. FML ® ointment 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 ® ointment 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 ® (fluorometholone ophthalmic ointment) 0.1% is supplied in a collapsible aluminum tube with a black low density polyethylene screw cap in the following size: 3.5 g in 3.5 g tube – NDC 0023-0316-04 Store at 15°-25°C (59°-77°F). Avoid exposure to temperatures above 40°C (104°F). Revised :   0 6 /2018 Distributed by: Allergan USA, Inc. Madison, NJ 07940 © 2018 Allergan. All rights reserved. FML® is a registered trademark of Allergan, Inc. Allergan® and its design are trademarks of Allergan, Inc. v1.0USPI0316

Authorization status:

New Drug Application

Summary of Product characteristics

FML- FLUOROMETHOLONE OINTMENT
ALLERGAN, INC.
----------
FML
(FLUOROMETHOLONE OPHTHALMIC OINTMENT) 0.1%
STERILE
DESCRIPTION
FML
(fluorometholone ophthalmic ointment) 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: phenylmercuric acetate
(0.0008%). INACTIVES: mineral
oil; petrolatum (and) lanolin alcohol; and white petrolatum.
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
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 equivalent for both drugs.
INDICATIONS AND USAGE
®
®
2
2
®
FML ointment is indicated for the treatment of
corticosteroid-responsive inflammation of the
palpebral and bulbar conjunctiva, cornea and anterior segment of the
globe.
CONTRAINDICAT