FLUOROMETHOLONE solution/ drops

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

fluorometholone (UNII: SV0CSG527L) (fluorometholone - UNII:SV0CSG527L)

Beschikbaar vanaf:

Pacific Pharma, Inc.

Toedieningsweg:

OPHTHALMIC

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

Fluorometholone ophthalmic suspension 0.1% is indicated for the treatment of corticosteroid-responsive inflammation of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe. Fluorometholone ophthalmic suspension 0.1% 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. Fluorometholone ophthalmic suspension 0.1% is also contraindicated in individuals with known or suspected hypersensitivity to any of the ingredients of this preparation and to other corticosteroids.

Product samenvatting:

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 60758-880-05 10 mL in 15 mL bottle NDC 60758-880-10 15 mL in 15 mL bottle NDC 60758-880-15 Store at 2°-25°C (36°-77°F); protect from freezing. Store in an upright position.  Revised : 12/2018 For more information, call 1-800-678-1605 Distributed for: Allergan USA, Inc. Madison, NJ 07940 © 2018 Allergan. All rights reserved. All trademarks are the property of their respective owners.  v1.0USPI880

Autorisatie-status:

New Drug Application Authorized Generic

Productkenmerken

FLUOROMETHOLONE- FLUOROMETHOLONE SOLUTION/ DROPS
PACIFIC PHARMA, INC.
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FLUOROMETHOLONE
FLUOROMETHOLONE
OPHTHALMIC SUSPENSION, USP 0.1%
S TERILE
DESCRIPTION
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.
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. Fluorometholone suspension
is formulated with a pH from 6.2 to 7.5. It has an osmolality range of
290-350 mOsm/kg.
STRUCTURAL FORMULA
FLUOROMETHOLONE
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
2
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, i