fluor-op- fluorometholone suspension

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Fluorometholone (UNII: SV0CSG527L) (Fluorometholone - UNII:SV0CSG527L)

Available from:

Novartis Ophthalmics

INN (International Name):

fluorometholone

Pharmaceutical form:

SUSPENSION

Composition:

0.1 mL in 100 mL

Administration route:

OPHTHALMIC

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

FLUOR-OP is indicated for the treatment of corticosteroid-responsive inflammation of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe. FLUOR-OP 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. FLUOR-OP 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:

FLUOR-OP (fluorometholone ophthalmic suspension, USP) 0.1% is supplied in plastic dropper bottles in the following sizes: 5 mL…………………………………………………………………………..NDC 58768-358-05 10 mL…………………………………………………………………………NDC 58768-358-10 15 mL…………………………………………………………………………NDC 58768-358-15 Store at controlled room temperature 15°-30°C (59°-86°F).  Protect from freezing. Shake well before using. Keep bottle tightly closed when not in use. Rx only Mfd. by OMJ Pharmaceuticals, Inc., San Germán, P.R., 00683 for: Novartis Ophthalmics Duluth, GA 30097 6069-B

Summary of Product characteristics

FLUOR-OP- FLUOROMETHOLONE SUSPENSION
NOVARTIS OPHTHALMICS
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FLUOR-OP
FLUOR-OP
(FLUOROMETHOLONE OPHTHALMIC SUSPENSION, USP) 0.1%
DESCRIPTION
FLUOR-OP (fluorometholone ophthalmic suspension, USP) 0.1%, is a
topical anti-inflammatory agent
for ophthalmic use.
CHEMICAL NAME:
9-fluoro-11ß,17-dihydroxy-6α-methylpregna-1,4-diene-3,20-dione.
CONTAINS :
Fluorometholone 0.1%
with: polyvinyl alcohol 1.4%; benzalkonium chloride 0.004%, edetate
disodium; sodium chloride;
sodium phosphate monobasic, monohydrate; sodium phosphate dibasic,
anhydrous; polysorbate 80;
sodium hydroxide to adjust the pH, and purified water.
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 on patients'
eyes treated with both dexamethasone and fluorometholone 0.1%
suspensions, fluorometholone
demonstrated a lower propensity to increase intraocular pressure than
did dexamethasone.
INDICATIONS AND USAGE
®
®
2
2
FLUOR-OP is indicated for the treatment of corticosteroid-responsive
inflammation of the palpebral
and bulbar conjunctiva, cornea and anterior segment of the globe.
CONTRAINDICATIONS
FLUOR-OP suspension is contraindicated in most viral dise