fml-s- fluorometholone and sulfacetamide sodium suspension

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

fluorometholone (UNII: SV0CSG527L) (fluorometholone - UNII:SV0CSG527L), sulfacetamide sodium (UNII: 4NRT660KJQ) (sulfacetamide - UNII:4965G3J0F5)

Available from:

Allergan, Inc.

INN (International Name):

fluorometholone and sulfacetamide sodium

Pharmaceutical form:

SUSPENSION

Composition:

1.0 mg in 1 mL

Administration route:

OPHTHALMIC

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

FML-S® ophthalmic suspension is indicated for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular infection or a risk of bacterial ocular infection exists. Ocular steroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe, where the inherent risk of steroid use in certain infective conjunctivitides is accepted to obtain a diminution in edema and inflammation. They are also indicated in chronic anterior uveitis and corneal injury from chemical, radiation or thermal burns or penetration of foreign bodies. The use of a combination drug with an anti-infective component is indicated where the risk of superficial ocular infection is high or where there is an expectation that potentially dangerous numbers of bacteria will be present in the eye. The anti-infective drug in this product, sulfacetamide, is active against the following common bacterial eye pathogens: Esche

Product summary:

FML-S® (fluorometholone and sulfacetamide sodium ophthalmic suspension, USP) 0.1%/10% is supplied sterile in opaque white LDPE plastic bottles with droppers with white high impact polystyrene (HIPS) caps as follows: Note: Store at 15°C - 30°C (59° -86°F). Protect from freezing and light. SHAKE WELL BEFORE USING. Do not use suspension if it is dark brown. Rx Only Rev February 2005 © 2005 Allergan, Inc. ® marks owned by Allergan, Inc. 7767X 71745US10P

Summary of Product characteristics

FML-S- FLUOROMETHOLONE AND SULFACETAMIDE SODIUM SUSPENSION
ALLERGAN, INC.
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FML-S
(FLUOROMETHOLONE AND SULFACETAMIDE SODIUM OPHTHALMIC SUSPENSION, USP)
0.1%/10%
Sterile
DESCRIPTION
FML-S® ophthalmic suspension is a topical
anti-inflammatory/anti-infective product for ophthalmic use.
CHEMICAL NAMES:
Fluorometholone:
9-Fluoro-11β,17-dihydroxy-6α–methylpregna-1,4-diene-3,20-dione.
Sulfacetamide sodium:
N-Sulfanilyacetamide monosodium salt monohydrate.
STRUCTURAL FORMULAS:
CONTAINS: ACTIVES: fluorometholone 0.1%; and sulfacetamide sodium 10%.
PRESERVATIVE: benzalkonium
chloride 0.006%. INACTIVES: edetate disodium; polysorbate 80;
polyvinyl alcohol (1.4%); povidone;
purified water; sodium chloride; sodium phosphate dibasic; sodium
phosphate, monobasic; sodium
thiosulfate; and hydrochloric acid and/or sodium hydroxide to adjust
the pH to 7.0 to 7.5.
®
CLINICAL PHARMACOLOGY
Corticosteroids suppress the inflammatory response to a variety of
agents and they 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. Since corticosteroids may inhibit the body's
defense mechanism against infection, a
concomitant antimicrobial drug may be used when this inhibition is
considered to be clinically
significant in a particular case.
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.
The anti-infective component in FML-S® ophthalmic suspension is
included to provide action against
specific organisms susceptible to it. Sulfacetamide sodium is active
in