FLUOROMETHOLONE OPHTHALMIC SUSPENSION- fluorometholone suspension/ drops

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Amneal Pharmaceuticals NY LLC

Administration route:

OPHTHALMIC

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Fluorometholone ophthalmic suspension 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 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 is also contraindicated in individuals with known or suspected hypersensitivity to any of the ingredients of this preparation and to other corticosteroids.

Product summary:

Fluorometholone Ophthalmic Suspension USP, 0.1% is a sterile, white to off-white homogenous suspension essentially free from foreign particles, filled in 10 mL or 15 mL low density polyethylene white opaque bottles and low density polyethylene white opaque nozzles with high density polyethylene pink caps. It is available as follows: 5 mL in 10 mL Containers (Filled to 1/2 Capacity):                NDC 60219-1585-3 10 mL in 15 mL Containers (Filled to 2/3 Capacity):              NDC 60219-1586-6 Storage: Store at 2° to 25°C (36° to 77°F). Protect from freezing. Store in an upright position. To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . This product’s labeling may have been updated. For the most recent Prescribing Information, please visit www.amneal.com. Manufactured by: Amneal Pharmaceuticals Private Limited  Parenteral Unit Ahmedabad 382213, INDIA Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 Rev. 01-2024 Version-01

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

FLUOROMETHOLONE OPHTHALMIC SUSPENSION-
FLUOROMETHOLONE SUSPENSION/ DROPS
AMNEAL PHARMACEUTICALS NY LLC
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FLUOROMETHOLONE OPHTHALMIC SUSPENSION USP, 0.1%
STERILE
DESCRIPTION
Fluorometholone Ophthalmic Suspension USP, 0.1% is a sterile, topical
anti-inflammatory
agent for ophthalmic use.
Fluorometholone, USP is practically white crystalline powder. It is
practically insoluble in
water, slightly soluble in alcohol, very slightly soluble in
chloroform and practically
insoluble in ether.
CHEMICAL NAME:
9-Fluoro-11ß,17-dihydroxy-6α-methylpregna-1,4-diene-3,20-dione.
STRUCTURAL FORMULA:
Molecular weight: 376.5 g/mol
Molecular formula: C
H
FO
Each mL of fluorometholone ophthalmic suspension USP, 0.1% contains:
ACTIVE: Fluorometholone USP, 0.1% (1 mg).
PRESERVATIVE: Benzalkonium chloride, 0.004% (0.04 mg).
INACTIVES: Edetate disodium; polysorbate 80; polyvinyl alcohol 1.4%;
water for injection;
sodium chloride; sodium phosphate, dibasic, anhydrous; sodium
phosphate, monobasic,
monohydrate; and sodium hydroxide to adjust pH.
Fluoromethonolone ophthamic suspension, USP is formulated with a pH
from 6.2 to 7.5.
It has an osmolality range of 290 mOsm/kg to 350 mOsm/kg.
CLINICAL PHARMACOLOGY
Corticosteroids inhibit the inflammatory response to a variety of
inciting agents and
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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
phosph