fluorometholone ophthalmic suspension

INDICATIONS AND USAGE 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.

DOSAGE AND ADMINISTRATION Shake well before using. Instill one drop into the conjunctival sac two to four times daily. During the initial 24 to 48 hours, the dosing frequency may be increased to one application every four hours. Care should be taken not to discontinue therapy prematurely. If signs and symptoms fail to improve after two days, the patient should be re-evaluated (see PRECAUTIONS ). The dosing of fluorometholone ophthalmic suspension may be reduced, but care should be taken not to discontinue therapy prematurely. In chronic conditions, withdrawal of treatment should be carried out by gradually decreasing the frequency of applications.

CONTRAINDICATIONS 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.

ADVERSE REACTIONS Adverse reactions include, in decreasing order of frequency, elevation of intraocular pressure (IOP) with possible development of glaucoma and infrequent optic nerve damage, posterior subcapsular cataract formation, and delayed wound healing. Although systemic effects are extremely uncommon, there have been rare occurrences of systemic hypercorticoidism after use of topical dermatologic steroids applied to the skin. Corticosteroid-containing preparations have also been reported to cause acute anterior uveitis and perforation of the globe. Keratitis, conjunctivitis, corneal ulcers, mydriasis, conjunctival hyperemia, loss of accommodation and ptosis have occasionally been reported following local use of corticosteroids. The development of secondary ocular infection (bacterial, fungal and viral) has occurred. Fungal and viral infections of the cornea are particularly prone to develop coincidentally with long-term applications of steroids. The possibility of fungal invasion should be considered in any persistent corneal ulceration where steroid treatment has been used (see WARNINGS ). Transient burning and stinging upon instillation and other minor symptoms of ocular irritation have been reported with the use of fluorometholone ophthalmic suspension. Other adverse events reported with the use of fluorometholone include: allergic reactions; foreign body sensation; erythema of eyelid; eyelid edema/eye swelling; eye discharge; eye pain; eye pruritus; lacrimation increased; rash; taste perversion; visual disturbance (blurry vision); and visual field defect.

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 22 H 29 FO 4 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. struc

HOW SUPPLIED 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