FLAREX Eye drops, suspension (2019)

Βιβλιογραφική αναφορά

Συγγραφείς

Eyevance Pharmaceuticals

Λέξεις κλειδιά

71776-100

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1. Description

FLAREX (fluorometholone acetate ophthalmic suspension) is a corticosteroid prepared as a sterile topical ophthalmic suspension. The active ingredient, fluorometholone acetate, is a white to creamy white ...

2. Clinical Pharmacology

Corticosteroids suppress the inflammatory response to inciting agents of mechanical, chemical or immunological nature. No generally accepted explanation of this steroid property has been advanced. Corticosteroids ...

3. Indications and Usage

FLAREX (fluorometholone acetate ophthalmic suspension) is indicated for use in the treatment of steroid responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior ...

4. Contraindications

Contraindicated in acute superficial herpes simplex keratitis, vaccinia, varicella, and most other viral diseases of cornea and conjunctiva; mycobacterial infection of the eye; fungal diseases; acute purulent ...

5. Warnings

FOR TOPICAL OPHTHALMIC USE ONLY. NOT FOR INJECTION. Use in the treatment of herpes simplex infection requires great caution. Prolonged use may result in glaucoma, damage to the optic nerve, defect in visual ...

6.1. General

Fungal infections of the cornea are particularly prone to develop coincidentally with long-term local steroid application. Fungus invasion must be considered in any persistent corneal ulceration where ...

6.2. Information for Patients

Do not touch dropper tip to any surface, as this may contaminate the suspension. The preservative in FLAREX (fluorometholone acetate ophthalmic suspension), benzalkonium chloride, may be absorbed by soft ...

6.6. Carcinogenesis, Mutagenesis, Impairment of Fertility

No studies have been conducted in animals or in humans to evaluate the possibility of these effects with fluorometholone.

6.7. Pregnancy

Fluorometholone has been shown to be embryocidal and teratogenic in rabbits when administered at low multiples of the human ocular dose. Fluorometholone was applied ocularly to rabbits daily on days 6-18 ...

6.9. Nursing Mothers

Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. It is not known whether topical ...

6.10. Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

6.11. Geriatric Use

No overall differences in safety or effectiveness have been observed between elderly and younger patients.

7. Adverse Reactions

Glaucoma with optic nerve damage, visual acuity and field defects, cataract formation, secondary ocular infection following suppression of host response, and perforation of the globe may occur. Postmarketing ...

10. Dosage and Administration

Shake Well Before Using. One to two drops instilled into the conjunctival sac(s) four times daily. During the initial 24 to 48 hours the dosage may be safely increased to two drops every two hours. If ...

11. How Supplied

FLAREX (fluorometholone acetate ophthalmic suspension) is supplied in white low density polyethylene (LDPE) bottles, with natural LDPE dispensing plugs and pink polypropylene closures. The product is supplied ...

12. Storage and Handling

Store upright between 2°C-25°C (36°F-77°F). Protect from freezing.