Flarex 1 mg/mL
fluorometholone acetate · SUSPENSION/ DROPS · Harrow Eye, LLC
Flarex is a suspension/ drops containing fluorometholone acetate at 1 mg/mL, taken ophthalmic. Manufactured by Harrow Eye, LLC.
Key Facts
- Brand Name
- Flarex
- Generic Name
- fluorometholone acetate
- NDC Code (Product)
82667-010- Manufacturer
- Harrow Eye, LLC
- Strength
- 1 mg/mL
- Dosage Form
- SUSPENSION/ DROPS
- Route
- OPHTHALMIC
- Marketing Status
- Application #
- NDA019079
- Marketing Start
- 03/31/2025
Recall History
No Recall HistoryFull Prescribing Information
Indications & Usage
INDICATIONS AND USAGE FLAREX (fluorometholone acetate ophthalmic suspension) 0.1% is indicated for use in the treatment of steroid responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the eye.
Dosage & Administration
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 no improvement after two weeks, consult physician. Care should be taken not to discontinue therapy prematurely. Not more than one bottle should be prescribed initially, and the prescription should not be refilled without further evaluation [see PRECAUTIONS ] .
Warnings
WARNINGS FOR TOPICAL OPHTHALMIC USE. 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 acuity and visual field, cataract formation and/or may aid in the establishment of secondary ocular infections from pathogens due to suppression of host response. Acute purulent infections of the eye may be masked or exacerbated by presence of steroid medication. Topical ophthalmic corticosteroids may slow corneal wound healing. In those diseases causing thinning of the cornea or sclera, perforation has been known to occur with chronic use of topical steroids. If these products are used for 10 days or longer, intraocular pressure (IOP) should be routinely monitored even though it may be difficult in children and uncooperative patients.
Contraindications
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 untreated infections, which like other diseases caused by microorganisms, may be masked or enhanced by the presence of the steroid; and in those persons who have known hypersensitivity to any component of this preparation.
Adverse Reactions
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 Experience The following reaction has been identified during post-marketing use of FLAREX ® (fluorometholone acetate ophthalmic suspension) 0.1% in clinical practice. Because reactions are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. The reaction, which has been chosen for inclusion due to either its seriousness, frequency of reporting, possible causal connection to FLAREX, or a combination of these factors, includes: dysgeusia. The following rare adverse reactions have been reported: Cushing's syndrome and adrenal suppression may occur after very frequent use of topical ophthalmic corticosteroids, particularly in very young children.
Frequently Asked Questions
What is Flarex used for?
Flarex contains fluorometholone acetate. It is a suspension/ drops taken ophthalmic. Consult your doctor for specific uses.
Is Flarex a controlled substance?
Flarex is not classified as a controlled substance by the DEA.
What is the generic name for Flarex?
The generic name for Flarex is fluorometholone acetate. There are no other listed brand versions of fluorometholone acetate.
What is the NDC code for Flarex 1 mg/mL?
The NDC (National Drug Code) for Flarex 1 mg/mL is 82667-010, listed by Harrow Eye, LLC.
Other Flarex Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)