Adult Dosing

Steroid-responsive inflammation of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe

• Instill 1-2 drops of 0.1% into the conjunctival sac(s) qid; during initial 24-48 hrs, may increase to 2 drops q2 hrs
• Instill 1 drop of 0.25% fluorometholone into the conjunctival sac(s) bid-qid
• Apply 1/2 inch ribbon of ointment to the conjunctival sac(s) qd-tid; during initial 24-48 hrs, may increase to 1 application q4 hrs

Note:

• Do not discontinue therapy prematurely
• Re-evaluate, if signs and symptoms fail to improve after 2 days

Pediatric Dosing

• Safety and effectiveness in pediatric patients have not been established (Flarex)
• Safety and effectiveness in pediatric patients <2 yrs of age have not been established (FML and FML Forte)

Steroid-responsive inflammation of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe (FML and FML Forte)

Children 2 yrs

• Instill 1 drop of 0.25% fluorometholone into the conjunctival sac(s) bid-qid
• Apply 1/2 inch ribbon of ointment to the conjunctival sac(s) qd-tid; during initial 24-48 hrs, may increase to 1 application q4 hrs

• Do not discontinue therapy prematurely
• Re-evaluate, if signs and symptoms fail to improve after 2 days

[Outline]

• Adult Dosing
• Pediatric Dosing

• Treatment of steroid-responsive inflammation of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe

• Hypersensitivity to any of the ingredients of the product
• Viral diseases of the cornea
• Viral diseases of the conjunctiva
• Ocular fungal infections
• Ocular mycobacterial infections
• Acute purulent untreated infections
• Use of soft contact lenses

• N/A

Renal Dose Adjustment

• Renal impairment: Dose adjustments not defined

Hepatic Dose Adjustment

• Hepatic impairment: Dose adjustments not defined

See Supplemental Patient Information

• It is for topical ophthalmic use only and not for injection
• Use cautiously in the treatment of herpes simplex infection
• Prolonged use may lead to 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 the presence of steroid medication
• In diseases causing thinning of the cornea or sclera, chronic use of topical steroids may lead to perforation
• Intraocular pressure should be checked frequently during therapy when used for 10 days or longer
• Long-term local steroid application is associated with the development of fungal infections of the cornea. Consider fungus invasion in any persistent corneal ulceration where a steroid has been used or is in use
• Do not touch the applicator tip with material from the eye, fingers, or other source in order to avoid contaminating the suspension
• Steroid use after cataract surgery may delay wound healing and increase the incidence of bleb formation
• Advise patients to avoid using contact lenses during treatment period

Use cautiously in

• Herpes simplex infection
• Glaucoma

Supplemental Patient Information

• Advise patients to discontinue the medication and consult their physician if inflammation or pain becomes aggravated or persists longer than 48 hours

Pregnancy Category:C

Breastfeeding: Safety unknown. Manufacturer advises caution.

• EENT: Increased IOP, glaucoma, acute anterior uveitis, perforation of the globe, keratitis, conjunctivitis, corneal ulcers, corneal thinning, mydriasis, conjunctival hyperemia, loss of accommodation and ptosis, transient burning and stinging upon instillation, ocular irritation, visual disturbance, infrequent optic nerve damage, posterior subcapsular cataract formation, delayed wound healing, secondary ocular infection
• GI: Taste perversion

• Corticosteroid; exact mechanism of action unknown; probably acts by induction of phospholipase A2 inhibitory proteins (lipocortins). These proteins inhibit the release of their common precursor, arachidonic acid, thereby controlling the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes
• Metabolism: Unknown
• Excretion: Unknown
• Half-life: Unknown

US Trade Name(s)

• Flarex
• FML
• FML Forte

US Availability

Flarex

• OPTH SUSP: 0.1%

FML

• OPTH SUSP: 0.1%
• OPTH OINT: 0.1%

FML Forte

• OPTH SUSP: 0.25%

Canadian Trade Name(s)

• Flarex
• FML
• FML Forte

Canadian Availability

fluorometholone (generic)

• OPTH SUSP: 0.1%

Flarex

• OPTH SUSP: 0.1%

FML

• OPTH DROPS: 0.1%

FML Forte

• OPTH SUSP: 0.25%

UK Trade Name(s)

• FML

UK Availability

FML

• OPTH SUSP: 0.1%

Australian Trade Name(s)

• Flarex
• Flucon
• FML

Australian Availability

Flarex, Flucon, FML

• OPTH SUSP: 0.1%

[Outline]

Ophthalmic

Ophthalmic Steroids

Pricing data from www.DrugStore.com in U.S.A.

• FML 0.1 % OINT [Tube] (ALLERGAN)
  3.5 % = $44.99
  10.5 % = $125.99
• FML Forte 0.25 % SUSP [Bottle] (ALLERGAN)
  10 % = $51.44
  30 % = $143.82
• Flarex 0.1 % SUSP [Bottle] (ALCON VISION)
  5 % = $51.99
  15 % = $135.98
• FML Liquifilm 0.1 % SUSP [Bottle] (ALLERGAN)
  10 % = $64.04
  30 % = $180.57

Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.