Dosing & Uses
Dosage Forms & Strengths
ophthalmic suspension as acetate
- 0.1% (Flarex)
ophthalmic suspension as base
- 0.1% (FML Liquifilm)
- 0.25% (FML Forte)
ophthalmic ointment
- 0.1% (FML)
Ocular Inflammation
Flarex suspension: Instill 1-2 gtt into conjunctival sac or affected eye(s) q6hr; may use q2hr during first 24-48 hr
FML Forte suspension: Instill 1 gtt into conjunctival sac 2-4 times daily; may instill 1 gtt q4hr during initial 24-48hr
FML ointment: Apply 0.5 in ribbon to conjunctival sac 1-3 times daily; may increase application to q4hr during initial 24-48hr
Re-evaluate therapy if improvement not seen within 2 days; do not discontinue prematurely
Dosage Forms & Strengths
ophthalmic suspension as acetate
- 0.1% (Flarex)
ophthalmic suspension as base
- 0.1% (FML Liquifilm)
- 0.25% (FML Forte)
ophthalmic ointment
- 0.1% (FML)
Ocular Inflammation
<2 years
- Safety and efficacy not established
>2 years
- Flarex suspension: Instill 1-2 gtt into conjunctival sac or affected eye(s) q6hr; may use q2hr during first 24-48 hr
- FML Forte suspension: Instill 1 gtt into conjunctival sac 2-4 times daily; may instill 1 gtt q4hr during initial 24-48hr
- FML ointment: Apply 0.5 in ribbon to conjunctival sac 1-3 times daily; may increase application to q4hr during initial 24-48hr
- Re-evaluate therapy if improvement not seen within 2 days; do not discontinue prematurely
Adverse Effects
Frequency Not Defined
Glaucoma
Cataract
Potentiate super infection
Slow wound healing
Hypercorticoidism (rare)
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)
Visual field defect
Postmarketing Reports
Dysgeusia
Warnings
Contraindications
Hypersensitivity to any component of the formulation
Herpes simplex keratitis, ocular fungal or mycobacterial infections; ocular viral disease
Cataracts, glaucoma, ophthalmic infection
Cautions
Monitor closely with diabetes mellitus
Prolonged use of corticosteroids may increase IOP in susceptible individuals, resulting in glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision, and in posterior subcapsular cataract formation; consider checking intraocular pressure frequently
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
Fungal infections of cornea are particularly prone to develop coincidentally with long-term local steroid application; fungus invasion must be considered in any persistent corneal ulceration where a steroid has been used or is in use
Use in the treatment of herpes simplex infection requires great caution
May aid in 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
May mask infection or enhance existing infection
May exacerbate severity of viral infections; use caution in patients with history of herpes simplex
Contact lenses should be removed during instillation of fluorometholone acetate ophthalmic suspension but may be reinserted 15 minutes after instillation
Patients should be advised that their vision may be temporarily blurred following dosing with fluorometholone acetate ophthalmic suspension; care should be exercised in operating machinery or driving a motor vehicle
Pregnancy & Lactation
Pregnancy Category: C
Lactation: Excretion in milk unknown; not recommended
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Synthetic fluorinated corticosteroid; inhibits inflammatory response including edema, leukocyte migration, capillary dilation, and scar formation
Pharmacokinetics
Absorption aqueous humor, & systemic absorption occurs
Images
Patient Handout
Formulary
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