fluorometholone (Rx)

Brand and Other Names:Flarex, FML, more...FML Forte
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Dosing & Uses

AdultPediatric

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
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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

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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

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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.

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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

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Images

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Formulary

FormularyPatient Discounts

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The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL Quantity Limits
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST Step Therapy
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR Other Restrictions
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.