Flarex, FML (fluorometholone) dosing, indications, interactions, adverse effects, and more

Sections

Sections fluorometholone
Dosing & Uses
Adverse Effects
Warnings
Pregnancy
Pharmacology
Images
Patient Handout
Formulary

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

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

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.

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

BRAND	FORM.	UNIT PRICE	PILL IMAGE
FML Liquifilm ophthalmic (eye) -	0.1 % drops
FML Liquifilm ophthalmic (eye) -	0.1 % drops
FML Forte ophthalmic (eye) -	0.25 % drops
FML Forte ophthalmic (eye) -	0.25 % drops
fluorometholone ophthalmic (eye) -	0.1 % drops
fluorometholone ophthalmic (eye) -	0.1 % drops
FML S.O.P. ophthalmic (eye) -	0.1 % ointment

Patient Handout

FLUOROMETHOLONE OINTMENT - OPHTHALMIC

(flewr-oh-METH-oh-lone)

COMMON BRAND NAME(S): FML S.O.P.

USES: This medication is used to treat certain eye conditions due to inflammation or injury. Fluorometholone works by relieving symptoms such as swelling, redness, and itching. It belongs to a class of drugs known as corticosteroids.

HOW TO USE: Do not wear contact lenses while you are using this medicine. Sterilize contact lenses according to the manufacturer's directions, and check with your doctor before you begin using them again.To apply the eye ointment, wash your hands first. To avoid contamination, do not touch the tube tip or let it touch your eye or any other surface. Gently pull down the lower eyelid to make a pouch. Place a 1/2 inch (1.5 centimeters) strip of ointment into the pouch. Gently close the eye and roll the eyeball in all directions to spread the medication. Try not to blink and do not rub the eye.Repeat these steps for your other eye if so directed. Apply as often as directed by your doctor. Wipe the tip of the ointment tube with a clean tissue to remove extra medication before recapping it.If you are using another kind of eye medication (for example, other drops or ointments), apply the eye drops first and wait at least 5 to 10 minutes before applying this eye ointment. Use eye drops before eye ointments to allow the drops to enter the eye.Use this medication regularly in order to get the most benefit from it. To help you remember, use it at the same time(s) each day.The dosage and length of treatment are based on your medical condition and response to treatment. Do not use this medication more often or for longer than prescribed because doing so may increase your risk of side effects.Continue to use this medication for the full time prescribed. Do not stop using this medication without consulting your doctor. Some conditions may become worse when the drug is suddenly stopped. Your dose may need to be gradually decreased.Do not use this product if it becomes contaminated (for example, the ointment turns a dark color or develops particles in it). Use of contaminated eye medication can cause infection, serious damage to the eye, and loss of vision. Contact your doctor or pharmacist for more information.Tell your doctor if your condition does not improve after 2 days or if it worsens.

SIDE EFFECTS: Temporary blurred vision may occur when you apply this medication. Rarely, stinging/burning of the eyes for 1 to 2 minutes may also occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Use of this medication for prolonged periods or in high doses may cause serious eye problems (such as high pressure inside the eyes and cataracts). Tell your doctor right away if any of these unlikely but serious side effects occur: vision problems, eye pain.This medication may mask the signs of an eye infection. It may also put you at greater risk of developing an eye infection, especially with prolonged use. Report any new or worsening symptoms such as eye discharge/swelling/redness or no improvement of your current eye condition. Your doctor will need to adjust your treatment.Tell your doctor right away if any of these unlikely but serious side effects occur: headache, dizziness.A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using fluorometholone, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: eye infections, recent eye surgery, cataracts, glaucoma (open-angle type), severe nearsightedness (myopia), diabetes.After you apply this drug, your vision may become temporarily blurred. Do not drive, use machinery, or do any activity that requires clear vision until you are sure you can perform such activities safely.Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).If you develop a new eye infection or injury, or require eye surgery, ask your doctor if you should continue to use your current tube of fluorometholone eye ointment or start a new tube.During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.It is not known if the medication in this product passes into breast milk. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: The effects of some drugs can change if you take other drugs or herbal products at the same time. This can increase your risk for serious side effects or may cause your medications not to work correctly. These drug interactions are possible, but do not always occur. Your doctor or pharmacist can often prevent or manage interactions by changing how you use your medications or by close monitoring.To help your doctor and pharmacist give you the best care, be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products) before starting treatment with this product. While using this product, do not start, stop, or change the dosage of any other medicines you are using without your doctor's approval.Keep a list of all the products you use. Share the list with your doctor and pharmacist to reduce your risk for serious medication problems.

OVERDOSE: This medicine may be harmful if swallowed. If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

NOTES: Do not share this medication with others.This medication has been prescribed for your current condition only. Do not use it later for another eye condition unless told to do so by your doctor. A different medication may be necessary in that case.Laboratory and/or medical tests (such as eye exams, measurement of the pressure inside the eyes) may be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

MISSED DOSE: If you miss a dose, apply it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.

STORAGE: Store at room temperature at or below 77 degrees F (25 degrees C) away from light and moisture. Avoid exposure to temperatures above 104 degrees F (40 degrees C). Do not store in the bathroom. Keep the tube tightly closed when not in use. Keep all medicines away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

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.

View explanations for tiers and restrictions

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.

Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.

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