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
Dosing considerations
- The initial prescription and renewal of the medication order should be made by a physician only after examination of the patient with the aid of magnification, such as slit lamp biomicroscopy, and, where appropriate, fluorescein staining; if signs and symptoms fail to improve after 2 days, the patient should be re-evaluated
- Not more than one bottle should be prescribed initially, and the prescription should not be refilled without further evaluation
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
Cushing’s syndrome (after very frequent use of topical ophthalmic corticosteroids)
Adrenal suppression (after very frequent use of topical ophthalmic corticosteroids)
Warnings
Contraindications
Hypersensitivity to any component of the formulation
Herpes simplex keratitis, ocular fungal or mycobacterial infections
Acute purulent untreated infections
Vaccinia, varicella, and most other viral diseases of cornea and conjunctiva
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
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; use great caution
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
Do not touch dropper tip to any surface, as this may contaminate the suspension; the preservative in this product 0.1%, benzalkonium chloride, may be absorbed by soft contact lenses; contact lenses should be removed during instillation of the drug but may be reinserted 15 minutes after instillation
Patients should be advised that their vision may be temporarily blurred following dosing with this drug; care should be exercised in operating machinery or driving a motor vehicle
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
Pregnancy & Lactation
Pregnancy
There are no adequate and well controlled studies in pregnant women, and it is not known whether this drug can cause fetal harm when administered to a pregnant woman; the drug should only be used during pregnancy only if potential benefit justifies the potential risk to the fetus
Animal data
- Fluorometholone has been shown to be embryocidal and teratogenic in rabbits when administered at low multiples of the human ocular dose; the drug was applied ocularly to rabbits daily on days 6-18 of gestation, and dose-related fetal loss, and fetal abnormalities including cleft palate, deformed rib cage, anomalous limbs and neural abnormalities such as encephalocele, craniorachischisis, and spina bifida were observed
Lactation
Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects
It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk; because many drugs are excreted in human milk, caution should be exercised when the drug is administered to a nursing woman
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
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| FML Forte ophthalmic (eye) - | 0.25 % drops |  | |
| FML Forte ophthalmic (eye) - | 0.25 % drops |  | |
| FML Liquifilm ophthalmic (eye) - | 0.1 % drops |  | |
| FML Liquifilm ophthalmic (eye) - | 0.1 % drops |  | |
| fluorometholone ophthalmic (eye) - | 0.1 % drops |  | |
| fluorometholone ophthalmic (eye) - | 0.1 % drops |  | |
| FML S.O.P. ophthalmic (eye) - | 0.1 % ointment |  |
Copyright © 2010 First DataBank, Inc.
Patient Handout
fluorometholone ophthalmic (eye)
FLUOROMETHOLONE SUSPENSION - OPHTHALMIC
(FLOOR-oh-METH-oh-lone)
COMMON BRAND NAME(S): FML, FML Forte
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: Unless otherwise directed by your doctor, 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.If your doctor does approve the wearing of contact lenses during treatment with this medication, remove the lenses before using the eye drops. The preservative in this product may be absorbed by contact lenses. Wait at least 15 minutes after each dose of the eye drop before wearing the lenses again.To apply eye drops, wash your hands first. Shake the bottle well before using. To avoid contamination, do not touch the dropper tip or let it touch your eye or any other surface.Tilt your head back, look upward, and pull down the lower eyelid to make a pouch. Hold the dropper directly over your eye and place 1 drop into the pouch. Look downward and gently close your eyes for 1 to 2 minutes. Place one finger at the corner of your eye (near the nose) and apply gentle pressure. This will prevent the medication from draining out. Try not to blink and do not rub your eye. Repeat these steps for your other eye if so directed and if your dose is for more than 1 drop.Apply as often as directed by your doctor. Do not rinse the dropper. Replace the dropper cap after each use.If you are using another kind of eye medication (for example, other drops or ointments), wait at least 5 to 10 minutes before applying other medications. 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, drops turn a dark color). 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: Stinging/burning of the eyes for 1 to 2 minutes and temporary blurred vision may occur when you apply this medication. If any of these effects last or get worse, 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, vision problems, 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 bottle of fluorometholone eye drops or start a new bottle.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, use 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: Different brands of this medication have different storage needs. Check the product package for instructions on how to store your brand, or ask your pharmacist. Do not freeze. Do not store in the bathroom. Keep the bottle upright and 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.
Information last revised December 2021. Copyright(c) 2022 First Databank, Inc.
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
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