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Fluorometholone

Fluorometholone ophthalmic suspension 0.1% is indicated for the treatment of corticosteroid-responsive inflammation of the palpebral and bulbar conjun.

Checked against the official label · Updated

Prescription medicine Ophthalmic Safety alerts on record

How to use Fluorometholone

What the official label says. If a doctor prescribed it, follow the prescription. Your pack's leaflet comes first if it is different.

Who it is for

Fluorometholone ophthalmic suspension 0.1% is indicated for the treatment of corticosteroid-responsive inflammation of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe.

How to take it and how often
  • Shake well before using
  • Instill one drop into the conjunctival sac two to four times daily
  • During the initial 24 to 48 hours, the dosing frequency may be increased to one application every four hours
  • Care should be taken not to discontinue therapy prematurely
  • If signs and symptoms fail to improve after two days, the patient should be re-evaluated (see PRECAUTIONS )
  • The dosing of fluorometholone ophthalmic suspension 0.1% may be reduced, but care should be taken not to discontinue therapy prematurely
  • In chronic conditions, withdrawal of treatment should be carried out by gradually decreasing the frequency of applications
Children

Safety and effectiveness in infants below the age of two years have not been established.

Older adults

No overall differences in safety or effectiveness have been observed between elderly and younger patients.

While you are taking it
  • If inflammation or pain persists longer than 48 hours or becomes aggravated, the patient should be advised to discontinue use of the medication and consult a physician
  • This product is sterile when packaged
  • To prevent contamination, care should be taken to avoid touching the bottle tip to eyelids or to any other surface
  • The use of this bottle by more than one person may spread infection
  • Keep bottle tightly closed when not in use
  • Keep out of the reach of children
  • The preservative in fluorometholone ophthalmic suspension, benzalkonium chloride, may be absorbed by soft contact lenses. …
Talk to a doctor first if
  • Fluorometholone ophthalmic suspension 0.1% is contraindicated in most viral diseases of the cornea and conjunctiva, including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, and also in mycobacterial infection of the eye, and fungal diseases of ocular structures
  • Fluorometholone ophthalmic suspension 0.1% is also contraindicated in individuals with known or suspected hypersensitivity to any of the ingredients of this preparation and to other corticosteroids
Warnings

Prolonged use of corticosteroids may increase intraocular pressure 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. Prolonged use may also suppress the host immune response and thus increase the hazard of secondary ocular infections. Various ocular diseases and long-term use of topical corticosteroids have been known to cause corneal and scleral thinning. Use of topical corticosteroids in the presence of thin corneal or scleral tissue may lead to perforation. …

Possible side effects

Adverse reactions include, in decreasing order of frequency, elevation of intraocular pressure (IOP) with possible development of glaucoma and infrequent optic nerve damage, posterior subcapsular cataract formation, and delayed wound healing. Although systemic effects are extremely uncommon, there have been rare occurrences of systemic hypercorticoidism after use of topical dermatologic steroids applied to the skin. Corticosteroid-containing preparations have also been reported to cause acute anterior uveitis and perforation of the globe. …

Pregnancy and breastfeeding

Pregnancy Teratogenic effects Fluorometholone has been shown to be embryocidal and teratogenic in rabbits when administered at low multiples of the human ocular dose. Fluorometholone 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 o …

How to store it

Storage: Store at 2°-25°C (36°-77°F); protect from freezing. Store in an upright position. Revised : 12/20 23 For more information, call 1-800-678-1605 Distributed for: AbbVie Inc. North Chicago, IL 60064 © 2023 AbbVie. All rights reserved. …

If you miss a dose

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.

From the official U.S. FDA label for this active ingredient. Your pack may have a different strength, so always read its leaflet. If a doctor prescribed it, follow the prescription. Ask a pharmacist if you are unsure. Label dated 2023-12-01.

Brands around the world

Products with Fluorometholone as the active ingredient. Names differ between countries.

Registered products

United States (FDA)

FluorometholoneFLUOROMETHOLONE 1 mg/mL · Solution/ Drops · Pacific Pharma, Inc.
NDC 60758-880Label
FlarexFLUOROMETHOLONE ACETATE 1 mg/mL · Suspension/ Drops · Harrow Eye, LLC
NDC 82667-010Label
FluorometholoneFLUOROMETHOLONE 1 kg/kg · Powder · EUROAPI FRANCE
NDC 82298-119Label
FluorometholoneFLUOROMETHOLONE 1 kg/kg · Powder · EUROAPI FRANCE
NDC 82298-120Label
Fluorometholone MicronizedFLUOROMETHOLONE 100 kg/100kg · Powder · Sicor S.r.l.
NDC 53183-0530Label

Nigeria (NAFDAC)

NAFDACFluomoline Eye Drops B4-7862NAFDACAFM-T Ophthalmic Suspension B4-6399

Other countries: check your pack's registration number and we point you to your regulator.

Safety alerts and recalls

FML (fluorometholone ophthalmic ointment) 0.1%, 3.5 g tube, Rx only, Allergan, Inc., Irvine, CA 92612, NDC 0023-0316-04, UPC 3 0023-0316-04 0.U.S. FDA Class II
24 Aug 2015 · Allergan Sales, LLC · TerminatedPresence of Particulate Matter: Due to customer complaints of small black particles, identified as part of the ointment tube cap, generated by the action of unscrewing the cap from the aluminum tube and potentially introducing the particle into the product.

A recall usually affects certain batches only. Compare the lot number on your pack.

Check your pack of Fluorometholone

Type the registration number on the pack, or scan it with your camera.

Or take photos of the pack
3 free checks left today Official sources: U.S. FDA · EMA (EU) · Health Canada · WHO alerts

Questions about Fluorometholone

What is Fluorometholone used for?

Fluorometholone ophthalmic suspension 0.1% is indicated for the treatment of corticosteroid-responsive inflammation of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe. (From the official U.S. FDA label.)

How do I take Fluorometholone?

Follow your prescription or the leaflet in your pack. The official label says: Shake well before using. Instill one drop into the conjunctival sac two to four times daily. During the initial 24 to 48 hours, the dosing frequency may be increased to one application every four hours. Care should be taken not to discontinue therapy prematurely. If signs and symptoms fail to improve after two days, the patient should be re-evaluated (see PRECAUTIONS ). The dos…

Do I need a prescription for Fluorometholone?

Usually yes. Fluorometholone is a prescription medicine in most countries. Rules differ by country.

What brands contain Fluorometholone?

Fluorometholone is sold under names such as Flarex, Fml, Fml Forte Liquifilm. Brand names differ between countries.

What are the side effects of Fluorometholone?

The official label lists: Adverse reactions include, in decreasing order of frequency, elevation of intraocular pressure (IOP) with possible development of glaucoma and infrequent optic nerve damage, posterior subcapsular cataract formation, and delayed wound healing. Although systemic effects are extremely uncommon, there have been rare occurrences of systemic hypercorticoidism after use of topical der… Tell your doctor about any side effect that bothers you or does not go away.

Can children take Fluorometholone?

Safety and effectiveness in infants below the age of two years have not been established. Always use the dose for the child's age or weight on the pack or prescription.

Can I take Fluorometholone when pregnant or breastfeeding?

Pregnancy Teratogenic effects Fluorometholone has been shown to be embryocidal and teratogenic in rabbits when administered at low multiples of the human ocular dose. Fluorometholone 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 abnormalit… Ask your doctor or midwife first.

How should I store Fluorometholone?

Storage: Store at 2°-25°C (36°-77°F); protect from freezing. Store in an upright position. Revised : 12/20 23 For more information, call 1-800-678-1605 Distributed for: AbbVie Inc. North Chicago, IL 60064 © 2023 AbbVie. All rights reserved. …

How can I check that my Fluorometholone is genuine?

Scan the registration number on your pack with PillVera (NAFDAC number in Nigeria, NDC in the United States, DIN in Canada), check the expiry date and buy only from licensed pharmacies.

Sources

This page shows what official sources say, in plain words. It is not medical advice: your prescription and your doctor or pharmacist come first. Brand names, strengths and rules differ between countries.