Fluorometholone

Fluorometholone is a prescription medication used to treat the symptoms of ocular inflammation.

• Fluorometholone is available under various brand names: Flarex, FML, FML Forte

Common side effects of Fluorometholone include:

• mild stinging or burning in the eyes,
• feeling like something is the eye,
• red or puffy eyes,
• blurred vision, and
• drooping eyelids

Serious side effects of Fluorometholone include:

• hives,
• difficulty breathing,
• swelling of the face, lips, tongue, or throat,
• pain behind the eyes,
• sudden vision changes,
• slow healing after the eye surgery,
• eye pain,
• tunnel vision,
• seeing halos around light,
• signs of new eye infection, and
• swelling, draining, or crusting of the eyes

Rare side effects of Fluorometholone include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult and pediatric dosage

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

• Adult dosage
  • Flarex Suspension: Instill 1-2 drops  into the conjunctival sac or affected eye(s) every 6 hours; may use every 2 hours during the first 24-48 hours
  • FML Forte suspension: Instill 1 drop into conjunctival sac 2-4 times daily; may instill 1 drop every 4 hours during initial 24-48 hours
  • FML ointment: Apply 0.5 in ribbon to conjunctival sac 1-3 times daily; may increase application to every 4 hours during initial 24-48 hours 30 mL, and divide the mixture into six 5 mL aliquots
• Pediatric dosage
  • Aged below 2 years
    • Safety and efficacy not established
  • Aged above 2 years
    • Flarex Suspension: Instill 1-2 drops  into the conjunctival sac or affected eye(s) every 6 hours; may use every 2 hours during the first 24-48 hours
    • FML Forte suspension: Instill 1 drop into conjunctival sac 2-4 times daily; may instill 1 drop every 4 hours during initial 24-48 hours
    • FML ointment: Apply 0.5 in ribbon to conjunctival sac 1-3 times daily; may increase application to every 4 hours during initial 24-48 hours 30 mL, and divide the mixture into six 5 mL aliquots

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Fluorometholone has no noted severe interactions with any other drugs.
• Fluorometholone has no noted serious interactions with any other drugs.
• Fluorometholone has no noted moderate interactions with any other drugs.
• Fluorometholone has no noted minor interactions with any other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, or if you have health questions or concerns.

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

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Fluorometholone?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Fluorometholone?”

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 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 the 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 the establishment of secondary ocular infections from pathogens due to the suppression of the host response
• Acute purulent infections of the eye may be masked or exacerbated by the presence of steroid medication
• May mask infection or enhance existing infection
• May exacerbate the severity of viral infections; use caution in patients with a history of herpes simplex; use great caution
• Contact lenses should be removed during the 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 the 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 the 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

• 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 the potential benefit justifies the potential risk to the fetus
• 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