Fluorometholone is a corticosteroid medication used to treat eye inflammation and conditions such as allergic conjunctivitis, uveitis, and keratitis. It belongs to a class of drugs called corticosteroids, which work by reducing inflammation in the eye.

Fluorometholone is typically available in the form of eye drops or ointment. It works by inhibiting the production of substances in the body that cause inflammation, swelling, and itching.

Fluorometholone (FML) eye drops and ointment are used to relieve inflammation of the eyes that may manifest as edema, redness, discharge, and pain.

Fluorometholone Uses:

• Ocular inflammation:
  • It is used to treat steroid-responsive ocular inflammation (inflammation of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the eye).

Fluorometholone (FML) Dose in Adults

Fluorometholone (FML) Dose in the treatment of Ocular inflammation: Ophthalmic:

When treating eye inflammation with fluorometholone, here's how to use it:

Ointment:

• Put a small amount (about the size of a pea or less) into the lower eyelid pocket.
• Do this 1 to 3 times a day.
• If your doctor says it's necessary, you might need to use it every 4 hours during the first day or two.

Suspension (eye drops):

• For 0.1% strength: Put 1 to 2 drops into the lower eyelid pocket.
• Do this 2 to 4 times a day.
• During the first day or two, you might need to use it every 2 hours or every 4 hours as advised by your doctor.
• For 0.25% strength: Use 1 drop in the lower eyelid pocket.
• Do this 2 to 4 times a day.
• During the first day or two, you might need to use it every 4 hours as directed by your doctor.

Important Points to Remember:

• If you don't see improvement within 2 to 14 days, talk to your doctor. They might need to adjust your treatment.
• Don't stop using the medication suddenly, especially if it's been helping. Your doctor will guide you on gradually reducing how often you use it before stopping completely.

Fluorometholone (FML) Dose in Children

For children aged 2 years and older, and adolescents, here's how to use fluorometholone for treating eye inflammation:

Ointment:

• Apply a small amount (about the size of a small line) into the space between the lower eyelid and the eye (conjunctival sac).
• Do these 1 to 3 times a day.
• If it's severe or as directed by your doctor, you might need to apply it every 4 hours during the first 1 to 2 days.

Suspension (eye drops):

• Use FML or FML Forte.
• Put 1 drop into the space between the lower eyelid and the eye (conjunctival sac).
• Do these 2 to 4 times a day.
• During the first 1 to 2 days, you might need to use it every 4 hours as advised by your doctor.

Important Points to Remember:

• If there's no improvement within 2 days, talk to your doctor. They may need to adjust your treatment.
• Don't stop the treatment suddenly, especially if it's a long-term condition. Your doctor will guide you on gradually reducing how often you use it before stopping completely.

Pregnancy Category: C

• In animal studies, adverse effects were seen when fluorometholone eye drops were used during pregnancy.
• We don't know exactly how much of the medication gets into the bloodstream when used on the eyes.
• If you need to use eye drops while pregnant, it's best to use the smallest amount that works.
• Your doctor might also suggest blocking the tear ducts to reduce the amount of medication that could reach the fetus.

Use during breastfeeding:

• Systemic corticosteroids, including fluorometholone, can be passed into breast milk.
• We're not sure how much of the medication gets into the bloodstream when applied as eye drops.
• The manufacturer suggests being cautious when using fluorometholone while breastfeeding.

Dose in Kidney Disease:

• The manufacturer's labeling for fluorometholone does not include specific dosage adjustments for individuals with renal impairment.
• This suggests that the medication can generally be used at the same dose in individuals with kidney problems as in those with normal kidney function.

Dose in Liver disease:

• The manufacturer's labeling for fluorometholone does not include specific dosage adjustments for individuals with hepatic impairment (liver problems).
• This suggests that the medication can generally be used at the same dose in individuals with liver issues as in those with normal liver function.

Side effects of Fluorometholone (FML):

• Dermatologic:
  • Skin rash
• Endocrine & metabolic:
  • Hypercorticoidism (rare)
• Gastrointestinal: Dysgeusia
  • Hypersensitivity: Hypersensitivity reaction
• Ophthalmic:
  • Bacterial Eye Infection (Secondary)
  • Blurred Vision
  • Burning Sensation Of Eyes
  • Cataract
  • Decreased Visual Acuity
  • Erythema Of Eyelid
  • Eye Discharge
  • Eye Irritation
  • Eyelid Edema
  • Eye Pain
  • Eye Pruritus
  • Foreign Body Sensation Of Eye
  • Fungal Eye Infection (Secondary)
  • Glaucoma
  • Increased Intraocular Pressure
  • Increased Lacrimation
  • Optic Nerve Damage
  • Stinging Of Eyes
  • Swelling Of Eye
  • Viral Eye Infection (Secondary)
  • Visual Field Defect
  • Wound Healing Impairment

Contraindications to Fluorometholone (FML):

Fluorometholone should not be used in certain conditions or situations:

• Hypersensitivity: If you've had an allergic reaction to fluorometholone, other corticosteroids, or any ingredient in the medication, you should avoid using it.
• Viral Eye Infections: Fluorometholone is not suitable for treating viral infections of the cornea and conjunctiva, including conditions like herpes simplex keratitis, vaccinia, and varicella.
• Mycobacterial or Fungal Eye Infections: It should not be used if you have mycobacterial or fungal infections of the eye.
• Untreated Eye Infections: If you have acute untreated purulent eye infections, you should not use fluorometholone. This is because corticosteroids like fluorometholone can mask or worsen these types of infections.

Warnings and precautions

Cataracts

• Using corticosteroids for a long time might lead to the development of cataracts, specifically a type called posterior subcapsular cataracts.
• If corticosteroids are used after cataract surgery, it could slow down healing or make it more likely for blebs (small fluid-filled bumps) to form.

Corneal thinning

• Corneal and scleral thinning can occur due to certain eye conditions or if corticosteroids are used for a long time.
• If someone already has thinning of the cornea or sclera, using corticosteroids can make it worse and may even lead to a hole in the eye (perforation).

Glaucoma:

• Using corticosteroids for a long time can increase the pressure inside the eye, a condition called elevated intraocular pressure (IOP), which may lead to glaucoma.
• Glaucoma can cause damage to the optic nerve, affect visual acuity (sharpness of vision), and create defects in the field of vision.
• If you have glaucoma or are at risk, be cautious when using corticosteroids.

Immunosuppression:

• Using corticosteroids for a long time can weaken the immune system, making it easier to get infections, including fungal ones.
• If you have a purulent (pus-filled) eye infection, using corticosteroids might hide the symptoms or make them worse.
• If you've been using corticosteroids and have a persistent corneal ulcer (an open sore on the eye), there's a chance it could be a fungal infection.

Herpes simplex

• If you have a history of herpes simplex (cold sores), be careful when using corticosteroids.
• It's important to be cautious because corticosteroids can sometimes reactivate the herpes virus.

Fluorometholone: Drug Interaction

Monitoring parameters:

Intraocular Pressure (Eye Pressure):

• If you're using corticosteroids for more than 10 days, watch out for changes in your eye pressure.
• Your doctor may need to check your eye pressure regularly to make sure it stays normal.

Signs or Symptoms of Infection:

• Pay attention to any signs or symptoms of infection while using corticosteroids.
• Let your doctor know if you notice any unusual symptoms such as redness, swelling, pain, or discharge from the eye.
• Prompt treatment may be needed if an infection occurs to prevent complications.

How to administer Fluorometholone (FML)?

For Topical Ophthalmic Use Only:

• Only use this medication in your eyes as directed by your doctor.

Preventing Contamination:

• Don't let the dropper or tube tip touch your eyelids or any other surfaces to prevent contamination.

Contact Lenses:

• Remove contact lenses before applying the medication.
• Wait for at least 15 minutes after applying before putting your contacts back in.

Shake Well Before Use:

• Shake the suspension well before using it to make sure the medication is properly mixed.

Mechanism of action of Fluorometholone (FML):

• Corticosteroids, like fluorometholone, work by blocking the body's inflammatory response, which includes swelling (edema), widening of blood vessels (capillary dilation), movement of white blood cells (leukocyte migration), and the formation of scars.
• Fluorometholone enters cells easily and triggers the production of lipocortins, which are proteins that help control the actions of certain inflammatory substances like prostaglandins and leukotrienes.
• This modulation helps reduce inflammation in the eye.

Absorption:

• Fluorometholone is mainly absorbed into the aqueous humor of the eye.

International Brand Names of Fluorometholone:

• Flarex
• FML
• FML Forte
• FML Liquifilm
• PMS-Fluorometholone
• SANDOZ Fluorometholone
• Aflarex
• Afm
• Efflumidex
• M.L.
• Flarex
• Florate
• Florom
• Flosef
• Flu Oph
• Flu-Base
• Fluaton
• Flucon
• Fluforte
• Flulon
• Flumelon
• Flumetholon
• Flumetholone
• Flumetol
• Flumetol NF Ofteno
• Flumex
• Fluoftal
• Fluoropos
• Flurolon
• Flurom
• FML
• FML Damla
• FML Liquifilm
• Fuluson
• Fumelon
• Inomet
• Isopto Flucon
• Medoflucon
• Ocuflam
• Ocumetholone
• Okilon
• Optiflur
• Optilone
• Rubalon
• Swixflur
• Ursnon

Fluorometholone Brand Names in Pakistan: