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:

• Ointment:
  • A small amount of the ointment (about 1/2 -inch ribbon) should be applied to the conjunctival sac one to three times a day.
  • In severe cases, the dosage frequency may be increased to every four hourly for the first 24 to 48 hours.
• Suspension:
  • 0.1%: Instill one or two drops into the conjunctival sac two to four times a day. In severe cases, the dosage frequency may be increased to every four hourly for the first 24 to 48 hours.
  • 0.25%: Instill a drop into the conjunctival sac two to four times a day. In severe cases, the dosage frequency may be increased to every four hourly for the first 24 to 48 hours.

Note:

• Patients should be re-evaluated after 2 - 14 days of the treatment if no improvement is noted.
• It is important not to discontinue the treatment prematurely. Patients on prolonged therapy should gradually taper off and discontinue. Abrupt treatment discontinuation should be avoided.

Fluorometholone (FML) Dose in Childrens

Note:

• Patients should be reevaluated after two days of the treatment. It is important not to discontinue the treatment prematurely.
• Patients on prolonged therapy should gradually taper off and discontinue. Abrupt treatment discontinuation should be avoided.

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

• Children ≥2 years and Adolescents: Ophthalmic:

  • Ointment:
    • A small amount of the ointment (about 1/2 -inch ribbon) should be applied to the conjunctival sac one to three times a day.
    • In severe cases, the dosage frequency may be increased to every four hourly for the first 24 to 48 hours.
  • Suspension:
    • FML, FML Forte: Instill a drop into the conjunctival sac two to four times a day. In severe cases, the dosage frequency may be increased to every four hourly for the first 24 to 48 hours.

Pregnancy Category: C

• Systemic drug use has been shown to cause adverse pregnancy outcomes in animal reproduction studies.
• It is unknown if topical ophthalmic application can cause systemic absorption. 
• To reduce systemic exposure, the manufacturer suggests that it be used for as short a time as possible in conjunction with punctal Occlusion.

Use during breastfeeding:

• Breastmilk is able to eliminate systemic corticosteroids. 
• It is unknown how much systemic absorption occurs after topical ophthalmic application. It is recommended that nursing mothers avoid using it.

Dose in Kidney Disease:

There are no dosage adjustments provided in the manufacturer's labeling.

Dose in Liver disease:

There are no dosage adjustments provided in the manufacturer's labeling.

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):

• Allergy reactions to fluorometholone or other corticosteroids or any component of this formulation
• Infections of the eye include:
  • Viral infections of the cornea or conjunctiva like epithelial herpes simplyx keratitis and vaccinia.
  • Mycobacterial and fungal infections of your eye.
  • An acute, untreated, bacterial infection of the eye that can be mask or worsened with steroids.

Warnings and precautions

• Cataracts

  • The development of posterior subcapsular cataracts may be caused by prolonged use of topical eye drops.
  •  Patients who have had cataract surgery may experience delayed healing and more bleb formation.

• Corneal thinning

  • Corticosteroids have been linked to corneal thinning, which can lead to corneal perforation.
  •  Patients at high risk for corneal perforation should avoid prolonged use of corticosteroids.

• Glaucoma:

  • Corticosteroids can cause intraocular hypertension and glaucoma. They may also impair vision acuity or damage the optic nerve.
  • Corticosteroids should be used with caution for patients with glaucoma. It is best to limit the treatment to 10 days if it is necessary.

• Immunosuppression:

  • Corticosteroids can cause superinfections, including fungal infections, that could be life-threatening. 
  • Corticosteroids may also mask or worsen the symptoms of acute bacterial infection.
  • Patients with persistent corneal ulceration need to be checked for fungal infections.

• Herpes simplex

  • Patients who have had a history of herpes sores should be cautious when applying topical corticosteroids and to ensure early diagnosis of a recurrence. 
  • If active infection is present, the treatment should be stopped.

Fluorometholone: Drug Interaction

Monitoring parameters:

• Monitor the intraocular pressure when the drug is used for 10 days or more.
• Observe the patient for signs and symptoms of infection.

How to administer Fluorometholone (FML)?

Ophthalmic:

• It is intended for ophthalmic use only. Patients must be asked to shake the suspension before using it.
• Contact lenses should be removed before instilling the medicine and should be reinserted after 15 minutes of the medication.
• The tip of the dropper should not be touched to the eyes or other surfaces to avoid contaminating it.

Mechanism of action of Fluorometholone (FML):

• It is a corticosteroid which inhibits inflammation due to various allergic and inflammatory conditions. 
• It is a corticosteroid that stimulates the production lipocortins, which modulate the activity protaglandins and leukotrienes.

Absorption:

• It is mostly absorbed into the aqueous humor.

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: