Usage
Fluorometholone is prescribed for steroid-responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe. It is classified as a topical ophthalmic corticosteroid. The drug works by suppressing the inflammatory response, reducing symptoms like swelling, redness, and itching.
Alternate Names
Fluorometholone acetate. Brand names include Flarex, FML, FML Forte, and FML Liquifilm.
How It Works
Pharmacodynamics: Fluorometholone exerts its anti-inflammatory effects by binding to glucocorticoid receptors in the eye, inhibiting inflammatory mediators like prostaglandins and leukotrienes, suppressing vascular permeability, and reducing inflammatory cell migration.
Pharmacokinetics: After topical ocular administration, fluorometholone penetrates the cornea and conjunctiva. Systemic absorption is minimal. It is metabolized primarily in the liver and excreted via the kidneys. Specific CYP enzyme interactions are not well documented.
Dosage
Standard Dosage
Adults:
Instill 1 to 2 drops into the conjunctival sac two to four times daily. During the initial 24 to 48 hours, the dosage may be increased up to 1 drop every 4 hours or 2 drops every 2 hours, depending on the specific formulation and severity of inflammation.
Children:
For children aged 2 years and older, the recommended dosage is similar to adults; however, careful monitoring is essential. The Flarex brand is not recommended for children younger than 18 years. Fluorometholone is not recommended for children younger than 2 years old.
Special Cases:
- Elderly Patients: Dosage adjustments are usually not necessary.
- Patients with Renal Impairment: Caution advised, although significant systemic absorption is uncommon.
- Patients with Hepatic Dysfunction: Dose adjustments might be needed due to altered metabolism.
- Patients with Comorbid Conditions: Individualized dosing may be required based on the condition.
Clinical Use Cases
Fluorometholone is not typically used in clinical settings like intubation, surgical procedures, mechanical ventilation, ICU, or emergency situations. It is primarily indicated for localized eye inflammation.
Dosage Adjustments
Dosage should be gradually tapered upon discontinuation after prolonged use to prevent a rebound effect. Modifications might be necessary for patients with specific metabolic disorders, genetic polymorphisms, or hepatic/renal dysfunction.
Side Effects
Common Side Effects
- Stinging or burning upon instillation
- Foreign body sensation
- Blurred vision
- Eyelid edema
- Increased tearing
- Redness of the eyelid or eye
- Eye discharge
- Itching
- Changes in taste perception
- Eye pain
- Increased intraocular pressure
Rare but Serious Side Effects
- Allergic reactions (hives, difficulty breathing, facial swelling)
- Glaucoma
- Cataracts
- Delayed wound healing after eye surgery
- Secondary ocular infections (bacterial, fungal, or viral)
- Vision changes
Long-Term Effects
- Increased risk of glaucoma, cataracts, and vision problems with prolonged use
- Thinning of the cornea or sclera
- Perforation of the globe
Adverse Drug Reactions (ADR)
- Severe allergic reactions
- Acute rise in intraocular pressure
- Worsening or masking of eye infections
Contraindications
- Hypersensitivity to fluorometholone or any component of the formulation.
- Acute herpes simplex keratitis (dendritic keratitis)
- Vaccinia
- Varicella
- Mycobacterial infection of the eye
- Fungal diseases of ocular structures
- Acute purulent untreated eye infections
- Untreated ocular fungal, viral, or mycobacterial infections
Drug Interactions
Clinically significant drug interactions are not well documented for topical fluorometholone due to limited systemic absorption. However, theoretical interactions may exist with drugs metabolized by the liver, although they are rarely clinically relevant. Always consult resources like DrugBank for the latest information on drug interactions.
Pregnancy and Breastfeeding
Fluorometholone is classified as Pregnancy Category C by the US FDA. It has shown adverse effects in animal studies, but there are insufficient human studies. It should be used in pregnancy only if the potential benefit justifies the potential risk. It is unknown if fluorometholone passes into breast milk. Caution is advised during breastfeeding.
Drug Profile Summary
- Mechanism of Action: Suppresses inflammatory response by binding to glucocorticoid receptors.
- Side Effects: Stinging, burning, blurred vision, increased intraocular pressure, allergic reactions, secondary infections.
- Contraindications: Hypersensitivity, herpes simplex keratitis, fungal/viral/mycobacterial eye infections.
- Drug Interactions: Minimal due to low systemic absorption.
- Pregnancy & Breastfeeding: Use with caution if benefits outweigh risks.
- Dosage: 1-2 drops 2-4 times/day; initial dose may be higher.
- Monitoring Parameters: Intraocular pressure, signs of infection.
Popular Combinations
Topical fluorometholone is typically used as monotherapy. Combined formulations with antibiotics may be used for specific indications (e.g., FML-NEO with neomycin sulfate).
Precautions
- Pre-existing glaucoma, diabetes mellitus, and cataracts require careful monitoring.
- Avoid contact lens wear during treatment.
- Monitor for signs of infection.
- Gradual tapering of dosage after prolonged use.
FAQs (Frequently Asked Questions)
Q1: What is the recommended dosage for Fluorometholone?
A: 1-2 drops in the affected eye(s) 2-4 times daily. The initial dose may be increased to 1 drop every 4 hours or 2 drops every 2 hours during the first 24-48 hours.
Q2: What are the common side effects of Fluorometholone?
A: Stinging, burning, foreign body sensation, blurred vision, eyelid edema, increased tearing, and changes in taste perception.
Q3: What are the contraindications for Fluorometholone?
A: Herpes simplex keratitis, vaccinia, varicella, mycobacterial eye infection, fungal eye diseases, acute purulent untreated eye infections, and hypersensitivity.
Q4: Can Fluorometholone be used during pregnancy or breastfeeding?
A: It should be used with caution if the potential benefit justifies the potential risk. Consult with a specialist.
Q5: How long can Fluorometholone be used?
A: Typically for short-term treatment. Prolonged use (beyond 10 days) requires careful monitoring of intraocular pressure and assessment for adverse effects.
Q6: What should be done if a dose is missed?
A: Instill the missed dose as soon as remembered. Do not double the dose.
Q7: Are there any specific drug interactions with Fluorometholone?
A: Clinically significant drug interactions are rare due to low systemic absorption. However, potential interactions may exist with other medications metabolized by the liver, although they are unlikely.
Q8: Can Fluorometholone be used in children?
A: Use in children younger than 2 years is not recommended. For children 2 years and older, the dosage is similar to adults, but careful monitoring is crucial.
Q9: What is the mechanism of action of Fluorometholone?
A: It binds to glucocorticoid receptors, inhibiting the inflammatory cascade, reducing inflammatory mediators, and suppressing vascular permeability.
