Fluorometholone

Registered South African indications:

• Steroid responsive inflammation of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe

Contraindications

South African recommendations

• Hypersensitivity to the active ingredient or to any of its excipients
• Viral diseases of the cornea and conjunctiva, including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella infection of the eye
• Tuberculosis of the eye
• Fungal diseases of ocular structures

Recommendations in other jurisdictions

• Hypersensitivity to the active substance or to any of the excipients
• Most viral diseases of the cornea and conjunctiva, including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella
• Mycobacterial infection of the eye
• Untreated bacterial infection of the eye
• Fungal diseases of ocular structures
• Any undiagnosed 'red eye'

Cautions

• Pregnancy
• Breastfeeding
• Prolonged use
• Glaucoma
• History of herpes simplex keratitis
• Concomitant use of soft contact lenses
• May impair ability to drive or operate machinery

Forms avail. in SA and covered in this monograph: opd

Dosages below include:

• South African registered indications and dosages

South African registered indications and dosages

Steroid responsive inflammation of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe

• Ophthalmic (opd): Initial (first 24-48hrs): Up to 2 drops into the conjunctival sac of the affected eye(s), hrly; Maintenance: 1-2 drops into the conjunctival sac of the affected eye(s) 2-4 times dly

Care should be taken not to discontinue therapy prematurely

Directions for use: Shake well before use. Tilt head back and look upward. Gently pull the lower eyelid down until there is a small pocket. Squeeze the upturned dropper bottle to release a drop into the affected eye(s). Release the lower lid and close eye for 30 seconds

Paed. forms avail. in SA and covered in this monograph: opd

Paed. dosages below include:

• South African registered indications and dosages

South African registered indications and dosages

Steroid responsive inflammation of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe

Younger than 2 years

• Not established for use

Older than 2 years

• No specific dosages provided

Pregnancy

• Caution
• There are no or limited amount of data from the use of fluorometholone in pregnant women. Studies in animals have shown reproductive toxicity. Fluorometholone is not recommended during pregnancy

Breastfeeding

• Caution; not recommended
• It is unknown whether fluorometholone is excreted in human milk. Fluorometholone should not be used during breastfeeding

Renal Impairment

• No dose adjustment recommended

Hepatic Impairment

• No dose adjustment recommended

Elderly

• No dose adjustment recommended 

Porphyria Information

• Not yet classified (NC)

Drugs in Sport

• Permitted - No warnings

Endocrine and Metabolic Disorders

• Systemic hypercorticoidism

Skin and Subcutaneous Tissue Disorders

• Rash

Immune, Blood and Lymphatic System Disorders

• Hypersensitivity

Sensory Disorders

• Increased intraocular pressure
• Eye irritation
• Conjunctival or ocular hyperaemia
• Eye pain
• Visual disturbance
• Foreign body sensation in eyes
• Eyelid oedema
• Blurred vision
• Eye discharge
• Eye pruritis
• Increased lacrimation
• Eye oedema or eye swelling
• Mydriasis
• Cataract (including subcapsular)
• Ulcerative keratitis
• Ocular infection (bacterial, fungal and viral)
• Visual field defect
• Punctate keratitis
• Glaucoma
• Optic nerve damage
• Dysgeusia
• Corneal calcification (use of phosphate-containing eye drops in patients with significantly damaged corneas)

Other

• Delayed wound healing

• CYP3A inhibitors
• Cobicistat-containing products

None routine. Specific cases may require

• Intraocular pressure

Special warnings

• Acute untreated infection of the eye may be masked or activity enhanced by the presence of steroid medication 
• Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids 

Fluorometholone is a synthetic corticosteroid (glucocorticoid), a derivative of desoxyprednisolone. It is a member of the group of universally known steroids used for the treatment of eye inflammation. Glucocorticosteroids bind to cytoplasmic receptors and control the synthesis of infection mediators thus damping inflammatory reactions (swelling, fibrin deposition, capillary dilatation, phagocyte migration) and also capillary proliferation, collagen deposition and scarring. 

Eye drops (per ml) 1mg

• Flucon (Alcon) originator
• FML Liquifilm (Allergan) originator