1 ml suspension contains 1 mg fluorometholone acetate.
Excipients with known effect: 1 ml suspension contains 0.1 mg benzalkonium chloride.
Excipients/Inactive Ingredients: Benzalkonium chloride 0.01%, Disodium edetate, Sodium dihydrogen phosphate monohydrate, Tyloxapol, Sodium chloride, Hydroxyethylcellulose, Concentrated hydrochloric acid and/or sodium hydroxide (to adjust pH), Purified water.
Pharmacotherapeutic group: Anti-inflammatory agents, corticosteroids. ATC code: S01 BA 07.
Pharmacology: Pharmacodynamics: Fluorometholone acetate is a synthetic steroid with strong anti-inflammatory properties.
Clinical studies have demonstrated that fluorometholone acetate is significantly more efficacious in the treatment of external ocular inflammation than fluorometholone.
Corticosteroids may cause a rise in intraocular pressure in some susceptible individuals. In a study using persons sensible to steroids, FLAREX ophthalmic suspension, demonstrated a significantly longer average time to produce a rise in intraocular pressure than did dexamethasome phosphate.
Pharmacokinetics: Results from animal studies have demonstrated that fluorometholone acetate, applied in the eye, is well absorbed and distributed in the cornea and the aqueous humor.
Toxicology: Preclinical safety data: No data provided.
For steroid responsive allergic and other inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the eye.
Posology: Adults: 1 to 2 drops in the conjunctival sac 4 times daily. During the initial 48 hours the dosage may be safely increased to 2 drops every 2 hours. If there is no improvement after 2 weeks, consult the physician. Care should be taken not to discontinue therapy prematurely.
Paediatric population: FLAREX is usually not recommended for pediatric use in children younger than 2 years of age since its safety and efficacy have not been established.
Elderly: There are no special precautions to be followed.
If used in patients with glaucoma, treatment should be limited to 2 weeks, unless longer treatment is justified (see Precautions).
Method of administration: For ocular use.
Shake well before use.
To prevent contamination of the dropper tip and solution, care must be taken not to touch the eyelids, surrounding areas, or other surfaces with the dropper tip. Keep bottle tightly closed when not in use.
A topical overdose of FLAREX is not likely to be associated with toxicity. A topical overdose of FLAREX can be flushed from the eye(s) with lukewarm water. Accidental ingestion is also unlikely to be associated with toxicity. Treatment of an accidental oral ingestion is symptomatic and supportive.
Hypersensitivity to the active substance or to any of the excipients listed in Description.
Vaccinia, varicella and other viral diseases of the cornea and conjunctiva.
Fungal diseases of ocular structures.
Mycobacterial ocular infections.
Untreated bacterial infections of the eye.
Herpitic keratitis (dendritic keratitis).
Corticosteroids should not be used with infections or injuries limited to the superficial corneal epithelium.
For ocular use only. Not for injection or ingestion.
The extensive and/or prolonged use of ophthalmic corticosteroids increases the risk of ocular complications and could cause systemic side effects. If the inflammatory condition does not respond within a reasonable period during the course of the therapy, other forms of therapy should be instituted to reduce these risks.
Topical application of corticosteroids may be accompanied by a decrease in the urinary secretion of cortisol as well as a decrease in plasma cortisol concentration. Corticosteroids have been associated with a decreased rate of growth in children, especially with high-dose or long-term treatment.
Prolonged use of ophthalmic corticosteroids may result in ocular hypertension and/or glaucoma, with damage to the optic nerve, reduced visual acuity and visual field defects, and posterior subcapsular cataract formation. In patients receiving ophthalmic corticosteroid therapy for 10 days of longer, intraocular pressure should be checked routinely and frequently, even though it may be difficult in children and uncooperative patients. Patients with a family or personal history of glaucoma have a higher risk of a corticosteroid-induced rise in intraocular pressure. Patients with glaucoma should be monitored weekly.
Corticosteroids may reduce infection resistance to and aid in the establishment of bacterial, viral or fungal infections and mask the clinical signs of infections, preventing recognition of ineffectiveness of the antibiotic.
The possibility of persistent fungal infections of the cornea should be considered after prolonged corticosteroid dosing. Fungal infection should be suspected in patients with persistent corneal ulceration who have been or are receiving these drugs, and corticosteroids therapy should be discontinued if fungal infection occurs.
Use with great caution, and only in conjunction with antiviral therapy, in the treatment of stromal keratitis or uveitis cause by herpes simplex; periodic slit-lamp microscopy is essential.
In those diseases causing thinning of the cornea or sclera, perforation of these tissues have been known to occur with the use of topical corticosteroids, especially after prolonged treatment.
Topical ophthalmic corticosteroids may slow corneal wound healing.
The treatment should not be discontinued prematurely as a flare of the inflammatory condition may occur with the sudden interruption of high doses of corticosteroids.
Contact lens wear is not recommended during the treatment of an ocular inflammation.
Additionally, this product contains benzalkonium chloride which may cause irritation and is known to discolor soft lenses. Avoid contact with soft contact lenses. Patients must be instructed to remove contact lenses prior to the application of FLAREX and wait at least 15 minutes before reinsertion.
After application of the eye drops following measures are useful to reduce systemic resorption: Keep the eyelid closed for 2 minutes.
Close the lacrimal duct with the finger for 2 minutes.
Effects on ability to drive and use machines: FLAREX has no or negligible influence on the ability to drive and use machines.
Temporarily blurred vision or other visual disturbances may affect the ability to drive or use machines. If blurred vision occurs at instillation, the patient must wait until the vision clears before driving or using machinery.
Fertility: There are no data regarding the effect of FLAREX on male or female fertility.
Pregnancy: There are no or limited amount of data from the use of FLAREX in pregnant women.
Fluorometholone can only be used during pregnancy if it is clearly necessary.
Fluorometholone, as other corticosteroids, has been found to be teratogenic in animal studies.
Animal studies with corticosteroids have shown reproductive toxicity. FLAREX is not recommended during pregnancy and in women of childbearing potential not using contraception.
Breastfeeding: There is insufficient information on whether fluorometholone from FLAREX is excreted in human milk. A risk to the suckling child cannot be excluded. Because of the potential for serious adverse reactions in nursing infants from fluorometholone, a decision must be made whether to discontinue breast-feeding or to discontinue treatment with FLAREX, taking into account the benefit of breast-feeding for the child and the benefit of the therapy for the woman.
The following adverse reactions are classified according to the following convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), or not known (cannot be estimated from the available data). Within each frequency-grouping, adverse reactions are presented in order of decreasing seriousness.
The following adverse reactions have been reported following use of this or similar ophthalmic preparations. (See table.)
Click on icon to see table/diagram/image
No clinical relevant interactions have been described with FLAREX.
During use of eye drops which are administered to dilate pupils (atropine and other anticholinergic substances), which may cause elevation of intraocular pressure, an additive elevation of intraocular pressure may occur if FLAREX is used concomitantly.
Ophthalmic corticosteroids may cause an increase in intraocular pressure, reducing the efficacy of glaucoma medications.
If more than one eye preparation is being used, the products must be administrated at least 5 minutes apart. Eye ointments should be administrated last.
Special precautions for disposal: No special requirements.
Incompatibilities: None known.
S01BA07 - fluorometholone ; Belongs to the class of corticosteroids. Used in the treatment of inflammation of the eye.
Ophth susp 0.1% (white to off-white suspension) x 5 mL.