- ANTI-INFLAMMATORY AGENTS
- OPHTHALMOLOGICAL DRUGS
- Pharmaceutical Form : Eye Drops
- Composition : Fluorometholone 1 mg + Tetryzoline HCl 0.25 mg /1 ml
- Active Substance : Fluorometholone +Tetryzoline HCl
The anti-inflammatory action of Fluorometholone is at least 40 times stronger than that of hydrocortisone . Like all anti-inflammatory glucocorticoids , Fluorometholone inhibits the phospholipase A2 , the first step in prostaglandine synthesis .
Fluorometholone also inhibits the chemotactic infiltration of neutrophils into the focus of inflammation .
Tetryzoline is an a-sympathomimetic , which causes local vasoconstriction .the vasoconstrictive action of Tetryzoline sets in rapidly and alleviates swelling , hyperaemia and irritation of the conjunctiva FLORA- T contains the viscosity- increasing excipient hydroxypropylmethylcellulos , it increases the effect of The product by Prolonging the retention time on the cornea .
-Acute allergic non-infectious conjunctivitis and keratitis with severe swelling and Hyperaemia .
– Non- infectious inflammation of the anterior segment of the eye (including anterior uveitis , episcleritis and Scleritis ).
– Postoperative conditions following squint , cataract and glaucoma operations along with
Supplementary antimicrobial therapy .
-Hypersensitivity to Fluorometholone , Tetryzoline , and other ingredients .
– Infectious conjunctivitis or keratitis .
-Injuries and ulcerous processes of the cornea , especially infections caused by virus , bacteria and fungus (e.g. herpes simplex , vaccinia , purulent untreated infections ,tuberculosis).
– In diseases associated with stromal damage of the cornea or sclera , the topical applications of corticosteroids may cause perforation of these tissues .
-Dry eyes, especially keratoconjunctivitis sicca (Sjogren’s syndrome ).
– Children under 2 years .
Adverse reactions :
A slight burning sensation may occur for a short time after application of the eye drops .Prolonged use may cause reactive congestion . In rare cases allergic reactions in the Form of palpebral eczema , keratitis punctata and periocular dermatitis have been reported .After application , FLORA- T eye drops may temporarily influence the visual acuity .Thus , patients driving vehicles or operating machinery should be alerted to the possibility of reduced reaction Time and thereby impaired capability to drive motor vehicles and to operate machinery .
FLORA- T should not be administered simultaneously with monoaminooxidase
Inhibitors or tricyclic antidepressants which could increase blood pressure through the vasonstrictive effects .
The preparation should only be administered after a careful risk /benefit evaluation in each individual patient in Case of :
– severe blood circulation diseases (e.g . Coronary heart condition , hypertonia ).
-metabolic disturbances (e.g. Hyperthyroidism , diabetes )
– patients , who are under treatment with monoaminooxidase -inhibitors and other potentially hypertensive drugs .
– History of cataract , herpes simplex infection .
-Rhinitis sicca .
After discontinuation of the preparation , reactive hyperaemia is possible .this preparation is not meant for prolonged use . In case of long -term treatment (more than 2or 3 days )patients should be regularly examined with regard to intraocular pressure , fungus invasion must be suspected in any persistent corneal ulceration .
-Administration during pregnancy and lactation is not recommended .
Other information :
As with any suspension , the bottle should be shaken well before use .
Close the bottle immediately after use , store eye drops at room temperature (15 -25 )° c.
Once opened the drops must not be used for longer than one month .
Adults : Instill one drop 2- 3 times daily into the conjunctival sac . In the first 24 – 48 hours , the dose may be increased to 1 drop hourly for adults . Caution should be exercised in the case of reactive Hyperaemia .
Children :(above 2 years ). No specific studies have been performed . Due to possible systemic adverse effects .
FLORA- T should be used with caution in children .
Packaging : Eye drops : Dropper bottle of 10 ml.