• Therapeutic Category
  • Pharmaceutical Form : Eye Drops
  • Composition : Fluorometholone 1 mg + Tetryzoline HCl 0.25 mg /1 ml
  • Active Substance : Fluorometholone +Tetryzoline HCl

Properties :

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 .

Indications :

-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 .

Contra  Indications:

-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).

– Glaucoma.

– 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 .

Interactions :

FLORA- T should not be administered simultaneously with monoaminooxidase

Inhibitors or tricyclic  antidepressants which could increase blood pressure through the vasonstrictive effects .

Precautions :

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 .

Dosage :

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.