Generic Information
FLUOROMETHOLONE + TETRAHYDROZOLINE
This eye drops is indicated in acute allergic, noninfectious conjunctivitis & keratitis, severe swelling & hyperaemia, noninfectious inflammation of the anterior segment of the eye (including anterior uveitis, episcleritis & scleritis) and post-operative conditions.
Ophthalmic Steroid preparations
Fluorometholone is thought to act by the induction of phospholipase A2 inhibitory proteins which control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor arachidonic acid. On the other hand, Tetrahydrozoline is an alpha agonist which constricts the conjunctival blood vessels and thereby relieves the redness of the eye.
Use in adult: Instill 1 drop into the conjunctival sac 2-3 times daily. The dose may be increased for severe and adult patient to 1 drop hourly for first one to two days. Use in children: Safety & effectiveness in children below 2 years of age have not been established.
It is contraindicated in infectious conjunctivitis or keratitis, injuries or ulcerous processes of the cornea, glaucoma, diseases associated with stromal damage of the cornea or sclera & dry eyes.
Mild burning sensation, reversible increase in intraocular pressure, reactive hyperemia, cataract & corneal defects, glaucoma, systemic effects (chronic use).
There are no adequate and well-controlled studies of Fluorometholone & Tetrahydrozoline in pregnancy or while breast-feeding. Therefore, this combination should be used during pregnancy only if the potential benefits justify the potential risk to the fetus.
When the product is used as directed, there is almost no likelihood of an overdose. No information on overdosage with fluorometholone is available. Overdosage with fluorometholone is unlikely to cause acute problems. The symptoms of acute overdosage with tetryzoline are CNS, cardiac and psychiatric disturbances, mydriasis, cyanosis and fever. CNS functions may be inhibited under certain circumstances. The following measures are possible in case of accidental ingestion and the occurrence of symptoms of intoxication: administration of activated charcoal, gastric lavage, artificial ventilation with oxygen, use of phentolamine to lower blood pressure (5 mg in saline solution, given i.v.). Vasopressors are contraindicated. Antipyretic and anticonvulsive therapy can be administered as necessary.
Avoid prolonged use. This preparation should be used after a careful risk benefit evaluation in case of patients with severe blood circulation diseases, metabolic disturbances, under treatment with MAOIs & other potentially hypertensive drugs, history of cataract, herpes simplex infection, rhinitis sicca.
Should not be used after the date marked "EXP" on the pack. This must be kept out of the reach and sight of children.