Refemoline Ophthalmic Solution 0.1%+0.025%

Uses

This eye drops is used for 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.

Refemoline Ophthalmic Solution 0.1%+0.025% is also used to associated treatment for these conditions: Anterior chamber inflammation, Conjunctivitis allergic, Corneal Inflammation, Inflammation, Ocular Inflammation, Ocular bacterial infections

How Refemoline Ophthalmic Solution 0.1%+0.025% works

There is no generally accepted explanation for the mechanism of action of ocular corticosteroids. However, corticosteroids are thought to act by the induction of phospholipase A2 inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor, arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A2. Their primary target is the cytosolic glucocorticoid receptor. After binding the receptor the newly formed receptor-ligand complex translocates itself into the cell nucleus, where it binds to many glucocorticoid response elements (GRE) in the promoter region of the target genes. The DNA bound receptor then interacts with basic transcription factors, causing the increase in expression of specific target genes.

Dosage

Refemoline Ophthalmic Solution 0.1%+0.025% dosage

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.

Side Effects

Mild burning sensation, reversible increase in intraocular pressure, reactive hyperemia, cataract & corneal defects, glaucoma, systemic effects (chronic use).

Toxicity

Side effects may include acute anterior uveitis and perforation of the globe. Keratitis, conjunctivitis, corneal ulcers, mydriasis, conjunctival hyperemia, loss of accommodation and ptosis have occasionally been reported following local use of corticosteroids. LD₅₀ = 234 mg/kg (rats)

Precaution

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.

Interaction

Specific drug interaction studies have not been conducted with Fluorometholone ophthalmic suspension.

Pregnancy & Breastfeeding 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.

Contraindication

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.

Acute Overdose

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.

Storage Condition

Should not be used after the date marked "EXP" on the pack. This must be kept out of the reach and sight of children.

Innovators Monograph

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