Mirolast Eye Drops (Pemirolast Potassium 0.1%)

Therapeutic Group: Ophthalmic Anti Allergic Preparations

Each ml contains Pemirolast Potassium INN 1 mg (0.1%).

Mirolast is a sterile, aqueous ophthalmic solution of Pemirolast Potassium. Pemirolast Potassium is a mast cell stabilizer that inhibits the invivo Type-1 immediate hypersensitivity reaction. The drug has been observed to block antigen-stimulated calcium ion influx into mast cells. Invitro and invivo studies have demonstrated that Pemirolast inhibits the antigen-induced release of inflammatory mediators (e.g., histamine, leukotriene C4, D4, E4) from human mast cells. Pemirolast also inhibits the chemotaxis of eosinophils into ocular tissue and prevents inflammatory mediator release from human eosinophils.

Pemirolast ophthalmic solution is indicated for the prevention of itching of the eye due to allergic conjunctivitis.

1 to 2 drops in each affected eye four times daily.

Burning of eye, dry eye, ocular discomfort, non ocular allergy, sinusitis, headache and sneezing or nasal congestion.

To prevent contaminating the dropper tip and solution, do not touch the eyelids or surrounding areas with the dropper tip Keep the bottle tightly closed when not in use Patients should be advised not to wear contact lens if their eye is red Mirolast should not be used to treat contact lens related irritation Patients should wait 10 minutes after applying Pemirolast before they insert contact lenses

Pemirolast ophthalmic solution is contraindicated in patients with previously demonstrated hypersensitivity to any of the ingredients of this product.

Pregnancy: There are no adequate and well-controlled studies in pregnant women. Pemirolast ophthalmic solution should be used during pregnancy only if the benefit outweighs the risk. Lactation: It is not known whether Pemirolast Potassium is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Pemirolast ophthalmic solution is administered to a nursing woman. Pediatric Use Safety and effectiveness in pediatric patients below the age of 3 years have not been established.

No information is available regarding the occurrence of overdose with ophthalmic preparations of Pemirolast. Storage Store at 15-25° C. Keep out of reach of children. Do not use more than 4 weeks after opening

Plastic dropper bottle containing 10 ml eye drops.