Betastin Sterile Eye Drops: Each ml contains Bepotastine Besilate INN 15 mg.
Bepotastine Besilate 1.5% is a sterile drops for ophthalmic use. Bepotastine is direct H1-receptor antagonist and an inhibitor of the release of histamine from mast cells.
Betastin is indicated for the treatment of itching associated with signs and symptoms of allergic conjunctivitis.
Instill one drop of Betastin eye drops into the affected eye(s) twice a day.
Pediatric Use: Safety and effectiveness in children below the age of 2 years have not been established.
The most common reported side effect occurring in approximately 25% of subjects was a mild taste following instillation. Other side effects occurring in 2-5% of subjects were eye irritation, headache, and nasopharyngitis.
• To minimize the risk of contamination, do not touch dropper tip to any surface.
• It should not be used to treat contact lens-related irritation.
• Patients should be advised not to wear contact lens when using this drop.
Pregnancy: Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. It should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the fetus.
Lactation: It is not known if Bepotastine besilate is excreted in human milk. Caution should be exercised when it is administered to a nursing woman.