Presentation

Betastin Sterile Eye Drops: Each ml contains Bepotastine Besilate INN 15 mg.

Description

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.

Indications

Betastin is indicated for the treatment of itching associated with signs and symptoms of allergic conjunctivitis.

Dosage & Administration

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.

Side Effects

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.

Precautions

? 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.

Use in Pregnancy & Lactation

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.

Drug Interaction

No information provided.

Over Dose

No information provided.

Storage

? Store in a cool, dry place & protected from light

? Keep out of reach of children

? Do not use more than 4 weeks after opening.

Commercial Pack

Betastin Sterile Eye Drops: Each plastic dropper bottle contains 5 ml of sterile eye drops.