Ocustin (Bepotastine Besilatr 1.5%)

Indication

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

Dosage & Administration

The recommended dose of Ocustin eye drops is 1 drop into the affected eye(s) twice a day (BID).

Precautions

Contamination:
To minimize the risk of contamination, do not touch dropper tip to any surface.
Keep bottle tightly closed when not in use.
Contact Lens:
Bepotastine Besilate should not be used to treat contact lens-related irritation.

Remove contact lenses prior to instillation of Bepotastine Besilate.

Special Populations
Pregnancy: Pregnancy Category C. Teratogenicity studies have been performed in animals. Bepotastine Besilate was not found to be teratogenic in rats during organogenesis and fetal development at oral doses up to 200 mg/kg/day (representing a systemic concentration approximately 3,300 times that anticipated for topical ocular use in humans), but did show some potential for causing skeletal abnormalities at 1,000 mg/kg/day. There were no teratogenic effects seen in rabbits at oral doses up to 500 mg/kg/day given during organogenesis and fetal development (>13,000 times the dose in humans on a mg/kg basis). No evidence of infertility was observed in rats given 200 mg/kg/day (approximately 3,300 times the topical ocular use in humans).

Nursing Mothers: It is not known if Bepotastine Besilate eye drops is excreted in human milk. Caution should be exercised when Bepotastine Besilate eye drops is administered to a nursing woman.
 

Pediatric Use: Safety and efficacy of Bepotastine Besilate eye drops have not been established in pediatric patients less than 2 years of age.

Geriatric Use: No overall difference in safety or effectiveness has been observed between elderly and younger patients.