Olopatadine Hydrochloride

1 INDICATIONSAND USAGE Olopatadine hydrochloride ophthalmic solution USP, 0.2 % is indicated for the treatment of ocular itching associated with allergic conjunctivitis. Olopatadine hydrochloride ophthalmic solution USP, 0.2 % is a mast cell stabilizer indicated for the treatment of ocular itching associated with allergic conjunctivitis.

None.

5.1 For topical ocular use only. Not for injection or oral use.

5.2 Contamination of Tip and Solution As with any eye drop, to prevent contaminating the dropper tip and solution, care should be taken not to touch the eyelids or surrounding areas with the dropper tip of the bottle. Keep bottle tightly closed when not in use.

5.3Contact Lens Use

Patients should be advised not to wear a contact lens if their eye is red. Olopatadine hydrochloride ophthalmic solution USP, 0.2% should not be used to treat contact lens related irritation. The preservative in Olopatadine hydrochloride ophthalmic solution USP 0.2%, benzalkonium chloride, may be absorbed by soft contact lenses. Patients who wear soft contact lenses and whose eyes are not red, should be instructed to wait at least ten minutes after instilling olopatadine hydrochloride ophthalmic solution USP, 0.2% before they insert their contact lenses.

For topical ocular use only. Not for injection or oral use (5.1).

8.1Pregnancy

Teratogenic effects: Pregnancy Category C Olopatadine was found not to be teratogenic in rats and rabbits. However, rats treated at 600 mg/kg/day, or 150,000 times the MROHD and rabbits treated at 400 mg/kg/day, or approximately 100,000 times the MROHD, during organogenesis showed a decrease in live fetuses. In addition, rats treated with 600 mg/kg/day of olopatadine during organogenesis showed a decrease in fetal weight.

Further, rats treated with 600 mg/kg/day of olopatadine during late gestation through the lactation period showed a decrease in neonatal survival and body weight. There are, however, no adequate and well- controlled studies in pregnant women. Because animal studies are not always predictive of human responses, this drug should be used in pregnant women only if the potential benefit to the mother justifies the potential risk to the embryo or fetus.