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.

Drug Facts Active Ingredients Purpose Olopatadine 0.2% (equivalent to olopatadine hydrochloride 0.222%) Antihistamine

DIRECTIONS • adults and children 2 years of age and older: • put 1 drop in the affected eye(s) twice daily, every 6 to 8 hours, no more than twice per day • if using other ophthalmic products while using this product, wait at least 5 minutes between each product • replace cap after each use • children under 2 years of age : consult a doctor

3 DOSAGE FORMS AND STRENGTHS Ophthalmic solution 0.2%: each ml contains 2.22 mg of olopatadine hydrochloride. Ophthalmic solution 0.2%: each ml contains 2.22 mg of olopatadine hydrochloride.

CONTRAINDICATIONS Olopatadine hydrochloride ophthalmic solution USP, 0.1% is contraindicated in persons with a known hypersensitivity to olopatadine hydrochloride, USP or any components of olopatadine hydrochloride ophthalmic solution USP, 0.1%.

Do not use if solution changes color or becomes cloudy if you are sensitive to any ingredient in this product to treat contact lens related irritation When using this product do not touch tip of container to any surface to avoid contamination remove contact lenses before use wait at least 10 minutes before reinserting contact lenses after use do not wear a contact lens if your eye is red

When using this product Do not touch tip of container to any surface to avoid contamination Remove contact lenses before use Wait at least 10 minutes before reinserting contact lenses after use Do not wear a contact lens if your eye is red

STOP USE AND ASK DOCTOR IF you experience: • eye pain • changes in vision • increased redness of the eye • itching worsens or lasts for more than 72 hours

6 ADVERSE REACTIONS Symptoms similar to cold syndrome and pharyngitis were reported at an incidence of approximately 10%. The following adverse experiences have been reported in 5% or less of patients: Ocular: blurred vision, burning or stinging, conjunctivitis, dry eye, foreign body sensation, hyperemia, hypersensitivity, keratitis, lid edema, pain and ocular pruritus. Non-ocular: asthenia, back pain, flu syndrome, headache, increased cough, infection, nausea, rhinitis, sinusitis and taste perversion. Some of these events were similar to the underlying disease being studied. Symptoms similar to cold syndrome and pharyngitis were reported at an incidence of approximately 10%. (6) To report SUSPECTED ADVERSE REACTIONS, contact Alembic Pharmaceutical Inc. at 1-866-210-9797 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy 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. 8.3 Nursing Mothers Olopatadine has been identified in the milk of nursing rats following oral administration. It is not known whether topical ocular administration could result in sufficient systemic absorption to produce detectable quantities in the human breast milk. Nevertheless, caution should be exercised when olopatadine hydrochloride ophthalmic solution USP, 0.2% is administered to a nursing mother. 8.4 Pediatric Use Safety and effectiveness in pediatric patients below the age of 2 years have not been established. 8.5 Geriatric Use No overall differences in safety and effectiveness have been observed between elderly and younger patients.

12.1 Mechanism of Action Olopatadine is a mast cell stabilizer and a histamine H1 antagonist. Decreased chemotaxis and inhibition of eosinophil activation has also been demonstrated.

DESCRIPTION Olopatadine hydrochloride ophthalmic solution USP, 0.1% is a sterile ophthalmic solution containing olopatadine, a relatively selective H 1 -receptor antagonist and inhibitor of histamine release from the mast cell for topical administration to the eyes. Olopatadine hydrochloride, USP is a white, crystalline, water-soluble powder with a molecular weight of 373.88. The chemical structure is presented below: Chemical Name: 11-[(Z)-3-(Dimethylamino)propylidene]-6-11-dihydrodibenz[b,e]oxepin-2-acetic acid hydrochloride Each mL of olopatadine hydrochloride ophthalmic solution USP, 0.1 % contains: Active : 1.11 mg olopatadine hydrochloride, USP equivalent to 1 mg olopatadine. Preservative: Benzalkonium chloride 0.01%. Inactives: Dibasic sodium phosphate; Sodium chloride; Hydrochloric acid/Sodium hydroxide (adjust pH); and Water for Injection. It has a pH of approximately 7 and an osmolality of approximately 300 mOsm/kg. chemical-structure

ACTIVE INGREDIENT(S) Olopatadine 0.2%................ (equivalent to olopatadine hydrochloride 0.222%)

16 HOW SUPPLIED/STORAGE AND HANDLING Olopatadine hydrochloride ophthalmic solution USP, 0.2% is supplied in a 5 mL screw neck white bottle with nozzle made with low density polyethylene and white color screw cap made with high density polyethylene Tamper evidence is provided with a tamper evident ring around the closure and neck area of the package. 2.5 mL fill in 5 mL bottle (NDC 62332-502-03) Storage Store at 2°C to 25°C (36°F to 77°F)