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Patanol Information

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DESCRIPTION

PATANOL (olopatadine hydrochloride ophthalmic solution) 0.1% is a sterile ophthalmic solution containing olopatadine, a relatively selective H1-receptor antagonist and inhibitor of histamine release from the mast cell for topical administration to the eyes. Olopatadine hydrochloride is a white, crystalline, water-soluble powder with a molecular weight of 373.88.

INDICATIONS AND USAGE

PATANOL (olopatadine hydrochloride ophthalmic solution) 0.1% is indicated for the treatment of the signs and symptoms of allergic conjunctivitis.

CONTRAINDICATIONS

PATANOL is contraindicated in persons with a known hypersensitivity to olopatadine hydrochloride or any components of PATANOL.

WARNINGS

PATANOL is for topical use only and not for injection or oral use.

PRECAUTIONS

Information for Patients: 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. Patients should be advised not to wear a contact lens if their eye is red. PATANOL should not be used to treat contact lens-related irritation. The preservative in PATANOL, 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 PATANOL before they insert their contact lenses.

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 human breast milk. Nevertheless, caution should be exercised when PATANOL is administered to a nursing mother.

Pediatric Use: Safety and effectiveness in pediatric patients below the age of 3 years have not been established.

ADVERSE REACTIONS

Headaches were reported at an incidence of 7%. The following adverse experiences were reported in less than 5% of patients: Asthenia, blurred vision, burning or stinging, cold syndrome, dry eye, foreign body sensation, hyperemia, hypersensitivity, keratitis, lid edema, nausea, pharyngitis, pruritus, rhinitis, sinusitis, and taste perversion. Some of these events were similar to the underlying disease being studied.

DOSAGE AND ADMINISTRATION

The recommended dose is one drop in each affected eye two times per day at an interval of 6 to 8 hours.

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