Pataday (Olopatadine Hydrochloride Ophthalmic Solution) Drug Information: Clinical Pharmacology

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May 27, 2012

Pataday

Allergy Drugs: Prescription and OTC »

Allergy medications overview

The arsenal of allergy drugs includes dozens of medications that relieve allergy symptoms when confronted with a trigger known as an allergen. That trigger could be something from a plant, such as pollen, or something from an animal (pet dander, dust mites, cockroaches). Other allergy triggers include certain fragrances or chemical substances.

What causes a person's allergic reaction is highly individual. But the reactions are often universal: swelling and inflammation, especially around the eyes, nose, and throat, usually accompanied by itching.

Some allergy medications work against the effects of histamines, which are released during an allergic reaction. Other medications reduce swelling, affect the immune system, or affect release of other substances associated with allergic reactions.

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CLINICAL PHARMACOLOGY

Mechanism of Action

Olopatadine is a mast cellstabilizer and a histamine H1 antagonist. Decreased chemotaxis and inhibition of eosinophil activation has also been demonstrated.

Pharmacokinetics

Systemic bioavailability data upon topical ocular administration of PATADAY™ (olopatadine hydrochloride ophthalmic solution) solution are not available. Following topical ocular administration of olopatadine 0.15% ophthalmic solution in man, olopatadine was shown to have a low systemic exposure. Two studies in normal volunteers (totaling 24 subjects) dosed bilaterally with olopatadine 0.15% ophthalmic solution once every 12 hours for 2 weeks demonstrated plasma concentrations to be generally below the quantitation limit of the assay ( < 0.5 ng/mL). Samples in which olopatadine was quantifiable were typically found within 2 hours of dosing and ranged from 0.5 to 1.3 ng/mL. The elimination half-life in plasma following oral dosing was 8 to 12 hours, and elimination was predominantly through renal excretion. Approximately 60 - 70% of the dose was recovered in the urine as parent drug. Two metabolites, the mono-desmethyl and the N-oxide, were detected at low concentrations in the urine.

Clinical Studies

Results from clinical studies of up to 12 weeks duration demonstrate that PATADAY™ (olopatadine hydrochloride ophthalmic solution) solution when dosed once a day is effective in the treatment of ocular itching associated with allergic conjunctivitis.

Last reviewed on RxList: 1/27/2011
This monograph has been modified to include the generic and brand name in many instances.