Pletal is indicated for the reduction of symptoms of intermittent claudication, as indicated by an increased walking distance.

The recommended dosage of Pletal is 100 mg b.i.d. taken at least half an hour before or two hours after breakfast and dinner. A dose of 50 mg b.i.d. should be considered during coadministration of such inhibitors of CYP3A4 as ketoconazole, itraconazole, erythromycin and diltiazem, and during coadministration of such inhibitors of CYP2C19 as omeprazole.

Patients may respond as early as 2 to 4 weeks after the initiation of therapy, but treatment for up to 12 weeks may be needed before a beneficial effect is experienced.

Discontinuation of Therapy: The available data suggest that the dosage of Pletal can be reduced or discontinued without rebound (i.e., platelet hyperaggregability).

Pletal is supplied as 50 mg and 100 mg tablets. The 50 mg tablets are white, triangular, debossed with Pletal 50, and provided in bottles of 60 tablets (NDC #59148-003-16).

The 100 mg tablets are white, round, debossed with Pletal 100, and provided in bottles of 60 tablets (NDC #59148-002-16).

Storage

Store Pletal tablets at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [See USP Controlled Room Temperature].

Manufactured for : Otsuka America Pharmaceutical, Inc. Rockville, MD 20850. Manufactured by : Otsuka America Pharmaceutical, Inc.Tokushima 771-0192, Japan. FDA revision date: 11/13/2007

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