"The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended the marketing of selexipag (Uptravi, Actelion Registration Ltd) for the treatment of adults with pulmonary arterial hypertension (PAH)./"...
DOSAGE AND ADMINISTRATION
The recommended dosage of PLETAL is 100 mg twice daily taken at least half an hour before or two hours after breakfast and dinner.
A dose reduction to 50 mg twice daily should be considered during co-administration with strong or moderate CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, erythromycin and diltiazem) and during co-administration with CYP2C19 inhibitors (e.g., ticlopidine, fluconazole and omeprazole. (see PRECAUTIONS AND Pharmacokinetic and Pharmacodynamic Drug-Drug Interactions) twice daily
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. If symptoms are unimproved after 3 months, discontinue Pletal.
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).
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, Ltd., Tokushima 771-0182, Japan. January 2015This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 2/13/2015
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