"The U.S. Food and Drug Administration today approved Zontivity (vorapaxar) tablets to reduce the risk of heart attack, stroke, cardiovascular death, and need for procedures to restore the blood flow to the heart in patients with a previous heart "...
Patients With History Of Myocardial Infarction (MI) Or With Peripheral Arterial Disease (PAD)
ZONTIVITY™ is indicated for the reduction of thrombotic cardiovascular events in patients with a history of myocardial infarction (MI) or with peripheral arterial disease (PAD). ZONTIVITY has been shown to reduce the rate of a combined endpoint of cardiovascular death, MI, stroke, and urgent coronary revascularization (UCR).
DOSAGE AND ADMINISTRATION
General Dosing Information
Take one tablet of ZONTIVITY 2.08 mg orally once daily, with or without food.
Coadministration With Other Antiplatelet Drugs
There is no experience with use of ZONTIVITY alone as the only administered antiplatelet agent. ZONTIVITY has been studied only as an addition to aspirin and/or clopidogrel. Use ZONTIVITY with aspirin and/or clopidogrel according to their indications or standard of care [see Clinical Studies]. There is limited clinical experience with other antiplatelet drugs.
Dosage Forms And Strengths
ZONTIVITY tablets, 2.08 mg vorapaxar, are yellow, oval-shaped, film-coated tablets with “351” on one side and the Merck logo on the other side.
Storage And Handling
ZONTIVITY tablets, 2.08 mg vorapaxar, are yellow, oval-shaped, film-coated tablets with “351” on one side and the Merck logo on the other side. They are supplied as follows:
NDC 0006-0351-31 bottles of 30 tablets
NDC 0006-0351-54 bottles of 90 tablets
NDC 0006-0351-48 unit dose packages of 100 tablets (one carton containing 10 10-count blister cards)
Storage of bottles
Store at 20-25°C (68-77°F), excursions permitted between 15-30°C (between 59-86°F). [See USP Controlled Room Temperature.] Store tablets in the original package with the bottle tightly closed. Keep the desiccant in the bottle to protect from moisture.
Storage of blisters
Store at 20-25°C (68-77°F), excursions permitted between 15-30°C (between 59-86°F). [See USP Controlled Room Temperature.] Store in the original package until use.
Manufactured for: Merck Sharp & Dohme Corp., a subsidiary of MERCK & CO., INC., Whitehouse Station, NJ 08889, USA. Manufactured by: MSD International GmbH (Singapore Branch), Singapore 638414, Singapore. Issued: 05/2014
Last reviewed on RxList: 5/28/2014
This monograph has been modified to include the generic and brand name in many instances.
Additional Zontivity Information
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