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Zontivity

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Zontivity

INDICATIONS

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.

HOW SUPPLIED

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.

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