Country: Bandaríkin
Tungumál: enska
Heimild: NLM (National Library of Medicine)
VORAPAXAR SULFATE (UNII: IN66038E6C) (VORAPAXAR - UNII:ZCE93644N2)
Aralez Pharmaceuticals Us Inc.
vorapaxar sulfate
vorapaxar 2.08 mg
ORAL
PRESCRIPTION DRUG
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). ZONTIVITY is contraindicated in patients with a history of stroke, TIA, or ICH because of an increased risk of ICH in this population [see Adverse Reactions (6)] . Discontinue ZONTIVITY in patients who experience a stroke, TIA, or ICH [see Adverse Reactions (6.1) and Clinical Studies (14)] . ZONTIVITY is contraindicated in patients with active pathological bleeding such as ICH or peptic ulcer [see Warnings and Precautions (5.1) and Adverse Reactions (6.1)] . Risk Summary Based on the potenti
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: 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.
New Drug Application
ZONTIVITY- VORAPAXAR TABLET, FILM COATED Aralez Pharmaceuticals Us Inc. ---------- MEDICATION GUIDE ZONTIVITY ® (ZON-TIV-ITI) (VORAPAXAR) TABLETS Read this Medication Guide before you start taking ZONTIVITY and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment. What is the most important information I should know about ZONTIVITY? ZONTIVITY is used to lower your chance of having another serious problem with your heart or blood vessels, but ZONTIVITY (and similar drugs) can cause bleeding that can be serious and lead to death. Call your doctor right away if you have any of these signs or symptoms of bleeding while taking ZONTIVITY: • bleeding that is severe or that you cannot control • pink, red, or brown urine • vomiting blood or your vomit looks like "coffee grounds" • red or black stools (looks like tar) • coughing up blood or blood clots. While you take ZONTIVITY and for about 4 weeks after your treatment with ZONTIVITY is stopped: • you may bruise and bleed more easily (nose bleeds may be common) • it will take longer than usual for any bleeding to stop. Do not take ZONTIVITY if you: • have had a stroke or "mini stroke" (also known as transient ischemic attack or TIA) • have had bleeding in your brain • currently have unusual bleeding, such as bleeding in your head, stomach or intestines (an ulcer). If you have a stroke, TIA, or bleeding in your brain while taking ZONTIVITY your doctor should stop your treatment with ZONTIVITY. Follow your doctor's instructions about stopping ZONTIVITY. Do not stop taking ZONTIVITY without talking to the doctor who prescribed it for you. What is ZONTIVITY? ZONTIVITY is a prescription medicine used to treat people who have • had a heart attack or • reduced blood flow in their legs (peripheral arterial disease). ZONTIVITY is used with aspirin and/or clopidogrel to lower your chance of having another serious problem with your heart o Lestu allt skjalið
ZONTIVITY- VORAPAXAR TABLET, FILM COATED ARALEZ PHARMACEUTICALS US INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE ZONTIVITY SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ZONTIVITY. ZONTIVITY (VORAPAXAR) TABLETS 2.08 MG*, FOR ORAL USE *EQUIVALENT TO 2.5 MG VORAPAXAR SULFATE INITIAL U.S. APPROVAL: 2014 WARNING: BLEEDING RISK _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ DO NOT USE ZONTIVITY IN PATIENTS WITH A HISTORY OF STROKE, TRANSIENT ISCHEMIC ATTACK (TIA), OR INTRACRANIAL HEMORRHAGE (ICH); OR ACTIVE PATHOLOGICAL BLEEDING. ( 4.1, 4.2) ANTIPLATELET AGENTS, INCLUDING ZONTIVITY, INCREASE THE RISK OF BLEEDING, INCLUDING ICH AND FATAL BLEEDING. ( 5.1) INDICATIONS AND USAGE ZONTIVITY is a protease-activated receptor-1 (PAR-1) antagonist 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. ( 1.1) DOSAGE AND ADMINISTRATION One tablet of ZONTIVITY orally once daily. ( 2.1) Use with aspirin and/or clopidogrel according to their indications or standard of care. There is limited clinical experience with other antiplatelet drugs and none with ZONTIVITY as the only antiplatelet agent. ( 2.2) DOSAGE FORMS AND STRENGTHS Tablets: 2.08 mg vorapaxar. ( 3) CONTRAINDICATIONS History of stroke, TIA, or ICH. ( 4.1) Active pathologic bleeding. ( 4.2) WARNINGS AND PRECAUTIONS Like other antiplatelet agents, ZONTIVITY increases the risk of bleeding. ( 5.1) Avoid use with strong CYP3A inhibitors or inducers. ( 5.2) ADVERSE REACTIONS Bleeding, including life-threatening and fatal bleeding, is the most commonly reported adverse reaction. ( 6.1) TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT ARALEZ PHARMACEUTICALS AT 1-833-694- 8235 OR FDA AT 1-800-FDA-1088 OR _WWW.FDA.GOV/MEDWATCH._ USE I Lestu allt skjalið