ZONTIVITY Rx

Indications for ZONTIVITY:

To reduce thrombotic cardiovascular events in patients with a history of myocardial infarction or with peripheral arterial disease.

Adult:

2.08mg once daily. Use with aspirin and/or clopidogrel according to their indications or standard of care.

Children:

Not established.

Contraindications:

History of stroke, transient ischemic attack (TIA), or intracranial hemorrhage (ICH). Active pathological bleeding (eg, peptic ulcer, ICH).

Boxed Warning:

Bleeding risk.

Warnings/Precautions:

Discontinue if stroke, TIA, or ICH occurs. Increased risk of bleeding (may be fatal). Consider underlying risk of bleeding before initiating (eg, older age, low body wt., reduced renal or hepatic function, history of bleeding disorders, concomitant certain medications). Hypotensive and has recently undergone coronary angiography, PCI, CABG or other surgeries: suspect bleeding and monitor. Severe hepatic impairment: not recommended. Elderly. Pregnancy (Cat. B). Nursing mothers: not recommended.

Pharmacological Class:

Protease-activated receptor-1 (PAR-1) antagonist.

Interactions:

Avoid concomitant strong CYP3A4 inhibitors (eg, ketoconazole, itraconazole, posaconazole, clarithromycin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, boceprevir, telaprevir, telithromycin, conivaptan). Avoid concomitant strong CYP3A4 inducers (eg, rifampin, carbamazepine, St. John’s wort, phenytoin). Avoid concomitant warfarin or other anticoagulants. Increased risk of bleeding with concomitant fibrinolytics, chronic NSAIDs, SSRIs, SNRIs.

Adverse Reactions:

Bleeding (may be fatal), anemia, depression, rashes, eruptions, exanthemas, iron deficiency, retinopathy or retinal disorder, diplopia/oculomotor disturbances.

Generic Availability:

NO

How Supplied:

Tabs—30, 90