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CORLANOR(Ivabradine)Tablets
2016-03-25 11:23:02 来源: 作者: 【 】 浏览:432次 评论:0

Generic Name and Formulations:
Ivabradine 5mg+, 7.5mg; tabs; +scored.

Company:
Amgen, Inc.
Indications for CORLANOR:
To reduce the risk of hospitalization for worsening heart failure in patients with stable, symptomatic chronic heart failure with LVEF ≤35%, who are in sinus rhythm with resting heart rate ≥70bpm and either are on maximally tolerated doses of beta-blockers or have a contraindication to beta-blocker use.

Adult:
Take with meals. ≥18yrs: Initially 5mg twice daily. Adjust dose after 2 weeks to achieve resting heart rate 50–60bpm (see full labeling); then adjust dose as needed based on resting heart rate and tolerability. Max dose 7.5mg twice daily. History of conduction defects or if bradycardia can lead to hemodynamic compromise: initially 2.5mg twice daily.

Children:
<18yrs: not established.

Contraindications:
Acute decompensated heart failure. BP <90/50mmgHg. Sick sinus syndrome, sinoatrial block, or 3rd degree AV block, unless paced. Resting heart rate <60bpm prior to treatment. Severe hepatic impairment. Pacemaker dependence. Concomitant strong CYP3A4 inhibitors (eg, itraconazole, clarithromycin, telithromycin, nelfinavir, nefazodone).

Warnings/Precautions:
Monitor cardiac rhythm regularly; discontinue if atrial fibrillation develops. Increased risk of bradycardia with sinus node dysfunction, conduction defects (eg, 1st or 2nd degree AV block, bundle branch block), ventricular dyssynchrony. Avoid in 2nd degree AV block, unless paced. Demand pacemakers set to rates ≥60bpm: not recommended. Pregnancy: monitor (esp. 3rd trimester for preterm birth). Use effective contraception during treatment. Nursing mothers: not recommended.

Interactions:
See Contraindications. Avoid concomitant moderate CYP3A4 inhibitors (eg, diltiazem, verapamil, grapefruit juice). Avoid concomitant CYP3A4 inducers (eg, St. John's wort, rifampicin, barbiturates, phenytoin). Increased risk of bradycardia with concomitant negative chronotropes (eg, digoxin, amiodarone, beta-blockers); monitor.

Pharmacological Class:
Hyperpolarization-activated cyclic nucleotide-gated (HCN) channel blocker.

Adverse Reactions:
Bradycardia, hypertension, atrial fibrillation, luminous phenomena (phosphenes); conduction disturbances.

Generic Availability:
NO

How Supplied:
Tabs—60, 180 

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