Hypersensitivity to ivabradine or to any excipients of Coralan; resting heart rate of <70 bpm prior to treatment; cardiogenic shock; acute myocardial infarction; severe hypotension (<90/50 mmHg); severe hepatic insufficiency; sick sinus syndrome; sino-atrial block; pacemaker-dependent; unstable angina; AV-block of 3rd degree, heart failure which has recently become worse.
Combination with strong cytochrome P450 3A4 inhibitors eg, azole antifungals (ketoconazole, itraconazole), macrolide antibiotics (clarithromycin, oral erythromycin, josamycin, telithromycin), HIV protease inhibitors (nelfinavir, ritonavir) and nefazodone (see Pharmacokinetics under Actions and Interactions). Combination with verapamil or diltiazem which are moderate CYP3A4 inhibitors with heart rate reducing properties (see Interactions).
Use in pregnancy & lactation: Women of childbearing potential should use appropriate contraceptive measures during treatment. There are no adequate data concerning the use of ivabradine in pregnant women. Animal reproduction studies have shown embryotoxic and teratogenic effects (see Toxicology under Actions). The potential risk for humans is unknown. Therefore, ivabradine is contraindicated during pregnancy.
Animal studies indicate that ivabradine is excreted in milk. Therefore, ivabradine is contraindicated in breastfeeding women.
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