Coralan Contraindications





Full Prescribing Info
Hypersensitivity to ivabradine or to any excipients of Coralan (see Description); resting heart rate <60 bpm prior to treatment; cardiogenic shock; acute MI; severe hypotension (<90/50 mmHg); severe hepatic insufficiency; sick sinus syndrome; sino-atrial block; unstable or acute heart failure; pacemaker dependent (heart rate imposed exclusively by the pacemaker); unstable angina; AV-block of 3rd degree.
Combination with strong cytochrome P-450 3A4 inhibitors eg, azole antifungals (ketoconazole, itraconazole), macrolide antibiotics (clarithromycin, oral erythromycin, josamycin, telithromycin), HIV protease inhibitors (nelfinavir, ritonavir) and nefazodone (see Pharmacology: Pharmacokinetics under Actions, and Interactions), Combination with verapamil or diltiazem which are moderate CYP3A4 inhibitors with heart rate reducing properties, Pregnancy, lactation and women of child-bearing potential not using appropriate contraceptive measures.
Use in Pregnancy: There are no or limited amount of data from the use of ivabradine in pregnant women. Studies in animals have shown reproductive toxicity. These studies have shown embryotoxic and teratogenic effects (see Toxicology under Actions). The potential risk for humans is unknown. Therefore, ivabradine is contraindicated during pregnancy.
Use in Lactation: Animal studies indicate that ivabradine is excreted in milk. Therefore, ivabradine is contraindicated during breastfeeding.
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