Coralan心健朗

Coralan

ivabradine

Manufacturer:

Servier

Distributor:

Zuellig
/
The Glory Medicina
Concise Prescribing Info
Contents
Ivabradine
Indications/Uses
Symptomatic treatment of chronic stable angina pectoris in CAD in adults w/ normal sinus rhythm who are unable to tolerate or w/ contraindication to use of β-blockers; in combination w/ β-blockers in patients inadequately controlled w/ an optimal β-blocker dose whose heart rate is >70 bpm. Treatment of chronic heart failure (NYHA class II-IV) w/ systolic dysfunction in combination w/ standard therapy including β-blocker therapy or when β-blocker is contraindicated or not tolerated in patients in sinus rhythm & whose heart rate is ≥75 bpm.
Dosage/Direction for Use
Initially 5 mg bd for 3-4 wk, followed by up-titration to target dose 7.5 mg bd depending on the therapeutic response. Reduce dose to 2.5 mg bd if heart rate decreases to <50 bpm or symptoms of bradycardia is present.
Administration
Should be taken with food: Avoid excessive consumption of grapefruit juice.
Contraindications
Hypersensitivity. Resting heart rate <70 beats/min prior to treatment, cardiogenic shock, acute MI, severe hypotension (<90/50 mmHg), severe hepatic insufficiency, sick sinus syndrome, SA block, unstable or acute heart failure, pacemaker-dependent patient, unstable angina, 3rd degree AV-block. Concomitant w/ strong CYP3A4 inhibitors eg, azole antifungals, macrolides, HIV protease inhibitors & nefazodone; concomitant w/ verapamil or diltiazem (moderate CYP3A4 inhibitors w/ heart-rate reducing properties). Severe hepatic insufficiency. Women of childbearing potential not using appropriate contraceptive measures. Pregnancy & lactation.
Special Precautions
Atrial fibrillation, 2nd degree AV block, chronic heart failure, stroke, retinitis pigmentosa; galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption (due to lactose content). Hypotension, HTN, congenital QT syndrome, moderate hepatic impairment, CrCl <15 mL/min. Concomitant w/ verapamil or diltiazem. May affect ability to drive or operate machinery. Childn <18 yr.
Adverse Reactions
Luminous phenomena (phosphenes), headache, dizziness, blurred vision, bradycardia, 1st degree AV block, ventricular extrasystoles, uncontrolled BP.
Drug Interactions
QT-prolonging drugs. CYP3A4 inhibitors (eg, azole antifungals, macrolides, HIV-protease inhibitors, nefazodone, diltiazem & verapamil) & inducers (eg, rifampicin, barbiturates, phenytoin, St. John's wort). Grapefruit juice; K-depleting diuretics.
MIMS Class
ATC Classification
C01EB17 - ivabradine ; Belongs to the class of other cardiac preparations.
Presentation/Packing
Form
Coralan FC tab 7.5 mg
Packing/Price
56's
Form
Coralan FC tab 5 mg
Packing/Price
56's
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