Coralan

Coralan

ivabradine

Manufacturer:

Servier

Distributor:

Maxxcare
Concise Prescribing Info
Contents
Ivabradine HCl
Indications/Uses
CAD. Symptomatic treatment of chronic stable angina pectoris in CAD patients w/ normal sinus rhythm when β-blockers are not suitable. In combination w/ β-blockers in patients inadequately controlled w/ an optimal β-blocker dose whose heart rate is >60 beats/min (bpm). CHF. Reduction of CV events (CV mortality or hospitalization for worsening heart failure) in adults in sinus rhythm w/ symptomatic chronic heart failure & w/ heart rate ≥70 bpm.
Dosage/Direction for Use
CAD Initially 5 mg bd, may be increased to 7.5 mg bd after 3-4 wk. CHF Initially 5 mg bd, may be increased to 7.5 mg bd after 2 wk. Titrate dose downward if heart rate <50 bpm persists. Elderly ≥75 yr Initially 2.5 mg bd.
Administration
Should be taken with food: Take during meals. Avoid grapefruit juice.
Contraindications
Hypersensitivity. Resting heart rate <60 bpm 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, unstable angina, 3rd-degree AV block. Concomitant strong CYP3A4 inhibitors eg, azole antifungals, macrolides, HIV PIs, nefazodone. Pregnancy & lactation.
Special Precautions
Atrial fibrillation or other cardiac arrhythmias, heart rate <50 bpm, NYHA class IV, 2nd-degree AV block, bradycardia, stroke, retinitis pigmentosa, mild to moderate hypotension, congenital QT syndrome, moderate hepatic insufficiency, severe renal insufficiency, galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption as it contains lactose. Childn <18 yr.
Adverse Reactions
Headache, dizziness; luminous phenomena (phosphenes); blurred vision; bradycardia, 1st-degree AV block, ventricular extrasystoles; uncontrolled BP, eosinophilia, hyperuricaemia, syncope, diplopia, visual impairment, vertigo, palpitations, supraventricular extrasystoles, hypotension, dyspnoea, nausea, constipation, diarrhoea, abdominal pain, angioedema, rash, muscle cramps, asthenia, fatigue, elevated creatinine in blood, ECG prolonged QT interval, erythema, pruritus, urticaria, malaise, atrial fibrillation, AV 2nd- & 3rd-degree block, sick sinus syndrome.
Drug Interactions
Concomitant use not recommended: QT-prolonging drugs eg, quinidine, disopyramide, bepridil, sotalol, ibutilide, amiodarone, pimozide, ziprasidone, sertindole, mefloquine, halofantrine, pentamidine, cisapride, erythromycin IV; moderate CYP3A4 inhibitors eg, diltiazem or verapamil. Concomitant use w/ precaution: K-depleting diuretics (eg, thiazide & loop diuretics), moderate CYP3A4 inhibitors eg, fluconazole & inducers (eg, rifampicin, barbiturates, phenytoin, St. John's wort; grapefruit juice. Concomitant use contraindicated: Potent CYP3A4 inhibitors eg, azole antifungals, macrolides, HIV PIs, nefazodone).
MIMS Class
ATC Classification
C01EB17 - ivabradine ; Belongs to the class of other cardiac preparations.
Presentation/Packing
Form
Coralan FC tab 5 mg
Packing/Price
4 × 14's
Form
Coralan FC tab 7.5 mg
Packing/Price
4 × 14's
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