Coralan Dosage & Drug Information

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Use In Pregnancy & Lactation Side Effects Drug Interactions Storage MIMS Class ATC Classification Regulatory Classification Presentation/Packing Brand Resources

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.

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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.

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Overdosage

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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; moderate CYP3A4 inhibitors eg, verapamil or diltiazem. Women of childbearing potential not using appropriate contraception. Pregnancy & lactation.

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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.

Use In Pregnancy & Lactation

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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).

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Storage

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Description

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Action

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MIMS Class

Anti-Anginal Drugs

ATC Classification

C01EB17 - ivabradine ; Belongs to the class of other cardiac preparations.

Regulatory Classification

POM

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

Coralan

ivabradine

Manufacturer:

Servier

Distributor:

Maxxcare