Carvedilol and Ivabradine

Betablocking Agent · Beta-blocker/Sinus node II inhibitor

Indications

Carvedilol + Ivabradine is indicated as substitution therapy in adult patients with normal sinus rhythm already controlled by ivabradine and carvedilol taken concomitantly at the same dose levels for: the symptomatic treatment of chronic stable angina pectoris in coronary artery disease patients, the treatment of chronic heart failure (II-IV NYHA-class) with systolic dysfunction.

Dosage

Adults: The recommended dose of Carvedilol + Ivabradine (Carivalan) is one tablet twice daily, once in the morning and once in the evening. Carvedilol + Ivabradine (Carivalan) should only be used in patients controlled on stable doses of the individual components given concurrently when carvedilol and ivabradine are at the optimal dose. The fixed dose combination is not suitable for initiation therapy. If a change of posology is required, titration should be done with the individual components carvedilol and ivabradine, ensuring the patient is maintained at an optimal dose of carvedilol and ivabradine. It is recommended that the decision to titrate treatment takes place with the availability of serial heart measurements, ECG or ambulatory 24-hour monitoring. If during treatment, heart rate decreases below 50 beats per minute at rest or the patient experiences symptoms related to…

Adverse Effects

Postural hypotension, bradycardia, dizziness, headache, GI upset. Reduced peripheral circulation, dry eyes, angina, A-V block, ventricular extra systole, blood pressure changes, atrial fibrillation, intermittent claudication, skin reaction, hypotension, oedema, headache, visual disturbances, wt gain, asthaenia, fatigue, asthma, dyspnoea, hypercholesterolaemia. Luminous Phenomena, blurred vision.

Risk Factor (Pregnancy/Lactation)

Pregnancy: Contraindicated in pregnancy. Lactation: Contraindicated or not recommended. Contraindications: Pretreatment resting heart rate < 60 beats per minute. Persistent symptoms of bradycardia or if heart rate persistently < 50 beats per minute. Cardiogenic shock, acute MI, severe hypotension (< 90/50 mm Hg), sick sinus syndrome, sino-atrial block, unstable or acute heart failure, pacemaker dependent, unstable angina, 2nd or 3rd degree AV block, cardiac arrhythmias, asthma, COPD, bronchospasm, metabolic acidosis, phaeochromocytoma, severe hepatic impairment, immediately after stroke. Marked fluid retention or overload requiring IV inotropic support. Precautions: Mild to moderate hypotension, renal insufficiency (Cr Cl < 15 mL/min), moderate hepatic impairment. Monitor regularly for atrial fibrillation, QT syndrome or QT prolongation. Intraventricular conduction defects and…

Interactions

General anaesthetics, class I antiarrhythmics, verapamil, digoxin, rifampicin, other antihypertensives, cimetidine, clonidine, hypoglycaemics, reserpine, MAOIs, cyclosporin, diltiazem. CYP3A4 inducers and inhibitors, thiazides, loop diuretics, Ca Channel blockers, drugs that prolong the QT interval, grapefruit juice.

Advice to Patient

Take with meals to minimize the risk of orthostatic hypotension. Contact prescriber if there is unrelieved swelling of extremities, difficulty in respiration, fatigue, unusual weight gain (>5 lb per week), unrelieved constipation or diarrhoea or unusual muscle weakness. Check blood pressure and pulse regularly before taking medication. If you have diabetes, regularly check blood glucose level. Avoid excessive intake of grapefruit juice. Inform prescriber before starting the medication if any surgery is due. Change position slowly.

Pharmacokinetics

CARVEDILOL: Onset of action: Antihypertensive effect: Alpha-blockade: Within 30 min. Beta-blockade: Within 1 hr. Peak antihypertensive effect: Approx. 1-2 hrs. Absorption: Oral: Rapid and extensive; but with large first pass effect; delayed with food. Metabolism: Extensively (98%) hepatic. Bioavailability: Immediate release: Approx. 25%-35%. Extended release: Approx. 85% of immediate release. Half-life elimination: Infants and children 6 wks-3.5 yrs: 2.2 hrs. Children and Adolescents 5.5-19 yrs: 3.6 hrs. Adults 7-10 hrs: Some have reported lower values. Adults 24-37 yrs: 5.2 hrs. R(+)-carvedilol: 5-9 hrs. S(-)-carvedilol: 7-11 hrs. Time to peak, plasma: Extended release: Approx. 5 hrs. Excretion: Primarily faeces. Urine (<2%). IVABRADINE: Metabolism: Extensively intestinal and hepatic. Bioavailability: Approx. 40%. Half-life elimination: Distribution: 2 hrs. Effective: Approx. 6…

Compiled by Healify Pharmacy from published drug references. How we compile it →

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