Concise Prescribing Info
Per 6.25 mg/5 mg FC tab Carvedilol 6.25 mg, ivabradine HCl 5 mg. Per 12.5 mg/5 mg FC tab Carvedilol 12.5 mg, ivabradine HCl 5 mg. Per 25 mg/5 mg FC tab Carvedilol 25 mg, ivabradine HCl 5 mg
Substitution therapy in adult w/ normal sinus rhythm already controlled by ivabradine & carvedilol taken concomitantly at the same dose levels for the symptomatic treatment of chronic stable angina pectoris in CAD patients; treatment of chronic heart failure (II-IV NYHA class) w/ systolic dysfunction.
Dosage/Direction for Use
Should be taken with food.
Hypersensitivity. Acute or unstable/decompensated heart failure, unstable angina, Prinzmetal's angina, AV-block of 2nd & 3rd degree, sick sinus syndrome (including SA block), symptomatic or severe bradycardia (<50 bpm), acute MI, cardiogenic shock, pacemaker dependent (heart rate imposed exclusively by the pacemaker), severe peripheral vascular disease (eg, Raynaud's phenomenon), severe hypotension (systolic arterial BP <90 mmHg, diastolic arterial BP <50 mmHg), COPD associated w/ bronchial obstruction, history of bronchospasm or asthma, metabolic acidosis, untreated pheochromocytoma. Combination w/ verapamil or diltiazem, strong cytochrome P450 3A4 inhibitors eg, azole antifungals (eg, ketoconazole, itraconazole), macrolide antibiotics (eg, clarithromycin, erythromycin per os, josamycin, telithromycin), HIV PIs (eg, nelfinavir, ritonavir) & nefazodone. Severe hepatic impairment. Women of child-bearing potential not using appropriate contraceptive measures. Pregnancy & lactation.
Special Precautions
History of serious hypersensitivity reactions & in those undergoing desensitization therapy as β-blockers. Not suitable for initiation therapy. Discontinue treatment if heart rate remains <50 bpm or symptoms of bradycardia persist despite dose reduction. Do not initiate in patients w/ a pretreatment resting heart rate <50 bpm. Not recommended in patients w/ atrial fibrillation or other cardiac arrhythmias that interfere w/ sinus node function. Not recommended in heart failure patients w/ NYHA functional classification IV; immediately after a stroke. Contraindicated w/ concomitant use w/ Ca channel blockers. Concomitant use w/ digitalis glycosides; QT prolonging medicinal products; anesth. Avoid abrupt cessation of therapy. Patients w/ congenital QT syndrome, HTN requiring BP treatment modifications, DM, peripheral vascular disease, thyrotoxicosis/hyperthyroidism. Wearing of contact lenses. Psoriasis. Avoid in patients w/ Lapp lactase deficiency or glucose-galactose malabsorption. May impair ability to drive or operate machinery. Monitor renal function in chronic heart failure patients w/ SBP <100 mmHg. Renal impairment CrCl <15 mL/min. Moderate hepatic impairment. Women of child-bearing potential should use appropriate contraceptive measures during treatment. Elderly. Childn & adolescents. Ivabradine: Lack of benefit on CV outcomes (eg, MI or CV death). Consider serial heart rate measurements, ECG or ambulatory 24-hr monitoring when determining resting heart rate when titration is considered. Not effective in the treatment or prevention of cardiac arrhythmias. Monitor for the occurrence of atrial fibrillation (sustained or paroxysmal) including ECG monitoring. Retinitis pigmentosa. Consider cessation of treatment if any unexpected deterioration in visual function occurs. Mild to moderate hypotension. Carvedilol: Reversible deterioration of renal function in chronic heart failure patients w/ low arterial BP (SBP < 100 mmHg), ischemic heart disease & diffuse vascular disease, &/or underlying renal insufficiency. Pheochromocytoma. Do not administer to patients w/ labile or secondary HTN, orthostatic hypotension, acute myocarditis, a hemodynamically relevant stenosis of the heart valves or ventricular outflow tract, end-stage peripheral arterial disease or who are concomitantly receiving an α1-receptor antagonist or α2-receptor agonist.
Adverse Reactions
Headache, dizziness; bradycardia. Ivabradine: Luminous phenomena (phosphenes). Blurred vision; 1st degree AV block, ventricular extrasystoles, atrial fibrillation; uncontrolled BP. Carvedilol: Heart failure; hypotension; asthenia, fatigue. Bronchitis, pneumonia, upper resp tract infection; anemia; hypercholesterolemia, deterioration in glycemic control in patients w/ preexisting diabetes; DM; depressive mood, depression; reduced lacrimation; visual impairment, eye irritation; pulmonary edema; postural hypotension, peripheral circulation disturbances; dyspnea, asthma in predisposed patients; nausea; diarrhea, abdominal pain, vomiting; pain in extremities, gout; renal failure & renal function abnormality in patients w/ diffuse vascular disease &/or underlying renal insufficiency, micturition disorders; pain, wt gain.
Drug Interactions
Ivabradine: Increased plasma conc w/ potent CYP3A4 inhibitors (eg, ketoconazole, itraconazole, clarithromycin, erythromycin per os, josamycin, telithromycin, nelfinavir, ritonavir, & nefazodone). Decreased plasma conc w/ CYPA 3A4 inducers. Increased exposure w/ & additional heart rate reduction of 5 bpm w/ diltiazem, verapamil. Increased risk of AV conduction disturbances w/ diltiazem & verapamil; grapefruit juice. Exacerbated QT prolongation w/ quinidine, disopyramide, bepridil, sotalol, ibutilide & amiodarone; pimozide, ziprasidone, sertindole, mefloquine, halofantrine, pentamidine, cisapride, IV erythromycin. Concomitant use w/ fluconazole. Decreased exposure w/ Hypericum perforatum (St John's Wort). Risk of severe arrhythmias w/ K-depleting diuretics (thiazide & loop diuretics). Carvedilol: Concomitant treatment w/ CYP 450 inhibitors (eg, cimetidine, fluoxetine, verapamil, ketoconazole, haloperidol, erythromycin). Potential increased β-blockade w/ quinidine, disopyramide, bepridil, sotalol, ibutilide & amiodarone; pimozide, ziprasidone, sertindole, mefloquine, halofantrine, pentamidine, cisapride, IV erythromycin. Risk of heart failure w/ IV class Ia or Ic antiarrhythmic agents. Reduced plasma conc w/ rifampicin. Increased AUC w/ cimetidine. Increased conc of digoxin & digitoxin; cyclosporine. Enhanced blood glucose-lowering effects of insulin & oral anti-diabetic medicines. Concomitant use w/ Catecholamine-depleting agents (eg, reserpine, guanethidine, methyldopa, guanfacine & MAOIs). May potentiate BP & heart rate lowering effects w/ clonidine. Reports of heart failure & severe hypotension w/ dihydropyridine. Synergistic, negative, inotropic & hypotensive effects w/ anesth. Antagonized bronchodilatory effects of β-agonist bronchodilators. May potentiate antihypertensive effects of α1-receptor antagonists. Increased BP & ability to control BP w/ NSAIDs. Reduced antihypertensive activity w/ estrogen & corticosteroids. Increased hypotensive effect w/ nitrates. Increased risk of hypotension & excessive bradycardia w/ sympathomimetics w/ α-mimetic & β-mimetic effects. Increased vasoconstriction w/ ergotamine. Increased neuromuscular block w/ neuromuscular blocking agents. Increased adverse effects w/ β-blockers in the form of eye drops. Reduced efficacy w/ barbiturates.
MIMS Class
Anti-Anginal Drugs / Beta-Blockers
ATC Classification
C07FX06 - carvedilol and ivabradine ; Belongs to the class of beta-blocking agents in combination with other cardiac drugs. Used in the treatment of cardiovascular diseases.
Carivalan FC tab 12.5 mg/5 mg
Carivalan FC tab 25 mg/5 mg
Carivalan FC tab 6.25 mg/5 mg
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