Carivalan

Carivalan

Manufacturer:

Servier

Distributor:

Maxxcare
Concise Prescribing Info
Contents
Per 6.25 mg/5 mg tab carvedilol 6.25 mg, ivabradine 5 mg. Per 6.25 mg/7.5 mg tab carvedilol 6.25 mg, ivabradine 7.5 mg. Per 12.5 mg/5 mg tab carvedilol 12.5 mg, ivabradine 5 mg. Per 12.5 mg/7.5 mg tab carvedilol 12.5 mg, ivabradine 7.5 mg. Per 25 mg/5 mg tab carvedilol 25 mg, ivabradine 5 mg
Indications/Uses
Substitution therapy in adult patients w/ normal sinus rhythm already controlled by ivabradine & carvedilol taken concomitantly at the same dose level for symptomatic chronic stable angina pectoris in CAD patients; chronic heart failure (NYHA class II-IV) w/ systolic dysfunction.
Administration
Should be taken with food: Avoid taking w/ grapefruit juice.
Contraindications
Hypersensitivity to carvedilol, ivabradine or other β-blockers. Heart failure (uncontrolled or worsening); unstable angina; Prinzmetal's angina; heart rhythm disorder; low heart rate (<50 beats/min), symptomatic or severe bradycardia; heart attack; cardiogenic shock; severe blood vessel disorder (eg, Raynaud's phenomenon); very low BP; COPD; history of breathing problems eg, asthma or bronchospasm; metabolic acidosis; untreated phaeochromocytoma. Patient whose heartbeat is exclusively regulated by a pacemaker. Concomitant use w/ antifungals (eg, ketoconazole, itraconazole), antibiotics (eg, clarithromycin, erythromycin (oral), josamycin & telithromycin), PIs (eg, nelfinavir, ritonavir), nefazodone, diltiazem or verapamil; other antihypertensives or antianginal drugs. Severe liver problems. Pregnancy & lactation.
Special Precautions
Do not stop treatment abruptly. History of hypersensitivity or patient undergoing desensitisation therapy. Patients w/ heart rhythm disorders, sustained atrial fibrillation or long QT syndrome; severe heart failure or heart failure w/ bundle branch block; symptoms of atrial fibrillation; uncontrolled BP; kidney problems; recent stroke (cerebral attack); conditions impacting or reducing blood flow; chronic eye retinal disease or deteriorating eyesight; diabetes; overactive thyroid gland; psoriasis. Patients undergoing cardioversion; surgery requiring general anaesth. Contact lens use. Concomitant use w/ α1-antagonist or α2-agonist. Not to be taken by patients w/ hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. May affect ability to drive or use machines. Women of childbearing potential not using reliable contraception. Childn & adolescent <18 yr.
Adverse Reactions
Luminous visual phenomena; headache; dizziness; heart failure; low BP, generalised weakness, feeling of tiredness. Lung/chest & upper resp tract infection; UTI; decreased RBCs; increased blood cholesterol levels; increased blood sugar levels, loss of blood sugar control in diabetes; wt gain; depression; decreased lacrimation, impaired/blurred vision, eye irritation; fluid retention; fluid build-up in lungs; slow heart rate; irregular heartbeats; irregular rapid heart contraction; feeling dizzy, lightheaded or faint when standing or sitting quickly; blood circulation problems; uncontrolled BP; shortness of breath, asthma; nausea, stomach pain, indigestion, diarrhoea, vomiting; pain in extremities; gout; kidney problems eg, urination problems; pain.
Drug Interactions
Fluconazole; rifampicin; QT prolonging medicines eg, quinidine, disopyramide, sotalol, ibutilide, amiodarone, bepridil, pimozide, ziprasidone, sertindole, mefloquine & halofantrine, IV erythromycin, pentamidine, cisapride; clonidine; dihydropyridines; diuretics eg, furosemide, hydrochlorothiazide, indapamide; other antihypertensives; nitrates; sympathomimetics eg, epinephrine & β2-agonists; class IA & IC IV antiarrhythmics; barbiturates; phenytoin; cimetidine; fluoxetine; Hypericum perforatum or St. John's wort; reserpine, guanethidine, methyldopa, guanfacine & MAOIs; digoxin & digitoxin; cyclosporin; insulin & antidiabetic agents; muscle relaxants used in anaesth; β-agonist bronchodilators; NSAIDs/antirheumatic agents; oestrogens; corticosteroids; ergotamine; other β-blockers (as eye drops).
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.
Presentation/Packing
Form
Carivalan FC tab 12.5 mg/5 mg
Packing/Price
14's;56's
Form
Carivalan FC tab 12.5 mg/7.5 mg
Packing/Price
14's;56's
Form
Carivalan FC tab 25 mg/5 mg
Packing/Price
14's;56's
Form
Carivalan FC tab 6.25 mg/5 mg
Packing/Price
14's;56's
Form
Carivalan FC tab 6.25 mg/7.5 mg
Packing/Price
14's;56's
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