Cardual 10 tablet: Each coated tablet contains Amlodipine 5mg as Besilate BP and Atorvastatin 10mg as Calcium INN.
Cardual ® is a combination preparation of Amlodipine & Atorvastatin. Amlodipine is a calcium channel blocker of dihydropyridine group having long duration of action. The contractile processes of cardiac muscle and vascular smooth muscle are dependent upon the movement of practical extracellular calcium ions into these cells through specific ion channels. Amlodipine inhibits calcium ion influx across cell membranes selectively, with a greater effect on vascular smooth muscle cells than on cardiac muscle cells. Thus, Amlodipine acts as a peripheral arterial vasodilator that causes a reduction in peripheral vascular resistance and reduction in blood pressure. In angina, Amlodipine reduces the total peripheral resistance (afterload) against which the heart works and reduces the rate pressure product, and thus myocardial oxygen demand, at any given level of exercise. Atorvastatin is a synthetic lipid-lowering agent. Atorvastatin inhibits 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase & stops cholesterol synthesis in the liver and by increasing the number of hepatic LDL receptors on the cell-surface to enhance uptake and catabolism of LDL. Atorvastatin reduces total-C, LDL-C, VLDL-C, apo B, TG, and non-HDL-C, and increases HDL-C.
The recommended starting dose of Cardual® should be based on the appropriate combination of recommendations for the monotherapies.
For adult Dosage of Cardual® must be individualized on the basis of both effectiveness and tolerance for each individual component in the treatment of hypertension/angina and hyperlipidemia.
Amlodipine: The recommended initial dose of amlodipine for patient with hypertension, chronic stable or vasospastic angina, coronary artery disease is 5mg once daily with a maximum dose of 10 mg once daily. Elderly individuals, or patients with hepatic insufficiency may be started on 2.5 mg once daily and this dose may be used when adding Amlodipine to other antihypertensive therapy.
Atorvastatin: Adults: The patient should be placed on a standard cholesterol-lowering diet before receiving Atorvastatin and should continue on this diet during treatment with Atorvastatin Hypercholesterolemia (Heterozygous Familial and Nonfamilial) and Mixed Dyslipidemia (Fredrickson Types IIa and IIb): The recommended starting dose of Atorvastatin is 10 mg daily. The dosage range is 10 to 80 mg once daily. Atorvastatin can be administered as a single dose at any time of the day with or without food. Homozygous Familial Hypercholesterolemia: The dosage of Atorvastatin in patients with homozygous FH is 10 to 80 mg daily. Patients with renal insufficiency: Renal disease has no influence on the plasma concentrations or lipid effects of Atorvastatin; thus no adjustment of dose is required.
Strong CYP3A4 inhibitors (itraconazole, clarithromycin) increase both amlodipine and atorvastatin exposure; gemfibrozil, fibrates, and cyclosporine increase rhabdomyolysis risk; simvastatin dose should not exceed 20 mg; CYP3A inducers (rifampin) decrease efficacy of both agents.
This combination contains atorvastatin and is therefore contraindicated in patients with active liver disease or unexplained persistent elevations of serum transaminases. It is also contraindicated in patients with known hypersensitivity to any component of this medication.
Common: Headache, edema, fatigue, flushing, dizziness, constipation, flatulence, dyspepsia, abdominal pain, nausea.
Overdose
There is no well-documented experience with Amlodipine overdosage. Since Amlodipine absorption is slow, gastric lavage may be worthwhile in some cases. Gross overdosage could result in excessive peripheral vasodilatation with subsequent marked and probably prolonged systemic hypotension. There is no specific treatment for atorvastatin overdosage
Category X (Contraindicated). Atorvastatin is contraindicated during pregnancy due to fetal risk; amlodipine can impair fetal perfusion. Lactation: Contraindicated during lactation.
Store below 30°C in a cool, dry place. Protect from light and moisture. Keep out of reach of children.