International generic name Diltiazem
Drug form and composition Tablets. One tablet contains 60 mg Diltiazem hydrochloride.
Indications Diltiazem is indicated in patients with stable and unstable angina pectoris; vasospastic angina pectoris (Prinzmetal); supraventricular tachyarrhythmias. System hypertension - as a monotherapy or in combination with other antihypertensive medicines.
Dosage and administration The preparation is used orally in dose 30-60 mg (1/2 - 1 tablet), 3-4 times daily. The dose may be gradually enhanced during the next 1-2 dais until the sufficient effect is achieved.
Contraindications Hypersensitivity to the preparation; acute myocardial infarction; atrioventricular conduction disorders (2-nd and 3-rd degree AV block); bradycardia; sick sinus syndrome; hypotension; severe hepatal diseases; pregnancy and nursing.
Special warnings and precautions The preparation should be used with care in patients with mild conduction defects (SA-block and 1-st degree AV-block), as well as in interventricular conduction disturbances. In adult patients and patients with severe liver and renal dysfunction the dosage of Diltiazem should be carefully appreciated. The patients in which the preparation causes headache, dizziness, and insomnia should drive and operate machinery with particular care.
Drug interactions Concomitant use of cimetidin and ranitidin leads to elevation of the plasma concentration of Diltiazem. Diltiazem potentiates the immunosupressive effect of the cyclophosphamide and elevates the serum level of digoxin (by 20 - 45%), ciclosporin A and carbamazepine. In combined treatment with β-adrenoreceptor blocking agents and antiarrhythmic medicines hypotension and heart failure may appear.
Adverse reactions Headache, dizziness, and weakness; bradycardia and hypotension; itching, and rash. Rarely gastrointestinal disorders may appear - nausea, vomiting, pyrosis, diarrhea or constipation. In high dosage perimaleolar swelling, elevation of the serum level of transaminases, bilirubin and alkal phosphatase may appear.
Pharmacological mechanisms Diltiazem is a high-specificity synthetic calcium channel blocker. The Diltiazem action is mainly due to reduction of the calcium-dependent contraction of the myocardium and to reduction of the oxygen and phosphate utilization; coronary artery relaxation; suppression of the SA-node activity and AV-node conduction. Diltiazem reduces the oxygen requirements of the cardiac muscle by two mechanisms: direct - influence the energy consuming metabolite processes in the cardiac muscle cells; and indirect - reduces the peripheral resistance, which causes additional reduction of the heart load. All described effects lead to a reduction of the coronary artery resistance; reduction of the intensity of heart muscle perfusion; prevention of the coronary artery spasm; reduction of the blood pressure and the heart rate. The preparation does not cause reflectory tachycardia. The favorable effect of Diltiazem on the atherogenesis process is due to its cytoprotective action on the vascular wall; inhibition of the thrombocytes aggregation and secretion; activation of the intracellular destruction of cholesterol.
Supplied 50 tablets of 60 mg.
Expiry 3 years. |