International generic name
Drug form and composition
Tablets. One tablet contains 60 mg Diltiazem hydrochloride.
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.
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
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.
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.
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.
50 tablets of 60 mg.