International generic name

Dipyridamole

Drug form and composition

Coated tablets. One coated tablet contains 25 mg Dipyridamole (as 100%).

Indications

Dipyridamole is used mainly as a platelet antiaggregant in patients with: cerebrovascular disease (in order to reduce the risk of stroke); coronary heart disease and myocardial infarction survivers; cardiovascular surgery (valve replacement, aortocoronary bypass operation, etc.).

Dosage and administration

The recommended therapeutic antiaggregant dose for primary and secondary prevention of the coronary heart disease and cerebrovascular disease is 50-75 mg, 3 times a day. In combined treatment with 325 mg aspirin, the dosage of dipyridamole is reduced up to 25-50 mg, 3 times a day. Duration of the treatment should be 7-12 mounts and more. Coated tablets should be taken 1 hour before or two hours after meal with some liquid. In prevention of thromboembolic complications after valve replacement dipyridamole is used in dose 75-100 mg, 4 times daily, in combination with anticoagulant therapy. In prevention of thrombosis in aortocoronary bypass operation the medicine is used in dose 100 mg 4 times daily, 2 days before surgery. After that Antistenocardin is applied as follows: 100 mg, 1 hour after surgery; 75 mg, combined with 325 mg aspirin, 7 hours after surgery; after that - 75 mg, 3 times a day, combined with 325 mg aspirin. As a monotherapy (without aspirin) in prevention of thromboembolic complications Antistenocardin is applied 7 days after surgery.

Contraindications

Hypersensitivity to dipyridamole and generalised sclerosis of the coronaries.

Special warnings and precautions

Antistenocardin should be given with caution in patients treated with heparin or oral anticoagulant drugs; patients with ulcer disease; congenital or hereditary diseases of the clotting system. The preparation should be applied with special care in patients with stable angina pectoris and evident stenoses of the coronaries, as a risk of “steal syndrome” inducing, manifested with angina pectoris and ECG-changes, exists. Antistenocardin should be used with care in persons with arterial hypertension, unstable blood pressure, and renal diseases (monitoring of the renal function is necessary). In long-term application of Antistenocardin hemostasis and clotting variables should be monitored. The preparation should not be administrated in pregnant and nursing women. If it is necessary, dipyridamole is used under a close physician control.

Drug interactions

Xantine derivatives (novphylline) may reduce the effect of Antistenocardin, so they should be avoided during the treatment with Antistenocardin. In concomitant treatment with heparin the risk of hemorrhages is enhanced. Antistenocardin elevates the maximal serum concentration and toxicity of aspirin. Antistenocardin potentiates the effect of nitrates, enhances cell concentration of doxorubicine and vinblastine, potentiates effects of adenosine, enhances metotrexate toxicity, and potentiates hypotensive effect of the calcium channel blockers.

Adverse reactions

In therapeutic doses adverse reactions are mild and transitory. Nausea, vomiting, dizziness, and headache were seen. In most cases these reactions resolve in long-term treatment. Due to its vasodilator capabilities in high doses Antistenocardin may cause hypotension and ECG-changes. Hypersensitivity reactions, such as itching and rash, may appear.

Pharmacological mechanisms

Antistenocardin belongs both to platelet antiaggregants and anti-angina pectoris preparations. The mechanism of its dilatative action on the coronary arteries is based on the adenosine accumulation in myocardium, resulting from blocking of adenosine deaminase and reducing adenosine infux in the cells. Adenosine is an endogene coronary artery dilating agent. It blocks phosphodiesterase, which leads to abrupt elevation of the cAMP level in the coronary arteries with consequent relaxation. Antistenocardin activates synthesis of prostacyclin - a powerful endogene vasodilator and platelet antiaggregant. Antistenocardin, in contrast to nitrates and calcium antagonists, exerts a vasodilatating action on the small coronary vessels, reducing pressure gradient between the proximal and distal stenosis portions of the vessel. Antithrombotic action of the preparation is based on the possibility to modify some aspects of the platelet function, for example, to inhibit platelet adhesion and aggregation. This influences the formation of the thrombus (clotting) and shortens platelet’s survival.

Supplied

60 or 1200 coated tablets of 25 mg.

Expiry

5 years