Dipyridamole (Tablets, Suspension) Instructions for Use

ATC Code

B01AC07 (Dipyridamole)

Active Substance

Dipyridamole (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Antiplatelet agent. Myotropic vasodilator

Pharmacotherapeutic Group

Vasodilating agent

Pharmacological Action

Dipyridamole dilates coronary vessels (mainly arterioles) and causes a significant increase in the volumetric blood flow rate.

It increases the oxygen content in the venous blood of the coronary sinus and its uptake by the myocardium.

It promotes the development of collateral coronary circulation, reduces total peripheral vascular resistance, improves microcirculation, and has an angioprotective effect.

These effects are due to the enhancement of endogenous adenosine activity by reducing its uptake by tissues and destruction (adenosine affects vascular smooth muscle and prevents the release of norepinephrine).

It is an antagonist of the endogenous aggregant adenosine diphosphate (ADP), inhibits phosphodiesterase, thereby reducing the release of aggregation activators from platelets – thromboxane, ADP, serotonin, etc., increases the synthesis of prostacyclin PgI2 by the vascular tissue endothelium, which prevents platelet aggregation.

It reduces platelet adhesiveness, prevents thrombus formation in vessels and reduces blood flow in the focus of ischemia.

The antiplatelet effect occurs at a plasma concentration of 0.1 µg/ml, dose-dependently prolongs the pathologically shortened platelet lifespan.

It dilates coronary arteries, especially unchanged ones, causes the steal phenomenon.

It is an interferon inducer, has a modulating effect on the functional activity of the interferon system, increases the reduced production of interferon alpha and gamma by blood leukocytes in vitro.

It increases nonspecific antiviral resistance to viral infections.

It normalizes venous outflow, reduces the frequency of deep vein thrombosis in the postoperative period.

It improves microcirculation in the retina and renal glomeruli.

It reduces the tone of cerebral vessels and is effective in dynamic disorders of cerebral circulation.

Pharmacokinetics

After oral administration, it is rapidly absorbed in the stomach (most) and small intestine.

Bioavailability is 37-66%.

C_max in blood plasma is observed 0.5-1 h after taking the drug.

Binding to plasma proteins is 80-95%.

It rapidly penetrates into tissues.

It accumulates in large quantities in the heart and red blood cells, is secreted into breast milk, about 6% of the plasma concentration.

It is metabolized in the liver to form a monoglucuronide, which is excreted in the bile (20% of the drug is included in the enterohepatic circulation).

T_1/2 – 20-30 min in the first phase, in the second phase – about 10 h.

Cumulation is possible (mainly in patients with impaired liver function).

Indications

• Treatment and prevention of cerebral circulation disorders of the ischemic type, dyscirculatory encephalopathy;
• Prevention of arterial and venous thrombosis and their complications, prevention of thromboembolism after heart valve replacement surgery;
• As part of complex therapy for any microcirculation disorders;
• As an interferon inducer and immunomodulator for the prevention of influenza, acute respiratory viral infections (ARVI).

ICD codes

Dosage Regimen

Suspension

Orally. Shake before use!

Take 1 hour before meals. The dosage regimen is set by the doctor individually depending on the severity of the disease and the patient’s response to treatment.

Unless otherwise prescribed by a doctor, the following dosage regimens are recommended: To reduce platelet aggregation, it is recommended to use Dipyridamole at a dose of 300 mg/day in several doses (2 teaspoons (100 mg) 3 times a day). In severe cases, the dose can be increased to 600 mg/day.

For the prevention of influenza and other ARVI, especially during epidemics, take Dipyridamole according to the following scheme: 50 mg (1 teaspoon) per day once every 7 days for 4-5 weeks.

For the prevention of relapses in patients who frequently suffer from respiratory viral infections, Dipyridamole is recommended according to the scheme: 100 mg (2 teaspoons) 2 times a day once a week for 8-10 weeks.

Tablets

Orally.

Single dose – 25-75 mg/day.

The frequency of administration and duration of use are set depending on the indications and treatment regimen.

Adverse Reactions

When using therapeutic doses, side effects are usually not pronounced and are transient, usually disappearing with longer use of the drug.

Side effects are listed below in descending order of frequency: common (1-10% of patients), uncommon (0.1-1% of patients), rare (0.01-0.1% of patients), very rare (less than 0.01% of patients), including individual reports.

From the cardiovascular system uncommon: palpitations, tachycardia, bradycardia, facial flushing, coronary steal syndrome (when using doses of more than 225 mg/day), decreased blood pressure;

From the digestive system uncommon: nausea, vomiting, diarrhea, epigastric pain;

From the blood and hemostasis system uncommon: thrombocytopenia, changes in the functional properties of platelets; rare: bleeding; very rare: increased bleeding;

Other weakness, dizziness, feeling of ear congestion, tinnitus, headache, facial skin hyperemia, arthritis, myalgia, rhinitis, allergic reactions (rash, urticaria, severe bronchospasm, angioedema), during surgical interventions in rare cases, increased bleeding during or after surgery.

If any of the side effects listed in the instructions worsen, or you notice any other side effects not listed in the instructions, inform your doctor.

Contraindications

• Hypersensitivity to the components of the drug;
• Acute myocardial infarction, unstable angina, widespread stenosing atherosclerosis of the coronary arteries, hypertrophic obstructive cardiomyopathy;
• Subvalvular aortic stenosis;
• Decompensated chronic heart failure;
• Arterial hypotension, collapse;
• Severe arterial hypertension;
• Severe arrhythmias;
• Hemorrhagic diathesis;
• Diseases with a tendency to bleeding (including gastric and duodenal ulcers);
• Chronic obstructive pulmonary disease (COPD);
• Hepatic and/or renal failure;
• Age under 18 years.

With caution. Coronary artery disease, including unstable angina and/or recent myocardial infarction, blood clotting disorders. If you have one of the listed diseases, be sure to consult your doctor before taking the drug. Use during pregnancy and breastfeeding: Dipyridamole can be prescribed during pregnancy and breastfeeding only if the expected benefit of therapy for the mother outweighs the potential risk to the fetus and child. Dipyridamole is secreted into breast milk in an amount of about 6% of the plasma concentration, therefore, during lactation, it is prescribed only in cases of absolute necessity.

Use in Pregnancy and Lactation

Dipyridamole can be prescribed during pregnancy and breastfeeding only if the expected benefit of therapy for the mother outweighs the potential risk to the fetus and child. Dipyridamole is secreted into breast milk in an amount of about 6% of the plasma concentration, therefore, during lactation, it is prescribed only in cases of absolute necessity.

Use in Hepatic Impairment

Contraindicated: hepatic failure.

Use in Renal Impairment

Contraindicated: renal failure.

Pediatric Use

Contraindicated in children under 18 years of age.

Special Precautions

In patients with severe myasthenia gravis, after prescribing dipyridamole, dose adjustment of the drugs used in complex therapy is necessary.

Patients constantly taking Dipyridamole orally should not be additionally prescribed it intravenously. If it is necessary to perform an intravenous dipyridamole stress test for the diagnosis of coronary artery diseases, oral administration of the drug must be discontinued 24 hours before the procedure.

Effect on the ability to drive vehicles and mechanisms

Due to possible dizziness, weakness and decreased blood pressure during the period of taking dipyridamole, the ability to concentrate and the speed of psychomotor reactions in patients may decrease. Therefore, during the period of treatment with the drug, caution should be exercised when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Overdose

Symptoms vasodilation, which is accompanied by decreased blood pressure, angina pectoris, tachycardia, weakness, dizziness, facial redness.

Treatment Symptomatic therapy.

In case of overdose, it is necessary to induce vomiting and perform gastric lavage. The dilating effect of the drug can be stopped by slow intravenous administration of aminophylline (50-100 mg over 60 seconds). For angina pectoris, take nitroglycerin sublingually.

Drug Interactions

With simultaneous use with anticoagulants (heparin, thrombolytics) or acetylsalicylic acid, the risk of hemorrhagic complications increases.

Taking antacids, xanthine derivatives (caffeine, theophylline) may lead to a decrease in the effectiveness of dipyridamole.

Dipyridamole may enhance the hypotensive effect of agents that lower blood pressure.

Dipyridamole may weaken the anticholinergic properties of cholinesterase inhibitors. The antiplatelet effect is enhanced when taking cephalosporin antibiotics (cefamandole, cefoperazone, cefotetan).

Storage Conditions

Store at a temperature not exceeding 25°C (77°F). Keep out of the reach of children.

Shelf Life

Shelf life. 2 years. The drug should not be used after the expiration date printed on the package.

Dispensing Status

The drug is dispensed by prescription.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.