Dipyridamole

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT DIPYRIDAMOLE

Composition:

Active substance: dipyridamole;

1 tablet contains dipyridamole 25 mg or 75 mg;

Excipients: lactose monohydrate; potato starch; magnesium stearate; talc; gelatin; dry mixture "Opadry II white" containing titanium dioxide (E 171), talc, polyethylene glycol, polyvinyl alcohol; coloring agent: for 25 mg tablets — Sepispers dry yellow R; for 75 mg tablets — Sunset Yellow FCF (E 110) Orange Yellow S.

Pharmaceutical form. Film-coated tablets.

Main physicochemical properties: film-coated tablets: 25 mg tablets — from light yellow to dark yellow in color; 75 mg tablets — from orange-pink to pink-orange in color.

Pharmacotherapeutic group. Antithrombotic agents. ATC code B01A C07.

Pharmacological properties.

Pharmacodynamics. Dipyridamole inhibits platelet aggregation and improves microcirculation, as well as has a mild vasodilating effect.

Pharmacokinetics. After oral administration, it is rapidly absorbed in the gastrointestinal tract, primarily in the stomach, with a minor part absorbed in the small intestine. Maximum blood concentration is registered within 1 hour after administration. Dipyridamole is almost completely bound to plasma proteins. It accumulates in the heart and erythrocytes. It is metabolized in the liver by conjugation with glucuronic acid. The half-life period is 20–30 minutes; dipyridamole is excreted in the form of monoglucuronide.

Clinical characteristics.

Indications. Treatment and prevention of cerebral circulation disorders of ischemic type; dyscirculatory encephalopathy; prevention of arterial and venous thrombosis, as well as their complications; prevention of thromboembolism after heart valve replacement surgery; prevention of placental insufficiency in complicated pregnancy; as part of complex therapy in any microcirculation disorders.

Contraindications. Hypersensitivity to the components of the drug. Extensive stenosing atherosclerosis of coronary arteries, acute myocardial infarction, decompensated heart failure, arterial hypotension (collapse), severe cardiac arrhythmias, unstable angina, subaortic stenosis, hemorrhagic diatheses, diseases with tendency to bleeding (peptic ulcer of stomach and duodenum).

Interaction with other medicinal products and other types of interactions. Xanthine derivatives contained in coffee or tea may reduce the drug's effect.

It should be taken into account that concomitant use of dipyridamole with anticoagulants or acetylsalicylic acid enhances the antithrombotic effect of the latter.

Dipyridamole may enhance the action of antihypertensive agents and reduce the cholinergic effect of cholinesterase inhibitors.

Dipyridamole increases adenosine concentration in blood plasma and enhances its effect on the cardiovascular system. Dose adjustment of adenosine may be necessary if concomitant use with dipyridamole cannot be avoided.

Dipyridamole may also inhibit the uptake of fludarabine and may reduce its efficacy.

When using the drug concomitantly with acetylsalicylic acid or anticoagulant agents, information regarding risks and incompatibility of these medicinal products should be taken into account.

Concomitant use with antacid agents may reduce the drug's efficacy.

Special precautions for use.

The drug should not be administered to patients with lactase deficiency, galactosemia, or glucose/galactose malabsorption syndrome.

If a patient has known intolerance to certain sugars, medical advice should be sought before taking this medicinal product.

Dipyridamole 75 mg tablets contain the colouring agent Sunset Yellow FCF (E 110) Orange Yellow S, which may cause allergic reactions.

Use during pregnancy or breastfeeding. The use of this medicinal product in pregnant women is possible only after the physician has carefully weighed the expected benefits against the potential risks.

Ability to affect reaction speed when driving or operating machinery. Even when used appropriately, dipyridamole may indirectly impair the ability to drive or operate machinery, as reactions may be altered due to a decrease in arterial blood pressure.

Dosage and Administration

For adults and children aged 12 years and older.
The recommended dose is 75–225 mg (3–9 tablets of 25 mg or 1–3 tablets of 75 mg) per day, divided into several doses. In severe diseases, the daily dose may be increased up to 600 mg.

The tablet should be taken on an empty stomach, without chewing or breaking, and swallowed with liquid, for example, one glass of water. Treatment should start with the lowest doses, which are then gradually increased. The duration of treatment and dosage are determined individually by a physician, depending on the patient's condition, disease course, and tolerability. Dipyridamole may be used for long-term therapy.

Children.
The use of dipyridamole in children under 12 years of age is not recommended due to insufficient clinical experience.

Overdose.

Symptoms: sensation of warmth, facial flushing, general weakness, dizziness, arterial hypotension, tachycardia, angina attacks.

Treatment: gastric lavage, induction of emesis, administration of sorbents.

The vasodilatory effect of dipyridamole can be reversed by intravenous administration of aminophylline (50–100 mg over 1 minute). In case of angina attacks, sublingual nitroglycerin should be administered.

Adverse Reactions.

Cardiovascular system: headache and dizziness of vascular origin, arterial hypotension, sensation of warmth and tachycardia, especially in patients taking vasodilators, worsening of ischemic heart disease manifestations such as angina, arrhythmia, myocardial infarction, skin flushing accompanied by sensation of warmth.

Gastrointestinal tract: nausea, vomiting, diarrhea, dyspepsia.

Skin and subcutaneous tissue: possible transient skin rash, urticaria.

Immune system: hypersensitivity reactions, including skin rashes, urticaria, possible severe bronchospasm and Quincke's edema.

Blood and lymphatic system: very rarely observed increased tendency to bleeding during or after surgical procedures, in individual cases thrombocytopenia developed.

Musculoskeletal and connective tissue: muscle pain.

Hepatobiliary system: dipyridamole has been found in gallbladder stones.

General disorders: general weakness.

Shelf life. 4 years.

Storage conditions. Store at a temperature not exceeding 25 °C in the original packaging.

Keep out of reach of children.

Packaging. 25 mg tablets: 50 tablets in bottles or containers; 50 tablets in a bottle or container in a carton; 10×5 in blisters in a carton; 40 in a blister.

75 mg tablets: 40 tablets in bottles or containers; 40 tablets in a bottle or container in a carton; 10×4 in blisters in a carton; 40 in a blister.

Prescription category. Prescription only.

Manufacturer.

Limited Liability Company "Experimental Plant "GNCLS".

LIMITED LIABILITY COMPANY "CORPORATION "ZDOROVIYA".

Manufacturer's location and address of business activity.

8 Vorobiova Street, Kharkiv, Kharkiv Region, Ukraine.

(Limited Liability Company "Experimental Plant "GNCLS")

22 Shevchenka Street, Kharkiv, Kharkiv Region, 61013, Ukraine.

(LIMITED LIABILITY COMPANY "CORPORATION "ZDOROVIYA")