Active substanceDipyridamoleDipyridamole
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  • Dosage form: & nbspfilm-coated tablets
    Composition:

    For 1 tablet:

    Core:

    Active substance: dipyridamole 25.00 mg.

    Excipients: corn starch - 67.750 mg lactose monohydrate - 28,500 mg, gelatin - 2.500 mg sodium carboxymethylstarch (type A) - 3,750 mg colloidal anhydrous silica - 1.250 mg of magnesium stearate - 1,250 mg.

    Shell: Hypromellose - 0,900 mg talc - 0.400 mg macrogol 6000 - 0.120 mg titanium dioxide (E 171) - 0.100 mg dye quinoline yellow (E 104) - 0.008 mg Simethicone emulsion - 0.002 mg.

    Description:

    Round tablets ploskotsilindricheskoy form, film-coated, yellow.

    Pharmacotherapeutic group:Vasodilator
    ATX: & nbsp

    B.01.A.C.07   Dipyridamole

    Pharmacodynamics:

    Dipiridamole inhibits aggregation and adhesion of platelets, improves microcirculation, has a mild vasodilating effect. The mechanism by which dipyridamole has a retarding effect on the aggregation of platelets, is associated with suppression of adenosine reuptake (platelet reactivity inhibitor) by endothelial cells, erythrocytes and platelets; activation of adenylate cyclase and inhibition of platelet phosphodiesterases. In this way, dipyridamole prevents the release of platelets aggregation activators - thromboxane (ThA2), ADP, serotonin, and others. Dipyridamole increases the synthesis of prostacyclin PgI2 endothelium of the vascular wall, normalizes the ratio PgI2 and ТхА2, preventing the aggregation of platelets; enhances the synthesis of endothelial nitric oxide (NABOUT). Dipiridamol reduces the adhesiveness of platelets, prevents the formation of blood clots in the vessels and stabilizes the blood flow in the source of ischemia.

    Dipiridamole dose-dependent extends the pathologically shortened life time of platelets.

    Dipiridamole, due to its vasodilating properties, contributes to a reduction in overall peripheral vascular resistance, improves microcirculation,has an angioprotective effect. These effects are due to the increased activity of endogenous adenosine (adenosine affects the smooth musculature of the vessels and prevents the release of norepinephrine). Dipyridamole has both angiogenic and arteriogenic activity, stimulating the formation of new capillaries and collateral arteries.

    Dipiridamole normalizes venous outflow, reduces the incidence of deep vein thrombosis in the postoperative period. Improves microcirculation in the retina of the eye and kidney glomeruli.

    In neurological practice, such pharmacodynamic effects of dipyridamole as a decrease in the tone of cerebral vessels and improvement of cerebral circulation are used. According to angiographic studies, the use of dipyridamole in combination with acetylsalicylic acid (ASA) is able to slow the progression of atherosclerosis.

    In obstetrical practice dipyridamole It is used to improve placental blood flow and prevent dystrophic changes in the placenta, eliminate fetal hypoxia and accumulate glycogen in them. Thus, it is advisable the use of dipyridamole for early manifestations of placental insufficiency in pregnant women with a high risk of placental insufficiency: intrauterine infection, preeclampsia (threat of preeclampsia and eclampsia), autoimmune disorders, extra-diseases (diabetes mellitus, metabolic syndrome); as well as diseases with a tendency to thrombosis.

    As a pyrimidine derivative, dipyridamole is an inducer of interferon and has a modulating effect on the functional activity of the interferon system, in vitro increases the decreased production of interferon alpha (α) and gamma (γ) blood leukocytes. Increases nonspecific antiviral resistance to viral infections.

    Pharmacokinetics:

    Ingestion dipyridamole quickly absorbed from the gastrointestinal tract. Bioavailability is 37-66%, the time to reach the maximum concentration (TFROMmax) in the blood plasma for about 2 hours. Dipyridamole almost completely binds to blood plasma proteins.

    After oral administration, there is a two-phase character of a decrease in the concentration of dipyridamole in the blood plasma.The half-life of the drug in the initial phase is 20-30 minutes, and in the final phase of elimination is 10-12 hours. Dipyridamole metabolized in the liver by binding to glucuronic acid. Is allocated mainly in bile and is excreted through the intestine in the form of monoglucuronide. A small amount of dipyridamole (1-3%) is excreted by the kidneys.

    Indications:

    - Treatment and prevention of cerebral circulation disorders according to the ischemic type;

    - encephalopathy;

    - prevention of arterial and venous thromboses and their complications;

    - prophylaxis of thromboembolism after the operation of prosthetic heart valves;

    - prevention of placental insufficiency in complicated pregnancies;

    - as part of complex therapy for disorders of microcirculation of any genesis;

    - as an inducer of interferon and immunomodulator for the prevention and treatment of influenza, ARVI.

    Contraindications:

    - Hypersensitivity to the components of the drug;

    - sugarase / isomaltase deficiency, galactose intolerance, lactase deficiency, glucose-galactose malabsorption;

    - acute myocardial infarction;

    - unstable angina;

    - common stenosing coronary artery atherosclerosis;

    - subaortic stenosis;

    - Decompensated heart failure;

    - severe arterial hypotension; collapse;

    - severe arterial hypertension;

    - severe heart rhythm disturbances;

    - chronic obstructive pulmonary disease (COPD);

    - decompensated kidney failure;

    - liver failure;

    - hemorrhagic diathesis;

    - diseases with a tendency to bleeding (peptic ulcer of the stomach and duodenum, etc.);

    - children under 12 years of age (efficacy and safety not studied).

    Pregnancy and lactation:

    Application of the drug Curantil® N 25 during pregnancy and during breastfeeding is possible only if the intended benefit to the mother exceeds the possible risk to the fetus and the baby. The duration of the course of treatment is determined by the doctor.

    Dosing and Administration:

    Tablets are taken orally, on an empty stomach, washed down with a small amount of water, without breaking and not cracking. The dose of the drug is selected depending on the indications, the severity of the disease and the patient's response to treatment. The duration of treatment is determined by the doctor.

    To reduce the aggregation of platelets, it is recommended to take the drug Curantil® N 25 in a daily dose of 75-225 mg.

    In severe cases, the daily dose can be increased to 600 mg.

    To prevent placental insufficiency, it is recommended to take the drug Curantil® N 25 in a dose of 25 mg (1 tablet 3 times a day). The maximum recommended daily dose is 225 mg.

    For the prevention and treatment of cerebral circulation disorders, the daily dose of dipyridamole is 225 to 450 mg (3 tablets of the preparation Kurantil® N 25 3-6 times a day).

    For the prevention of influenza and other acute respiratory viral infections, especially during epidemics, it is recommended that the drug Curantil® N 25 according to the following scheme: 50 mg (2 tablets) once every 7 days for 4-5 weeks.

    For the prevention of recurrences in patients with respiratory viral infections, who are often ill, it is recommended to take Curantil® N 25 on the next scheme: 100 mg (2 tablets 2 times at day with interval at 2 hours) 1 time at a week at flow 8-10 weeks.

    Curantil® N 25 is suitable for long-term treatment.

    Side effects:

    When using the drug in therapeutic doses, side effects are usually not are expressed and carry a transient nature.

    In the tests in vitro and in vivo no evidence of mutagenic or carcinogenic potential.In animal experiments, there were no indications of teratogenic effects.

    Possible side effects when using Curantil® N 25 are shown below in the descending frequency of occurrence: often (≥ 1/100, <1/10), infrequently (≥ 1/1000, <1/100), rarely (≥ 1/10000, <1/1000), very rarely (<1/10 000), including individual messages.

    From the cardiovascular system:

    Infrequently: tachycardia, blood flushes to the face, lowering blood pressure (especially when combined with other vasodilators), coronary steal syndrome (when used at a dose of more than 225 mg / day).

    From the digestive system:

    Infrequently: nausea, vomiting, diarrhea, epigastric pain. Usually these side effects disappear with a longer application of the drug Curantil® N 25.

    Co the sides of the blood and the system of homeostasis:

    Infrequently: thrombocytopenia, changes in the functional properties of platelets, bleeding.

    Rarely: increased bleeding after surgical interventions.

    From the immune system:

    Rarely: allergic reactions, such as a skin rash, hives.

    Other: weakness, dizziness, headache, hyperemia of the skin of the face, arthritis, myalgia, rhinitis.

    Some messages: increased symptoms of coronary heart disease (CHD), such as angina pectoris, myocardial infarction.

    Overdose:

    Symptoms: a marked decrease in blood pressure, development or exacerbation of angina attacks, tachycardia, a sensation of "hot flashes", weakness and dizziness.

    Treatment: apply measures in accordance with the general standards of medical care adopted for accidental poisoning (vomiting, gastric lavage, the use of adsorbents to reduce absorption (Activated carbon etc.). The undesirable vasodilating effect of the drug can be suppressed with a slow (50-100 mg / min) intravenous injection of aminophylline. In case of symptoms of angina pectoris, sublingual application of nitroglycerin is indicated.

    Interaction:

    Xanthine derivatives (coffee, tea, theophylline derivatives) can weaken the vasodilating effect of dipyridamole.

    Dipyridamole with simultaneous application can enhance the action anticoagulants and acetylsalicylic acid.

    Dipyridamole enhances the effect of antihypertensive drugs.

    Weaken the properties of cholinesterase inhibitors.

    Cephalosporins increase the antithrombotic effect of dipyridamole.

    Antacids reduce the maximum concentration of dipyridamole due to reduced absorption.

    Effect on the ability to drive transp. cf. and fur:In connection with the possible decrease in blood pressure during the period of taking the drug Kurantil® N 25 the ability to concentrate and the speed of psychomotor reactions in patients can be reduced. Therefore, during the treatment with the drug Kurantil® N 25 caution should be exercised when driving vehicles and engaging in potentially hazardous activities that require increased attention and speed of psychomotor reactions.
    Form release / dosage:

    Film-coated tablets, 25 mg.

    Packaging:

    For 120 tablets, covered with a film coating, into the bottles of colorless glass with nominal capacity of 30 ml, closed with a plastic plug-shock absorber.

    One bottle together with the instruction for use is placed in a cardboard box.

    Storage conditions:

    At a temperature of no higher than 25 ° C in a dark place.

    Keep the medicine out of the reach of children!
    Shelf life:

    3 years.

    Do not use after the expiration date stated on the package.

    Terms of leave from pharmacies:On prescription
    Registration number:П N013897 / 01
    Date of registration:28.03.2012 / 13.03.2017
    Expiration Date:Unlimited
    The owner of the registration certificate:BERLIN-PHARMA, CJSC BERLIN-PHARMA, CJSC Russia
    Manufacturer: & nbsp
    Representation: & nbspBERLIN-CHEMI / MENARINI PHARMA GmbH BERLIN-CHEMI / MENARINI PHARMA GmbH Germany
    Information update date: & nbsp07.02.2018
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