Dipiridamole-FPO - instructions for use, dose, side effects, contraindications

Composition:1 tablet contains:
active substance: dipyridamole 25 mg / 50 mg / 75 mg;
Excipients: lactose monohydrate 22.5 mg / 21.2 mg / 31.8 mg, copovidone 2.1 mg / 3.2 mg / 4.8 mg, microcrystalline cellulose 28.4 mg / 42.6 mg / 63.9 mg, magnesium stearate 0.8 mg / 1.2 mg / 1.8 mg, croscarmellose sodium 1.2 mg / 1.8 mg / 2.7 mg;
excipients for the shell: hypromellose (hydroxypropylmethylcellulose) 2.8 mg / 4.2 mg / 6.3 mg, talc 0.16 mg / 0.24 mg / 0.36 mg, titanium dioxide 0.54 mg / 0.81 mg / 1.215 mg, Tween 80 (polysorbate 80) 0.48 mg / 0.72 mg / 1.08 mg, quinoline yellow dye 0.02 mg / 0.03 mg / 0.045 mg.

Description:Round biconvex tablets, covered with a film coating of yellow color; on the cross-section the nucleus is yellow.

Pharmacotherapeutic group:Vasodilator

ATX: & nbsp

B.01.A.C.07 Dipyridamole

Pharmacodynamics:Dipyridamole has a retarding effect on the aggregation of platelets, improves microcirculation. Has vasodilator effect.
As a pyrimidine derivative, dipyridamole is an inducer of interferon and has a modulating effect on the functional activity of the interferon system, increases the decreased production of interferon alpha (α) and gamma (γ) by blood leukocytes in vitro.
Dipiridamol increases non-specific antiviral resistance to viral infections.

Pharmacokinetics:The maximum concentration of dipyridamole in the plasma is reached within 1 hour after ingestion. Dipyridamole almost completely binds to blood proteins. Accumulation of dipyridamole occurs in myocardiocytes and in erythrocytes. Dipyridamole metabolized in the liver by binding to glucuronic acid. The half-life is 20 to 30 minutes in the first phase, in the second phase about 10 hours. Possible cumulation (mainly in patients with impaired liver function). It is excreted with bile in the form of monoglyukuronide.

Indications:Treatment and prevention of cerebral circulation disorders by ischemic type, dyscirculatory encephalopathy.
Prevention of arterial and venous thromboses and their complications, prophylaxis of thromboembolism after the operation of prosthetic heart valves.
As part of complex therapy for any violations of microcirculation.
As an inducer of interferon and immunomodulator for the prevention and treatment of influenza, acute respiratory viral infections.

Contraindications:Hypersensitivity to dipyridamole or other components of the drug, acute myocardial infarction, unstable angina, widespread stenosing coronary artery atherosclerosis, subaortic stenosis of the aorta, decompensated chronic heart failure, arterial hypotension, collapse, hypertension, severe heart rhythm disorders, hemorrhagic diathesis, chronic obstructive diseases lungs, diseases with an increased risk of bleeding (including ulcer and I have the same illness udka and duodenal ulcers), liver failure, kidney failure, lactose intolerance, lactase deficiency, glucose-galactose malabsorption,children under 12 years of age (efficacy and safety in this age group are not established).

Carefully:Patients with violations of the liver, during breastfeeding.

Pregnancy and lactation:The use of the drug during pregnancy and breastfeeding is not recommended. Use of the drug is possible if the expected benefit for the mother exceeds the potential risk to the fetus. If you need to use the drug during breastfeeding, breastfeeding should be discarded.

Dosing and Administration:Inside, not liquid, squeezed a small amount of liquid. Dipyridamole it is recommended to take an empty stomach. The dose and duration of treatment depend on the nature, severity of the disease and the effectiveness of the treatment.
To reduce the aggregation of platelets, it is recommended that dipyridamole in a dose of 75 - 225 mg per day in several doses. In severe cases, the dose may be increased to 600 mg per day.
For the prevention of thromboembolic syndrome, stent thrombosis and aortocoronary shunts - on the first day of 50 mg together with acetylsalicylic acid, then 100 mg,the frequency of reception is 4 times a day (cancellation 7 days after the operation, if the patient continues taking acetylsalicylic acid at a dose of 325 mg per day) or 100 mg 4 times a day for 2 days before surgery and 100 mg 1 hour after surgery if necessary in combination with warfarin).
For the prevention of influenza, other acute respiratory diseases, especially during epidemics, take the following scheme: 50 mg per day 1 time per 7 days for 4 to 5 weeks.
For the prevention of relapse, in patients with respiratory viral infections, who are often ill, dipyridamole it is recommended to take the following scheme: 100 mg per day (2 times 50 mg at intervals of 2 hours) once a week for 8-10 weeks.

Side effects:From the heart: palpitations, bradycardia, in high doses the drug can cause arterial hypotension, a sensation of "hot flashes" and tachycardia, a syndrome of coronary stealing (at a dose of more than 225 mg per day).
From the side of the blood and lymphatic system: thrombocytopenia, changes in the functional properties of platelets, increased bleeding, bleeding.
From the gastrointestinal tract: nausea, vomiting, diarrhea, epigastric pain.
From the central nervous system: weakness, dizziness, headache.
From the skin and subcutaneous tissues: allergic reactions, including rash, itchy skin, hives.
From the side of the hearing organ and labyrinthine disorders: sensation of ear congestion, noise in the head.
Other: arthritis, myalgia, rhinitis.
Side effects are usually not expressed, have a transient nature and disappear with prolonged use of the drug.
If any of the side effects listed in the manual are aggravated, or if you notice any other side effects not listed in the instructions, inform your doctor.

Overdose:Symptoms: short-term decrease in blood pressure.
Treatment: symptomatic (including the management of vasopressor agents).

Interaction:Xanthine derivatives (coffee, tea) can weaken the vasodilating and antithrombotic effects of dipyridamole. The use of dipyridamole simultaneously with direct and indirect anticoagulants (heparin) and thrombolytic agents or acetylsalicylic acid increases the risk of hemorrhagic complications, which must be taken into account when used together.
Dipyridamole can increase the effect of antihypertensive drugs.
Dipyridamole can weaken the anticholinergic properties of cholinesterase inhibitors.
When taking antibiotics cephalosporins (cefamandol, cefaperazone, cefatetan), penicillin antibiotics, tetracyclines, chloramphenicol, beta-lactams, nicotinic acid, the anti-aggregative effect of dipyridamole is enhanced.
Antacids reduce the maximum concentration of dipyridamole in blood plasma due to reduced absorption.

Special instructions:To reduce the dyspeptic phenomena are taken with milk. In the treatment should be avoided the use of natural coffee and tea, weakening the effect of dipyridamole.
If coronary steal syndrome occurs, an aminophylline is indicated to improve intracardiac blood flow.

Effect on the ability to drive transp. cf. and fur:Given the possibility of developing unwanted reactions from the central nervous system and the cardiovascular system (for example, arterial hypotension, dizziness and weakness) during the treatment period, care must be taken when driving vehicles,servicing of moving mechanisms and engaging in other potentially hazardous activities requiring increased concentration of attention and speed of psychomotor reactions.

Form release / dosage:Film coated tablets, 25 mg, 50 mg and 75 mg.

Packaging:For 10, 15, 20 or 30 tablets in a contour mesh box made of polyvinylchloride film and aluminum foil printed lacquered.
By 1, 2, 3, 4, 5, 10 or 12 contour mesh packages together with instructions for use in a pack of cardboard.

Storage conditions:At a temperature of no higher than 25 ° C. Keep out of the reach of children.

Shelf life:3 years.
Do not use after the expiry date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:LS-001628

Date of registration:24.10.2011 / 24.02.2016

Expiration Date:Unlimited

The owner of the registration certificate:OBOLENSKOE PHARMACEUTICAL ENTERPRISE, CJSC OBOLENSKOE PHARMACEUTICAL ENTERPRISE, CJSC Russia

Manufacturer: & nbsp

OBOLENSKOE PHARMACEUTICAL ENTERPRISE, CJSC Russia

Information update date: & nbsp2016-10-24

Illustrated instructions

Instructions

Dipyridamole-FPO® (Dipiridamol-FPO)