Sidnofarm 2 mg tablets № 30
Author Ольга Кияница
|Amount in a package||30|
|Manufacturer||Vitamins JSC (Ukraine, Uman)|
|The main medicament||Sidnofarm|
Sidnofarm (SYDNOPHARM) instructions for use
active ingredient: Molsidomine; 1 tablet contains molsidomine 2 mg;
auxiliary substances: lactose, mannitol (E 421), wheat starch, microcrystalline cellulose, hypromellose, silicon dioxide colloid, magnesium stearate, peppermint oil, yellow sunset FCF (E 110).
Basic physical and chemical properties:
round, biconvex tablets with a diameter of 8 mm with a notch on one side, a pale pink color with a mint smell.
Vasodilators used in the treatment of heart disease. Molsidomine. ATX Code C01D X12.
Molsidomine detects venodilatichu, antiplatelet, analgesic and prolonged antianginal action. Venodilatulicha activity is due to the release after a number of metabolic transformations of nitric oxide (NO), which stimulates soluble guanylate cyclase, therefore Molsidomine is considered as a donor of NO. Accumulation of cyclic guanosine monophosphate (cGMP) causes relaxation of smooth muscle cells of the vascular wall (mostly veins). Decrease in preload, even without affecting the contractility of the myocardium, leads to a restoration of the correlation between the oxygen demand and its intake disturbed in patients with coronary insufficiency. It extends the affected by atherosclerosis, but are capable of dilatation, large epicardial coronary arteries, improves peripheral circulation.
Increases tolerance to physical activity, reduces manifestations of angiospasm. Suppresses the early phase of platelet aggregation, reduces the synthesis and release of serotonin, thromboxane and other proaggregant.
Reduces preload on the myocardium in patients with chronic heart failure, reduces pressure in the pulmonary artery, reduces the filling of the left ventricle and myocardial wall stress, stroke volume of the heart. The action begins 20 minutes after admission, reaches a maximum after 0.5-1 hour and persists for 6:00. Unlike nitrates, the development of tolerance with a decrease in efficacy in long-term therapy is not characteristic.
After oral administration, it is almost completely absorbed from the gastrointestinal tract. Bioavailability is 60-70%. The maximum concentration (4.4 μg / ml) is reached after 1:00. When ingested after a meal, the absorption slows, but does not decrease (the maximum concentration in the blood plasma is reached 30-60 minutes later than when taken on an empty stomach). The minimum effective concentration of Molsidomine in blood plasma is 3-5 ng / ml. Virtually does not bind to blood plasma proteins. In the liver, it is metabolized to form a pharmacologically active compound SIN-1 (3-morpholino-sydnonimine), from which a very unstable substance SIN-1a (N-morpholino-N-aminosinonitrile) is formed, which releases NO to form a pharmacologically inactive SIN-1c compound. In the course of metabolism, other metabolites are formed. It is excreted by the kidneys by 90% (in the form of metabolites), 9% by the intestine. The half-life is from 1 to 3.5 hours. NOT cumulated (including in patients with renal insufficiency).
In severe hepatic insufficiency (an increase in the bromsulfalein test from 20% to 50%), a delay in excretion and an increase in its concentration in the blood plasma was noted.
Ischemic heart disease: prevention of attacks of stable and unstable angina (especially in elderly patients and with individual intolerance to nitrates).
As part of the combined treatment of chronic heart failure.
Hypersensitivity to the active or to any of the auxiliary substances, acute anginal infection, acute myocardial infarction, acute circulatory insufficiency, including shock (including cardiogenic), vascular collapse, severe arterial hypotension (systolic pressure below 100 mm Hg). , simultaneous use of phosphodiesterase 5 (PDE5) inhibitors (sildenafil, vardenafil, tadalafil) due to a high risk of arterial hypotension; toxic pulmonary edema, decreased central venous pressure.
Interaction with other drugs and other interactions
With simultaneous use with peripheral vasodilators, blockers of "slow" calcium channels (BOD), antihypertensive drugs and ethanol, the antihypertensive effect of the drug increases.
With simultaneous use with acetylsalicylic acid, its antiaggregant activity is enhanced.
There is a high risk of developing arterial hypotension with simultaneous use with PDE-5 inhibitors, such as sildenafil, vardenafil, tadalafil. The combined use of the sydnofarm preparation with PDE-5 inhibitors is contraindicated.
Sidnofarma can be used simultaneously with other antianginal drugs (for example, add to two- or three-component therapy - nitrates, BOD and β-adrenergic blockers.
You should avoid drinking alcohol during treatment sidnofarma.
Do not use to treat acute attacks of angina pectoris!
Precautions should be taken with hypertrophic obstructive cardiomyopathy, constrictive pericarditis, a decrease in pressure in the ventricles of the heart, with stenosis of the aorta or mitral stenosis. With a pronounced impaired liver function (an increase in bromsulfaleinovoy sample by 20-50%) increases the concentration of molsidomine in the blood plasma and the half-life, which requires correction of the dose of the drug.
With renal failure, the concentration of molsidomine in the blood plasma does not change.
Particular attention in the treatment of the drug requires patients after hemorrhagic stroke, with cerebral blood flow and increased intracranial pressure, patients with recent myocardial infarction, patients with glaucoma and with a predisposition to hypotensive reactions or in the presence of arterial hypotension.
Elderly patients with functional deficiency of the liver or kidney drug should be prescribed in smaller doses.
The preparation contains 0.06 g of lactose monohydrate. Patients with rare hereditary problems of galactose intolerance, deficiency of lactase Lappa or glucose-galactose by malabsorption should not use the drug.
Wheat starch may contain gluten, but in small amounts, and is therefore considered safe for individuals with celiac disease.
The dye E 110 can cause allergic reactions.
Use during pregnancy and lactation
The use of the drug in the first trimester of pregnancy is contraindicated.
The possibility of using the drug after the first trimester requires a thorough evaluation of the relationship between the benefits to the mother and the potential risk to the fetus.
It is not recommended to use the drug during the period of breastfeeding.
If necessary, treatment should stop breastfeeding.
The ability to influence the reaction rate when driving vehicles or other mechanisms
Given the adverse reactions of the drug (dizziness) and the possible negative impact on the concentration of attention of persons driving a car or working with other mechanisms, the drug should be administered with caution after a thorough assessment of the possible risk.
Dosing and Administration
The drug should be taken orally, during or after a meal, with a sufficient amount of liquid.
For the prevention of attacks of angina, appoint 1-2 mg (½-1 tablet) 4-6 times a day on the first and second day of therapy, after which the dose should be raised to 2-4 mg 2-3 times a day as needed.
Dosage regimen is individual and depends on the type and stage of the disease, the severity of clinical symptoms.Usually the daily dose is 2-4 mg (1-2 tablets), divided into 2 uniform doses. Sometimes the dose can be increased to 6-8 mg (3-4 tablets), should be distributed to 3-4 reception.
The maximum daily dose is 12 mg.
The duration of treatment depends on the course of the disease and is determined by the doctor.
The use of the drug is contraindicated in children.
Symptoms: bradycardia, weakness, drowsiness, severe headache, dizziness and arterial hypotension, tachycardia accompanied by nausea and vomiting; in severe cases - collapse.
Treatment: measures are taken to rapidly remove the drug from the body (gastric lavage, forced diuresis), symptomatic therapy.
There is no data on the effectiveness of dialysis in overdose.
From the side of the nervous system: headache (usually minor, disappears during further treatment), dizziness, increased fatigue, slowed down speed of psychomotor and motor reactions (in most cases at the beginning of treatment), weakness.
From the gastrointestinal tract: nausea, loss of appetite, diarrhea, vomiting.
From the cardiovascular system: thrombocytopenia, circulatory failure, shock with high blood pressure, marked reduction in blood pressure, rarely - to the development of collapse, tachycardia, reddening of the face.
On the part of the immune system: hypersensitivity reactions, including allergic reactions, pruritus, rash, bronchospasm, anaphylactic shock.
From the skin and subcutaneous tissues: urticaria.
Store in the original packaging at a temperature not higher than 25 ° C. Keep out of the reach of children.
For 10 tablets in blisters of PVC film and aluminum foil. For 3 blisters in a cardboard box.
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