Instructions for use Sidocard tablets 4 mg blister No. 30
Composition
active ingredient: molsidomine;
1 tablet contains molsidomine 2 mg or 4 mg;
Excipients: lactose monohydrate; mannitol (E 421); wheat starch; microcrystalline cellulose; hypromellose (hydroxypropylmethylcellulose); colloidal anhydrous silica; magnesium stearate; peppermint oil; sunset yellow FCF (E 110).
Dosage form
Pills.
Main physicochemical properties: round tablets with a flat surface with beveled edges, with a score on one side, light pink in color, with a mint odor.
Pharmacotherapeutic group
Vasodilators used in cardiology.
ATX code C01D X12.
Pharmacological properties
Pharmacodynamics.
The drug exhibits a long-lasting antianginal effect (6–12 hours). It has a beneficial effect on myocardial preload and metabolism, as a result of which the need for oxygen decreases sharply. In the body, it is spontaneously biotransformed into the active metabolite SIN-1A, which has a pronounced vasodilator effect primarily on the main venous vessels. It increases the diameter of subendocardial vessels and coronary blood flow; improves the supply of oxygen to the myocardium, which, in turn, increases the tolerance to physical exertion of patients with ischemic heart disease. Molsidomine is an NO donor. It activates guanylate cyclase and increases the intracellular concentration of cGMP. With prolonged use of molsidomine, clinically significant tolerance to it does not develop. It can be used in case of nitrate intolerance and in case of development of nitrate tolerance.
Pharmacokinetics.
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 hour. When taken orally after a meal, absorption slows down, but does not decrease (the maximum concentration in 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. It practically does not bind to blood plasma proteins. It is metabolized in the liver to form the pharmacologically active compound SIN-1 (3-morpholino-sydnonimine), from which the very unstable substance SIN-1a (N-morpholino-N-aminosintonitrile) is formed, which releases NO to form the pharmacologically inactive compound SIN-1c. Other metabolites are also formed during metabolism. Excreted by the kidneys by 90% (in the form of metabolites), 9% through the intestines. The half-life is from 1 to 3.5 hours. Does not accumulate (including in patients with renal failure).
In severe liver failure (increase in the bromsulfalein test value from 20% to 50%), a slowdown in excretion and an increase in its concentration in blood plasma were noted.
Indication
Coronary 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.
Contraindication
Hypersensitivity to any component of the drug, acute angina attack, acute circulatory failure, including shock (including cardiogenic), vascular collapse, severe arterial hypotension (systolic blood pressure less than 100 mm Hg), glaucoma, especially angle-closure, acute stage of myocardial infarction, especially with a decrease in blood pressure, simultaneous use of phosphodiesterase 5 (PDE 5) inhibitors (sildenafil, vardenafil, tadalafil) - due to the high risk of developing arterial hypotension; toxic pulmonary edema, decreased central venous pressure, pregnancy and breastfeeding, children's age (up to 18 years).
Interaction with other medicinal products and other types of interactions
The drug can be used simultaneously with beta-blockers and calcium antagonists.
Alcohol consumption during treatment with the drug Sidnocard is completely excluded.
When molsidomine is used simultaneously with peripheral vasodilators, calcium ion antagonists, and antihypertensive agents, the hypotensive effect is potentiated. When molsidomine is used simultaneously with acetylsalicylic acid, the antiplatelet effect is potentiated.
Sildenafil is contraindicated in treatment with molsidomine. Sildenafil potentiates the hypotensive effect of molsidomine, which may result in irreversible arterial hypotension and increased myocardial ischemia.
If it is necessary to take molsidomine after treatment with sildenafil, this can be done only 24 hours after the end of taking the latter.
Application features
Do not use for the treatment of acute angina attacks!
Use with caution in hypertrophic obstructive cardiomyopathy, constrictive pericarditis, decreased pressure in the ventricles of the heart, aortic stenosis or mitral stenosis. In severe liver dysfunction (increase in bromsulfalein test value by 20–50%), the concentration of molsidomine in the blood plasma increases and the half-life increases, which requires dose adjustment of the drug.
Special attention when treating with the drug Sydnocard is required by patients after hemorrhagic stroke, with cerebral circulation disorders and increased intracranial pressure; patients with a recent myocardial infarction, patients with glaucoma and with a tendency to hypotensive reactions or in the presence of arterial hypotension.
With long-term use of nitrates, it is recommended to include molsidomine in the treatment regimen to prevent the development of nitrate tolerance.
Elderly patients with functional liver or kidney failure are prescribed the drug in lower doses.
This medicinal product contains lactose and should not be administered to patients with rare hereditary forms of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption.
Wheat starch, which is part of the medicinal product, may contain gluten, but in small quantities, and therefore the drug is considered safe for patients with celiac disease.
Due to the presence of the dye sunset yellow FCF (E 110) in the composition of the medicinal product, allergic reactions are possible.
Use during pregnancy or breastfeeding
It is contraindicated to use the drug during pregnancy and breastfeeding.
If it is necessary to use the drug in breastfeeding women, breastfeeding should be discontinued for the period of treatment.
Ability to influence reaction speed 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 people who drive a car or work with other mechanisms, the drug is prescribed with caution after a careful assessment of the possible risk.
Method of administration and doses
The medicine should be taken orally during or after meals, with sufficient liquid.
To prevent angina attacks, use 1–2 mg (½–1 tablet) 4–6 times a day on the first and second days of therapy, then, if necessary, increase the dose to 2–4 mg 2–3 times a day.
The dosage regimen is individual and depends on the nature and stage of the disease, the severity of clinical symptoms. Usually the daily dose is 2–4 mg, divided into 2 equal doses. Sometimes the dose is increased to 6–8 mg, divided into 3–4 doses.
The maximum daily dose is 12 mg.
The duration of treatment depends on the course of the disease and is determined by the doctor.
Children
The use of the drug is contraindicated in children (under 18 years of age).
Overdose
Symptoms: bradycardia, weakness, tachycardia, severe headache, dizziness and hypotension, accompanied by nausea and vomiting; in severe cases - collapse.
Treatment: measures are taken to quickly remove the drug from the body (gastric lavage, forced diuresis), symptomatic therapy.
There are no data on the effectiveness of dialysis in overdose.
Adverse reactions
From the nervous system: headache (usually minor, disappears during further treatment), dizziness, increased fatigue, slowed psychomotor and motor reactions (in most cases at the beginning of treatment), weakness.
Gastrointestinal: nausea, loss of appetite, diarrhea, vomiting.
From the cardiovascular system: thrombocytopenia, circulatory failure, shock with increased blood pressure, pronounced decrease in blood pressure, rarely - to the development of collapse, tachycardia, redness of the face.
Immune system disorders: hypersensitivity reactions, including allergic reactions, itching, rash, bronchospasm, anaphylactic shock.
Skin and subcutaneous tissue disorders: urticaria.
Expiration date
2 years.
Storage conditions
Store in the original packaging at a temperature not exceeding 25 °C.
Keep out of reach of children.
Packaging
10 tablets in a blister; 3 blisters in a pack.
Vacation category
According to the recipe.
Producer
PJSC "Kyiv Vitamin Plant".
Location of the manufacturer and address of its place of business
04073, Ukraine, Kyiv, Kopylivska St., 38.
