Sydnopharm (Molsidomin) 2 mg , 30 pcs.

Sopharma, Bulgaria

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Product Overview

Composition

1 tablet contains:


active substance:

molsidomine 2.00 mg.

Excipients:

lactose,

wheat starch,

mannitol,

colloidal silicon dioxide,

magnesium stearate,

hydroxypropyl methylcellulose,

mint oil

dye "Sunset yellow"

microcrystalline cellulose.

pharmachologic effect

Pharmacodynamics


Sydnopharm has venodilating, antiplatelet, analgesic and antianginal effects. Venodilating activity is due to the release, after a series of metabolic transformations, of nitric oxide (NO), which stimulates soluble guanylate cyclase; therefore, molsidamine is regarded as a "donor" of NO. The accumulation of cGMP causes relaxation of the smooth muscle cells of the vascular wall (to a greater extent, veins). A decrease in preload, even without a direct effect on myocardial contractility, leads to the restoration of the ratio between oxygen demand and oxygen intake, disturbed in patients with coronary insufficiency (oxygen demand decreases by 26%). Can expand vasodilatable narrowed parts of the coronary arteries, improves collateral circulation. Increases load tolerance, reduces the number of angina attacks that occur during exercise. Suppresses the early phase of platelet aggregation, reduces the release and synthesis of serotonin, thromboxane and other proaggregants.

In patients with chronic heart failure, reducing the preload, helps to reduce the size of the heart chambers. Reduces pressure in the pulmonary artery, reduces left ventricular filling and myocardial wall tension, stroke volume. The action begins 20 minutes after ingestion, reaches a maximum in 0.5-1 hour and lasts up to 6 hours. Unlike nitrates, the development of tolerance with a decrease in effectiveness during prolonged therapy is uncommon.

Pharmacokinetics


After oral administration, Sidnopharm is almost completely absorbed from the gastrointestinal tract. Bioavailability is 60-70%. The maximum concentration is reached (4.4 μg / ml) -1 hour. When taken orally after a meal, absorption slows down, 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. Practically does not bind to blood plasma proteins. In the liver, it is metabolized to form the pharmacologically active compound SIN-1, (3-morpholino-sydnonimine), from which a very unstable substance SIN-la (N-morpholino-N-aminosyntonitrile) is formed, which releases NO to form the pharmacologically inactive compound SIN-lc. In the course of metabolism, other metabolites are formed.

It is excreted by the kidneys by 90% (in the form of metabolites), 9% through the intestines. The half-life is 0.85 - 2.35 hours. It does not cumulate (including in patients with renal failure). In severe hepatic failure (an increase in the bromsulfalein test up to 20-50%), a slowdown in excretion and an increase in its concentration in blood plasma are noted.

Indications

Prevention of angina attacks.

Application during pregnancy and lactation

The use of Sydnopharm is contraindicated in pregnancy.

If it is necessary to prescribe the drug during lactation, you should refuse breastfeeding.

Contraindications

  • Hypersensitivity to Sidnopharm,
  • severe arterial hypotension (systolic blood pressure below 100 mm Hg),
  • collapse,
  • cardiogenic shock,
  • low filling pressure of the left ventricle,
  • acute myocardial infarction with arterial hypotension,
  • toxic pulmonary edema,
  • concomitant use of sildenafil,
  • pregnancy,
  • lactation period,
  • age up to 18 years (efficacy and safety have not been established).

With caution
Patients after a hemorrhagic stroke, with increased intracranial pressure, patients prone to arterial hypotension; old age, glaucoma (especially angle-closure), cerebrovascular accident.

Side effects

  • Headache (usually minor, disappears with further treatment); a decrease in blood pressure, collapse (with an initially high blood pressure (BP), the severity of its decrease is greater than with an initially normal or low blood pressure);
  • redness of the skin of the face;
  • slowing down the speed of mental and motor reactions (mostly at the beginning of treatment);
  • dizziness;
  • nausea, loss of appetite, diarrhea;
  • tachycardia;
  • allergic reactions (skin rash, itching, bronchospasm, rarely - anaphylactic shock).

Interaction

With the simultaneous appointment of Sidnopharm with other vasodilators, antihypertensive drugs and ethanol, the severity of the hypotensive effect increases.

Acetylsalicylic acid enhances antiplatelet activity.

How to take, course of administration and dosage

Inside, regardless of food intake. Sydnopharm tablets are swallowed whole, without chewing and drinking a sufficient amount of liquid.

Taking the drug is started with small doses - ½ -1 tablet 2 times a day.

If the therapeutic effect is insufficient, the frequency of administration is increased up to 3 times a day.

The maximum daily dose is 6 mg.

The dosage and duration of treatment are set individually.

Overdose

Symptoms: severe headaches, marked decrease in blood pressure, tachycardia.

Treatment: symptomatic.

Special instructions

Do not use Sidnopharm to relieve angina attacks!

The first dose of the drug is prescribed with caution (and under the control of blood pressure), intense headaches and an excessive decrease in blood pressure with loss of consciousness are possible.

Elderly patients with impaired liver and kidney function and arterial hypotension require dose adjustment.

During treatment, ethanol should be excluded.

If it is necessary to prescribe the drug during lactation, you should refuse breastfeeding.

During the treatment period (especially at the beginning), it is necessary to refrain from driving vehicles and engaging in potentially hazardous activities that require increased concentration of attention and speed of psychomotor reactions.

Release form

Pills

Storage conditions

In a dry, dark place, at a temperature not exceeding 25 ° C.
 
Keep out of the reach of children.

Shelf life

3 years.

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