Кальцигард® Retard

General characteristics. Structure:

Active ingredient: 20 mg of nifedipine.

Excipients: lactose, starch, microcrystallic cellulose, twin-80, polyethyleneglycol, stearic acid, polyvinylpirrolidone, magnesium stearate, sodium lauryl sulfate.

Cardiological drug.

Pharmacological properties:

Pharmacodynamics. Kaltsigard Retard (nifedipine), derivative dihydropyridine, has anti-anginal and hypotensive activity. Slows down receipt of calcium ions in cardiomyocytes and cells of smooth muscles of vessels. Relaxes smooth muscles of coronary and peripheral arteries. Expanding peripheral vessels, reduces the peripheric resistance and an afterload on heart. Increases a coronary blood stream, reduces the need of a myocardium for oxygen.

At reception twice a day Kaltsigard Retard provides control of the increased arterial pressure within 24 hours. Kaltsigard Retard reduces arterial pressure in such a way that its percentage decrease is directly connected with initial size. At patients with normal arterial pressure Kaltsigard Retard renders small or has no effect on blood pressure at all.

Pharmacokinetics. After intake Kaltsigard Retard is completely soaked up from digestive tract. After reception of a single dose of drug there is a gradual controlled increase in its concentration in a blood plasma which keeps with insignificant fluctuations before the following administration of drug in 12 hours. Almost it is completely metabolized in a liver with formation of inactive metabolites. 60%-80% of nifedipine in the form of metabolites are removed with urine. The elimination half-life makes about 2 hours. Less than 0,1% of drug are found in urine in an invariable look Other part is removed with a stake in the form of metabolites. The pharmacokinetics of drug can change at patients with chronic diseases of a liver.

Indications to use:

Kaltsigard Retard is intended for treatment of stable stenocardia; vasospastic stenocardia, arterial hypertension, Raynaud's disease.

Route of administration and doses:

The mode of dosing is set individually. The average dose makes 1 tablet (20 mg) two times a day with a small amount of liquid in time or after food. At insufficient expressiveness of clinical effect perhaps gradual increase in a dose. The maximum dose of drug makes 40 mg two times a day.

Features of use:

At some patients, especially in an initiation of treatment, emergence of attacks of stenocardia is possible that demands drug withdrawal.

Side effects:

From cardiovascular system: perhaps - a hyperemia of the person, feeling of heat, tachycardia, peripheral hypostases, arterial hypotension.

From the central nervous system: headache, dizziness, increased fatigue, drowsiness. At use of high doses of drug isolated cases of developing of paresthesia of extremities, a tremor, easy visual disturbances, a sleep disorder are celebrated;

From digestive tract and a liver: nausea, lock, diarrhea. At long administration of drug cases of increase in activity of "hepatic" transaminases in blood serum, emergence of an intra hepatic cholestasia can be observed;

From system of a hemopoiesis: in rare instances – reversible thrombocytopenia, a leukopenia, anemia;

From an urinary system: increase in a daily urine; patients with a renal failure have a deterioration in function of kidneys;

Allergic reactions: seldom – urticaria, a skin itch;

Others: at prolonged use – a mialgiya, a gynecomastia, a hyperplasia of gums, a hyperglycemia.

Interaction with other medicines:

At simultaneous use Kaltsigarda Retard and:

• beta adrenoblockers, other anti-hypertensive drugs, tricyclic antidepressants, diuretics, vazodilatator – amplifies hypotensive effects of drug;
• in combination with nitrates tachycardia and strengthening of hypotensive action is observed; diltiazem - the clearance of nifedipine decreases. When using such combination it is necessary to reduce a dose Kaltsigarda Retard and to watch carefully patients;
• antiarrhytmic drugs (for example, Amiodaronum and quinidine) – their negative inotropic effect can amplify;
• digoxin the clearance of digoxin decreases, digoxin level in plasma and danger of development of digoksinovy intoxication increases. In these cases it is necessary to reduce doses of digoxin and to check its level in a blood plasma;
• theophylline increase in level of theophylline in plasma is possible that demands dose adjustment;
• Cimetidinum and, to a lesser extent, ranitidine nifedipine level in plasma can increase and amplify its action;
• Vincristinum removal of the last of an organism is at a loss that increases danger of increase in the side effects caused by Vincristinum;
• cephalosporins bioavailability of cephalosporins increases.

Contraindications:

Hypersensitivity to nifedipine, other derivatives of dihydropyridine or other components of a ready dosage form; arterial hypotension, cardiogenic shock, a collapse, the expressed aortal stenosis, SSSU, instability stenocardia, the expressed heart failure, an acute stage of a myocardial infarction (within the first 4 weeks), pregnancy, the lactation period.

Overdose:

Symptoms: the expressed arterial hypotension, disturbance of a heart rhythm (bradycardia or tachycardia). At increase of the phenomena of intoxication there can be a hypoxia, cardiogenic shock, consciousness disturbances.

Treatment: gastric lavage, reception of absorbent carbon, intravenous administration of salts of calcium. Symptomatic treatment. The hemodialysis is not effective.

Storage conditions:

To store at a temperature below 30 °C in the place protected from light and moisture. To store in the place, unavailable to children. A period of validity - 3 years from the date of production. Not to use after the term specified on packaging.

Issue conditions:

According to the recipe

Packaging:

10 tablets in the blister from PVC of a film and aluminum foil. 3 blisters or 10 blisters with the application instruction in a cardboard pack. A sample not for sale: 4 tablets or 10 tablets in the blister from PVC of a film and aluminum foil. 1 blister with the application instruction is packed into a cardboard pack.