Nikardiya

General characteristics. Structure:

Active agent: nifedipine of 10 mg; excipients: gipromeloza, cellulose microcrystallic, lactose, моногидрад, calcium hydrophosphate, dihydrate, corn starch, magnesium stearate, Tabkot of the CU Orange 2115.

Pharmacological properties:

Pharmacodynamics. Nifedipine possesses anti-anginal and anti-hypertensive action. Inhibits receipt of calcium ions, mainly, in cells of smooth muscles of arterial vessels. Reduces a spasm and expands coronary and peripheral (mainly, arterial) vessels, the arterial pressure, the general peripheric vascular resistance reduces and it is insignificant - contractility of a myocardium, reduces an afterload and the need of a myocardium for oxygen. Increases a coronary blood stream. Does not exert the oppressing impact on the carrying-out system of heart. 

Pharmacokinetics. Nikardiya possesses high extent of absorption - more than 90%. Bioavailability of drug fluctuates from 43 to 77%. Has effect of "the first passing" through a liver. Meal increases Nikardiya's bioavailability. Drug provides gradual release of active agent in a system blood stream where the maximum concentration is reached in 1,2 - 4,0 hours. Communication with proteins – high (92-98%). It is metabolized in a liver. Active metabolites are not revealed. 

The elimination half-life of Nikardiya makes from 3,8 to 16,9 hours. It is brought out of an organism preferential by kidneys in the form of inactive metabolites (70-80% of the accepted dose). Nifedipine does not kumulirutsya in an organism. In insignificant quantities gets through a blood-brain barrier, it is allocated with breast milk. 

At long reception (2-3 months) tolerance to effect of drug develops. 

Indications to use:

- prevention and treatment of stable stenocardia (including alternative); 

- arterial hypertension (in the form of monotherapy or in combination with other anti-hypertensive drugs); 

- Raynaud's disease. 

Route of administration and doses:

The mode of dosing is set individually, depending on severity of a disease and reaction of the patient to the carried-out therapy. It is recommended to accept drug in time or after meal, washing down with a small amount of water. Initial dose: on 1 tablet (10 mg) 2 times a day. If necessary the dose of drug can be increased to 2 tablets (20 mg) 2 times a day. The maximum daily dose – 120 mg. At the elderly patients or patients receiving combined (anti-anginal or hypotensive) therapy smaller doses of nifedipine are usually appointed. 

Features of use:

To appoint with care the patient with the expressed heart failure, heavy disturbances of cerebral circulation, a diabetes mellitus, malignant arterial hypertension, to the patient who are on a hemodialysis (because of risk of developing of arterial hypotension); at purpose of drug nursing mothers should resolve an issue of the breastfeeding termination; with care to appoint the patient with abnormal liver functions and/or kidneys; the treatment termination by drug needs to be made gradually because of possible development of a syndrome of "cancellation". During treatment by nifedipine it is necessary to refrain from alcohol use. With care to appoint drug to drivers of motor transport and persons of other professions demanding bystry mental or physical reaction. 

Side effects:

From cardiovascular system: perhaps - a hyperemia of the person, feeling of heat, tachycardia, peripheral hypostases, arterial hypotonia. Special instructions: at some patients, especially in an initiation of treatment, emergence of attacks of stenocardia is possible that demands drug withdrawal; 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, 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 and immunopathological reactions: seldom - urticaria, a skin itch; others: at prolonged use - a mialgiya, a gynecomastia, a hyperplasia of gums, a hyperglycemia, hypostases of the lower extremities. 

Interaction with other medicines:

- at co-administration with b-adrenoblockers, along with strengthening of ipotenzivny effect development of heart failure is possible; 

- at simultaneous use of nifedipine and quinidine reduction of concentration of quinidine in a blood plasma is noted. 

- in combination with nitrates strengthening of anti-anginal effects is observed; 

- the concomitant use of Cimetidinum, anti-hypertensive means, diuretics, tricyclic antidepressants, can lead to strengthening of hypotensive effect 

- at co-administration of Nikardiya with digoxin and theophylline increase in concentration of digoxin and theophylline in a blood plasma is noted that demands correction of their dose; 

- simultaneous performing therapy with rifampicin leads to easing of efficiency of nifedipine since rifampicin induces activity of enzymes of a liver, accelerating nifedipine metabolism. 

Contraindications:

- acute myocardial infarction; 

- cardiogenic shock; 

- the expressed arterial hypotension (systolic arterial pressure - is lower than 90 mm hg); 

- hypersensitivity to nifedipine and other derivatives of dihydropyridine; 

- sick sinus syndrome; 

- the expressed heart failure; 

- the expressed aortal stenosis; 

- idiopathic hypertrophic subaortal stenosis; 

- pregnancy, lactation period; 

- children's age. 

Overdose:

Symptoms: arterial hypotension, tachycardia, oppression of activity of a sinus node, bradycardia, arrhythmia. 

Treatment: a gastric lavage with purpose of absorbent carbon, the symptomatic therapy directed to normalization of arterial pressure: intravenous administration of 10% of solution of Calcium chloratum or gluconate of calcium; at a sharp lowering of arterial pressure – intravenous infusions of noradrenaline; at development of heart failure – intravenous administration of strophanthin. 

Storage conditions:

To store at a temperature not above 25 °C, in protected from light and the place, unavailable to children. 

Issue conditions:

According to the recipe

Packaging:

Blisters on 10 tablets. In packaging of 50 and 100 tablets.