Active substanceNifedipineNifedipine
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  • Dosage form: & nbsppills
    Composition:

    Each tablet contains as active substance nifedipine - 0.01 g.

    Excipients: potato starch, milk sugar, aerosil, magnesium stearate, microcrystalline cellulose, low molecular weight polyvinylpyrrolidone, - to a tablet weighing 0.1 g.

    Description:

    Tablets are yellow, flat, cylindrical with a bevel.

    Pharmacotherapeutic group:Calcium channel blocker, dihydropyridine derivative
    ATX: & nbsp

    C.08.C.A.05   Nifedipine

    Pharmacodynamics:Nifedipine has an antianginal and antihypertensive effect. Inhibits the intake of calcium ions, mainly in the cells of the smooth muscles of arterial vessels. Reduces spasm and expands coronary and peripheral (mainly arterial) vessels, lowers blood pressure, general peripheral vascular resistance and slightly -contractility of the myocardium, reduces afterload and the need for myocardium in oxygen. Increases coronary blood flow. Does not have a depressing effect on the conduction system of the heart.
    Indications:

    - Ischemic heart disease - stable angina (including variant angina);

    - arterial hypertension (in the form of monotherapy or in combination with other antihypertensive drugs).

    Contraindications:

    - Acute stage of myocardial infarction (first week);

    - cardiogenic shock;

    - severe arterial hypotension (systolic blood pressure below 90 mm Hg);

    - hypersensitivity to nifedipine and other dihydropyridine derivatives;

    - syndrome of weakness of the sinus node;

    - severe heart failure;

    - severe aortic stenosis;

    - idiopathic hypertrophic subaortic stenosis;

    - pregnancy, lactation;

    - children's age till 18 years.

    Carefully:

    Assign with caution to patients:

    - with severe heart failure,

    - severe disorders of cerebral circulation,

    - Diabetes mellitus,

    - malignant hypertension,

    - with impaired liver and / or kidney function;

    - patients who are on hemodialysis (because of the risk of arterial hypotension).

    Pregnancy and lactation:When prescribing the drug, nursing mothers should decide whether to stop breastfeeding;
    Dosing and Administration:The dosage regimen is set individually, depending on the degree of severity of the disease and the patient's response to ongoing therapy. It is recommended to take the drug during or after a meal, with a small amount of water. Initial dose: 1 tablet (10 mg) 2-3 times a day. If necessary, the dose of the drug can be increased to 2 tablets (20 mg) 2-3 times a day. The maximum daily dose is 80 mg. In elderly patients or patients receiving combined (antianginal or antihypertensive) therapy, lower doses of nifedipine are usually prescribed.
    Side effects:

    From the cardiovascular system: possibly - hyperemia of the face, a feeling of heat, tachycardia, peripheral edema, lowering of blood pressure. In some patients, especially at the beginning of treatment, angina attacks may occur, which requires the withdrawal of the drug;

    From the central nervous system: headache, dizziness, fatigue, drowsiness. When applying high doses of the drug, single cases of paresthesia of the extremities, tremor, visual impairment, sleep disturbance were noted;

    From the gastrointestinal tract and liver: nausea, constipation, diarrhea. With prolonged use of the drug, there may be cases of increased activity of "hepatic" transaminases, the occurrence of intrahepatic cholestasis;

    On the part of the hematopoiesis system: in rare cases - reversible thrombocytopenia, leukopenia, anemia;

    From the urinary system: an increase in daily diuresis; in patients with renal failure - impaired renal function;

    Allergic and immunopathological reactions: rarely - hives, itchy skin;

    Others: with long-term use - myalgia, gynecomastia, gingival hyperplasia, hyperglycemia, edema of the lower extremities.

    Overdose:

    Symptoms: decrease in arterial pressure, tachycardia, suppression of sinus node activity, bradycardia, arrhythmia.

    Treatment: gastric lavage with the appointment of activated charcoal, symptomatic therapy,aimed at stabilizing the activity of the cardiovascular system and respiration.

    Interaction:

    - With the simultaneous appointment of beta-blockers, along with the strengthening of the hypotensive effect, the development of heart failure is possible;

    - with the simultaneous use of nifedipine and quinidine a decrease in the concentration of quinidine in the blood plasma;

    - in combination with nitrates there is an increase in antianginal effects;

    - simultaneous reception cimetidine, antihypertensive agents, diuretics, tricyclic antidepressants, can lead to an increase in the hypotensive effect;

    - with the simultaneous administration of nifedipine with digoxin and theophylline there is an increase in the concentration of digoxin and theophylline in the blood plasma, which requires correction of their dose;

    - simultaneous therapy with rifampicin leads to a weakening of the effectiveness of nifedipine, tk. rifampicin induces the activity of liver enzymes, accelerating the metabolism of nifedipine.

    Special instructions:

    - The termination of treatment with the drug must be made gradually because of the possible development of the "withdrawal" syndrome;

    - During treatment with nifedipine, you should refrain from drinking alcohol.

    Effect on the ability to drive transp. cf. and fur:With caution, prescribe the drug to vehicle drivers and other professionals requiring a quick mental or physical reaction.
    Form release / dosage:

    Tablets 10 mg.

    Packaging:10 tablets per contour cell pack. For 5 contour mesh packages together with the instruction for use are placed in a pack of cardboard.
    Storage conditions:

    In a dry, protected from light place at a temperature of no higher than 25 ° C. Keep out of the reach of children.

    Shelf life:

    3 years.

    Do not use after the expiration date printed on the package.

    Terms of leave from pharmacies:On prescription
    Registration number:P N001584 / 01-2002
    Date of registration:22.07.2008 / 20.07.2009
    Expiration Date:Unlimited
    The owner of the registration certificate:OBOLENSKOE PHARMACEUTICAL ENTERPRISE, CJSC OBOLENSKOE PHARMACEUTICAL ENTERPRISE, CJSC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp23.06.2018
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