Buy Nifecard HL film-coated tablets 30 mg No. 30 in pharmacies

Composition and release form

10 pcs in blister; There are 2 or 3 blisters in a cardboard pack.

Pharmacodynamics

Nifedipine is a selective blocker of “slow” calcium channels, a 1,4-dihydropyridine derivative. Has antianginal and hypotensive effects. Reduces the flow of extracellular calcium into cardiomyocytes and smooth muscle cells of the coronary and peripheral arteries; in high doses inhibits the release of calcium ions from intracellular stores. Reduces the number of functioning channels without affecting the time of their activation, inactivation and recovery.

It uncouples the processes of excitation and contraction in the myocardium, mediated by tropomyosin and troponin, and in vascular smooth muscles, mediated by calmodulin. In therapeutic doses, it normalizes the transmembrane current of calcium ions, which is disturbed in a number of pathological conditions, primarily in arterial hypertension. Does not affect the tone of the veins. Strengthens coronary blood flow, improves blood supply to ischemic areas of the myocardium without developing the steal phenomenon, and activates the functioning of collaterals.

Improves myocardial function, reduces the force of heart contractions and myocardial oxygen demand. By dilating peripheral arteries, it lowers blood pressure and reduces total peripheral resistance and afterload on the heart. Almost no effect on the sinoauricular and atrioventricular nodes. Increases renal blood flow, causes moderate natriuresis.

Inhibits platelet aggregation and has antiatherogenic properties (especially with long-term use). Reduces pressure in the pulmonary artery and has a positive effect on the blood supply to the blood vessels of the brain.

Nifecard xl 30 mg 30 pcs. modified-release film-coated tablets

pharmachologic effect

Selective BMCC, a derivative of 1,4-dihydropyridine.
It has a vasodilating, antianginal and hypotensive effect. The use of Nifecard CL reduces the Ca2+ current in cardiomyocytes and smooth muscle cells of the coronary and peripheral arteries; in high doses suppresses the release of Ca2+ from intracellular stores. Reduces the number of functioning channels without affecting the time of their activation, inactivation and recovery. It uncouples the processes of excitation and contraction in the myocardium, mediated by tropomyosin and troponin, and in vascular smooth muscles, mediated by calmodulin. In therapeutic doses, it normalizes the transmembrane Ca2+ current, which is disturbed in a number of pathological conditions, primarily in arterial hypertension. Does not affect the tone of the veins.

Strengthens coronary blood flow, improves blood supply to ischemic areas of the myocardium without developing the “steal” phenomenon, and activates the functioning of collaterals. By dilating peripheral arteries, it reduces peripheral vascular resistance, myocardial tone, afterload, myocardial oxygen demand and increases the duration of LV diastolic relaxation. It has virtually no effect on the SA and AV nodes and does not have antiarrhythmic activity. Increases renal blood flow, causes moderate natriuresis. The negative chrono-, dromo- and inotropic effects are overlapped by reflex activation of the sympathoadrenal system and an increase in heart rate in response to peripheral vasodilation.

Time of onset of effect: 20 minutes - with oral administration of Nifecard CL, 5 minutes - with sublingual administration of capsule contents; duration of effect: 4-6 hours - for tablets and capsules, 12-24 hours - for prolonged forms.

Composition and release form Nifecard xl 30 mg 30 pcs. modified-release film-coated tablets

Tablets - 1 tablet:

• Active substance: nifedipine 30 mg;
• Excipients: povidone - 75 mg, sodium lauryl sulfate - 2.4 mg, hypromellose (hydroxypropyl methylcellulose) - 185.8 mg, Ludipress® (mixture of lactose monohydrate, povidone, crospovidone in the ratio 93:3.5:3.5) - 70 mg, talc (magnesium hydrosilicate) - 6 mg, magnesium stearate - 0.8 mg.
• Shell composition: hypromellose phthalate (hydroxypropyl methylcellulose phthalate) - 18.2 mg, triethyl citrate - 1.8 mg, hypromellose (hydroxypropyl methylcellulose 2910) - 3 mg, hyprolose (hydroxypropylcellulose) - 3 mg, macrogol (polyethylene glycol) - 1 mg, talc (magnesium hydrosilicate) - 0.5 mg, titanium dioxide - 1.93 mg, iron dye yellow oxide - 0.57 mg.

10 pieces. - blisters (3) - cardboard packs.

Description of the dosage form

Modified-release, light brownish-yellow to light brownish-orange, film-coated tablets, round, biconvex, with "NDP 30" debossed on one side; yellow in cross section.

Directions for use and doses

The dose of Nifecard HL is 1 tablet. 30 or 60 mg/day once. Dose selection begins with 30 mg/day, correction is carried out at intervals of 7-14 days.

The maximum daily dose is 90 mg.

Pharmacodynamics

Nifedipine is a selective CCB, a 1,4-dihydropyridine derivative. Has antianginal and antihypertensive effects. Reduces the flow of extracellular calcium into cardiomyocytes and smooth muscle cells of the coronary and peripheral arteries; in high doses inhibits the release of calcium ions from intracellular stores. Reduces the number of functioning channels without affecting the time of their activation, inactivation and recovery.

It uncouples the processes of excitation and contraction in the myocardium, mediated by tropomyosin and troponin, and in vascular smooth muscles, mediated by calmodulin. In therapeutic doses, it normalizes the transmembrane current of calcium ions, which is disturbed in a number of pathological conditions, primarily in arterial hypertension. Does not affect the tone of the veins. Strengthens coronary blood flow, improves blood supply to ischemic areas of the myocardium without developing the steal phenomenon, and activates the functioning of collaterals.

Improves myocardial function, reduces the force of heart contractions and myocardial oxygen demand. By expanding peripheral arteries, it lowers blood pressure and reduces peripheral vascular resistance and afterload on the heart. Almost no effect on the sinoatrial and AV nodes. Increases renal blood flow, causes moderate natriuresis.

Inhibits platelet aggregation and has antiatherogenic properties (especially with long-term use). Reduces pressure in the pulmonary artery and has a positive effect on the blood supply to the blood vessels of the brain.

Pharmacokinetics

Nifecard® CL, due to the delayed release of the active substance, provides a gradual, controlled increase in plasma concentrations of nifedipine. The plasma concentration of nifedipine reaches a plateau after approximately 6 hours and is maintained with minor fluctuations for 24 hours. Nifedipine is rapidly and almost completely absorbed after oral administration (92–98%). Characterized by a high percentage of binding to blood plasma proteins (90%). T1/2 is approximately 2 hours. Metabolized in the liver. No active metabolites were identified. It is excreted in the form of inactive metabolites mainly by the kidneys (80%) and bile (20%).

Nifedipine penetrates the blood-brain barrier and the placental barrier and is excreted in breast milk.

There is no cumulative effect.

Chronic renal failure, hemodialysis and peritoneal dialysis do not affect pharmacokinetics.

If liver function is impaired, the clearance of nifedipine is reduced. In case of severe liver dysfunction, dose adjustment may be required.

In elderly patients, when administered intravenously, the clearance of nifedipine was reduced by 33% compared to young healthy volunteers.

With long-term use, the development of tolerance to nifedipine may occur.

Indications for use Nifecard xl 30 mg 30 pcs. modified-release film-coated tablets

Angina pectoris (tension, stable without vasospasm, stable vasospastic, unstable vasospastic with ineffectiveness of beta-blockers and nitrates); arterial hypertension (including renovascular), relief of hypertensive crisis; Raynaud's disease and syndrome; spasm of the coronary arteries (during diagnostic or therapeutic interventions - percutaneous transluminal coronary angioplasty, vascular recanalization or coronary artery bypass grafting); differential diagnosis between functional and organic stenosis of the coronary arteries; hypertension in the “lesser” circulation.

Contraindications

Hypersensitivity to the components of Nifecard CL, severe arterial hypotension (systolic blood pressure below 90 mm Hg), pregnancy, lactation.

Carefully. Severe stenosis of the aortic orifice or mitral valve, HOCM, severe bradycardia or tachycardia, SSSU, CHF, mild or moderate arterial hypotension, severe cerebrovascular accidents, myocardial infarction with LV failure, gastrointestinal obstruction (for sustained-release forms), liver failure, renal insufficiency (especially patients on hemodialysis - a high risk of excessive and unpredictable decrease in blood pressure), older age, children under 18 years of age (the effectiveness and safety of use have not been studied).

Application of Nifecard chl 30 mg 30 pcs. modified-release film-coated tablets during pregnancy and lactation

The drug is contraindicated for use during pregnancy and breastfeeding.

special instructions

During treatment with Nifecard CL, care must be taken when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Overdose

Symptoms: headache, flushing of the facial skin, prolonged pronounced decrease in blood pressure, suppression of sinus node function, bradycardia, bradyarrhythmia.

Treatment: in case of severe poisoning (collapse, depression of the sinus node), gastric lavage is performed and activated charcoal is prescribed. The antidote is Ca2+ preparations: slow intravenous administration of 10% CaCl2 or calcium gluconate is indicated, followed by switching to a long-term infusion.

Side effects Nifecard xl 30 mg 30 pcs. modified-release film-coated tablets

From the cardiovascular system: tachycardia, arrhythmias, peripheral edema (ankles, feet, legs), manifestations of excessive vasodilation (asymptomatic decrease in blood pressure, “flushes” of blood to the facial skin, flushing of the facial skin, feeling of heat), excessive decrease in blood pressure (rarely), fainting , development or worsening of heart failure (usually worsening of an existing one). In some patients (especially with severe obstructive lesions of the coronary arteries), at the beginning of treatment or when the dose is increased, attacks of angina pectoris may occur, including the development of myocardial infarction (requires discontinuation of the drug).

From the nervous system: headache, dizziness, increased fatigue, asthenia, drowsiness. With long-term ingestion in high doses - paresthesia of the limbs, tremor, extrapyramidal (parkinsonian) disorders (ataxia, mask-like face, shuffling gait, stiffness of the arms or legs, tremor of the hands and fingers, difficulty swallowing), depression.

From the digestive system: dry mouth, increased appetite, dyspepsia (nausea, diarrhea or constipation); rarely - gum hyperplasia (bleeding, pain, swelling), with long-term use - liver dysfunction (intrahepatic cholestasis, increased activity of liver transaminases).

From the musculoskeletal system: rarely - arthralgia, swelling of the joints, myalgia.

From the hematopoietic organs: anemia, leukopenia, thrombocytopenia, thrombocytopenic purpura, asymptomatic agranulocytosis.

From the urinary system: increased daily diuresis, deterioration of renal function (in patients with renal failure).

Allergic reactions to the components of Nifecard HL: rarely - itching, urticaria, exanthema, autoimmune hepatitis.

Other: rarely - visual impairment (including transient loss of vision against the background of Cmax in plasma), gynecomastia (in elderly patients, completely disappearing after withdrawal), galactorrhea, hyperglycemia, pulmonary edema (difficulty breathing, cough, wheezing), increase in body weight.

Drug interactions

Reduces the concentration of quinidine in plasma.

The use of Nifecard CL increases the concentration of digoxin in plasma, and therefore the clinical effect and concentration of digoxin in plasma should be monitored.

Inducers of microsomal liver enzymes (rifampicin, etc.) reduce the concentration of Nifecard CL.

The severity of the decrease in blood pressure is enhanced by other antihypertensive drugs, nitrates, cimetidine (suppression of metabolism; ranitidine and famotidine do not have a significant effect on the metabolism of BMCC), inhalational anesthetics, diuretics and tricyclic antidepressants.

In combination with nitrates, tachycardia increases.

The hypotensive effect of Nifecard CL is reduced by sympathomimetics, NSAIDs (suppression of Pg synthesis in the kidneys and Na+ and fluid retention in the body), estrogens (fluid retention in the body).

Ca2+ preparations can reduce the effect of BMCC.

It can displace drugs characterized by a high degree of binding from their connection with proteins (including indirect anticoagulants - derivatives of coumarin and indanedione, anticonvulsants, NSAIDs, quinine, salicylates, sulfinpyrazone), as a result of which their concentrations in plasma may increase.

The use of Nifecard CL suppresses the metabolism of prazosin and other alpha-blockers, as a result of which the hypotensive effect may be enhanced.

Li+ preparations can enhance the toxic effects of Nifecard CL (nausea, vomiting, diarrhea, ataxia, tremor, tinnitus).

Procainamide, quinidine and other drugs that cause prolongation of the QT interval enhance the negative inotropic effect and may increase the risk of significant prolongation of the QT interval.

Pharmacokinetics

Nifecard® CL, due to the delayed release of the active substance, provides a gradual, controlled increase in plasma concentrations of nifedipine. The plasma concentration of nifedipine reaches a plateau after approximately 6 hours and is maintained with minor fluctuations for 24 hours. Nifedipine is rapidly and almost completely absorbed after oral administration (92–98%). Characterized by a high percentage of binding to blood plasma proteins (90%). T1/2 is approximately 2 hours. Metabolized in the liver. No active metabolites were identified. It is excreted in the form of inactive metabolites mainly by the kidneys (80%) and bile (20%).

Nifedipine penetrates the blood-brain barrier and the placental barrier and is excreted in breast milk.

There is no cumulative effect. Chronic renal failure, hemodialysis and peritoneal dialysis do not affect pharmacokinetics. With long-term use, the development of tolerance to nifedipine may occur.

Nifecard HL

Nifecard CL (INN - nifedipine) is a blocker of the so-called “slow” calcium channels or, as representatives of this pharmacological group are also called, a calcium antagonist. Calcium channel blockers are first-line drugs in the treatment of most cardiovascular diseases. Thus, dihydropyridine derivatives, including drugs with a short period of action, are widely used in the treatment of arterial hypertension. The history of the use of these drugs in cardiological practice has its ups and downs, and when long-acting dosage forms (with modified or controlled release) were created, this became a real breakthrough, because This ensured convenience and safety of use due to the gradual increase and stability of the concentration of the active substance in the blood. Data from clinical trials indicate not only the antihypertensive effectiveness of second-generation ihydropyridine derivatives, but also their positive effect on the organs that suffer most from arterial hypertension. Nifecard CL is a three-phase dosage form SR/GITS (slow release and gastrointestinal therapeutic system). It has antianginal (anti-ischemic) and antihypertensive effects. Inhibits the “traffic” of calcium ions from the extracellular space into the cells of the heart and blood vessels. At high therapeutic concentrations, it suppresses the release of calcium ions from intracellular stores. Turns off “extra” calcium channels from work, without affecting the time of their activation, inactivation and regeneration. As a result of the action of Nifecard CL, the processes of excitation reduction in the myocardium and vascular smooth muscles are uncoupled.

The drug has virtually no effect on the tone of the veins. Intensifies coronary blood flow, while improving blood supply to ischemic areas of the myocardium without the occurrence of the so-called. the “steal” phenomenon (worsening ischemia due to the outflow of blood into nearby, non-ischemic areas), activates collateral blood flow in the myocardium. While taking the drug, the functional characteristics of the myocardium improve, the heart no longer contracts so much, which reduces its need for oxygen. By increasing the lumen of peripheral arteries, Nifecard CL lowers blood pressure and reduces total peripheral vascular resistance and afterload. Has virtually no effect on the sinoatrial and atrioventricular nodes. Activates blood flow in the kidneys, slightly increasing sodium excretion from the body. Suppresses platelet aggregation (sticking together) and exhibits an antiatherogenic effect with long-term use. “Blows off steam” in the pulmonary artery, reducing the pressure in it. Improves blood supply to cerebral vessels.

After oral administration, Nifecard ChL is almost completely (92-98%) absorbed in the gastrointestinal tract. The slow release of the active substance ensures a smooth increase and subsequent stability of the concentration of nifedipine in the blood plasma. The drug is taken 1 time per day. The standard “starting” dose of nifecard CL is 30 mg. If necessary, this can be done gradually. at 1-2 week intervals, increase to the permissible maximum of 90 mg.

Contraindications

hypersensitivity to nifedipine or components of the drug and other 1,4-dihydropyridine derivatives;

severe arterial hypotension (sBP below 90 mm Hg);

severe stenosis of the aortic valve;

chronic heart failure in the stage of decompensation, cardiogenic shock (risk of developing myocardial infarction), acute period of myocardial infarction (during the first 4 weeks);

I trimester of pregnancy, lactation period.

With caution: severe stenosis of the aortic orifice or mitral valve, hypertrophic obstructive cardiomyopathy, severe tachycardia, sick sinus syndrome, malignant arterial hypertension, myocardial infarction with left ventricular failure, unstable angina, simultaneous administration of beta-blockers or cardiac glycosides, concomitant use of rifampicin, severe cerebrovascular accidents, liver and/or kidney dysfunction, hemodialysis (risk of arterial hypotension), age under 18 years (efficacy and safety have not been established).

Side effects

From the cardiovascular system: manifestations of excessive vasodilation (asymptomatic decrease in blood pressure, flushing of the facial skin, flushing of the facial skin, feeling of heat), tachycardia, palpitations, arrhythmia, peripheral edema, chest pain; rarely - excessive decrease in blood pressure, fainting, syncope; in some patients, especially at the beginning of treatment, angina attacks may occur, which requires discontinuation of the drug. Isolated cases of myocardial infarction have been described.

From the side of the central nervous system: headache, dizziness, increased fatigue, weakness, drowsiness. With long-term oral administration in high doses - paresthesia of the limbs, depression, anxiety, extrapyramidal (parkinsonian) disorders (ataxia, mask-like face, shuffling gait, stiffness in the movements of the arms and legs, tremor of the hands and fingers, difficulty swallowing).

From the digestive system: dry mouth, loss of appetite, dyspepsia (nausea, diarrhea or constipation); rarely - gum hyperplasia (bleeding, pain, swelling), with long-term use - liver dysfunction (intrahepatic cholestasis, increased activity of liver transaminases).

From the hematopoietic organs: anemia, asymptomatic agranulocytosis, thrombocytopenia, thrombocytopenic purpura, leukopenia.

Allergic reactions: rarely - skin itching, exanthema, exfoliative dermatitis, photodermatitis; very rarely - autoimmune hepatitis.

From the musculoskeletal system: arthritis; rarely - arthralgia, swelling of the joints, myalgia, convulsions of the upper and lower extremities.

From the urinary system: increased daily diuresis, deterioration of renal function (in patients with renal failure).

Other: rarely - difficulty breathing, cough; very rarely - visual impairment (including transient blindness at the maximum concentration of nifedipine in the blood plasma), gynecomastia (in elderly patients, completely disappearing after discontinuation of the drug), hyperglycemia, galactorrhea, pulmonary edema, bronchospasm, weight gain.

Buy Nifecard HL film-coated tablets 30 mg No. 30 in pharmacies

Instructions for use Nifecard HL tab p.o 30 mg No. 30

Dosage forms tablets 30 mg Synonyms Adalat Vero-Nifedipine Calcigard retard Cordafen Cordaflex Cordaflex RD Cordipin Cordipin retard Cordipin HL Corinfar Corinfar retard Corinfar Uno Nifedipine-FPO Nifecard CL Osmo-Adalat Phenigidine Group Calcium channel blockers of the dihydropyridine group International nonproprietary name Nifedipine Co becoming the Active substance - nifedipine. Manufacturers Lek DD (Slovenia) Pharmacological action Antianginal, hypotensive. Blocks calcium channels, inhibits the transmembrane flow of calcium ions into smooth muscle cells of arterial vessels and cardiomyocytes. Dilates peripheral, mainly arterial vessels, incl. coronary, lowers blood pressure, reduces total peripheral vascular resistance and afterload on the heart. Increases coronary blood flow, reduces the strength of heart contractions, heart function and myocardial oxygen demand. Improves myocardial function and helps reduce heart size in chronic heart failure. Reduces pressure in the pulmonary artery and has a positive effect on cerebral hemodynamics. Inhibits platelet aggregation, has antiatherogenic properties, improves post-stenotic circulation in atherosclerosis. Increases the excretion of sodium and water, reduces myometrial tone. When taken orally, it is quickly and completely absorbed. The bioavailability of all dosage forms is 40-60%. About 90% of the dose taken is bound to plasma proteins. After oral administration, the maximum concentration in plasma is created after 30 minutes, the half-life is 2-4 hours. It is excreted by the kidneys in the form of inactive metabolites and with feces. In small quantities it passes through the blood-brain barrier and the placental barrier and penetrates into breast milk. Does not have mutagenic or carcinogenic activity. Side effects From the cardiovascular system and blood (hematopoiesis, hemostasis: facial flushing with a feeling of heat, palpitations, tachycardia, hypotension (up to fainting), angina-like pain, very rarely - anemia, leukopenia, thrombocytopenia, thrombocytopenic purpura. With from the nervous system and sensory organs: dizziness, headache, stunnedness, changes in visual perception, impaired sensitivity in the arms and legs. From the gastrointestinal tract: constipation, nausea, diarrhea, gum hyperplasia (with long-term treatment), increased activity of liver transaminases. side of the respiratory system: bronchospasm. From the musculoskeletal system: myalgia, tremor. Allergic reactions: itching, urticaria, exanthema, exfoliative dermatitis. Others: swelling and redness of the hands and feet, photodermatitis, hyperglycemia, gynecomastia (in elderly patients) , burning sensation at the injection site (with intravenous administration) Indications for use Arterial hypertension, including hypertensive crisis, prevention of angina attacks (incl. Prinzmetal's angina), hypertrophic cardiomyopathy (obstructive, etc.), Raynaud's disease, pulmonary hypertension, broncho-obstructive syndrome. Contraindications Hypersensitivity, acute period of myocardial infarction (first 8 days), cardiogenic shock, severe aortic stenosis, heart failure in the stage of decompensation, severe arterial hypotension, tachycardia, pregnancy, breastfeeding. Restrictions on use: You should refrain from using the drug in pediatric practice, since the safety and effectiveness of its use in children have not been determined. Method of administration and dosage Orally, during or after meals, in the form of tablets, capsules, dragees, adults - 10 mg 3-4 times a day. In special cases (variant angina, severe arterial hypertension), it is possible to increase the dose to 20 mg 4-6 times a day for a short time. The maximum daily dose is 120 mg. For arterial hypertension - 10 mg 3 times a day (if necessary, the dose is increased over 7-14 days to 20-30 mg per dose. To relieve a hypertensive crisis and an attack of angina, 10-20 mg sublingually or orally once, if necessary - through 10 minutes repeatedly in the form of capsules and tablets of prolonged action (it is recommended to first bite or puncture the capsule) - 20-40 mg 2 times a day (for Prinzmetal's angina - up to 120 mg / day); in the form of ultraretard tablets - 40-80 mg 1 once a day (the tablet is not chewed). Overdose Symptoms: severe bradycardia, bradyarrhythmia, arterial hypotension, in severe cases - collapse, conduction slowdown. When taking a large number of retard tablets, signs of intoxication appear no earlier than 3-4 hours later and may additionally expressed in loss of consciousness up to coma, cardiogenic shock, convulsions, hyperglycemia, metabolic acidosis, hypoxia.Treatment: gastric lavage, intake of activated charcoal, administration of norepinephrine, calcium chloride or calcium gluconate in atropine solution intravenously. Hemodialysis is ineffective. Interaction The hypotensive effect is enhanced by nitrates, diuretics, beta-blockers, tricyclic antidepressants, fentanyl, and alcohol. Increases the activity of theophylline, reduces the renal clearance of digoxin. Increases the side effects of vincristine (reduces excretion). Increases the bioavailability of cephalosporins (cefixime). Cimetidine and ranitidine increase plasma levels. Diltiazem slows metabolism (requires a reduction in the dose of nifedipine). Incompatible with rifampicin (accelerates biotransformation and does not allow creating effective concentrations). Grapefruit juice (large quantities) increases bioavailability. Increases the concentration of cardiac glycosides in the blood. Special instructions: Elderly patients are advised to reduce the daily dose (decreased metabolism). Use with caution while working for vehicle drivers and people whose profession involves increased concentration. The drug should be discontinued gradually. In patients with stable angina, at the beginning of treatment, a paradoxical increase in anginal pain may occur; with severe coronary sclerosis and unstable angina, aggravation of myocardial ischemia may occur. It is not recommended to use short-acting drugs for long-term treatment of angina or hypertension, because the development of unpredictable changes in blood pressure and reflex angina is possible. Storage conditions Store at room temperature, in a cool, dry place, away from children.

Interaction

The severity of the decrease in blood pressure increases with the simultaneous use of other antihypertensive drugs, beta-blockers, nitrates, cimetidine (to a lesser extent ranitidine), inhalational anesthetics, diuretics and tricyclic antidepressants.

Nifedipine causes a decrease in the concentration of quinidine in the blood plasma; after discontinuation of nifedipine, a sharp increase in the concentration of quinidine may occur.

Increases the plasma concentration of digoxin and theophylline, and therefore the clinical effect and the content of digoxin and theophylline in the blood plasma should be monitored.

Inducers of microsomal liver enzymes (rifampicin, etc.) reduce the concentration of nifedipine.

In combination with nitrates, tachycardia increases. The hypotensive effect is reduced by sympathomimetics, NSAIDs, estrogens, and calcium supplements.

Nifedipine can displace drugs characterized by a high degree of binding from protein binding (including indirect anticoagulants - coumarin and indanedione derivatives, anticonvulsants, NSAIDs, quinine, salicylates, sulfinpyrazone), as a result of which their concentration in the blood plasma may increase.

Nifedipine inhibits the elimination of vincristine from the body and may cause increased side effects of vincristine; if necessary, the dose of vincristine is reduced.

Nifedipine may enhance the toxic effects of lithium preparations (nausea, vomiting, diarrhea, ataxia, tremor, tinnitus).

With the simultaneous administration of cephalosporins (for example, cefixime) and nifedipine, the bioavailability of cephalosporin increases by 70%.

Grapefruit juice suppresses the metabolism of nifedipine in the body, and therefore their simultaneous use is contraindicated.

Overdose

Symptoms: peripheral vasodilation with severe and possibly prolonged systemic arterial hypotension (headache, flushing of the facial skin, prolonged pronounced decrease in blood pressure, depression of the sinus node, bradycardia and/or tachycardia, bradyarrhythmia).

In case of severe poisoning - loss of consciousness, coma.

Treatment: consists of standard procedures for removing the drug from the body (prescription of activated carbon, gastric lavage), restoration of stable hemodynamic parameters, careful monitoring of the activity of the heart, lungs and excretory system. Due to the high degree of binding to plasma proteins, hemodialysis is ineffective. The antidote is calcium preparations.

The clearance of nifedipine is increased in patients with impaired liver function.

special instructions

It is recommended to discontinue treatment with Nifecard® XL gradually. It should be borne in mind that angina pectoris may occur at the beginning of treatment, especially after recent abrupt withdrawal of beta-blockers (the latter should be withdrawn gradually).

The simultaneous administration of beta-blockers must be carried out under conditions of careful medical supervision, as this may cause an excessive decrease in blood pressure, and in some cases, aggravation of symptoms of heart failure.

In case of severe heart failure, the drug is dosed with great caution.

Diagnostic criteria for prescribing the drug for vasospastic angina are: a classic clinical picture, accompanied by an increase in the ST segment, the occurrence of ergonovine-induced angina or coronary artery spasm, detection of coronary spasm during angiography or identification of an angiospastic component without confirmation (for example, with a different voltage threshold or with unstable angina, when ECG data indicate transient vasospasm).

For patients with severe obstructive cardiomyopathy, there is a risk of increased frequency, severity and duration of angina attacks after taking nifedipine; in this case, discontinuation of the drug is necessary.

In patients on hemodialysis with high blood pressure and irreversible kidney failure, with a reduced total blood volume, the drug should be used with caution; a sharp drop in blood pressure may occur.

Patients with impaired liver function are closely monitored and, if necessary, reduce the dose of the drug and/or use other dosage forms of nifedipine.

If during therapy the patient requires surgery under general anesthesia, it is necessary to inform the anesthesiologist about the nature of the therapy being performed.

During treatment, positive results are possible with direct Coombs test and laboratory tests for antinuclear antibodies.

Impact on psycho-emotional abilities

During the treatment period, you must be careful when engaging in potentially hazardous activities that require increased concentration and speed of psychomotor reactions, and refrain from drinking ethanol.

Nifecard HL tablet p/pl.ob. with control vysv. 60 mg per blister. in pack №10x3

Name

Nifecard HL tablet p/pl.ob. with control vysv. 60 mg per blister. in pack №10x3

Description

60 mg: Pale brownish-yellow to pale brownish-orange, round, biconvex, film-coated 60 mg tablets with “NDP 60” debossed on one side. Unevenness and roughness of the surface are allowed.

Main active ingredient

Nifedipine

Release form

Pills

Dosage

60mg

pharmachologic effect

Pharmacodynamics

Nifedipine is a 1,4-dihydropyridine type calcium channel blocker. It reduces peripheral vascular resistance and therefore blood pressure. Nifedipine dilates large coronary arteries and arterioles in both normal and ischemic areas of the myocardium, and also significantly reduces spasm of the coronary arteries. Nifedipine increases the supply of oxygen to the myocardium, which is responsible for its effectiveness in the treatment of angina pectoris.

Pharmacokinetics

Nifedipine is rapidly and almost completely absorbed after oral administration (> 90%). Bioavailability is approximately 86%. Due to the prolonged release of the active substance, Nifecard HL provides a gradual, controlled increase in the plasma concentration of nifedipine, reaching a plateau approximately 6 hours after taking the first dose. After subsequent doses are taken at 24-hour intervals, plasma concentrations are maintained at a plateau level with minimal fluctuations. The binding of nifedipine to plasma proteins depends on the concentration and varies between 92–98%. In patients with impaired renal or hepatic function, protein binding may be reduced. Nifedipine is largely metabolized in the liver. The metabolites are inactive, highly soluble in water and, along with trace amounts of unchanged nifedipine, are excreted in the urine, accounting for 60% to 80% of the administered dose. The rest of nifedipine is excreted in the feces in the form of metabolites excreted in bile. The pharmacokinetics of nifedipine depends little on the degree of renal dysfunction. With normal liver and kidney function, the half-life of nifedipine from plasma ranges from 2 to 5 hours (in standard dosage forms). Most of nifedipine is excreted in the urine. Nifedipine is practically not excreted by hemodialysis and hemosorption. Impaired renal function Pharmacokinetics are no different. Therefore, if renal function is impaired, there is no need to adjust the dose of the drug. Impaired liver function The half-life of the drug is significantly increased, and the overall clearance is reduced. An increase in half-life of up to 7 hours has been reported in patients with cirrhosis. Children Nifedipine exhibits antihypertensive effects, but the recommended dose, long-term safety and effects on the cardiovascular system remain unknown. There is no dosage form for children.

Indications for use

Nifecard CL is indicated for adults for the treatment of: - for the treatment of all degrees of arterial hypertension; - for the prevention of attacks of chronic stable angina, both as monotherapy and in combination with beta-blockers.

Directions for use and doses

Doses For mild to moderate arterial hypertension, the recommended starting dose is 20 mg once daily. For severe arterial hypertension, the recommended starting dose is 30 mg (1 tablet) once a day. If necessary, the dose can be increased according to individual indications to a maximum of 90 mg once a day. For the prevention of angina attacks, the recommended starting dose is 30 mg (1 tablet) once a day. According to individual indications, the dose can be increased to a maximum of 90 mg once a day. When patients are transferred from therapy with other calcium antagonists, such as diltiazem or verapamil, to therapy with Nifecard CL, the preventive antianginal effect is maintained. With this transition, the recommended initial dose of Nifecard CL is 30 mg once a day. According to clinical indications, the dose can be gradually increased. When used concomitantly with CYP3A4 inhibitors or inducers, nifedipine dose adjustment or drug discontinuation may be required. Duration of treatment Unlimited. Special categories of patients Children The safety and effectiveness of treatment with Nifecard HL in children under 18 years of age has not been established. Elderly patients No dose adjustment is required in patients over 65 years of age. Patients with impaired renal function No dose adjustment is required in patients with impaired renal function. Directions for use: For oral administration. The tablets are swallowed whole with a glass of water, regardless of meals, always at the same time of day, preferably in the morning. Nifecard HL tablets should be swallowed whole; they are not allowed to be broken, chewed or crushed. Nifecard XL should not be taken simultaneously with grapefruit juice.

Use during pregnancy and lactation

Fertility If in vitro fertilization fails repeatedly and there are no other explanations, the use of calcium channel blockers such as Nifecard XL may be a possible cause, since they can impair sperm function by causing reversible biochemical changes in the head of the sperm. Pregnancy Nifecard CL should not be used during pregnancy, except in cases where, due to the clinical condition of the patient, the use of this drug is necessary. The drug should be prescribed only to women with severe arterial hypertension when standard therapy is ineffective. Based on the available information, a negative effect of the drug on the fetus or newborn cannot be excluded. According to the available clinical data, no specific prenatal risk was identified. However, there was an increase in the number of perinatal asphyxias, caesarean sections, as well as premature births and intrauterine growth retardation. What exactly could have caused this increase—hypertension, its therapy, or the specific effect of the drug—has not been clarified. Blood pressure should be closely monitored, especially when used in combination with intravenous magnesium sulfate, due to the potential for excessive reduction in blood pressure, which may cause harm to both the mother and the fetus. Acute pulmonary edema has been observed when calcium channel blockers, including nifedipine, were used as a tocolytic during pregnancy, especially in pregnancies with two or more fetuses, with intravenous administration of the drug and/or concomitant use of beta-2 receptor agonists. Breastfeeding Nifedipine is excreted into breast milk. Its concentration in breast milk is almost similar to that in the mother's blood plasma. This drug is not recommended for use during breastfeeding.

Precautionary measures

Caution should be exercised in patients with severe hypotension (severe hypotension with systolic pressure less than 90 mmHg), symptomatic heart failure and severe aortic valve stenosis. For symptomatic heart failure caused by left ventricular systolic dysfunction, the drug is prescribed with caution. In patients with a left ventricular ejection fraction of less than 30%, the use of calcium channel antagonists is not recommended. The drug should not be used in patients with obstructive cardiomyopathy. In severe obstructive coronary artery disease, nifedipine may (although rarely) increase the frequency, severity and duration of angina attacks. In such cases, the drug is discontinued. With malignant arterial hypertension and hypovolemia in patients on hemodialysis, blood pressure (BP) may sharply decrease, which is the result of vasodilation. Nifedipine is metabolized by the CYP3A4 isoenzyme of the cytochrome P450 system. Drugs that inhibit or induce this enzyme may affect both the first pass of nifedipine through the liver and its clearance (see “Interactions with other medicinal products and other types of interactions”). Drugs that can inhibit the CYP3A4 isoenzyme of the cytochrome P450 system and, therefore, increase the concentrations of nifedipine in the blood plasma include: - macrolide antibiotics (eg, erythromycin); - HIV protease inhibitors (eg, ritonavir); - azole antifungal drugs (eg, ketoconazole); - antidepressants nefazodone and fluoxetine; - quinupristin/dalfopristin; - valproic acid; - cimetidine. When used together with the listed active substances, careful monitoring of blood pressure is required and, if necessary, a reduction in the dose of nifedipine. Use for liver failure If liver function is impaired, discontinuation of the drug is necessary (see “Contraindications”). Use in diabetes mellitus Prescribing Nifecard CL may require adjustment of hypoglycemic therapy. In patients with possible hyperglycemia, the drug is prescribed with caution. Use for severe cerebrovascular diseases Low doses should be used. When prescribing Nifecard CL tablets to patients with gastrointestinal tract (GIT) stenoses, due to the possible development of symptoms of obstruction or bezoar formation, caution should be exercised (see “Contraindications”). Isolated cases of the development of obstructive symptoms in the absence of any gastrointestinal disorders in the anamnesis have been described. When performing an X-ray examination using barium contrast, Nifecard CL tablets may cause false-positive results (for example, filling defects that can be mistakenly regarded as polyps). Information on some excipients The drug contains lactose monohydrate, so it should not be taken by patients with rare hereditary disorders such as galactose intolerance, lactase deficiency or glucose-galactose malabsorption syndrome.

Interaction with other drugs

Medicines affecting nifedipine Metabolism of nifedipine is mainly carried out through the CYP3A4 isoenzyme, localized in the liver and intestinal mucosa. Substances that inhibit or induce this enzyme may affect both the first passage of nifedipine through the liver (when administered orally) and its clearance (see "Special Instructions and Precautions for Use"). The strength and duration of drug interactions should be taken into account when nifedipine is co-administered with the following medicinal products. Drugs that induce the CYP3A4 isoenzyme Rifampicin is a highly active inducer of the CYP3A4 isoenzyme of the cytochrome P450 system. When used simultaneously with rifampicin, the bioavailability of nifedipine is significantly reduced, thereby reducing its effectiveness. Therefore, the use of nifedipine in combination with rifampicin is contraindicated (see “Contraindications”). Medicines that increase the exposure of nifedipine: - macrolide antibiotics (eg, erythromycin); - HIV protease inhibitors (eg, ritonavir); - azole antifungals (eg, ketoconazole); - fluoxetine; - nefazodone; - quinupristin/dalfopristin; - cisapride; - valproic acid; - cimetidine; - diltiazem. When used simultaneously with inducers of the CYP3A4 isoenzyme of the cytochrome P450 system, the clinical response to nifedipine should be monitored and, if necessary, an increase in the dose of nifedipine should be considered. If the dose of nifedipine was increased during concomitant therapy with these drugs, then when discontinuing them, a reduction in the dose of nifedipine should be considered. Medicines that reduce the exposure of nifedipine: - rifampicin (see above); - phenytoin; - carbamazepine; - phenobarbital. Effect of nifedipine on other drugs Nifedipine may enhance the hypotensive effect of concomitant antihypertensive drugs. When using nifedipine simultaneously with beta-blockers, the patient's condition requires careful monitoring, since in isolated cases heart failure has worsened. Digoxin. When used together, nifedipine may reduce the clearance of digoxin and, therefore, increase its plasma concentration. Therefore, as a precaution, it is necessary to monitor for signs of digoxin overdose and, if necessary, reduce the dose of this glycoside. Quinidine. With the simultaneous use of nifedipine and quinidine, a decrease in the concentration of the latter in the blood plasma may be observed, and after discontinuation of nifedipine, in some cases, a noticeable increase in the concentration of quinidine in plasma may be observed. Therefore, when prescribing or discontinuing nifedipine, it is recommended to monitor the level of quinidine in the blood plasma and, if necessary, adjust the dose of quinidine. Blood pressure should be carefully monitored and the dose of nifedipine reduced if necessary. Tacrolimus. Tacrolimus is metabolized by the CYP3A4 isoenzyme of the cytochrome P450 system. Published data indicate that when nifedipine and tacrolimus are used concomitantly, the dose of the latter can be reduced in selected cases. When using both drugs simultaneously, plasma concentrations of tacrolimus should be monitored and, if necessary, a dose reduction should be considered. Interaction with food Grapefruit juice inhibits the CYP3A4 isoenzyme of the cytochrome P450 system. Simultaneous administration leads to an increase in the concentration of nifedipine in the blood plasma, enhancing the hypotensive effect of nifedipine. With regular consumption of grapefruit juice, this effect can persist for another 3 days after its last use. During treatment with nifedipine, you should avoid eating grapefruits or grapefruit juice (see “Dosage and Administration”). Other interactions Nifedipine may cause a false increase in the spectrophotometric values ​​of vanillyl mandelic acid without affecting HPLC readings.

Contraindications

- Hypersensitivity to the active substance, other dihydropyridines or to any of the excipients of the drug; - cardiogenic shock, aortic stenosis (clinically significant), unstable angina, myocardial infarction and in the first 4 weeks after it; - attack of angina pectoris; - malignant arterial hypertension (the safety of nifedipine has not been established); - liver dysfunction; — obstruction of the gastrointestinal tract, esophagus or narrowing of the lumen of the gastrointestinal tract of any degree in the anamnesis; — patients with valve ileostomy according to Kokk (ileostomy after proctocolectomy); - inflammatory bowel disease or Crohn's disease; — Nifecard CL cannot be used for secondary prevention of myocardial infarction; — Nifecard CL cannot be used in combination with rifampicin.

Compound

Each film-coated, controlled-release tablet contains 60 mg of nifedipine. Excipients Core: povidone, sodium lauryl sulfate, hypromellose, Ludipress® (a mixture of lactose monohydrate, povidone and crospovidone), talc, magnesium stearate. Shell: hypromellose phthalate, triethyl citrate, hypromellose, hydroxypropylcellulose, polyethylene glycol 400, talc, titanium dioxide (E171), iron oxide yellow (E172).

Overdose

In case of severe intoxication with nifedipine, the following symptoms are possible: impaired consciousness up to coma, drop in blood pressure, heart rhythm disturbances such as tachycardia or bradycardia, hyperglycemia, metabolic acidosis, hypoxia, cardiogenic shock with pulmonary edema. The main goal of treatment is to remove the active substance of the drug and achieve hemodynamic stability. In case of oral administration, gastric lavage is indicated, if necessary in combination with small intestinal lavage, especially in case of intoxication with slow-release drugs. Nifedipine is not eliminated by dialysis, but the use of plasmapheresis is recommended (due to the high degree of binding of nifedipine to plasma proteins and the relatively low volume of distribution). Heart rhythm disturbances such as bradycardia are treated symptomatically with β-sympathomimetics; Life-threatening cases of heart rhythm disturbances such as bradycardia require the installation of a temporary pacemaker. Hypotension in cardiogenic shock and arterial vasodilation should be treated with calcium preparations (10–20 ml of 10% calcium gluconate solution IV slowly, the administration can be repeated if necessary). As a result, serum calcium levels may reach or slightly exceed the upper limit of normal values. If the use of a calcium supplement fails to achieve the required increase in blood pressure, vasoconstrictor sympathomimetics such as dopamine or norepinephrine are additionally prescribed. The dose of these drugs is determined solely by the effect achieved. Due to the risk of cardiac overload, additional fluid and volume replacement solutions should be administered with caution.

Side effect

The following are adverse drug reactions (ADRs) observed in placebo-controlled studies of nifedipine (Clinical Trials Database (nifedipine n = 2661; placebo n = 1486; accessed February 22, 2006) and the ACTION study (nifedipine n = 3825 ; placebo n = 3840)). They are classified into frequency categories developed by CIOMS III. ADRs classified as “common” were observed with a frequency of less than 3%, with the exception of edema (9.9%) and headache (3.9%). The incidence of adverse reactions to drugs containing nifedipine is summarized below. Within each frequency category, adverse reactions are presented in order of decreasing severity. The frequency of reactions was determined as follows: frequent (≥1/100 and

Storage conditions

Keep out of the reach of children. Store in original packaging at a temperature not exceeding 25 °C.

Buy Nifecard HL tablet p/pl.ob. with control vysv. 60 mg per blister. in pack No. 10x3 in the pharmacy

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