At what pressure and how to take Kordaflex tablets according to the instructions for use, what do the reviews say and what are the available analogues? Cordaflex rd - instructions for use Application for violations of liver function

The page contains instructions for use Cordaflex. It is available in various dosage forms of the drug (tablets 10 mg, 20 mg retard, 40 mg RD), and also has a number of analogues. This annotation has been verified by experts. Leave your feedback about the use of Cordaflex, which will help other site visitors. The drug is used for various diseases (arterial hypertension or pressure reduction, angina pectoris, Raynaud's syndrome). The tool has a number of side effects and features of interaction with other substances. Doses of the drug differ for adults and children. There are restrictions on the use of the drug during pregnancy and during breastfeeding. Treatment with Kordaflex can only be prescribed by a qualified doctor. The duration of therapy may vary and depends on the specific disease. The composition of the drug.

Instructions for use and dosing regimen

The dosage regimen is set individually, depending on the severity of the disease and the patient's response to therapy.

Adults Cordaflex in the form of coated tablets are prescribed 10 mg (1 tablet) 3 times a day. If necessary, the dose of the drug can be increased to 20 mg (2 tablets) 1-2 times a day. The maximum daily dose is 40 mg. The interval between doses of the drug is at least 2 hours.

To accelerate the action of the drug at the beginning of the development of an attack of angina pectoris or a hypertensive crisis, the tablet should be chewed, held in the mouth for a while, and then swallowed with a small amount of water.

If it is necessary to increase the dose to 80-120 mg per day for the treatment of angina pectoris or arterial hypertension, it is recommended to transfer the patient to taking the drug in the form of prolonged-release tablets.

When carrying out course therapy, it is recommended to use Cordaflex in the form of prolonged-release tablets. The initial dose is 20 mg (1 tablet) 2 times a day with an interval of 12 hours. If necessary, the dose of the drug is gradually increased until the optimal clinical effect is achieved. For long-term maintenance therapy, as a rule, it is enough to take 20-40 mg (1-2 tablets) 2 times a day. The maximum daily dose is 120 mg.

With moderate impairment of liver or kidney function, correction of the dosing regimen is not required. With severe liver dysfunction, the maximum daily dose should not exceed 40 mg.

The drug in the form of tablets containing 10 mg of nifedipine is taken orally before meals, in the form of prolonged-release tablets - regardless of the meal, without chewing, with a small amount of water.

Kordaflex RD

The dose should be selected individually, depending on the severity of the patient's condition and the effectiveness of treatment.

In case of arterial hypertension, Cordaflex RD is prescribed 40 mg (1 tablet) 1 time per day. If necessary, the dose can be increased to 80 mg (2 tablets in 1-2 doses). Increasing the dose over 80 mg is not recommended.

With coronary artery disease, 40 mg (1 tablet) is prescribed 1 time per day. If necessary, the dose can be increased to 80 mg (2 tablets in 1 or 2 doses). Doses greater than 80 mg may be given in exceptional cases under medical supervision. The daily dose should not exceed 120 mg.

Tablets should be taken with meals (eg breakfast), swallowed whole and washed down with plenty of water.

In case of impaired renal or hepatic function, the drug is recommended to be used with caution in the same doses as in normal renal or hepatic function. Tolerance may develop. With a significant decrease in liver function, a dose of 40 mg per day should not be exceeded.

Compound

Nifedipine + excipients.

Release forms

Film-coated tablets 10 mg.

Long-acting tablets, film-coated 20 mg (retard).

Tablets with controlled release, coated 40 mg (Cordaflex RD).

Cordaflex- a selective blocker of slow calcium channels, a derivative of 1,4-dihydropyridine. It has antihypertensive and antianginal effects.

Nifedipine (the active substance of Cordaflex) reduces the flow of extracellular calcium ions into cardiomyocytes and smooth muscle cells of the coronary and peripheral arteries. In therapeutic doses, it normalizes the transmembrane current of calcium ions, which is disturbed in a number of pathological conditions, primarily in arterial hypertension. Reduces spasm and dilates coronary and peripheral arterial vessels, reduces OPSS, reduces afterload and myocardial oxygen demand. At the same time, it improves the blood supply to ischemic areas of the myocardium without the development of the "steal" syndrome, and also increases the number of functioning collaterals.

Cordaflex has practically no effect on the sinoatrial and AV node and does not have both pro- and antiarrhythmic effects. Does not affect the tone of the veins. Nifedipine increases renal blood flow, causing moderate natriuresis. In high doses, it inhibits the release of calcium ions from intracellular depots. Reduces the number of functioning calcium channels without affecting the time of their activation, inactivation and recovery.

After a single dose of Cordaflex, the duration of the effect exceeds 24 hours.

Pharmacokinetics

When taken orally, it is rapidly and almost completely (more than 90%) absorbed from the gastrointestinal tract. Bioavailability - 40-70%. After ingestion of 1 long-acting tablet 20 mg (retard), the therapeutic concentration of nifedipine in the blood plasma is reached after 1 hour and remains at a constant level for up to 6 hours (prolonged-release plateau), and gradually decreases over the next 30-36 hours. Binding to plasma proteins (albumin) is 94-97%. Unbound nifedipine is distributed in all organs and tissues. Penetrates through the blood-brain barrier (BBB) ​​(less than 5%), through the placental barrier, excreted in breast milk. Does not accumulate. Nifedipine is extensively metabolized in the liver with the formation of 3 metabolites that do not have pharmacological activity. 60-80% of the ingested dose of the drug is excreted in the urine in the form of inactive metabolites, the rest - with bile and feces. In elderly patients, the metabolism of nifedipine in the liver is reduced.

Indications

• arterial hypertension of various origins, including hypertensive crises (for 10 mg tablets);
• IHD: for the prevention of attacks in various forms of angina pectoris (stable and post-infarction), incl. angiospastic (Prinzmetal's angina);
• Raynaud's syndrome (for prolonged-release tablets).

Contraindications

• acute stage of myocardial infarction;
• cardiogenic shock;
• severe arterial hypotension (systolic blood pressure below 90 mm Hg);
• severe aortic or mitral stenosis, idiopathic hypertrophic subaortic stenosis;
• severe heart failure;
• 1 trimester of pregnancy;
• lactation period (breastfeeding);
• children and adolescents up to 18 years of age;
• hypersensitivity to nifedipine and other components of the drug.

special instructions

The antihypertensive effect of Cordaflex is enhanced by hypovolemia. The decrease in pressure in the pulmonary artery and hypovolemia after dialysis can also enhance the effects of the drug, and therefore a reduction in its dose is recommended.

In rare cases, at the beginning of the course of treatment with Cordaflex or with an increase in its dose shortly after taking the drug, chest pain (angina pectoris due to paradoxical ischemia) may occur. If a causal relationship between taking the drug and angina pectoris is found, treatment should be discontinued.

With arterial hypertension or coronary artery disease, abrupt withdrawal of nifedipine can cause a hypertensive crisis or myocardial ischemia (the "rebound" phenomenon).

If during therapy the patient requires surgical intervention under general anesthesia, it is necessary to inform the anesthesiologist about the ongoing Cordaflex therapy.

Elderly patients are more likely to have reduced cerebral blood flow due to severe peripheral vasodilation.

During course treatment with Cordaflex, the use of alcoholic beverages is not recommended due to the risk of an excessive decrease in blood pressure.

Influence on the ability to drive vehicles and control mechanisms

In the initial, individually determined period of application of Cordaflex, driving vehicles and engaging in other potentially hazardous activities that require quick psychomotor reactions are not allowed. In the course of further treatment, the degree of restriction is determined depending on the individual patient's response to the drug.

Side effect

• flushing of the skin of the face;
• severe arterial hypotension;
• peripheral edema;
• tachycardia;
• increased angina attacks (drug withdrawal required);
• increased heart failure;
• fainting;
• headache;
• dizziness;
• increased fatigue;
• sleep disturbances (drowsiness or insomnia);
• visual impairment;
• paresthesia in the limbs;
• tremor;
• diarrhea;
• constipation;
• nausea;
• heartburn;
• dry mouth;
• flatulence;
• gingivitis;
• anorexia;
• thrombocytopenia, thrombocytopenic purpura, leukopenia, anemia;
• increased daily diuresis;
• deterioration of kidney function in patients with chronic renal failure;
• myalgia;
• gynecomastia;
• hyperglycemia (completely disappear after discontinuation of the drug);
• change in body weight;
• galactorrhea;
• hives;
• exanthema;
• skin itching;
• autoimmune hepatitis;
• feeling of heat;
• weakness;
• sweating;
• fever;
• chills;
• photodermatitis.

drug interaction

Rational from the point of view of enhancing the antihypertensive and antianginal action is the combination of Cordaflex with beta-blockers, diuretics, ACE inhibitors, nitrates. All of the above combinations in most clinical situations are safe and effective, because they lead to summation or potentiation of effects, however, in some cases there is a risk of a pronounced decrease in blood pressure and an increase in symptoms of heart failure.

The combination of Cordaflex with clonidine, methyldopa, octadine, prazosin is possible, according to indications, but can cause severe orthostatic hypotension.

Strengthening of the hypotensive effect is also observed in combination therapy with cimetidine, ranitidine and tricyclic antidepressants.

Nifedipine increases the concentration of digoxin and theophylline in blood plasma, and therefore the clinical effect and / or the content of digoxin and theophylline in blood plasma should be monitored.

Procaine, quinidine and other drugs that cause QT interval prolongation increase the negative inotropic effect and increase the risk of QT interval prolongation. Under the influence of nifedipine, the concentration of quinidine in the blood serum is significantly reduced, which, apparently, is due to a decrease in its bioavailability, as well as the induction of enzymes that inactivate quinidine. With the abolition of nifedipine, a transient increase in the concentration of quinidine (approximately 2 times) is observed, which reaches a maximum level at 3-4 days. Caution should be exercised when using such combinations, especially in patients with impaired left ventricular function.

Nifedipine can displace drugs with a high degree of binding from protein binding (including indirect anticoagulants - coumarin and indandione derivatives, non-steroidal anti-inflammatory drugs (NSAIDs)), as a result of which their plasma concentrations may increase.

With simultaneous appointment with rifampicin, phenytoin and calcium preparations, the effect of nifedipine is weakened.

Nifedipine inhibits the excretion of vincristine from the body and may increase the side effects of vincristine, if necessary, reduce the dose of vincristine.

Diltiazem inhibits the metabolism of nifedipine in the body, if necessary, reduce the dose of nifedipine.

Grapefruit juice, erythromycin and azole antifungals (fluconazole, itraconazole, ketoconazole) can inhibit the metabolism of nifedipine and therefore enhance its effects.

Alcohol enhances the hypotensive effect of Nifedipine.

Similarly, the simultaneous use of Cordaflex and cimetidine increases the concentration of nifedipine in the blood plasma, enhances its effects; however, simultaneous use with ranitidine does not lead to a significant increase in the concentration of nifedipine in the blood plasma.

Since nifedipine is metabolized by the CYP3A4 isoenzyme, any inhibitor or inducer of this enzyme can affect the metabolism of nifedipine. Cyclosporine is also a substrate of the CYP3A4 isoenzyme; therefore, with the combined use of cyclosporine and nifedipine, each can increase the duration of the effect of the other.

Analogues of the drug Cordaflex

Structural analogues for the active substance:

• Adalat;
• Calciguard retard;
• Kordafen;
• Cordaflex RD;
• Cordipin;
• Cordipin retard;
• Corinfar;
• Corinfar retard;
• Corinfar UNO;
• Nicardia;
• Nicardia SD retard;
• Nifadil;
• Nifebene;
• Nifehexal;
• Nifedex;
• Nifedicap;
• Nifedicor;
• Nifedipine;
• Nifecard;
• Nifelat;
• Nifesan;
• Osmo Adalat;
• Sanfidipin;
• Sponif 10;
• Fenigidin.

Use in elderly patients

In elderly patients, the pharmacokinetics of nifedipine changes, and therefore the initial dose of the drug is reduced by 2 times and lower doses may be required to maintain the therapeutic effect.

Use in children

Due to the lack of sufficient clinical data, the drug is not recommended for use in children and adolescents under the age of 18 years.

Use during pregnancy and lactation

Excipients: cellulose - 10 mg, microcrystalline cellulose - 48.5 mg, lactose - 30 mg, hypromellose 4000 mPa.s - 20 mg, magnesium stearate - 1.5 mg, colloidal anhydrous silicon dioxide - 0.75 mg.

Shell composition: hypromellose 15 mPa.s - 2 mg, macrogol 6000 - 0.07 mg, macrogol 400 - 1.1 mg, red iron oxide (E172) - 0.9 mg, titanium dioxide (E171) - 2 mg, talc - 1 mg.

10 pieces. - blisters (1) - packs of cardboard.
10 pieces. - blisters (3) - packs of cardboard.

pharmachologic effect

Selective blocker of slow calcium channels, a derivative of 1,4-dihydropyridine. It has antihypertensive and antianginal effects.

Reduces the flow of extracellular calcium ions into cardiomyocytes and smooth muscle cells of the coronary and peripheral arteries. In therapeutic doses, it normalizes the transmembrane current of calcium ions, which is disturbed in a number of pathological conditions, primarily in arterial hypertension. Reduces spasm and dilates coronary and peripheral arterial vessels, reduces OPSS, reduces afterload and myocardial oxygen demand. At the same time, it improves the blood supply to ischemic areas of the myocardium without the development of the "steal" syndrome, and also increases the number of functioning collaterals.

Nifedipine has practically no effect on the sinoatrial and AV node and does not have both pro- and antiarrhythmic effects. Does not affect the tone of the veins. Nifedipine increases renal blood flow, causing moderate natriuresis. In high doses, it inhibits the release of calcium ions from intracellular depots. Reduces the number of functioning calcium channels without affecting the time of their activation, inactivation and recovery.

After a single dose of the drug RD, the duration of the effect exceeds 24 hours.

Pharmacokinetics

Suction

After oral administration, the drug is rapidly and almost completely (90%) absorbed from the gastrointestinal tract. When developing the dosage form of Cordaflex RD, zero-order release kinetics was chosen in order to ensure a constant release rate of the active substance. The relative bioavailability of Cordaflex RD is about 60%. C max in the blood is 29.4±12.0 ng/ml. The plasma concentration of the drug reaches a plateau after 7.4±6.4 hours after each dose. Cmax of nifedipine in blood plasma is achieved by combining the administration of Kordaflex RD with food. However, at the end of the dosing interval, the concentration of the drug in the blood plasma does not change.

After taking Cordaflex RD, after 24 hours, the concentration of nifedipine in the blood plasma reaches a minimum level of 12.0 ± 6.5 ng / ml, which is twice the concentration achieved after taking Cordaflex 20 mg tablets (usual dosage form) 2 times / day.

Distribution

Binding to plasma proteins (albumin) is 94-97%. Studies with labeled nifedipine in animals have shown that unbound nifedipine is distributed in all organs and tissues. It was found that the concentration of nifedipine is higher in the myocardium than in skeletal muscle. There is no cumulative effect.

Metabolism

Nifedipine is mainly metabolized in the liver to inactive metabolites.

breeding

60-80% of the ingested dose of the drug is excreted in the urine in the form of inactive metabolites, the rest - with bile and feces. ±6.0 h at steady state.

Pharmacokinetics in specific clinical settings

In case of impaired renal function, the pharmacokinetics of nifedipine does not change.

With a significant decrease in liver function, the clearance of nifedipine decreases, so it is not recommended to exceed the daily dose.

Indications

• arterial hypertension;
• stable angina (angina pectoris);
• post-infarction angina;
• angiospastic angina (Prinzmetal's angina).

Contraindications

• unstable angina;
• myocardial infarction with left ventricular failure;
• severe arterial hypotension with the risk of collapse in cardiovascular shock with respiratory manifestations;
• hypersensitivity to nifedipine, other components of the drug, other derivatives of 1,4-dihydropyridine.

FROM caution the drug should be used for acute myocardial infarction during the first 4 weeks, severe aortic stenosis, severe mitral valve stenosis, hypertrophic obstructive cardiomyopathy, severe bradycardia or tachycardia, SSS, chronic heart failure, severe cerebrovascular accident, renal or hepatic insufficiency (especially in patients on hemodialysis due to the high risk of excessive and unpredictable decrease in blood pressure), in patients under the age of 18 years (because safety and efficacy have not been established), in elderly patients (due to the greatest likelihood of age-related impairment of kidney and liver function ).

Dosage

The dose should be selected individually, depending on the severity of the patient's condition and the effectiveness of treatment.

At arterial hypertension Cordaflex RD is prescribed 40 mg (1 tab.) 1 time / day. If necessary, the dose can be increased to 80 mg (2 tablets in 1-2 doses). Increasing the dose over 80 mg is not recommended.

At ischemic heart disease appoint 40 mg (1 tab.) 1 time / day. If necessary, the dose can be increased to 80 mg (2 tablets in 1 or 2 doses). Doses greater than 80 mg may be given in exceptional cases under medical supervision. The daily dose should not exceed 120 mg.

Tablets should be taken with meals (eg breakfast), swallowed whole and washed down with plenty of water.

At kidney or liver dysfunction the drug is recommended to be used with caution in the same doses as in normal kidney or liver function. Tolerance may develop. At a significant decrease in liver function do not exceed a dose of 40 mg / day.

Side effects

From the side of the cardiovascular system: at the beginning of treatment - flushing of the skin of the face, a pronounced decrease in blood pressure, tachycardia; peripheral edema (ankles, feet, legs); rarely - an increase in angina attacks (which is typical for other vasoactive drugs and requires discontinuation of the drug), heart failure.

From the side of the central nervous system and peripheral nervous system: headache, dizziness, fatigue, drowsiness; with prolonged use in high doses - paresthesia in the limbs, tremor.

From the digestive system: nausea, heartburn, diarrhea or constipation; rarely with prolonged use - intrahepatic cholestasis, increased activity of hepatic transaminases (pass after drug withdrawal); in some cases - gingival hyperplasia.

From the hematopoietic system: rarely - thrombocytopenia, thrombocytopenic purpura, leukopenia; in some cases - anemia.

From the urinary system: increased daily diuresis; rarely - deterioration of kidney function in patients with chronic renal failure.

From the musculoskeletal system: myalgia; very rarely - arthritis, arthralgia.

Allergic reactions: rarely - urticaria, exanthema, pruritus; very rarely - photodermatitis.

Others: in some cases - visual impairment, gynecomastia, hyperglycemia (completely disappear after discontinuation of the drug), changes in body weight, galactorrhea.

In the vast majority of cases, Cordaflex RD is well tolerated by patients.

Overdose

Symptoms: headache, arterial hypotension, and also (as well as under the influence of other vasodilators) a violation of the energy supply of the myocardium (an attack of angina pectoris).

Treatment: immediately after an overdose, as a first aid, you can rinse the stomach and give. If necessary, small bowel lavage can be done, which is especially useful in case of an overdose of controlled release drugs.

Since nifedipine is highly bound to plasma proteins, dialysis is not effective, and plasmapheresis may be effective.

Symptoms of arrhythmia with bradycardia can be eliminated by the introduction of beta-sympathomimetics. For life-threatening bradycardia, an artificial pacemaker should be used.

In severe arterial hypotension, infusion of norepinephrine (norepinephrine) in standard doses is indicated. With the development of symptoms of heart failure, intravenous administration of fast-acting digitalis glycosides is recommended.

Due to the lack of a specific antidote, symptomatic therapy is indicated. Dopamine, isoprenaline and 10% (10-20 ml IV) can be used as antidotes.

drug interaction

Cordaflex RD can be successfully used as part of combination therapy.

Rational in terms of antihypertensive and antianginal effects is the combination of Cordaflex RD with beta-blockers, diuretics, ACE inhibitors, nitrates.

The combined use of Cordaflex RD with beta-blockers in most clinical situations is safe and highly effective, because. leads to summation and potentiation of effects, however, in some cases there is a risk of arterial hypotension and increased heart failure.

Strengthening of the hypotensive effect is also observed in combination therapy with cimetidine, ranitidine and tricyclic antidepressants.

Against the background of treatment with corticosteroids and NSAIDs, the effectiveness of Kordaflex RD does not decrease.

Cordaflex RD increases the concentration of digoxin and theophylline, in this regard, the clinical effect and / or the content of digoxin and theophylline in blood plasma should be monitored.

With simultaneous administration with rifampicin and calcium preparations, the effect of Cordaflex RD is weakened.

Procaine, quinidine and other drugs that cause QT interval prolongation increase the negative inotropic effect and increase the risk of QT interval prolongation. Under the influence of Kordaflex RD, the concentration of quinidine in the blood serum is significantly reduced, which, apparently, is due to a decrease in its bioavailability, as well as the induction of enzymes involved in the metabolism of quinidine. With the abolition of Kordaflex RD, a transient increase in the concentration of quinidine (approximately 2 times) is observed, which reaches its maximum level on days 3-4. The use of this combination requires caution, especially in patients with impaired left ventricular function.

Nifedipine can displace drugs with a high degree of binding from protein binding (including indirect anticoagulants - coumarin and indandione derivatives, anticonvulsants, NSAIDs), as a result of which their plasma concentrations may increase.

Because It has been shown that carbamazepine and phenobarbital, by activating liver enzymes, reduce the plasma concentration of other calcium channel blockers, a similar decrease in the plasma concentration of nifedipine cannot be ruled out.

Inhibiting the activity of enzymes, led to an increase in the concentration in the blood plasma of other calcium channel blockers, therefore, an increase in the concentration of nifedipine in the blood plasma while taking valproic acid cannot be ruled out.

Nifedipine inhibits the excretion of vincristine from the body and may increase its side effects (if necessary, reduce the dose of vincristine).

Diltiazem inhibits the metabolism of nifedipine in the body, careful monitoring is necessary, if necessary, reduce the dose of nifedipine.

Grapefruit juice inhibits the metabolism of nifedipine in the body, and therefore it is not recommended to use it with nifedipine.

special instructions

After myocardial infarction, the drug should be started only after stabilization of hemodynamic parameters.

Patients with acute myocardial infarction and within 30 days after it should not use short-acting calcium channel blockers derived from 1,4-dihydropyridine. When prescribing calcium channel blockers, controlled release derivatives of 1,4-dihydropyridine, to such patients, careful monitoring is necessary. These drugs are more appropriate to prescribe in the absence of a tendency to tachycardia, as well as in patients who have ineffective beta-blockers or have contraindications to their use.

In cases of insufficient effectiveness of Cordaflex RD monotherapy, it is advisable to continue treatment using effective combinations with other drugs.

Patients with heart failure before starting treatment with Cordaflex RD are recommended to conduct appropriate therapy with digitalis preparations.

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

Influence on the ability to drive vehicles and control mechanisms

In the initial individually determined period of treatment, it is necessary to refrain from potentially hazardous activities that require a quick mental and motor reaction. In the process of further treatment, the degree of restrictions is determined depending on the individual tolerability of the drug.

Pregnancy and lactation

The appointment of the drug Cordaflex RD during pregnancy can be recommended if it is impossible to use other drugs that do not have restrictions on the use.

Since nifedipine is excreted in breast milk, you should refrain from prescribing the drug during lactation, or stop breastfeeding during treatment.

Use in the elderly

FROM caution the drug should be used in elderly patients (due to the greatest likelihood of age-related disorders of the kidneys and liver).

Terms of dispensing from pharmacies

The drug is dispensed by prescription.

Terms and conditions of storage

The drug should be stored at a temperature not exceeding 30 ° C, protected from direct sunlight and out of the reach of children. Shelf life - 5 years.

pharmachologic effect

Selective calcium channel blocker class II, dihydropyridine derivative. Causes antianginal and hypotensive effects. Expands the coronary and peripheral arteries, reduces myocardial oxygen demand by reducing the afterload on the heart. It has a slight negative inotropic effect. Virtually no antiarrhythmic activity. Does not have a depressing effect on the conduction system of the heart. As a result of a decrease in peripheral vascular resistance and a decrease in blood pressure, it can cause a slight reflex tachycardia.

Pharmacokinetics

Suction
When taken orally, it is rapidly and almost completely (more than 90%) absorbed from the gastrointestinal tract. Bioavailability - about 50%. Cmax in the blood is achieved 1-3 hours after administration.
Distribution
Plasma protein binding - more than 90%.
Metabolism
Nifedipine is extensively metabolized in the liver with the formation of several metabolites that do not have pharmacological activity.
breeding
70-80% of nifedipine is excreted by the kidneys as inactive metabolites, the rest is through the intestines. T1 / 2 is 2-4 hours.
Pharmacokinetics in special clinical situations
In the elderly, the metabolism of nifedipine in the liver is reduced.

Indications

Ischemic heart disease: for the prevention (in some cases - relief) of attacks in various forms of angina pectoris, incl. angiospastic (Prinzmetal's angina);
- arterial hypertension of various origins;
- Raynaud's syndrome.

Dosing regimen

Adults Cordaflex 10 mg are prescribed 1 tab. 3-4 times / day. If necessary, the dose is gradually increased to 20 mg 2 times / day. The maximum daily dose is 40 mg.
When conducting course therapy, it is recommended to use a prolonged form of the drug - Cordaflex Retard 20 mg. The drug is prescribed 20-40 mg 2 times / day.
For the elderly, the initial dose of the drug is halved.
The drug is taken regardless of the meal.

Side effect

From the side of the cardiovascular system: severe arterial hypotension, hyperemia of the skin, peripheral edema, tachycardia; rarely - increased angina attacks.
From the side of the central nervous system and peripheral nervous system: sleep disturbances, drowsiness, minor transient visual impairment, paresthesia, tremor.
From the digestive system: diarrhea, constipation, nausea, heartburn, intrahepatic cholestasis, increased activity of hepatic transaminases; very rarely - hypertrophic gingivitis.
From the hemopoietic system: thrombocytopenia, leukopenia; rarely - anemia.
Allergic reactions: exanthema, pruritus.
Other: flushing of the face and skin of the upper body, fever, hyperhidrosis, myalgia, gynecomastia, decreased libido.

Contraindications

– cardiogenic shock;
- severe arterial hypotension (systolic blood pressure below 90 mm Hg);
- severe aortic stenosis, idiopathic hypertrophic subaortic stenosis;
– I trimester of pregnancy;
- severe heart failure;
- Hypersensitivity to nifedipine.

Pregnancy and lactation

Cordaflex is contraindicated for use in the first trimester of pregnancy.
The use of Cordaflex in pregnant women is indicated only in cases where the normalization of blood pressure is not possible with the use of other antihypertensive drugs.
Since nifedipine is excreted in breast milk, Cordaflex should be avoided during lactation or breastfeeding should be stopped during drug treatment.

special instructions

Cordaflex is prescribed with caution to patients with malignant hypertension, hypovolemia, or those on hemodialysis due to the risk of severe arterial hypotension against the background of peripheral vasodilation.
Elderly patients are more likely to have reduced cerebral blood flow due to severe peripheral vasodilation.
In cases of insufficient effectiveness of antianginal or hypotensive monotherapy with Cordaflex, combined treatment with the use of nitrates and beta-blockers is indicated.
In chronic heart failure, the combined use of Kordaflex and cardiac glycosides in individually determined doses is possible.
During course treatment with Cordaflex, alcohol is prohibited due to the risk of an excessive decrease in blood pressure.
Pediatric use
Due to the lack of sufficient clinical data, the drug is not recommended for use in children under the age of 18 years.
Influence on the ability to drive vehicles and control mechanisms
In the initial, individually determined period of application of Cordaflex, it is not allowed to drive vehicles and engage in other potentially hazardous activities that require quick psychomotor reactions. In the course of further treatment, the degree of restriction is determined depending on the individual patient's response to the drug.

Overdose

Symptoms: severe arterial hypotension, headache, collapse, tachycardia, inhibition of the sinus node, bradycardia, arrhythmia.
Treatment: given the absence of a specific antidote, in cases of early detoxification, gastric lavage is performed with the appointment of activated charcoal. Once, and then according to indications in the form of a long-term infusion, 10% solutions of calcium gluconate or calcium chloride are administered intravenously. With a sharp decrease in blood pressure, an intravenous infusion of norepinephrine is indicated, with the development of heart failure - glycosides.

drug interaction

The combined use of nitrates with Cordaflex significantly enhances the antianginal effect.
The simultaneous use of Cordaflex and beta-blockers in most clinical situations is effective and safe, as it leads to the summation of the antianginal and antihypertensive effects of the drugs, however, in some cases, severe arterial hypotension and heart failure may develop.
Rational, from the point of view of enhancing the hypotensive effect, consider the combination of Cordaflex with clonidine (clopheline), alpha-methyldopa (dopegyt), diuretics, captopril, octadine, prazosin, reserpine; do not use Cordaflex with apressin.
With the simultaneous use of Kordaflex and calcium preparations, the effect of nifedipine decreases due to the antagonistic interaction caused by an increase in the concentration of calcium ions in the extracellular space.
The hypotensive effect of Kordaflex, when used simultaneously with cimetidine, is significantly enhanced due to an increase in the concentration of nifedipine in the blood plasma, which requires dose adjustment of the drugs.
Under the influence of Cordaflex, the concentration of quinidine in the blood serum is significantly reduced, which, apparently, is due to a decrease in the bioavailability of quinidine, the induction of enzymes that inactivate it, an increase in blood flow in the liver and kidneys, an increase in the volume of distribution of the drug, as well as a change in hemodynamics. When Cordaflex is canceled after its simultaneous use with quinidine, a transient increase in the concentration (approximately 2 times) of the latter in serum is observed, which reaches a maximum level on the 3-4th day after cancellation, as well as a prolongation of the QT interval on the ECG. Thus, when using a combination of quinidine with Cordaflex, caution should be exercised, especially in patients with left ventricular depression.
With simultaneous appointment with rifampicin, a weakening of the action of Cordaflex will be observed.

Terms and conditions of storage

The drug should be stored in a place protected from light at room temperature. Shelf life - 4 years.
Terms of dispensing from pharmacies
The drug is dispensed by prescription.

Is a medicinal product. A doctor's consultation is required.

Calcium channel blockers

in a blister 10 pcs.; in a cardboard pack 1 or 3 blisters.

Cordaflex ® RD drug with controlled release of the active substance has ample opportunities for highly effective combination therapy. Rational, in terms of antihypertensive and antianginal effects, is the combination of Cordaflex ® RD 40 mg with beta-blockers, diuretics, ACE inhibitors, nitrates.

The combined use of Kordaflex ® RD with beta-blockers is safe and effective in most clinical situations, because leads to summation and potentiation of effects, however, in some cases there is a risk of arterial hypotension and increased heart failure.

Strengthening of the hypotensive effect is also observed in combination therapy with cimetidine, ranitidine and tricyclic antidepressants.

Cordaflex ® RD 40 mg does not reduce its effectiveness during treatment with steroid drugs and NSAIDs.

Nifedipine increases the concentration of digoxin and theophylline, and therefore the clinical effect and / or the content of digoxin and theophylline in blood plasma should be monitored.

With simultaneous appointment with rifampicin and calcium preparations, the effect of nifedipine is weakened.

Procaine, quinidine and other drugs that cause QT interval prolongation increase the negative inotropic effect and increase the risk of QT interval prolongation. Under the influence of nifedipine, the concentration of quinidine in the blood serum is significantly reduced, which, apparently, is due to a decrease in its bioavailability, as well as the induction of enzymes that inactivate quinidine. With the abolition of nifedipine, a transient increase in the concentration of quinidine (approximately 2 times) is observed, which reaches a maximum level on the 3-4th day. Caution should be exercised when using such combinations, especially in patients with impaired left ventricular function.

Nifedipine can displace drugs with a high degree of binding from protein binding (including indirect anticoagulants - coumarin and indandione derivatives, NSAIDs), as a result of which their concentration in blood plasma may increase.

Since it has been shown that carbamazepine and phenobarbital, by activating liver enzymes, reduce the plasma concentration of other CCBs, a similar decrease in the plasma concentration of nifedipine cannot be excluded.

Valproic acid, inhibiting the activity of enzymes, led to an increase in the plasma concentration of other CCBs, therefore, an increase in the concentration of nifedipine in the blood plasma while taking valproic acid cannot be ruled out.

Nifedipine inhibits the excretion of vincristine from the body and may increase the side effects of vincristine (if necessary, reduce the dose of vincristine).

Diltiazem inhibits the metabolism of nifedipine in the body, so careful monitoring is necessary (if necessary, reduce the dose of nifedipine).

Grapefruit juice inhibits the metabolism of nifedipine in the body, and therefore it is not recommended to use it with nifedipine.

arterial hypertension;

stable angina (angina pectoris), post-infarction angina, and vasospastic angina (Prinzmetal's angina).

hypersensitivity to nifedipine or any other component of the drug, other derivatives of 1,4-dihydropyridine;

severe arterial hypotension with the risk of collapse in cardiovascular shock with respiratory manifestations;

unstable angina;

myocardial infarction with left ventricular failure.

Carefully: severe aortic stenosis, acute myocardial infarction (during the first 4 weeks), severe mitral valve stenosis, hypertrophic obstructive cardiomyopathy, severe bradycardia or tachycardia, sick sinus syndrome, chronic heart failure, severe cerebrovascular accident, age up to 18 years (effectiveness and safety has not been established), advanced age, renal and hepatic insufficiency (especially patients on hemodialysis - a high risk of excessive and unpredictable decrease in blood pressure).

inside, in the morning, during meals (for example, breakfast), without chewing and drinking plenty of water.

The dose should be selected individually, depending on the severity of the patient's condition and the response to therapy.

Arterial hypertension. 1 tab. Cordaflex ® RD 40 mg once a day. If necessary, the dose can be increased to 80 mg (2 tablets of Cordaflex ® RD 40 mg for 1 or 2 doses). Increasing the dose above 80 mg is not recommended.

Cardiac ischemia. 1 tab. Cordaflex ® RD 40 mg once a day. If necessary, the dose can be increased to 80 mg (2 tablets of Cordaflex ® RD 40 mg for 1 or 2 doses). Doses above 80 mg may be given in exceptional cases under medical supervision. The daily dose should not exceed 120 mg.

Decreased renal or hepatic function. It is recommended to use with caution the same doses as in the case of normal kidney or liver function (tolerance may develop). With a significant decrease in liver function, it is not recommended to exceed a daily dose of 40 mg.

In the vast majority of cases, Cordaflex ® RD 40 mg is well tolerated by patients.

In some cases, especially in the initial period of treatment, the following transient adverse events may occur.

From the CCC: at the beginning of treatment - flushing of the skin of the face, a pronounced decrease in blood pressure, tachycardia; peripheral edema (ankles, feet, lower legs); rarely - the appearance of angina attacks (which is typical for other vasodilators and requires discontinuation of the drug), heart failure.

From the side of the central nervous system: headache, dizziness, fatigue, drowsiness. With prolonged use in high doses - paresthesia in the limbs, tremor.

From the digestive system: nausea, heartburn, diarrhea or constipation; rarely with long-term use - intrahepatic cholestasis, increased activity of liver enzymes, passing after discontinuation of the drug; very rarely - gingival hyperplasia.

From the hematopoietic system: rarely - thrombocytopenia, thrombocytopenic purpura, leukopenia; very rarely - anemia.

From the urinary system: increase in daily diuresis; rarely - deterioration of kidney function (in patients with renal insufficiency).

From the musculoskeletal system: myalgia; very rarely - arthritis, arthralgia.

Allergic reactions: rarely - urticaria, exanthema, pruritus; very rarely - photodermatitis.

Others: very rarely - visual impairment, gynecomastia, hyperglycemia, completely disappearing after discontinuation of the drug; change in body weight, galactorrhea.

Symptoms acute overdose: headache, pronounced decrease in blood pressure, as well as a violation of the energy supply of the myocardium (an attack of angina pectoris).

Treatment: in the early stages after the detection of an overdose, gastric lavage and the appointment of activated charcoal are recommended as first aid. If necessary, lavage of the small intestine, which is especially advisable in case of an overdose of drugs with controlled release.

Hemodialysis is ineffective, because. nifedipine is largely bound to plasma proteins. Plasmapheresis may be effective.

Symptoms of cardiac arrhythmia with bradycardia can be eliminated by the introduction of beta-agonists. For life-threatening bradycardia, an artificial pacemaker should be used.

With a pronounced decrease in blood pressure, an infusion of the usual doses of norepinephrine (norepinephrine) is indicated. With the development of symptoms of heart failure, intravenous administration of fast-acting digitalis glycosides is recommended.

Due to the lack of a specific antidote, symptomatic therapy is indicated. Dopamine, isoprenaline, and 10% calcium gluconate (10–20 ml IV) can be used as antidotes.

In a place protected from direct sunlight, at a temperature not exceeding 30 ° C

Coated tablets contain 10 mg nifedipine in each as an active substance. For excipients: polyvinyl butyral in the amount of 0.7 mg; talc (1 mg); 0.3 mg magnesium stearate ; 4 mg hydroxypropyl cellulose ; lactose monohydrate (15 mg); croscarmellose sodium (13 mg); microcellulose (46 mg). The shell consists of hypromellose - 2.63 mg; titanium dioxide C.I. 77891 - 0.82 mg; iron oxide yellow - 0.3 mg and magnesium stearate - 0.25 mg.

Long-acting film-coated tablets contain the same active substance, but at a dose of 20 mg. As auxiliary substances in each of them are the following substances: microcellulose (99 mg); lactose monohydrate (30 mg); croscarmellose sodium (26 mg); copolymers of methyl methacrylate and ethyl methacrylate in a ratio of 1:2 (1.9 mg); talc (2 mg); magnesium stearate (0.6 mg); hyprolosis (0.5 mg). The film sheath is made from hypromellose - 5.26 mg; titanium dioxide - 1.64 mg; red iron oxide - 0.6 mg; magnesium stearate - 0.5 mg.

Release form

There are two options for the release form of the drug:

• Coated tablets, 10 mg each. Every 100 tablets are placed in a brown glass bottle. Vials are individually packed in cardboard boxes.
• Film-coated tablets with prolonged action. Each tablet weighs 20 mg. Put 30 or 60 tablets in brown glass bottles. Vials must be sealed with polyethylene caps, which have a control of the first opening. The bottle is packed in a cardboard box.

pharmachologic effect

Contraindications

Contraindications are:

• intolerance nifedipine , other derivatives 1,4-dihydropyridine , additional components that make up the tablets;
• arterial hypotension ;
• unstable angina ;
• the presence at the moment or more recently of an acute, pronounced aortic stenosis ;
• idiopathic subaortic stenosis ;
• chronic heart failure during the period of decompensation;
• childhood.

With extreme caution, it is prescribed to elderly patients, those who have impaired renal function, and patients.

Side effects

Cordaflex is usually well tolerated. Side effects appear rarely, more often at the beginning of treatment (then they may become weaker or disappear).

There are such side effects:

• On the heart and blood vessels: lowering blood pressure, hyperemia face and body, swelling in the limbs , accelerated heart rate, paradoxical angina attack , development acute heart failure .
• to the nervous system: fatigue , emotional lability , sleep disorders, headache, .
• To the gastrointestinal tract: occurrence , nausea , vomit , stool disorders, dryness or inflammation of the oral mucosa, intrahepatic cholestasis , as well as increased activity of certain liver enzymes.
• For the circulatory system: thrombocytopenia , leukopenia , anemia .
• For the urinary system: increased daily diuresis, decreased kidney function.

Allergic reactions may occur, exanthems , .

Application instruction of Kordafleks (Way and dosage)

The drug is taken orally. Coated tablets of 10 mg are swallowed whole before meals, washed down with water.

The dosage is set individually, as it depends very much on the severity of the disease, the type of disease and the body's response to the therapy. Start with 1 tablet (10 mg) 3 times a day. Between doses of the drug should take at least 2 hours. The maximum dose per day is 40 mg.

Tablets with prolonged action, with a film shell, are swallowed whole, washed down with water. In this case, the initial dose is 1 tablet 2 times a day. In any case, the daily dose is divided into 2 doses, between which a 12-hour interval must be observed.

According to the instructions for the use of Cordaflex, the drug should be discontinued gradually.

Overdose

Overdose nifedipine the following consequences may occur:

• arterial hypotension ;
• pain behind the sternum (similar to an attack angina pectoris );
• loss of consciousness;
• collapse ;
• ventricular or nodular extrasystole ;
• bradycardia .

Interaction

Cordaflex should not be administered with alcohol-containing preparations.

Possible development orthostatic hypotension when used with methyldopa , , as well as with and octadin .nifedipine significantly slow down his metabolism.

Terms of sale

The drug is sold exclusively by prescription.

Storage conditions

The temperature of the room in which the medicine is stored should not exceed 30 ° C.

Best before date

Cordaflex analogues (drugs with a similar effect)

Analogues are such drugs: Adalat , Vero-Nifedipine , Calcigard Retard , Zanifed , Cordaflex Retard , Cordipin Retard , Cordipin XL Corinfar , Nifedicap , and some other drugs.

Cordaflex Retard has particularly similar pharmaceutical characteristics and therapeutic applications.

Synonyms

Nifedipine , Kordafen .

children

Not used in pediatrics.

With alcohol

Simultaneous use is prohibited.

During pregnancy and lactation

It can be prescribed at the time only if other drugs are ineffective.

During lactation, drugs containing nifedipine .