Cordaflex RD instructions for use, contraindications, side effects, reviews. Description of the pharmacological action

arterial hypertension;

Stable angina (angina), postinfarction angina, and vasospastic angina (Prinzmetal's angina).

Release form of the drug Cordaflex RD

controlled release tablets, film-coated 40 mg; blister 10, cardboard pack 1;

Controlled release tablets, film-coated 40 mg; blister 10, cardboard pack 3;

Compound
Tablets with controlled release, coated 1 tab.
nifedipine 40 mg
Excipients: cellulose; MCC; lactose; hypromellose 4000; magnesium stearate; silicon dioxide colloidal anhydrous
tablet shell: hypromellose 15; macrogol 6000; macrogol 400; iron oxide red E172; titanium dioxide E171; talc
in a blister 10 pcs.; in a cardboard pack 1 or 3 blisters.

Pharmacodynamics of Cordaflex RD

The active ingredient in Cordaflex® RD is nifedipine. It has antihypertensive and antianginal effects. Reduces the current of extracellular calcium ions into cardiomyocytes and smooth muscle cells of the coronary and peripheral arteries. AT therapeutic doses normalizes the transmembrane Ca2+ current, disturbed in a number of pathological conditions, especially when arterial hypertension. Reduces spasm and dilates coronary and peripheral arterial vessels, reduces peripheral vascular resistance, 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 activates the functioning of collaterals. Nifedipine has practically no effect on the sinoatrial and AV nodes and does not have both proarrhythmic and antiarrhythmic action. Does not affect the tone of the veins. Nifedipine increases renal blood flow, causing moderate natriuresis. AT high doses inhibits the release of calcium ions from intracellular depots. Reduces the number of operating calcium channels without affecting the time of their activation, inactivation and recovery.

Pharmacokinetics of Cordaflex RD

Suction

Nifedipine is rapidly and almost completely (90%) absorbed from the gastrointestinal tract after oral administration. The duration of the effect after a single dose of Cordaflex® RD exceeds 24 hours. active substance zero-order release kinetics was chosen for Cordaflex® RD to ensure a constant release rate. Relative bioavailability - about 60%. Cmax in blood plasma is equal to (29.4±12.0) ng/ml (x±SD); the plasma concentration of the drug reaches a plateau after (7.4 ± 6.4) hours after each dose. The maximum levels of the drug in blood plasma are achieved when combined with food. However, at the end of the dosing interval, the plasma concentration of the drug does not change.

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 muscles. There is no cumulative effect.

Metabolism

Nifedipine is completely transformed into inactive metabolites.

breeding

In the form of inactive metabolites, 60-80% of the oral dose is excreted in the urine, the rest is excreted in the bile and feces. T1 / 2 of nifedipine from blood plasma is approximately 2 hours. However, the release of the drug Cordaflex® RD is longer - up to (14.9 ± 6.0) hours in the equilibrium concentration phase. The concentration of the drug in the blood plasma reaches a minimum (12.0 ± 6.5) ng / ml 24 hours after administration, which is twice the concentration achieved after taking Kordaflex® 20 mg tablets 2 times a day.

In case of impaired renal function, the pharmacokinetics of nifedipine does not change (nifedipine is excreted in the urine in small amounts). With a significant decrease in liver function, the clearance of nifedipine decreases, so it is not recommended to exceed daily dose.

Use of Cordaflex RD during pregnancy

The use of nifedipine in pregnant women is recommended when it is impossible to use other drugs that do not have restrictions.

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

Contraindications to the use of Cordaflex RD

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;

Not stable angina;

Myocardial infarction with left ventricular failure.

Carefully:

Severe aortic stenosis;

Acute myocardial infarction (during the first 4 weeks);

Severe stenosis mitral valve;

Hypertrophic obstructive cardiomyopathy;

Severe bradycardia or tachycardia;

Sick sinus syndrome;

Chronic heart failure;

Severe violations cerebral circulation;

Age up to 18 years (efficacy and safety not established);

Elderly age;

Renal and liver failure(especially patients on hemodialysis - high risk excessive and unpredictable decrease in blood pressure).

Side effects of the drug Cordaflex RD

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

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

From the side of cardio-vascular system: at the beginning of treatment - flushing of the skin of the face, hypotension, tachycardia; peripheral edema (ankles, feet, 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. At long-term use in high doses - paresthesia in the limbs, tremor.

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

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

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

Dosage and administration of Cordaflex RD

Inside, in the morning, during meals (for example, breakfast), without chewing and drinking enough water.

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

Arterial hypertension

1 tab. Cordaflex® RD 1 time per 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 1 time per day. If necessary, the dose can be increased to 80 mg (2 tablets of Kordaflex® RD for 1 or 2 doses). Doses above 80 mg can be prescribed 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 for normal function kidneys or liver (possible development of tolerance). With a significant decrease in liver function, it is not recommended to exceed a daily dose of 40 mg.

Overdose with Cordaflex RD

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: on early stages after an overdose is detected, gastric lavage and the appointment of activated carbon. Rinse if necessary small intestine, which is especially useful in case of overdose of drugs with controlled release.

Hemodialysis is ineffective, because. nifedipine in to a large extent binds to proteins. Plasmapheresis may be effective.

Symptoms of the disorder heart rate with bradycardia can be eliminated by the introduction of beta-agonists. At life threatening bradycardia, an artificial pacemaker should be used.

With a pronounced decrease in blood pressure, an infusion is indicated usual doses norepinephrine (norepinephrine). 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. Dopamine, isoprenaline, and 10% calcium gluconate (10–20 ml IV) can be used as antidotes.

Interactions of the drug Cordaflex RD with other drugs

Cordaflex® RD preparation with controlled release active substance has ample opportunities for high-performance combination therapy. Rational, in terms of antihypertensive and antianginal effects, is the combination of Kordaflex® RD with beta-blockers, diuretics, ACE inhibitors, nitrates.

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

Gain hypotensive effect observed also in combination therapy with cimetidine, ranitidine and tricyclic antidepressants.

Does not reduce its effectiveness against the background of treatment steroid drugs and NSAIDs.

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

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

Procaine, quinidine, and other drugs that prolong the QT interval increase 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 (incl. indirect anticoagulants- derivatives of coumarin and indandione, 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 CCAs, therefore, an increase in the concentration of nifedipine in the blood plasma with simultaneous reception with valproic acid.

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, 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.

Special instructions for taking Cordaflex RD

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

Patients with acute infarction myocardial infarction and within 30 days after it should not use CCB short action 1,4-dihydropyridine type. In the treatment of such patients (CCB controlled release type 1,4-dihydropyridine), careful monitoring is necessary. It is more advisable 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 the initial individually determined period of treatment, it is necessary to refrain from potentially dangerous species activities requiring rapid psychomotor reactions. In the process further treatment the degree of restriction is determined depending on individual tolerance drug.

In cases of insufficient effectiveness of Cordaflex® RD monotherapy, it is advisable to continue treatment using effective combinations with other drugs (see "Interaction").

In patients with heart failure, proper therapy with digitalis preparations is recommended before starting treatment with Cordaflex® RD.

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

Caution should be exercised in elderly patients due to more likely age-related disorders kidney and liver function.

Storage conditions of the drug Cordaflex RD

List B.: Protected from direct sunlight place, at a temperature not exceeding 30 °C.

Shelf life of Cordaflex RD

Belonging of the drug Cordaflex RD to ATX-classification:

C Cardiovascular system

C08 Calcium channel blockers

C08C Selective calcium channel blockers with predominantly vascular effects

C08CA Dihydropyridine derivatives

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

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 pectoris (angina pectoris);

- post-infarction angina pectoris;

- 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 in acute myocardial infarction during the first 4 weeks, expressed aortic stenosis, severe mitral valve stenosis, hypertrophic obstructive cardiomyopathy, severe bradycardia or tachycardia, SSS, with 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 (since safety and efficacy have not been established), in elderly patients (due to most likely age-related disorders of the kidneys and liver).

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 CNS 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 side 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) 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. Washing can be done if needed. thin department intestines, which is especially useful in case of overdose of drugs with controlled release.

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, norepinephrine (norepinephrine) infusion is indicated in standard doses. 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, but 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 others medicines, causing QT interval prolongation, increase the negative inotropic effect and increase the risk of QT interval prolongation. Under the influence of Cordaflex 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 concentration in blood plasma 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 derivatives of 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 surgical intervention 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 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 sun rays and a place inaccessible to children. Shelf life - 5 years.

Minimum age from.	18 years
Mode of application	oral
Amount in a package	30 pcs
Best before date	60 months
Maximum allowable storage temperature, °С	30°C
Storage conditions	in a dry place
Release form	Coated tablets
Manufacturer country	Hungary
Vacation order	On prescription
Active substance	Nifedipine (Nifedipine)
Scope of application	Cardiovascular diseases
Pharmacological group	C08CA Dihydropyridine derivatives

Instructions for use

Active ingredients

Release form

Tablets

Compound

Nifedipine 40 mg 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 .c - 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.

Pharmacological effect

Selective blocker of slow calcium channels, a derivative of 1,4-dihydropyridine. It has antihypertensive and antianginal effects. Nifedipine 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 blood supply to ischemic areas of the myocardium without the development of 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. It reduces the number of functioning calcium channels, without affecting the time of their activation, inactivation and recovery. After a single dose of Cordaflex RD, the duration of the effect exceeds 24 hours.

Pharmacokinetics

Absorption 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%. Cmax in plasma 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 when taking Cordaflex RD in combination 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 (common drug 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 with the formation of inactive metabolites. Removal of 60-80% of the ingested dose of the drug is excreted in the urine as inactive metabolites, the rest is excreted in the bile and feces. T1 / 2 of nifedipine from blood plasma is about 2 hours However, after taking Cordaflex RD, the excretion of nifedipine occurs for a longer time - up to 14.9 ± 6.0 hours in an equilibrium state. Pharmacokinetics in special clinical conditions 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, therefore it is not recommended to exceed the daily dose.

Indications

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

Contraindications

Unstable angina; - myocardial infarction with left ventricular failure; - severe arterial hypotension with a risk of collapse in cardiovascular shock with respiratory manifestations; - hypersensitivity to nifedipine, other components of the drug, other derivatives of 1,4-dihydropyridine. The drug should be used with caution when 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 (since safety and efficacy have not been established), in elderly patients (due to the greatest likelihood of age-related impaired renal function and liver).

Precautionary measures

During the treatment period, an exacerbation of psoriasis is possible. With pheochromocytoma, propranolol can be used only after taking an alpha-blocker. After a long course of treatment, propranolol should be discontinued gradually, under medical supervision. When conducting anesthesia, it is necessary to stop taking propranolol or choose an agent for anesthesia with a minimal negative inotropic effect. Influence on the ability to drive vehicles and control mechanisms In patients whose activities require heightened attention, the use of propranolol in the outpatient setting should only be considered after evaluation individual reaction patient.

Use during pregnancy and lactation

The appointment of the drug Cordaflex RD during pregnancy may be recommended if it is impossible to use other drugs that do not have restrictions on use. Since nifedipine is excreted in breast milk, you should refrain from prescribing the drug during lactation or stop breastfeeding during treatment.

Dosage and administration

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 tab.) 1 time / day. If necessary, the dose can be increased to 80 mg (2 tablets in 1-2 doses). Increasing the dose of more than 80 mg is not recommended. With coronary artery disease, 40 mg (1 tab.) is prescribed 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 (for example, 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 for normal renal function or liver. Tolerance may develop. With a significant decrease in liver function, a dose of 40 mg / day should not be exceeded.

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 disturbances, gynecomastia, hyperglycemia (completely disappear after discontinuation of the drug), changes in body weight, galactorrhea. In the vast majority of cases, Kordaflex RD is well tolerated by patients.

Overdose

Symptoms: headache, arterial hypotension, and also (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 wash the stomach and give activated charcoal. If necessary, small bowel lavage can be done, which is especially useful in case of an overdose of drugs with controlled release. Since nifedipine is highly bound to plasma proteins, dialysis is not effective, and plasmapheresis may be effective. -sympathomimetics. With life-threatening bradycardia, an artificial pacemaker should be used. In severe arterial hypotension, an 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% calcium gluconate (10-20 ml IV) can be used as antidotes.

Interaction with other drugs

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. An increase in 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 Cordaflex RD does not decrease. Cordaflex RD increases the concentration of digoxin and theophylline, in connection with this, the clinical effect and / or the content of digoxin and theophylline in the blood plasma should be monitored. When administered simultaneously with rifampicin and calcium preparations, the effect of Cordaflex RD is weakened. Procaine, quinidine and other drugs that cause an interval prolongation QT, enhance the negative inotropic effect and increase the risk of prolongation of the QT interval. Under the influence of Cordaflex 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 such a combination requires caution, especially in patients with impaired left ventricular function. Nifedipine can displace drugs characterized by 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. 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 concentration of nifedipine in the blood plasma cannot be ruled out. Valproic acid, by inhibiting the activity of enzymes, led to an increase in the plasma concentration of other calcium channel blockers , therefore, an increase in the concentration of nifedipine in the blood plasma while taking it with valproic acid cannot be excluded. Nifedipine inhibits the excretion of vincristine from the body and may cause an increase in 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 calcium channel blockers, short-acting 1,4-dihydropyridine derivatives. 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 Kordaflex RD monotherapy, it is advisable to continue treatment using effective combinations with other drugs. insufficiency before starting treatment with Cordaflex RD recommend 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. 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 fast mental and motor oh reactions. In the course of further treatment, the degree of restrictions is determined depending on the individual tolerability of the drug.

KORDAFLEKS RD (CORDAFLEX RD)

Nifedipine
Representation EGIS JSC
Registration certificate holder EGIS PHARMACEUTICALS, Ltd.
ProducedSIEGFRIED Ltd. ATX code: C08CA05

Release form, composition and packaging

Coated tablets, controlled release red-brown, round, biconvex, chamfered, odorless.

1 tab. nifedipine 40 mg

Excipients: cellulose, microcrystalline cellulose, lactose, hypromellose 4000, magnesium stearate, anhydrous colloidal silicon oxide.

Shell composition: hypromellose 15, macrogol 6000, macrogol 400, iron oxide red (E172), titanium dioxide (E171), talc.

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

Clinical and pharmacological group

Calcium channel blocker

Registration Nos.

tab. with controller release, covering shell, 40 mg: 10 or 30 pcs. - LS-001219, 03.02.06

pharmachologic effect

Selective blocker of slow calcium channels, a derivative of 1,4-dihydropyridine. It has antihypertensive and antianginal effects. Nifedipine 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 Ca 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 Ca 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 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, the release kinetics of the "zero" order was chosen in order to ensure a constant release rate of the active substance. The relative bioavailability of Cordaflex RD is about 60%. Cmax in plasma is 29.4±12.0 mg/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 when taking Cordaflex RD in combination with food.

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.

Withdrawal.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. T1 / 2 of nifedipine from blood plasma is about 2 hours. condition.

There is no cumulative effect.

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 of various etiologies (primary or secondary);
stable angina (angina), post-infarction angina (after stabilization of hemodynamic parameters), angiospastic angina (Prinzmetal's angina).

Dosing regimen

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

With 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.

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

From the hemopoietic 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).

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

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.

The drug should be used with caution in acute myocardial infarction during the first 4 weeks, severe aortic stenosis, severe mitral valve stenosis, hypertrophic obstructive cardiomyopathy, severe bradycardia or tachycardia, SSSU, chronic heart failure, severe cerebrovascular accident, renal or hepatic insufficiency ( especially in patients on hemodialysis due to the high risk of excessive and unpredictable reduction in blood pressure), in patients under the age of 18 years (since safety and efficacy have not been established), in elderly patients.

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 use.

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

special instructions

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

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, you need to rinse the stomach and prescribe adsorbents.

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

Symptoms of cardiac arrhythmia with bradycardia can be eliminated by the introduction of β-sympathomimetics. For life-threatening bradycardia, temporary pacemakers should be used.

In severe arterial hypotension, norepinephrine infusion is indicated in standard doses. 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) may be used.

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.

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 Cordaflex 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 Cordaflex RD, a transient increase in the concentration of quinidine (approximately 2 times) is observed, which reaches a maximum level on days 3-4, as well as a prolongation of the QT interval on the ECG. The use of this combination requires caution, especially in patients with left ventricular depression.

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

Valproic acid, inhibiting the activity of enzymes, led to an increase in the plasma concentration 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 cause an increase in its side effects (if necessary, reduce the dose of vincristine).

ATX code

Description of the drug "Cordaflex RD" on this page is a simplified and supplemented version official instructions by application. Before purchasing and using the drug, you should consult a doctor and read the annotation approved by the manufacturer.

Instructions for medical use drug

Description of the pharmacological action

Indications for use

Arterial hypertension;
- stable angina (angina), postinfarction angina, and vasospastic angina (Prinzmetal's angina).

Release form

controlled release tablets, film-coated 40 mg; blister 10, cardboard pack 1;
controlled release tablets, film-coated 40 mg; blister 10, cardboard pack 3;

Compound
Tablets with controlled release, coated 1 tab.
nifedipine 40 mg
excipients: cellulose; MCC; lactose; hypromellose 4000; magnesium stearate; silicon dioxide colloidal anhydrous
tablet shell: hypromellose 15; macrogol 6000; macrogol 400; iron oxide red E172; titanium dioxide E171; talc
in a blister 10 pcs.; in a cardboard pack 1 or 3 blisters.

Pharmacodynamics

The active ingredient in Cordaflex® RD is nifedipine. 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 Ca2+ current, 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 activates the functioning of collaterals. Nifedipine has practically no effect on the sinoatrial and AV nodes and does not have both proarrhythmic 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.

Pharmacokinetics

Suction

Nifedipine is rapidly and almost completely (90%) absorbed from the gastrointestinal tract after oral administration. The duration of the effect after a single dose of Cordaflex® RD exceeds 24 hours. When developing the active substance of Cordaflex® RD, a zero-order release kinetics was chosen to ensure a constant release rate. Relative bioavailability - about 60%. Cmax in blood plasma is equal to (29.4±12.0) ng/ml (x±SD); the plasma concentration of the drug reaches a plateau after (7.4 ± 6.4) hours after each dose. The maximum levels of the drug in blood plasma are achieved when combined with food. However, at the end of the dosing interval, the plasma concentration of the drug does not change.

Distribution

Metabolism

Nifedipine is completely transformed into inactive metabolites.

breeding

Use during pregnancy

The use of nifedipine in pregnant women is recommended when it is impossible to use other drugs that do not have restrictions.

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

Contraindications for use

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 violations cerebral circulation;
- age up to 18 years (efficacy and safety have not been established);
- elderly age;
- renal and hepatic insufficiency (especially patients on hemodialysis - high risk of excessive and unpredictable decrease in blood pressure).

Side effects

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

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

From the side of the cardiovascular system: at the beginning of treatment - flushing of the skin of the face, hypotension, tachycardia; peripheral edema (ankles, feet, 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 levels of liver enzymes, passing after drug withdrawal; very rarely - gingival hyperplasia.

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

From the urinary system: an increase in 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: very rarely - visual impairment, gynecomastia, hyperglycemia, completely disappearing after discontinuation of the drug; change in body weight, galactorrhea.

Dosage and administration

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. The following doses may be recommended:

Arterial hypertension

1 tab. Cordaflex® RD 1 time per 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 1 time per day. If necessary, the dose can be increased to 80 mg (2 tablets of Kordaflex® RD 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.

Overdose

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

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 highly protein bound. 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.

Interactions with other drugs

The 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 with beta-blockers, diuretics, ACE inhibitors, nitrates.

The combined use of Cordaflex® 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.

Does not reduce its effectiveness against the background of 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.

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

Nifedipine inhibits the excretion of vincristine from the body and may cause an increase in its side effects (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.

Special instructions for admission

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 a short-acting CCB such as 1,4-dihydropyridine. In the treatment of such patients (CCB controlled release type 1,4-dihydropyridine), careful monitoring is necessary. It is more advisable 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 the initial individually determined period of treatment, it is necessary to refrain from potentially hazardous activities that require quick psychomotor reactions. In the course of further treatment, the degree of restrictions is determined depending on the individual tolerability of the drug.

In cases of insufficient effectiveness of Cordaflex® RD monotherapy, it is advisable to continue treatment using effective combinations with other drugs (see "Interaction").

In patients with heart failure, proper therapy with digitalis preparations is recommended before starting treatment with Cordaflex® RD.

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

Caution should be exercised in elderly patients due to the greater likelihood of age-related impaired renal and hepatic function.

Storage conditions

List B.: In a place protected from direct sunlight, at a temperature not exceeding 30 ° C.

Best before date

Belonging to ATX-classification:

** The Medication Guide is for informational purposes only. For more complete information please refer to the manufacturer's instructions. Do not self-medicate; Before you start using Cordaflex RD, you should consult a doctor. EUROLAB is not responsible for the consequences caused by the use of the information posted on the portal. Any information on the site does not replace the advice of a doctor and cannot serve as a guarantee positive effect medicinal product.

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