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

arterial hypertension;

Stable angina (angina pectoris), post-infarction angina, as well as vasospastic angina (Prinzmetal angina).

Release form of the drug Cordaflex RD

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

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

Compound
Controlled-release film-coated tablets 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
10 pcs in blister; in a cardboard pack 1 or 3 blisters.

Pharmacodynamics of the drug Cordaflex RD

The active ingredient of the drug Cordaflex® RD is nifedipine. Has antihypertensive and antianginal effects. Reduces the flow of extracellular calcium ions into cardiomyocytes and smooth muscle cells of coronary and peripheral arteries. IN therapeutic doses normalizes the transmembrane Ca2+ current, disturbed by 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 blood supply to ischemic areas of the myocardium without developing the “steal” syndrome, and also activates the functioning of collaterals. Nifedipine has virtually no effect on the sinoatrial and AV nodes and does not have either proarrhythmogenic or antiarrhythmic action. Does not affect the tone of the veins. Nifedipine increases renal blood flow, causing moderate natriuresis. IN high doses inhibits the release of calcium ions from intracellular stores. Reduces the number of functioning calcium channels without affecting the time of their activation, inactivation and recovery.

Pharmacokinetics of the drug 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. During development active substance Cordaflex® RD has zero-order release kinetics to ensure a constant release rate. Relative bioavailability is about 60%. Cmax in blood plasma is (29.4±12.0) ng/ml (x±SD); The plasma concentration of the drug reaches a plateau after (7.4 ± 6.4) hours after taking each dose. Maximum levels of the drug in blood plasma are achieved when it is taken in combination with food. However, at the end of the dosing interval, the plasma concentration of the drug does not change.

Distribution

Binding to blood 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.

Removal

In the form of inactive metabolites, 60–80% of the dose taken orally is excreted in the urine, the remainder in 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 Cordaflex® 20 mg tablets 2 times a day.

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

Use of the drug Cordaflex RD during pregnancy

The use of nifedipine in pregnant women is recommended if it is impossible to use other drugs without restrictions.

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

Contraindications to the use of the drug Cordaflex RD

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

Severe arterial hypotension with a risk of collapse in cardiovascular shock with respiratory manifestations;

Not stable angina;

Myocardial infarction with left ventricular failure.

With caution:

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 have not been established);

Old 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, Cordaflex® RD is well tolerated by patients.

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

From the outside cardiovascular system: at the beginning of treatment - facial skin flushing, 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, increased fatigue, drowsiness. At long-term use in high doses - paresthesia in the limbs, tremor.

From the outside digestive system: nausea, heartburn, diarrhea or constipation; rarely with long-term use- intrahepatic cholestasis, increased levels of liver enzymes, which disappears after discontinuation of the drug; very rarely - gum hyperplasia.

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

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

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

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

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

Method of administration and dosage of the drug Cordaflex RD

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

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

Arterial hypertension

1 table each Cordaflex® RD 1 time per day. If necessary, the dose can be increased to 80 mg (2 tablets of Cordaflex® RD 40 mg in 1 or 2 doses). Increasing the dose above 80 mg is not recommended.

Coronary heart disease

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

If renal or hepatic function decreases

It is recommended to use with caution the same doses as for normal function kidneys or liver (possible development of tolerance). If there is a significant decrease in liver function, it is not recommended to exceed the daily dose of 40 mg.

Overdose of Cordaflex RD

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

Treatment: on early stages after an overdose is detected, gastric lavage and administration are recommended as first aid measures. activated carbon. If necessary, rinse small intestine, which is especially useful in cases of overdose of controlled-release drugs.

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

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

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

Due to the lack of a specific antidote, it is indicated 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

Controlled release Cordaflex® RD active substance has ample opportunities for highly efficient combination therapy. Rational, from the point of view 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 cases clinical situations safe and effective, because leads to summation and potentiation of effects, but in some cases there is a risk arterial hypotension and worsening heart failure.

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

Does not reduce its effectiveness during 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 the blood plasma.

When administered simultaneously with rifampicin and calcium preparations, the effect of nifedipine is weakened.

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

Nifedipine can displace drugs characterized by 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 the blood plasma may increase.

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

Valproic acid, inhibiting the activity of enzymes, led to an increase in the concentration of other CCBs in the blood plasma; therefore, an increase in the concentration of nifedipine in the blood plasma cannot be excluded when simultaneous administration with valproic acid.

Nifedipine inhibits the elimination 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 when taking Cordaflex RD

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

Patients with acute heart attack myocardium and should not use CCBs for 30 days after it short acting type 1,4-dihydropyridine. When treating such patients (controlled-release CCBs such as 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 in whom beta-blockers are ineffective or have contraindications to their use.

During the initial individually determined period of treatment, it is necessary to refrain from potentially dangerous species activities requiring fast psychomotor reactions. In progress further treatment the degree of restrictions 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, appropriate 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 performed.

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

Storage conditions for the drug Cordaflex RD

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

Shelf life of the drug Cordaflex RD

The drug Cordaflex RD belongs to the ATX classification:

C Cardiovascular system

C08 Calcium channel blockers

C08C Selective calcium channel blockers with a predominant effect on blood vessels

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 pcs. - blisters (1) - cardboard packs.
10 pcs. - blisters (3) - cardboard packs.

Pharmacological action

Selective blocker of slow calcium channels, 1,4-dihydropyridine derivative. 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 peripheral vascular resistance, 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 virtually no effect on the sinoatrial and AV node and does not have either pro- or 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 stores. 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 quickly and almost completely (90%) absorbed from the gastrointestinal tract. When developing the dosage form of the drug Cordaflex RD, zero-order release kinetics was chosen in order to ensure a constant rate of release of the active substance. The relative bioavailability of Cordaflex RD is about 60%. Cmax in the blood is 29.4±12.0 ng/ml. The concentration of the drug in plasma reaches a plateau 7.4 ± 6.4 hours after taking each dose. Cmax of nifedipine in blood plasma is achieved when taking the drug Cordaflex 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 blood plasma proteins (albumin) is 94-97%. Studies with labeled nifedipine in animals have shown that unbound nifedipine is distributed in all organs and tissues. Nifedipine concentrations were found to be higher in the myocardium than in skeletal muscles. There is no cumulative effect.

Metabolism

Nifedipine is mainly metabolized in the liver to form inactive metabolites.

Removal

60-80% of the dose of the drug taken orally is excreted in the urine in the form of inactive metabolites, the remaining part is excreted in bile and feces. T1/2 of nifedipine from the blood plasma is about 2 hours. However, after taking Cordaflex RD, excretion of nifedipine occurs over a longer period - up to 14.9 ±6.0 h at steady state.

Pharmacokinetics in special clinical conditions

If renal function is impaired, the pharmacokinetics of nifedipine does not change.

With a significant decrease in liver function, the clearance of nifedipine is reduced, 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 a risk of collapse in cardiovascular shock with respiratory manifestations;

- hypersensitivity to nifedipine, other components of the drug, other 1,4-dihydropyridine derivatives.

WITH 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, SSSU, with chronic heart failure, severe cerebrovascular accidents, renal or liver failure (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 effectiveness have not been established), in elderly patients (due to most likely age-related disorders 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 tablet) 1 time/day. If necessary, the dose can be increased to 80 mg (2 tablets in 1-2 doses). Dose increases beyond 80 mg are not recommended.

At IHD prescribed 40 mg (1 tablet) 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.

The tablets should be taken with a meal (such as breakfast), swallowed whole and with plenty of water.

At impaired renal or liver function The drug is recommended to be used with caution in the same doses as for normal renal or hepatic function. Tolerance may develop. At significant decrease in liver function the dose should not exceed 40 mg/day.

Side effects

From the cardiovascular system: at the beginning of treatment - facial skin hyperemia, marked decrease in blood pressure, tachycardia; peripheral edema (ankles, feet, legs); rarely - increased frequency of angina attacks (which is typical for other vasoactive drugs and requires discontinuation of the drug), heart failure.

From the central nervous system and peripheral nervous system: headache, dizziness, increased fatigue, drowsiness; with long-term 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 transaminases (disappears after discontinuation of the drug); in some cases - gum hyperplasia.

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

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

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

Allergic reactions: rarely - urticaria, exanthema, itching; 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 under the influence of other vasodilators) violation of the energy supply of the myocardium (angina attack).

Treatment: Immediately after an overdose, you can rinse the stomach and give it as first aid. If necessary, you can rinse thin section intestines, which is especially appropriate in case of overdose of controlled-release drugs.

Because nifedipine is highly bound to plasma proteins, dialysis is not effective, but plasmapheresis may be effective.

Symptoms of heart rhythm disturbances with bradycardia can be eliminated by the administration of beta sympathomimetics. For life-threatening bradycardia, an artificial pacemaker should be used.

For severe hypotension, an infusion of norepinephrine (noradrenaline) is indicated. standard doses. If symptoms of heart failure develop, 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 interactions

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

The combination of Cordaflex RD with beta-blockers, diuretics, ACE inhibitors, and nitrates is rational from the point of view of antihypertensive and antianginal effects.

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

An increase in the hypotensive effect is also observed during combination therapy with cimetidine, ranitidine and tricyclic antidepressants.

During treatment with corticosteroids and NSAIDs, the effectiveness of Cordaflex RD does not decrease.

Cordaflex RD increases the concentration of digoxin and theophylline; therefore, 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 others medicines Causing prolongation of the QT interval, 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 is apparently due to a decrease in its bioavailability, as well as the induction of enzymes involved in the metabolism of quinidine. When Cordaflex RD is discontinued, a transient increase in quinidine concentration is observed (approximately 2 times), which reaches a 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 characterized by a high degree of binding from protein binding (including indirect anticoagulants - coumarin and indanedione derivatives, anticonvulsants, NSAIDs), as a result of which their concentrations in the blood plasma may increase.

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

Inhibiting the activity of enzymes led to an increase in the concentration in the blood plasma of other calcium channel blockers, so an increase in the concentration of nifedipine in the blood plasma cannot be excluded when taken simultaneously with valproic acid.

Nifedipine inhibits the elimination 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 for 30 days after it should not use short-acting calcium channel blockers derived from 1,4-dihydropyridine. When prescribing calcium channel blockers - 1,4-dihydropyridine controlled-release derivatives - 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 in whom beta-blockers are ineffective 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 are recommended to undergo appropriate therapy with digitalis preparations 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 performed.

Impact on the ability to drive vehicles and operate machinery

During the initial individually determined period of treatment, it is necessary to refrain from potentially dangerous 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 use of Cordaflex RD during pregnancy may be recommended if it is impossible to use other drugs that do not have restrictions on their use.

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

Use in old age

WITH caution the drug should be used in elderly patients (due to the greatest likelihood of age-related impairment of kidney and liver function).

Conditions for dispensing from pharmacies

The drug is available with a prescription.

Storage conditions and periods

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

Minimum age from.	18 years old
Directions for use	Orally
Quantity per package	30 pcs
Best before date	60 months
Maximum permissible storage temperature, °C	30°C
Storage conditions	In a dry place
Release form	Film-coated tablets
Country of origin	Hungary
Leave procedure	By prescription
Active ingredient	Nifedipine
Scope of application	Cardiovascular diseases
Pharmacological group	C08CA Dihydropyridine derivatives

Instructions for use

Active ingredients

Release form

Pills

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 .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.

Pharmacological effect

Selective blocker of slow calcium channels, 1,4-dihydropyridine derivative. 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 peripheral vascular resistance, 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 virtually no effect on the sinoatrial and AV node and does not have either pro- or 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 stores. Reduces the number of functioning calcium channels without affecting the time of their activation, inactivation and recovery. After a single dose of the drug Cordaflex RD, the duration of the effect exceeds 24 hours.

Pharmakinetics

Absorption After oral administration, the drug is quickly and almost completely (90%) absorbed from the gastrointestinal tract. When developing the dosage form of the drug Cordaflex RD, zero-order release kinetics was chosen in order to ensure a constant rate of release of the active substance. The relative bioavailability of Cordaflex RD is about 60%. Cmax in blood plasma is 29.4±12.0 ng/ml. The concentration of the drug in plasma reaches a plateau 7.4 ± 6.4 hours after taking each dose. Cmax of nifedipine in blood plasma is achieved when taking the drug Cordaflex 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 (regular drug form) 2 times/day. Distribution: Binding to blood plasma proteins (albumin) is 94-97%. Studies with labeled nifedipine in animals have shown that unbound nifedipine is distributed in all organs and tissues. Nifedipine concentrations were found to be higher in the myocardium than in skeletal muscles. There is no cumulative effect. Metabolism Nifedipine is mainly metabolized in the liver with the formation of inactive metabolites. Excretion: 60-80% of the dose taken orally is excreted in the urine in the form of inactive metabolites, the remaining part is excreted in bile and feces. T1/2 of nifedipine from blood plasma is about 2 hours However, after taking Cordaflex RD, the elimination of nifedipine occurs over a longer period - up to 14.9 ± 6.0 hours at steady state. Pharmacokinetics in special clinical conditions When renal function is impaired, the pharmacokinetics of nifedipine does not change. With a significant decrease in liver function, the clearance of nifedipine is reduced, so it is not recommended to exceed the daily dose.

Indications

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

Contraindications

Unstable angina; - myocardial infarction with left ventricular failure; - severe arterial hypotension with the risk of collapse in cardiovascular shock with respiratory manifestations; - increased sensitivity to nifedipine, other components of the drug, other 1,4-dihydropyridine derivatives. 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, SSSS, with chronic heart failure, severe cerebrovascular accidents, renal or hepatic failure (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 effectiveness have not been established), in elderly patients (due to the greatest likelihood of age-related impairment of kidney and liver function).

Precautions

During the treatment period, exacerbation of psoriasis is possible. For pheochromocytoma, propranolol can be used only after taking an alpha-blocker. After a long course of treatment, propranolol should be discontinued gradually, under the supervision of a physician. During treatment with propranolol, intravenous administration of verapamil, diltiazem should be avoided. Several days before When performing anesthesia, it is necessary to stop taking propranolol or select an anesthetic agent with minimal negative inotropic effect. Influence on the ability to drive vehicles and operate machinery in patients whose activities require increased attention, the use of propranolol on an outpatient basis should only be decided after an assessment individual reaction patient.

Use during pregnancy and breastfeeding

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

Directions for use and doses

The dose should be selected individually, depending on the severity of the patient’s condition and the effectiveness of treatment. For arterial hypertension, Cordaflex RD is prescribed 40 mg (1 tablet) 1 time/day. If necessary, the dose can be increased to 80 mg (2 tablets in 1-2 doses). Increasing the dose to more than 80 mg is not recommended. For ischemic heart disease, 40 mg (1 tablet) 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 sufficient water. In case of impaired renal or liver function, the drug is recommended to be used with caution in the same doses as for normal renal function or liver. Tolerance may develop. If there is a significant decrease in liver function, the dose should not exceed 40 mg/day.

Side effects

From the cardiovascular system: at the beginning of treatment - facial skin flushing, marked decrease in blood pressure, tachycardia; peripheral edema (ankles, feet, legs); rarely - increased frequency of angina attacks (which is typical for other vasoactive drugs and requires discontinuation of the drug), heart failure. From the central nervous system and peripheral nervous system: headache, dizziness, fatigue, drowsiness; with long-term use in high doses - paresthesia in the extremities, tremor. From the digestive system: nausea, heartburn, diarrhea or constipation; rarely with long-term use - intrahepatic cholestasis, increased activity of liver transaminases (disappears after discontinuation of the drug); in some cases - gum hyperplasia. From the hematopoietic system: rarely - thrombocytopenia, thrombocytopenic purpura, leukopenia; in some cases - anemia. From the urinary system: increased daily diuresis; rarely - deterioration of renal function in patients with chronic renal failure. From the musculoskeletal system: myalgia; very rarely - arthritis, arthralgia. Allergic reactions: rarely - urticaria, exanthema, itching; 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, the drug Cordaflex RD is well tolerated by patients.

Overdose

Symptoms: headache, arterial hypotension, and also (as under the influence of other vasodilators) disruption of the energy supply to the myocardium (angina attack). Treatment: immediately after an overdose, as first aid, you can rinse the stomach and give activated charcoal. If necessary, small intestinal lavage can be done, which is especially useful in case of overdose of controlled-release drugs. Since nifedipine is highly bound to plasma proteins, dialysis is not effective, but plasmapheresis may be effective. Symptoms of cardiac arrhythmias with bradycardia can be eliminated by administering beta -sympathomimetics. For life-threatening bradycardia, an artificial pacemaker should be used. For severe hypotension, an infusion of norepinephrine (norepinephrine) in standard doses is indicated. If symptoms of heart failure develop, 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. The combination of Cordaflex RD with beta-blockers, diuretics, ACE inhibitors, and nitrates is rational from the point of view of antihypertensive and antianginal effects. The combined use of Cordaflex RD with beta-blockers is safe and highly effective in most clinical situations, because leads to summation and potentiation of effects, however, in some cases there is a risk of developing arterial hypotension and worsening heart failure. An increase in the hypotensive effect is also observed in combination therapy with cimetidine, ranitidine and tricyclic antidepressants. During treatment with corticosteroids and NSAIDs, the effectiveness of Cordaflex RD does not decrease. Cordaflex RD increases the concentration of digoxin and theophylline; therefore, 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 prolongation of the interval QT, enhance the negative inotropic effect and increase the risk of QT prolongation. Under the influence of Cordaflex RD, the concentration of quinidine in the blood serum is significantly reduced, which is apparently due to a decrease in its bioavailability, as well as the induction of enzymes involved in the metabolism of quinidine. When Cordaflex RD is discontinued, a transient increase in quinidine concentration is observed (approximately 2 times), which reaches a 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 indanedione derivatives, anticonvulsants, NSAIDs), as a result their concentrations 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 concentration of nifedipine in the blood plasma cannot be excluded. 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 cannot be excluded when taken simultaneously with valproic acid. Nifedipine inhibits the elimination of vincristine from the body and may cause an increase in its side effects (if necessary, the dose of vincristine is reduced). Diltiazem suppresses the metabolism of nifedipine in the body; careful monitoring is necessary; if necessary, reduce the dose of nifedipine. Grapefruit juice suppresses 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 for 30 days after it should not use short-acting calcium channel blockers, derivatives of 1,4-dihydropyridine. When prescribing calcium channel blockers - 1,4-dihydropyridine controlled-release derivatives - to such patients, careful monitoring is necessary. It is more advisable to prescribe these drugs in the absence of a tendency to tachycardia, as well as in patients in whom beta-blockers are ineffective 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. For patients with heart disease insufficiency before starting treatment with Cordaflex RD, it is recommended to carry out 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. During treatment, alcohol consumption is not recommended due to the risk of an excessive decrease in blood pressure. Impact on the ability to drive vehicles and operate machinery. During the initial individually determined period of treatment, it is necessary to refrain from potentially dangerous 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.

CORDAFLEX RD

Nifedipine
Representation EGIS JSC
Registration Certificate Holder EGIS PHARMACEUTICALS, Ltd.
ProducedSIEGFRIED, Ltd. ATX code: C08CA05

Release form, composition and packaging

Controlled-release film-coated tablets red-brown color, round, biconvex, chamfered, odorless.

1 tab. nifedipine 40 mg

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

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

10 pcs. - blisters (1) - cardboard packs.
10 pcs. - blisters (3) - cardboard packs.

Clinical and pharmacological group

Calcium channel blocker

Registration No.

tab. with controll. release, covering coated, 40 mg: 10 or 30 pcs. - LS-001219, 02/03/06

Pharmacological action

Selective blocker of slow calcium channels, 1,4-dihydropyridine derivative. 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 peripheral vascular resistance, 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 virtually no effect on the sinoatrial and AV node and does not have either pro- or 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 stores. 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 quickly and almost completely (90%) absorbed from the gastrointestinal tract. When developing the dosage form of the drug Cordaflex RD, “zero” order release kinetics was chosen in order to ensure a constant rate of release of the active substance. The relative bioavailability of Cordaflex RD is about 60%. Cmax in blood plasma is 29.4±12.0 mg/ml. The concentration of the drug in plasma reaches a plateau 7.4 ± 6.4 hours after taking each dose. Cmax of nifedipine in blood plasma is achieved when taking the drug Cordaflex RD 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 (regular dosage form) 2 times a day.

Distribution. Binding to blood plasma proteins (albumin) is 94-97%. Studies with labeled nifedipine in animals have shown that unbound nifedipine is distributed in all organs and tissues. Nifedipine concentrations were found to be higher in the myocardium than in skeletal muscles. There is no cumulative effect.

Metabolism.Nifedipine is mainly metabolized in the liver to form inactive metabolites.

Excretion.60-80% of the dose of the drug taken orally is excreted in the urine in the form of inactive metabolites, the remaining part is excreted in bile and feces. T1/2 of nifedipine from blood plasma is about 2 hours. However, excretion of nifedipine occurs over a longer period - up to 14.9 ± 6.0 hours at equilibrium condition.

There is no cumulative effect.

Pharmacokinetics in special clinical conditions

If renal function is impaired, the pharmacokinetics of nifedipine does not change. With a significant decrease in liver function, the clearance of nifedipine is reduced, so it is not recommended to exceed the daily dose.

Indications

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

Dosage regimen

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

For arterial hypertension, Cordaflex RD is prescribed 40 mg (1 tablet) 1 time/day. If necessary, the dose can be increased to 80 mg (2 tablets in 1-2 doses). Dose increases beyond 80 mg are not recommended.

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

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

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

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

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

Other: 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 a risk of collapse in cardiovascular shock with respiratory manifestations;
hypersensitivity to nifedipine, other components of the drug, other 1,4-dihydropyridine derivatives.

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, SSSS, chronic heart failure, severe cerebrovascular accidents, renal or hepatic failure ( 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 effectiveness have not been established), in elderly patients.

Pregnancy and lactation

The use of Cordaflex RD during pregnancy may be recommended if it is impossible to use other drugs that do not have restrictions on their 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 are recommended to undergo appropriate therapy with digitalis preparations 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 performed.

Impact on the ability to drive vehicles and operate machinery

In the initial period of treatment, it is necessary to refrain from potentially dangerous 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.

Overdose

Symptoms: headache, arterial hypotension, and also (as under the influence of other vasodilators) disruption of the energy supply to the myocardium (angina attack).

Treatment: immediately after an overdose, you need to rinse the stomach and prescribe adsorbents.

Because nifedipine is highly bound to plasma proteins, dialysis is not effective, but plasmapheresis may be effective.

Symptoms of cardiac arrhythmias with bradycardia can be eliminated by the administration of β-sympathomimetics. Temporary pacemakers should be used for life-threatening bradycardia.

For severe hypotension, infusion of norepinephrine in standard doses is indicated. If symptoms of heart failure develop, 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.

Drug interactions

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

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

An increase in the hypotensive effect is also observed during combination therapy with cimetidine, ranitidine and tricyclic antidepressants.

During treatment with corticosteroids and NSAIDs, the effectiveness of Cordaflex RD does not decrease.

Cordaflex RD increases the concentration of digoxin and theophylline; therefore, 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 QT prolongation enhance the negative inotropic effect and increase the risk of QT prolongation. Under the influence of Cordaflex RD, the concentration of quinidine in the blood serum is significantly reduced, which is apparently due to a decrease in its bioavailability, as well as the induction of enzymes involved in the metabolism of quinidine. When Cordaflex RD is discontinued, there is a transient increase in quinidine concentration (approximately 2 times), 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 depressed left ventricular function.

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

Valproic acid, inhibiting the activity of enzymes, led to an increase in the plasma concentration of other calcium channel blockers, so an increase in the concentration of nifedipine in the blood plasma cannot be excluded when taken simultaneously with valproic acid.

Nifedipine inhibits the elimination of vincristine from the body and may cause increased side effects (if necessary, reduce the dose of vincristine).

ATX Code

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

Instructions for medical use drug

Description of pharmacological action

Indications for use

Arterial hypertension;
- stable angina (angina pectoris), post-infarction angina, as well as vasospastic angina (Prinzmetal angina).

Release form

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

Pharmacodynamics

The active ingredient of the drug Cordaflex® RD is nifedipine. 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 peripheral vascular resistance, reduces afterload and myocardial oxygen demand. At the same time, it improves blood supply to ischemic areas of the myocardium without developing the “steal” syndrome, and also activates the functioning of collaterals. Nifedipine has virtually no effect on the sinoatrial and AV nodes and does not have either proarrhythmic or 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 stores. 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 the drug Cordaflex® RD exceeds 24 hours. When developing the active substance of the drug Cordaflex® RD, zero-order release kinetics was chosen in order to ensure a constant release rate. Relative bioavailability is about 60%. Cmax in blood plasma is (29.4±12.0) ng/ml (x±SD); The plasma concentration of the drug reaches a plateau after (7.4 ± 6.4) hours after taking each dose. Maximum levels of the drug in blood plasma are achieved when it is taken in combination with food. However, at the end of the dosing interval, the plasma concentration of the drug does not change.

Distribution

Binding to blood plasma proteins (albumin) is 94–97%. Studies with labeled nifedipine in animals have shown that unbound nifedipine is distributed in all organs and tissues. Nifedipine concentrations were found to be higher in the myocardium than in skeletal muscles. There is no cumulative effect.

Metabolism

Nifedipine is completely transformed into inactive metabolites.

Removal

Use during pregnancy

The use of nifedipine in pregnant women is recommended if it is impossible to use other drugs without 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

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

With caution:
- 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 under 18 years (efficacy and safety have not been established);
- old age;
- renal and liver failure (especially patients on hemodialysis - high risk of excessive and unpredictable decrease in blood pressure).

Side effects

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

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

From the cardiovascular system: at the beginning of treatment - facial skin flushing, 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, increased fatigue, drowsiness. With long-term 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, which disappears after discontinuation of the drug; very rarely - gum hyperplasia.

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

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

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

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

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

Directions for use and doses

Orally, in the morning, during meals (for example, breakfast), without chewing and with a sufficient amount of water.

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

Arterial hypertension

1 table each Cordaflex® RD 1 time per day. If necessary, the dose can be increased to 80 mg (2 tablets of Cordaflex® RD 40 mg in 1 or 2 doses). Increasing the dose above 80 mg is not recommended.

Coronary heart disease

If renal or hepatic function decreases

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

Overdose

Symptoms of acute overdose: headache, marked decrease in blood pressure, as well as impaired energy supply to the myocardium (angina attack).

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

Hemodialysis is ineffective because Nifedipine is highly protein bound. Plasmapheresis may be effective.

Symptoms of heart rhythm disturbances with bradycardia can be eliminated by the administration of beta-agonists. For life-threatening bradycardia, an artificial pacemaker should be used.

With a pronounced decrease in blood pressure, an infusion of usual doses of norepinephrine (norepinephrine) is indicated. If symptoms of heart failure develop, 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 drug Cordaflex® RD with controlled release of the active substance has wide possibilities for highly effective combination therapy. Rational, from the point of view of antihypertensive and antianginal effects, is the combination of Cordaflex® RD with beta-blockers, diuretics, ACE inhibitors, and 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.

An increase in the hypotensive effect is also observed during combination therapy with cimetidine, ranitidine and tricyclic antidepressants.

Does not reduce its effectiveness during treatment with steroids and NSAIDs.

Nifedipine increases the concentration of digoxin and theophylline, and therefore 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 nifedipine is weakened.

Procaine, quinidine and other drugs that cause prolongation of the QT interval enhance the negative inotropic effect and increase the risk of prolongation of the QT interval. Under the influence of nifedipine, the concentration of quinidine in the blood serum is significantly reduced, which is apparently due to a decrease in its bioavailability, as well as the induction of enzymes that inactivate quinidine. When nifedipine is discontinued, a transient increase in quinidine concentration is observed (approximately 2 times), which reaches its maximum level on the 3rd–4th day. Caution should be exercised when using such combinations, 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 indanedione derivatives, NSAIDs), as a result of which their concentration in the blood plasma may increase.

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 cannot be excluded when taken simultaneously with valproic acid.

Nifedipine inhibits the elimination of vincristine from the body and may cause increased 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 use

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

Patients with acute myocardial infarction and for 30 days afterward should not use short-acting CCBs such as 1,4-dihydropyridine. When treating such patients (controlled-release CCBs such as 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 in whom beta-blockers are ineffective or have contraindications to their use.

During the initial individually determined period of treatment, it is necessary to refrain from potentially hazardous activities that require rapid psychomotor reactions. In the process 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, appropriate 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 performed.

Caution should be exercised in elderly patients due to the greater likelihood of age-related impairment of 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

ATX classification:

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