Cordaflex tablets: instructions for use, price and reviews. Indications for use of the drug

Compound

Coated tablets contain 10 mg of nifedipine each as an active substance. Excipients: polyvinyl butyral in an amount of 0.7 mg; talc (1 mg); 0.3 mg magnesium stearate ; 4 mg hydroxypropylcellulose ; lactose monohydrate (15 mg); croscarmellose sodium (13 mg); microcellulose (46 mg). The shell consists of hypromellose - 2.63 mg; titanium dioxide CI 77891 - 0.82 mg; yellow iron oxide - 0.3 mg and magnesium stearate - 0.25 mg.
Long-acting film-coated tablets contain the same active substance, but in a dose of 20 mg. Each of them contains the following substances as auxiliary substances: microcellulose (99 mg); lactose monohydrate (30 mg); croscarmellose sodium (26 mg); copolymers of methyl methacrylate and ethyl methacrylate in a ratio of 1:2 (1.9 mg); talc (2 mg); magnesium stearate (0.6 mg); hyprolose (0.5 mg). The film shell is made of hypromellose - 5.26 mg; titanium dioxide - 1.64 mg; red iron oxide - 0.6 mg; magnesium stearate - 0.5 mg.

Cordaflex

Release form, composition and packaging

Yellow film-coated tablets, matte or slightly shiny, round, biconvex, with a slight characteristic odor.

1 tab. nifedipine 10 mg.

Excipients: polyvinyl butyral, magnesium stearate, talc, hydroxypropylcellulose, croscarmellose sodium, lactose monohydrate, microcrystalline cellulose, titanium dioxide, yellow iron oxide, hypromellose.

Extended-release tablets, brownish-purple film-coated, round, biconvex, with a matte or slightly shiny surface, odorless or with a slight characteristic odor; on the break - yellow with a narrow strip of brownish-purple color along the edges.

1 tab. nifedipine 20 mg.

Excipients: microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, hydroxypropylcellulose, polyvinylbutyral B 30 T, talc, magnesium stearate.

Shell composition: hypromellose, titanium dioxide, red iron oxide, magnesium stearate.

Clinical and pharmacological group

Calcium channel blocker.

pharmachologic effect

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 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 nodes 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 Cordaflex in the form of extended-release tablets, the clinical effect develops within 20 minutes, the duration of the clinical effect is 12-24 hours.

Pharmacokinetics

Suction

When taken orally, it is quickly and almost completely (more than 90%) absorbed from the gastrointestinal tract. Bioavailability - 40-70%.

After oral administration of Cordaflex in tablet form, 10 mg Cmax in the blood is achieved 0.5-1 hour after administration.

After oral administration of 1 tablet of prolonged action 20 mg, the therapeutic concentration of nifedipine in the blood plasma is achieved after 1 hour and remains at a constant level for up to 6 hours (prolonged action plateau), and gradually decreases in the next 30-36 hours.

Distribution

Binding to blood plasma proteins (albumin) is 94-97%. Unbound nifedipine is distributed in all organs and tissues.

Penetrates through the BBB (less than 5%), through the placental barrier, and is excreted in breast milk.

Does not accumulate.

Metabolism

Nifedipine is extensively metabolized in the liver with the formation of 3 metabolites that do not have pharmacological activity.

Removal

After oral administration of Cordaflex in the form of a 10 mg tablet, T1/2 of nifedipine is 2 hours, after taking a prolonged-release tablet 20 mg - about 3.8-16.9 hours.

60-80% of the drug dose taken orally is excreted in the urine in the form of inactive metabolites, the remaining part is excreted in bile and feces.

Pharmacokinetics in special clinical situations

In elderly patients, the metabolism of nifedipine in the liver is reduced.

In patients with liver failure, total clearance decreases and T1/2 of nifedipine increases.

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

Indications for use of the drug

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

Dosage regimen

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

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

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

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

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

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

For moderate impairment of liver or kidney function, no dosage adjustment is required. In case of severe liver dysfunction, the maximum daily dose should not exceed 40 mg.

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

Side effect

From the cardiovascular system: facial skin flushing, severe arterial hypotension, peripheral edema, tachycardia; rarely - increased angina attacks (drug discontinuation required), increased heart failure, fainting.
From the central nervous system and peripheral nervous system: headache, dizziness, increased fatigue, sleep disturbances (drowsiness or insomnia); in isolated cases - mood lability, visual impairment; with long-term use in high doses - paresthesia in the limbs, tremor.
From the digestive system: diarrhea, constipation, nausea, heartburn; rarely (with long-term use of the drug) - dry mouth, flatulence, intrahepatic cholestasis, increased activity of liver transaminases; in some cases - gum hyperplasia, gingivitis, anorexia.
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; in isolated cases - arthritis.
From the endocrine system: in isolated cases - gynecomastia, hyperglycemia (completely disappear after discontinuation of the drug), changes in body weight, galactorrhea.

Allergic reactions: rarely - urticaria, exanthema, itching; in some cases - autoimmune hepatitis.

Other: feeling of heat; in isolated cases - weakness, sweating, fever, chills, photodermatitis.

Contraindications to the use of the drug

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

Cordaflex should be used with caution in chronic heart failure, hypertrophic obstructive cardiomyopathy, severe cerebrovascular accidents, CVS, severe tachycardia, severe liver and/or kidney dysfunction, malignant arterial hypertension, in patients on hemodialysis (due to the risk of severe arterial hypotension against the background of peripheral vasodilation), with lactose intolerance, as well as in elderly patients.

Release form

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

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

Pharmacodynamics and pharmacokinetics

Nifedipine is a selective blocker of slow calcium channels, one of the 1,4-dihydropyridine derivatives. Its effect is manifested in a decrease in the flow of extracellular calcium ions into cardiomyocytes and smooth muscle cells of the arteries. Nifedipine can also increase renal blood flow, causing moderate natriuresis .

After taking one tablet of Cordaflex, which has a prolonged action, the clinical effect usually develops after 20 minutes, the effect lasts from 12 to 24 hours.

After administration, it is quickly, almost completely (at least 90%) absorbed from the digestive tract. And the bioavailability of the drug is in the range of 40-70%.

The maximum concentration of the active substance in the blood is found 30-60 minutes after taking the drug.

After taking one tablet with a prolonged action, the therapeutic concentration in the blood plasma is achieved within an hour and remains at an equal level for up to 6 hours; over the next 30-36 hours, a gradual decrease in concentration is observed.

Nifedipine has the property of binding to blood plasma proteins, in particular albumins , penetrating the blood-brain barrier (in small quantities - no more than 5%), through the placenta , and can be excreted in breast milk.

The half-life is 2 hours for a 10 mg tablet; for a 20 mg extended-release tablet it is approximately 3.8-16.9 hours.

Cordaflex tablet p/o film prolong. fl 20mg 60 pcs

Drugs that affect nifedipine: Nifedipine is metabolized with the participation of the cytochrome P450 isoenzyme CYP3A4 of the liver and intestinal mucosa. Drugs that induce or block this enzyme may interfere with the first-pass effect (when taken orally) or alter the clearance of nifedipine. The extent and duration of these interactions should be considered if nifedipine is co-administered with the following drugs. Rifampicin: Rifampicin significantly induces the CYP3A4 isoenzyme. When used together with rifampicin, the bioavailability of nifedipine is sharply reduced, thus reducing the effectiveness of the drug. Therefore, the combined use of nifedipine with rifampicin is contraindicated; When used together with the following weak/moderate inhibitors of the CYP3A4 isoenzyme, blood pressure control is necessary and it may be necessary to reduce the dose of nifedipine.

Drugs that increase the concentration of nifedipine in the blood: - Macrolides (for example, erythromycin): the interaction of macrolides with nifepidin has not been studied. It is known that some macrolide antibiotics inhibit the metabolism of other drugs involving the CYP3A4 isoenzyme. Therefore, when used together, a possible increase in the concentration of nifedipine in the blood plasma cannot be excluded. Despite the fact that azithromycin belongs to the class of macrolides in its structure, it is not an inhibitor of the CYP3A4 isoenzyme; -HIV protease inhibitors (eg, ritonavir): There are no clinical studies of the interaction of HIV protease inhibitors with nifedipine. Drugs belonging to this group are known to inhibit the CYP3A4 isoenzyme of cytochrome P450. In addition, it was found that drugs of this group in vitro inhibit the metabolism of nifedipine mediated by the CYP3A4 isoenzyme. Therefore, when used together with nifedipine, it cannot be excluded that its concentration in the blood plasma will increase significantly as a result of a slowdown in the “first pass” effect. In addition, a slower elimination of the drug cannot be ruled out; -Antifungals, azoles (eg, ketoconazole): No clinical studies have been conducted on the interaction of azole antifungals with nifedipine. It is known that some drugs in this group inhibit the CYP3A4 isoenzyme of cytochrome P450. In addition, it was found that drugs of this group in vitro inhibit the metabolism of nifedipine mediated by the CYP3A4 isoenzyme. Therefore, when used together with nifedipine, it cannot be excluded that its concentration in the blood plasma will increase significantly as a result of a slowdown in the “first pass” effect; in addition, a slower elimination of the drug cannot be ruled out; -Fluoxetine: No clinical studies have been conducted on the interaction of fluoxetine with nifedipine. It is known that fluoxetine in vitro inhibits the metabolism of nifedipine mediated by the cytochrome P450 isoenzyme CYP3A4. Therefore, when used together with nifedipine, an increase in its concentration in the blood plasma cannot be excluded; -Nefazodone: There are no clinical studies of the interaction of nefazodone with nifedipine. It is known that nefazodone in vitro inhibits the metabolism of nifedipine mediated by the cytochrome P450 isoenzyme CYP3A4. Therefore, when used together with nifedipine, an increase in its concentration in the blood plasma cannot be excluded; -Quinupristin/dalfopristin: when quinupristin/dalfopristin is co-administered with nifedipine, the plasma concentration of nifedipine may increase; -Valproic acid: No clinical studies have been conducted on the interaction of valproic acid with nifedipine. Since valproic acid, by inhibiting the enzyme, increases the concentration of another calcium channel inhibitor - nimodipine - in the blood plasma, an increase in the effect in this case cannot be ruled out; -Cimetidine: since cimetidine inhibits the CYP3A4 isoenzyme of cytochrome P450, it increases the concentration of nifedipine in the blood plasma, enhancing its hypotensive effect; -Diltiazem: increases the exposure (AUC) of nifedipine.

Other types of interactions: -Cisapride: combined use of cisapride with nifedipine leads to an increase in the concentration of nifedipine in the blood plasma.

Drugs that induce the CYP3A4 isoenzyme of cytochrome P450: - Antiepileptic drugs (phenobarbital, phenytoin, carbamazepine): phenytoin induces the CYP3A4 isoenzyme of cytochrome P450. With simultaneous use of phenytoin with nifedipine, the bioavailability and, accordingly, the effectiveness of the latter decreases. When using these drugs together, clinical efficacy should be monitored and the dose of nifedipine should be increased if necessary. In this case, upon completion of treatment with phenytoin, it may be necessary to increase the dose of nifedipine. If the dose of nifedipine was increased when the two drugs were used together, then after discontinuation of treatment with phenytoin, the possibility of lowering the dose of nifedipine should be considered. There have been no clinical studies on the interaction of carbamazepine or phenobarbital with nifedipine. Due to the fact that carbamazepine, as an inducer of the cytochrome P450 isoenzyme CYP3A4, reduces the blood concentration of nimodipine, a calcium channel blocker similar in structure, the possibility of a decrease in the concentration of nifedipine in the blood plasma and a deterioration in its effectiveness cannot be ruled out.

Effect of nifedipine on other drugs: - Antihypertensive drugs: when prescribed together with the following antihypertensive drugs, the antihypertensive effects can be summed up: diuretics; beta blockers; angiotensin-converting enzyme inhibitors (ACE inhibitors); angiotensin receptor antagonists; other calcium channel blockers; alpha-blockers; phosphodiesterase-5 inhibitors; methyldopa; magnesium sulfate; -Beta-blockers: When nifedipine is co-administered with beta-blockers, careful monitoring is necessary, as worsening of HF has been reported in some cases.

-Digoxin: Concomitant use with digoxin may lead to an increase in the plasma concentration of this drug due to a decrease in its clearance. Due to the danger of digoxin overdose, patients' condition should be monitored and, if necessary, the dose of the glycoside should be reduced; -Quinidine: when quinidine is combined with nifedipine, the concentration of quinidine in the blood plasma may decrease, and after discontinuation of nifedipine, in some cases an increase in the concentration of quinidine in the blood is observed. According to some literature data, when the two drugs were used together, an increase in the concentration of nifedipine in the blood plasma was observed; other authors did not observe changes in the pharmacokinetics of nifedipine. Thus, if quinidine is necessary during nifedipine therapy, blood pressure should be carefully monitored and, if necessary, the dose of nifedipine should be reduced; -Tacrolimus: Tacrolimus is metabolized with the participation of the cytochrome P450 isoenzyme CYP3A4. According to the published literature, co-administration of tacrolimus with nifedipine may increase the plasma concentration of tacrolimus. Tacrolimus concentrations should be monitored and the dose reduced if necessary; - Vincristine: when used simultaneously with nifedipine, the excretion of vincristine is reduced, which may require a reduction in its dose; -Cephalosporins: when used simultaneously with nifedipine, the concentration of cephalosporins in the blood plasma increases; -Nitrates: it is necessary to take into account the synergistic effect when using nifedipine and nitrates simultaneously; -Theophylline: nifedipine increases the concentration of theophylline in the blood plasma when used simultaneously; -Fentanyl: simultaneous use of fentanyl and nifedipine can lead to a significant decrease in blood pressure, therefore, if possible, it is recommended to discontinue nifedipine at least 36 hours before anesthesia with fentanyl; -Indirect anticoagulants: In rare cases, prolongation of prothrombin time has been reported when indirect anticoagulants (for example, warfarin) are used simultaneously with nifedipine. The clinical significance of this effect is unknown.

Contraindications

Contraindications are:

intolerance to nifedipine , other 1,4-dihydropyridine , additional components included in the tablets;
arterial hypotension;
unstable angina;
the current or recent presence of acute myocardial infarction or severe aortic stenosis ;
idiopathic subaortic stenosis;
chronic heart failure during the period of decompensation;
childhood.

It is prescribed with special caution to elderly patients, those with impaired renal function, and patients with diabetes mellitus .

Cordaflex rd tab p/o with counter-highlight. 40 mg 30 pcs

Arterial hypotension: Nifedipine dilates peripheral arteries, reduces blood pressure and can lead to severe arterial hypotension. The drug should be used with caution in patients with severe arterial hypotension (blood pressure below 90 mm Hg), especially in patients with coronary artery disease or cerebrovascular diseases, in whom an excessive decrease in blood pressure can lead to the development of myocardial infarction or stroke. Particular caution and careful medical supervision are also necessary in patients on hemodialysis (risk of a significant decrease in blood pressure), during pregnancy (the drug is contraindicated during pregnancy, but in exceptional cases its use is necessary). In case of severe arterial hypotension, reduce the dose or temporarily stop taking nifedipine. The risk of developing arterial hypotension is higher in patients taking beta-blockers. The simultaneous use of nifedipine and beta-blockers must be carried out under conditions of careful medical supervision, since this may cause an excessive decrease in blood pressure, and in some cases, aggravation of the symptoms of CHF. Severe hypotension and/or high fluid requirements have been reported in patients receiving nifedipine and beta-blocker therapy during coronary artery bypass graft surgery under general anesthesia with high doses of fentanyl. If during therapy the patient requires surgical intervention under general anesthesia, then it is necessary to inform the anesthesiologist about the nature of the therapy being performed. If surgery is planned under general anesthesia using high doses of fentanyl, it is recommended to stop taking Cordaflex® RD at least 36 hours before surgery. Arterial hypertension: There is no experience in the clinical use of nifedipine drugs for malignant hypertension. The drug Cordaflex® RD should not be used to lower blood pressure during a hypertensive crisis.

Chronic ischemic heart disease: The drug Cordaflex® RD should not be used for the relief of acute attacks of angina and for the secondary prevention of cardiovascular complications in patients who have had an MI.

Unstable angina and/or myocardial infarction: In rare cases, in patients with coronary artery disease (especially with severe obstructive lesions of the coronary arteries), an increase in the frequency, duration and/or severity of angina attacks was noted, as well as, in isolated cases, the development of myocardial infarction after starting the use of BMCC (including nifedipine) or after increasing their dosage. The mechanism of development of this phenomenon has not been studied. Nifedipine immediate-release tablets are contraindicated in acute MI. There is no experience in the clinical use of nifedipine preparations in the form of extended-release tablets for acute MI and unstable angina, and therefore their use in these diseases is contraindicated.

Chronic heart failure (CHF): BMCC (including nifedipine) should be used with extreme caution in patients with CHF. In case of decompensated CHF, the use of Cordaflex® RD is not recommended.

Beta-blocker withdrawal syndrome: In patients with angina, stopping beta-blockers may lead to a withdrawal syndrome (increased frequency, duration and/or severity of angina attacks), possibly due to increased sensitivity to catecholamines. Prescribing nifedipine does not prevent the development of beta-blocker withdrawal syndrome, but can even lead to its intensification due to the reflex release of catecholamines in response to peripheral vasodilation. Nifedipine does not have an antiarrhythmic effect and does not prevent the occurrence of cardiac arrhythmias when beta-blockers are abruptly discontinued. If it is necessary to discontinue therapy with a beta-blocker, its dose should be gradually reduced over 8-10 days before prescribing nifedipine.

Discontinuation of therapy: Discontinuation of nifedipine drugs should be carried out gradually (there is a risk of developing withdrawal syndrome).

Aortic stenosis / mitral stenosis / hypertrophic obstructive cardiomyopathy: As with all drugs that have a vasodilating effect, nifedipine should be used with caution in patients with aortic stenosis, mitral stenosis or hypertrophic obstructive cardiomyopathy. In patients with hemodynamically significant obstruction of the LV outflow tract (for example, with severe aortic stenosis), the use of the drug is contraindicated. Patients with obstructive cardiomyopathy are at risk of increased frequency, severity, and duration of angina attacks after taking nifedipine. In this case, discontinuation of the drug is necessary.

Peripheral edema: When using nifedipine drugs, mild or moderate peripheral edema associated with dilatation of peripheral arteries was observed. Edema is usually localized in the lower extremities and sometimes decreases with the use of diuretics. In patients with concomitant CHF, peripheral edema associated with the use of nifedipine should be carefully differentiated from symptoms of progression of LV dysfunction.

Diabetes mellitus: In patients with diabetes mellitus, when using nifedipine preparations, the body's response to insulin and glucose may change, which may require changes in the therapy of such patients.

Liver dysfunction: In rare cases, when using nifedipine preparations, an increase in the activity of certain enzymes, such as alkaline phosphatase, creatine phosphokinase, lactate dehydrogenase, aspartate aminotransferase (AST) and alanine aminotransferase (ALT), was observed, which is usually transient, but can sometimes be significant. A cause-and-effect relationship with nifedipine is uncertain in most cases, but is highly likely in some cases. These changes in laboratory parameters are rarely accompanied by clinical symptoms. However, cases of cholestasis with or without jaundice have been described, as well as rare cases of autoimmune hepatitis. Patients with impaired liver function are closely monitored and, if necessary, the dose of the drug is reduced and/or other dosage forms of nifedipine are used.

Impaired renal function: The use of nifedipine drugs in patients with impaired renal function is safe; No dose adjustment of nifedipine is required. In some cases, patients with chronic renal failure experienced a transient increase in serum urea nitrogen and creatinine concentrations. A cause-and-effect relationship with nifedipine is uncertain in most cases, but is highly likely in some cases. In patients with malignant hypertension undergoing hemodialysis, hypovolemia (decrease in circulating blood volume) after the dialysis procedure may enhance the antihypertensive effect of nifedipine and lead to a sharp decrease in blood pressure. In such patients, Cordaflex RD should be used with extreme caution; if necessary, the dose of the drug should be reduced.

Drug interactions: Nifedipine is metabolized by the CYP3A4 isoenzyme. Drugs that suppress or induce CYP3A4 may affect the first-pass effect through the liver or the clearance of nifedipine. Medicines that are weak or moderate inhibitors of the CYP3A4 isoenzyme that increase the concentration of nifedipine in the blood plasma include: macrolides (for example, erythromycin); HIV protease inhibitors (eg, ritonavir); azole antifungals (for example, ketoconazole); antidepressants (nefazodone and fluoxetine); quinupristin/dalfopristin; valproic acid; cimetidine When using nifedipine and these drugs simultaneously, it is necessary to monitor blood pressure and, if necessary, adjust the dose of nifedipine.

Surgery/general anesthesia: Inhalational anesthetics may enhance the reduction in blood pressure. If during therapy the patient requires surgery under general anesthesia, the anesthesiologist must be informed that the patient is taking nifedipine.

Diagnostic tests: During treatment, positive results are possible with direct Coombs test (with or without hemolytic anemia) and laboratory tests for antinuclear antibodies. Nifedipine, like other BMCCs, inhibits platelet aggregation in vitro. A small number of clinical studies support data on a statistically significant decrease in platelet aggregation and an increase in bleeding time. Presumably, the cause of such changes is the blockade of calcium transport across the platelet membrane. The clinical significance of this effect is unknown. Nifedipine may cause a false increase in the concentration of vanillylmandelic acid in urine when determined by the spectrophotometric method, but does not affect the measurement results when using the high-performance liquid chromatography (HPLC) method.

Alcohol: During treatment, it is not recommended to drink alcoholic beverages due to the risk of an excessive decrease in blood pressure.

Use in elderly patients: Caution should be exercised when using nifedipine drugs in elderly patients due to the high likelihood of age-related impairment of renal function. Effect on the ability to drive. In some patients, especially at the beginning of treatment, nifedipine may cause dizziness, which reduces the ability to drive vehicles and other mechanisms. In the future, the degree of restrictions depends on the individual tolerance of nifedipine. During the treatment period, especially at the beginning of treatment or when changing the dose, care must be taken when driving, engaging in potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Side effects

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

There are such side effects:

On the heart and blood vessels: decreased blood pressure, flushing of the face and torso, swelling in the extremities , accelerated heart rate, paradoxical attack of angina , development of acute heart failure .
On the nervous system: increased fatigue , dizziness , weakness , emotional lability , sleep disturbances, headache, tremor , paresthesia .
On the gastrointestinal tract: the occurrence of heartburn , nausea , vomiting , flatulence , stool disorders, dryness or inflammation of the oral mucosa, intrahepatic cholestasis , as well as increased activity of certain liver enzymes.
On the circulatory system: thrombocytopenia , leukopenia , anemia .
On the urinary system: increased daily diuresis, night urination , decreased renal function.

Allergic reactions may occur in the form of urticaria , exanthema , and skin itching .

conclusions

Cordaflex is a highly effective antianginal and antihypertensive agent from the group of calcium channel blockers. Due to this, as well as its low cost, it has become widespread in the treatment of acute attacks of cardiovascular diseases.

However, it has a number of contraindications and can also cause various adverse reactions. The most common is a sharp drop in blood pressure. To avoid them, you must strictly adhere to dosages and recommendations for use.

Instructions for use of Cordaflex (Method and dosage)

The drug is taken orally. 10 mg film-coated tablets are swallowed whole before meals with water.

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

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

According to the instructions for use of Cordaflex, discontinuation of the drug should be carried out gradually.

Cordaflex

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

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

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

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

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

For moderate impairment of liver or kidney function, no dosage adjustment is required. In case of severe liver dysfunction, the maximum daily dose should not exceed 40 mg.

Overdose

Symptoms: severe arterial hypotension, tachycardia, chest pain (angina), headache, collapse, loss of consciousness, nodal or ventricular extrasystole due to inhibition of the sinus node, bradycardia, fainting. In severe cases, disturbances of consciousness leading to coma, hyperkalemia, metabolic alkalosis, hypoxia, cardiogenic shock with pulmonary edema are possible.

Treatment: given the lack of a specific antidote, in cases of early detoxification, gastric lavage is performed with the administration of activated charcoal. If necessary, small intestinal lavage can be done, which is more appropriate in case of overdose of controlled-release drugs. When prescribing laxatives, it should be taken into account that taking slow calcium channel blockers suppresses intestinal motility to the point of complete atony.

Since nifedipine is highly bound to plasma proteins, hemodialysis is not effective, but plasmapheresis may be effective.

Symptomatic therapy is indicated. Symptoms of cardiac arrhythmias with bradycardia can be eliminated by administering beta-agonists and/or atropine. 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) or epinephrine (adrenaline) is indicated; dopamine (maximum dose 25 mcg/kg body weight/min), dobutamine (maximum dose 15 mcg/kg body weight/min), isoprenaline and 10% calcium gluconate solution (10-20 ml i.v.). If symptoms of heart failure develop, intravenous administration of fast-acting cardiac glycosides is recommended.

Overdose

An overdose of nifedipine may cause the following consequences:

arterial hypotension;
chest pain (similar to an angina );
tachycardia;
loss of consciousness;
collapse;
ventricular or nodal extrasystole ;
bradycardia.

In severe cases, the development of metabolic alkalosis , cardiogenic shock with pulmonary edema, hypoxia , hyperkalemia , as well as disturbances of consciousness, which can progress to coma .

Interaction

Cordaflex should not be administered with alcohol-containing medications.

Orthostatic hypotension may develop when used with methyldopa , clonidine , as well as prazosin and octadine .

Cimetidine , ranitidine and tricyclic antidepressants will potentiate the antihypertensive effect .

When Cordaflex is combined with theophylline and digoxin , it is necessary to monitor the plasma concentrations of these drugs, as they may increase.

Phenytoin , calcium supplements and rifampicin reduce the effect of nifedipine .

Cordaflex reduces the rate of elimination of vincristine , which increases the risk of side effects. Therefore, dose adjustment is necessary.

Erythromycin , diltiazem , grapefruit juice in large quantities, azole antimicrobial drugs when taken with nifedipine significantly slow down its metabolism.

Cordaflex®

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

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

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

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

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 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 a maximum level on days 3-4. 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 - derivatives of coumarin and indanedione, NSAIDs), as a result of which their concentrations in the blood plasma may increase.

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

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

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

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

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

Since nifedipine is metabolized by the CYP3A4 isoenzyme, any inhibitor or inducer of this enzyme may affect the metabolism of nifedipine. Cyclosporine is also a CYP3A4 substrate; therefore, when cyclosporine and nifedipine are used together, each may increase the duration of the effect of the other.

Cordaflex analogues (drugs that have a similar effect)

Level 4 ATC code matches:
Lacipil

Cordafen

Azomex

Nimodipine

Felodipin

Nifedipine

Farmadipin

Amlotop

Nimotop

Tenox

Nifecard HL

Cordipin

Felodip

Normodipine

Phenigidine

Norvask

Lerkamen

Corinfar

Vero-Amlodipine

Amlodipine

Analogs are the following drugs: Adalat , Vero-Nifedipine , Calcigard Retard , Zanifed , Cordafen , Cordaflex Retard , Cordipin , Cordipin Retard , Cordipine XL Corinfar , Nifedicap , Nifedipine and some other drugs.

Cordaflex Retard has particularly similar pharmaceutical characteristics and therapeutic applications.

Cordaflex price, where to buy

The price for 10 mg tablets is 72-95 rubles for 10 pieces, for 20 mg tablets – 63-139 rubles for 30 pieces, 74-168 rubles for 60 pieces.

Online pharmacies in RussiaRussia

ZdravCity

Cordaflex tab.
p.o 10 mg n100Egis 97 rub. order
Cordaflex tablets p.p.o. prolonged action 20 mg 30 pcs. Egis
91 rub. order
Cordaflex tablets p.p.o. prolonged action 20 mg 60 pcs. Egis
127 RUR order
Cordaflex RD tablets p.p.o. with control release 40 mg 30 pcs Arena Pharmaceuticals GmbH/Egis
RUB 202 order