CORDAFLEX RD PILLS COATED 40MG

Dosage form

Coated tablets

Composition

1 pill with a controlled release, coated, contains: Nifedipine 40 mg.

Excipients: cellulose, microcrystalline cellulose, lactose, hypromellose 4000, Magnesium stearate, anhydrous colloidal silicon dioxide.

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

Packaging

In the blister of 10 tablets. In packing 3 blisters.

Mechanism of action

Cordaflex RD is a selective blocker of slow Calcium channels, a derivative of 1,4-dihydropyridine.

It has antihypertensive and antianginal effect. Nifedipine reduces the current of extracellular calcium ions into the interior of cardiomyocytes and smooth muscle cells of the coronary and peripheral arteries. In therapeutic doses, it normalizes the transmembrane current of calcium ions, disturbed in a number of pathological conditions, especially in hypertension. Decreases spasm and dilates coronary and peripheral arterial vessels, lowers round coronary artery disease, reduces afterload and myocardial oxygen demand.At the same time, it improves the blood supply to the ischemic zones of the myocardium without the development of the robbery syndrome, and also increases the number of functioning collaterals.

Nifedipine has virtually no effect on the sinoatrial and AV node and does not have both pro-and anti-arrhythmic 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 depots. Reduces the number of functioning calcium channels, without affecting the time of their activation, inactivation and recovery.

After a single dose of Cordaflex RD, the effect lasts more than 24 hours.

Indications and usage

- Arterial hypertension.
- Stable angina (angina pectoris).
- Postinfarction angina.
- Angiospastic stenocardia (Prinzmetal's stenocardia).

Contraindications

- Unstable angina.
- Myocardial infarction with left ventricular failure.
- Severe arterial hypotension with the risk of collapse during cardiovascular shock with respiratory manifestations.
- Hypersensitivity to nifedipine, other components of the drug, other 1,4-dihydropyridine derivatives.

With caution should use the drug in the following cases:

- In 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 disorders of cerebral circulation.
- In renal or hepatic insufficiency (especially in patients on hemodialysis because of the high risk of excessive and unpredictable decrease in blood pressure).
- In patients under the age of 18 years (since safety and efficacy have not been established).
- In elderly patients (due to the highest probability of age-related disorders of the kidneys and liver).

Pregnancy and Breastfeeding

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

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

Dosage and administration

The dose should be selected individually, depending on the severity of the patient's condition and the effectiveness of treatment. Cordaflex RD pills should be taken with food (for example, breakfast), swallowed whole and drink plenty of water.

In hypertension, Cordaflex RD is prescribed 40 mg (1 tablet) 1 time / day. If necessary, the dose can be increased to 80 mg (2 pills in 1-2 doses).Increasing the dose of more than 80 mg is not recommended.

In IHD, 40 mg is prescribed (1 tablet) 1 time / day. If necessary, the dose can be increased to 80 mg (2 pills in 1 or 2 doses). Doses of more than 80 mg can be given in exceptional cases under medical supervision. The daily dose should not exceed 120 mg.

In cases of impaired renal or hepatic function, the drug is recommended to be used with caution in the same doses as in normal renal or hepatic function. Possible development of tolerance. With a significant decrease in liver function should not exceed a dose of 40 mg / day.

Adverse reactions

In most cases, the drug Cordaflex RD is well tolerated by patients.

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

Nervous system: headache, dizziness, fatigue, drowsiness; with prolonged use in high doses - paresthesia in the limbs, tremor.

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

Hemic and lymphatic: rarely - thrombocytopenia, thrombocytopenic purpura, leukopenia; in some cases, anemia.

Urogenital: increase daily diuresis; rarely - deterioration of renal function in patients with chronic renal failure.

Musculoskeletal system: myalgia; very rarely - arthritis, arthralgia.

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

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

Special notes

After myocardial infarction, taking 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 calcium channel blockers derived short-acting 1,4-dihydropyridine. When such patients are prescribed calcium channel blockers - derivatives of 1,4-dihydropyridine with controlled release, careful observation is necessary. It is more expedient to prescribe these drugs in the absence of a tendency to tachycardia, as well as to patients who are not effective beta-blockers or there are contraindications to their use.

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

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

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

During treatment, alcohol is not recommended due to the risk of an excessive decrease in blood pressure.

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

Drug interactions

Cordaflex RD can be successfully used in combination therapy. From the point of view of antihypertensive and antianginal effects, the combination of Cordaflex RD with beta-blockers, diuretics, ACE inhibitors, and nitrates is rational. The combined use of Cordaflex RD with beta-blockers in most clinical situations is safe and highly effective, since leads to the summation and potentiation of effects, but in some cases there is a risk of arterial hypotension and increased heart failure.

Increased hypotensive effect is also observed in combination therapy with cimetidine, Ranitidine and tricyclic antidepressants.The treatment with corticosteroids and NSAIDs does not reduce the effectiveness of Cordaflex RD. 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. With simultaneous appointment with rifampicin and calcium preparations, the effect of Cordaflex RD is weakened.

Procaine, quinidine, and other drugs that prolong the QT interval increase 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 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. With the cancellation of Cordaflex RD, there is a transient increase in the concentration of quinidine (approximately 2 times), which reaches a maximum level of 3-4 days, as well as prolongation of the QT interval on the ECG. The use of this combination requires caution, especially in patients with impaired left ventricular function.

Nifedipine can displace drugs that are characterized by a high degree of binding (including indirect anticoagulants - derivatives of coumarin and indanoin, anticonvulsants, NSAIDs) due to protein, and their plasma concentrations may increase.

Since it was shown that Carbamazepine and phenobarbital, by activating liver enzymes, reduce the plasma concentration of other calcium channel blockers, a similar decrease in plasma nifedipine concentration cannot be ruled out.

Valproic acid, inhibiting the activity of enzymes, led to an increase in plasma concentration of other calcium channel blockers, therefore an increase in plasma concentration of nifedipine in the blood plasma cannot be ruled out while being taken with valproic acid.

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

Diltiazem inhibits nifedipine metabolism in the body, careful observation is necessary, and 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.

Symptoms: headache, arterial hypotension, as well as (as well as under the influence of other vasodilators) violation of myocardial energy supply (angina pectoris attack).
Treatment: immediately after an overdose as a first aid, you can wash the stomach and give activated charcoal. If necessary, lavage of the small intestine can be done, which is especially advisable in case of overdose of controlled-release drugs. Since nifedipine is highly associated with plasma proteins, dialysis is not effective, and plasmapheresis can be effective. Symptoms of heart rhythm with bradycardia can be eliminated by beta. -Sympathomimetics.In life-threatening bradycardia, an artificial pacemaker should be used. In severe hypotension, norepinephrine (norepinephrine) is given in standard doses. With the development of symptoms of heart failure, it is recommended in / in the introduction of fast-acting glycosides of digitalis. Due to the lack of a specific antidote, symptomatic therapy is indicated. Dopamine, isoprenaline and 10% Calcium gluconate can be used as antidotes (10-20 ml IV).

The drug should be stored in a place protected from direct sunlight at a temperature not higher than 30 ° C.

4 years.

Cordaflex rd