Cordaflex RD, controlled-release pills 40mg 30pcs

Composition

Nifedipine Auxiliary substances:

microcrystalline cellulose,

lactose monohydrate,

sodium croscarmellose,

hydroxypropylcellulose,

polyvinyl butyral In 30 T,

talc,

magnesium stearate.

Pharmacological action

KORDAFLEX RD is a selective slow calcium channel blocker, a 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 coronary and peripheral arteries.

In therapeutic doses, it normalizes the transmembrane flow of calcium ions, which is disturbed in a number of pathological conditions, primarily in arterial hypertension. Reduces spasm and dilates coronary and peripheral arterial vessels, reduces OPSS, reduces afterload and myocardial oxygen demand. At the same time, it improves blood supply to ischemic areas of the myocardium without the development of “stealing” 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. It does not affect the tone of the veins. Nifedipine increases renal blood flow, causing moderate natriuresis. In high doses, it inhibits the release of calcium ions from intracellular depots. Reduces the number of functioning calcium channels, without affecting the time of their activation, inactivation and recovery. After a single dose of Kordaflex in the form of long-acting tablets, the clinical effect develops in 20 minutes, the duration of the clinical effect is 12-24 hours.

Indications

• arterial hypertension of various origins, including hypertensive crises;
• IHD: for the prevention of seizures in various forms of angina, including angiospastic;
• Raynaud’s syndrome.

Use during pregnancy and lactation

Kordaflex® is contraindicated for use in the first trimester of pregnancy. The use of Kordaflex in pregnant women is indicated only in cases where normalization of blood pressure is impossible with the use of other antihypertensive drugs. Since nifedipine is excreted in breast milk, you should avoid using Kordaflex during lactation or stop breastfeeding during treatment with the drug.

Contraindications

• acute stage of myocardial infarction;
• cardiogenic shock;
• severe arterial hypotension;
• severe aortic or mitral stenosis, idiopathic hypertrophic subaortic stenosis;
• severe heart failure;
• I trimester of pregnancy;
• lactation period;
• children and adolescents under 18 years of age;
• hypersensitivity to nifedipine and other components of the drug.

Kordaflex® should be used with caution in patients with chronic heart failure, hypertrophic obstructive cardiomyopathy, severe cerebral circulatory disorders, SSR, severe tachycardia, severe liver and/or kidney function disorders, malignant arterial hypertension, patients undergoing hemodialysis, lactose intolerance, and elderly patients.

Side effects

From the cardiovascular system: at the beginning of treatment – hyperemia of the facial skin, a marked decrease in blood pressure, tachycardia; peripheral edema; rarely-increased frequency of angina attacks, heart failure.

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

From the digestive system: nausea, heartburn, diarrhea or constipation; rarely with prolonged use – intrahepatic cholestasis, increased activity of hepatic transaminases; 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, pruritus; very rarely – photodermatitis.

Other: in some cases – visual disturbances, gynecomastia, hyperglycemia, weight loss, galactorrhea.

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

Interaction

The combination of Kordaflex with beta-blockers, diuretics, ACE inhibitors, nitrates is rational from the point of view of enhancing the antihypertensive and antianginal effects. All of the above combinations are safe and effective in most clinical situations, since they lead to a summation or potentiation of the effects, but in some cases there is a risk of a pronounced decrease in blood pressure and increased symptoms of heart failure. The combination of Kordaflex with clonidine, methyldopa, octadine, prazosine is possible according to indications, but may cause severe orthostatic hypotension. An increase in the hypotensive effect is also observed in 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 prolongation of the QT interval increase 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 decreases significantly, which is probably due to a decrease in its bioavailability, as well as the induction of enzymes that inactivate quinidine. When nifedipine is discontinued, there is a transient increase in the concentration of quinidine (approximately 2 times), which reaches its maximum level on day 3-4. Caution should be exercised when using such combinations, especially in patients with left ventricular dysfunction. Nifedipine can displace drugs with a high degree of binding from protein binding (including indirect anticoagulants-coumarin and indandione derivatives, NSAIDs), as a result of which their plasma concentrations may increase. When administered concomitantly with rifampicin, phenytoin and calcium supplements, the effect of nifedipine is weakened. Nifedipine inhibits the elimination of vincristine from the body and may cause an increase in the side effect of vincristine, if necessary, the dose of vincristine is reduced. Diltiazem suppresses the metabolism of nifedipine in the body, if necessary, reduce the dose of nifedipine. Grapefruit juice, erythromycin, and azole antifungal medications (fluconazole, intraconazole, and ketoconazole) can inhibit nifedipine metabolism and therefore enhance its effects. Similarly, concomitant use of Cordaflex and cimetidine increases the plasma concentration of nifedipine and enhances its effects; however, concomitant use with ranitidine does not significantly increase the plasma concentration of nifedipine. Since nifedipine is metabolized by the CYP3A4 isoenzyme, any inhibitor or inducer of this enzyme can affect the metabolism of nifedipine. Cyclosporine is also a substrate of the CYP3A4 isoenzyme; therefore, when cyclosporine and nifedipine are used together, each can increase the duration of the other’s effect.

How to take, course of use and dosage

The dosage regimen is set individually, depending on the severity of the disease and the patient’s response to the therapy. Adults Kordaflex® in the form of coated tablets are prescribed 10 mg (1 tab. ) 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. To speed up the action of the drug at the beginning of an angina attack 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 take the drug in the form of long-acting tablets. During the course of therapy, it is recommended to use Kordaflex® in the form of long-acting tablets. The initial dose is 20 mg (1 tab. ) 2 times / 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 sufficient 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. No dosage adjustment is required for moderate hepatic or renal impairment. With severe hepatic impairment, 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 long – acting tablets-regardless of food intake, without chewing, with a small amount of water.

Overdose

Symptoms: headache, hypotension, as well as a violation of the energy supply of the myocardium.

Treatment: immediately after an overdose, as a first aid, you can wash the stomach and give activated charcoal. If necessary, small bowel lavage can be performed, which is especially advisable in the case of an overdose of controlled-release drugs.

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

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

In severe hypotension, an infusion of norepinephrine (norepinephrine) in standard doses is indicated. If symptoms of heart failure develop, intravenous use of fast-acting digitalis glycosides is recommended.

Due to the lack of a specific antidote, symptomatic therapy is indicated. As antidotes, you can use dopamine, isoprenaline and 10% calcium gluconate (10-20 ml iv).

Special instructions

The antihypertensive effect of Kordaflex increases with hypovolemia. Reduced pulmonary artery pressure and hypovolemia after dialysis may also increase the effects of the drug, and therefore a dose reduction is recommended.

In rare cases, chest pain may occur at the beginning of the course of treatment with Kordaflex or when its dose is increased shortly after taking the drug. If a causal relationship is found between taking the drug and angina pectoris, treatment should be discontinued.

In patients with arterial hypertension or coronary vascular disease, abrupt withdrawal of nifedipine may cause a hypertensive crisis or myocardial ischemia.

If the patient needs surgery under general anesthesia during therapy, it is necessary to inform the anesthesiologist about the treatment with Cordaflex.

Elderly patients are more likely to have decreased cerebral blood flow due to severe peripheral vasodilation. During the course of treatment with Kordaflex, the use of alcoholic beverages is not recommended due to the risk of excessive lowering of blood pressure.

Use in pediatrics

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

Influence on the ability to drive motor vehicles and manage mechanisms

During the initial, individually determined period of application of Kordaflex, driving vehicles and engaging in other potentially dangerous activities that require rapid psychomotor reactions are not allowed. In the course of further treatment, the degree of restrictions is determined depending on the individual patient’s reaction to the drug.

Form of production

Controlled release, film-coated tablets.

Storage conditions

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

Shelf life

5 years

Active ingredient

Nifedipine

Conditions of release from pharmacies

By prescription

Dosage form

Tablets