nifedipine | Cordaflex tablets coated.ob. 10 mg 100 pcs.

Release form

Tablets.

Packing

100 pcs.

Pharmacological action

Cordaflex is a selective slow calcium channel blocker derived from 1,4-dihydropyridine. It has antihypertensive and antianginal effects. Nifedipine reduces the flow of extracellular calcium ions into the 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, especially in arterial hypertension. Reduces spasm and dilates the coronary and peripheral arterial vessels, reduces OPSS, reduces afterload and oxygen demand of the myocardium. At the same time, it improves blood supply to the ischemic zones of the myocardium without the development of a robbery syndrome, and also increases the number of functioning collaterals.

Nifedipine has virtually no effect on the sinoatrial and AV nodes and has no pro- or antiarrhythmic effects. Does not affect the tone of the veins. Nifedipine enhances 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 administration of Cordaflex in the form of prolonged-release tablets, the clinical effect develops after 20 minutes, the duration of the clinical effect is 12-24 hours.

Indications

- arterial hypertension of various genesis, including hypertensive crises (for 10 mg tablets)

- IHD: for the prevention of seizures in various forms of angina pectoris, including angiospastic (Prinzmetal angina)

- Raynaud's syndrome (for prolonged-release tablets).

Contraindications

- 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 (breastfeeding)

- children and adolescents under 18

- increased sensitivity to other drugs Cordaflex.

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

Use during pregnancy and lactation

Cordaflex® is contraindicated for use in the first trimester of pregnancy.

The use of Cordaflex in pregnant women is indicated only in cases where normalization of blood pressure is not possible when using other antihypertensive drugs.

Since nifedipine is excreted in breast milk, Cordaflex should be avoided during lactation or breast-feeding should be discontinued during treatment with the drug.

Special instructions

The antihypertensive effect of Cordaflex is enhanced with hypovolemia. Pressure reduction in the pulmonary artery and hypovolemia after dialysis can also enhance the effects of the drug, and therefore it is recommended to reduce its dose.

In rare cases, chest pain (angina pectoris due to paradoxical ischemia) may occur at the beginning of the course of treatment with Cordaflex or soon after taking the drug. If a causal relationship between taking the drug and angina is detected, treatment should be discontinued.

In arterial hypertension or coronary artery disease, abrupt withdrawal of nifedipine can cause hypertensive crisis or myocardial ischemia (ricochet phenomenon).

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

In elderly patients, a decrease in cerebral blood flow is more likely due to sharp peripheral vasodilation.

During the course of treatment with Cordaflex, the use of alcoholic beverages is not recommended because of the risk of an excessive decrease in 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 vehicles and control mechanisms

In the initial, individually defined period of application of Cordaflex, driving vehicles and engaging in other potentially dangerous activities that require quick psychomotor reactions are not allowed. In the course of further treatment, the degree of restriction is determined depending on the individual patient response to the drug.

Composition

1 tablet: - nifedipine 10 mg

Excipients: polyvinyl butyral, magnesium stearate, talc, hydroxypropyl cellulose, croscarmellose sodium, lactose monohydrate, microcrystalline cellulose, titanium dioxide, ferric oxide, ferric oxide.

Dosage and administration of

Dosage regimen is set individually, depending on the severity of the disease and the patient's response to the therapy.

Adults Cordaflex® in the form of coated tablets is prescribed 10 mg (1 tab) 3 times / 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 accelerate the effect of the drug at the beginning of the development of an attack of angina pectoris 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 necessary, 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 prolonged-release tablets.

During the course of therapy, it is recommended to use Cordaflex® in the form of sustained-release 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 enough to take 20-40 mg (1-2 tablets) 2 times / 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 hepatic or renal impairment, dosage adjustment is not required. With severe impaired liver function, the maximum daily dose should not exceed 40 mg.

The drug is in the form of tablets containing 10 mg of nifedipine, taken orally before meals.

Side effects

From the cardiovascular system: facial skin hyperemia, severe hypotension, peripheral edema, tachycardia rarely - increased angina attacks (drug withdrawal required), increased heart failure, fainting.

From the side of the central nervous system and peripheral nervous system: headache, dizziness, fatigue, sleep disturbances (drowsiness or insomnia) in isolated cases - mood lability, visual impairment with prolonged use in high doses - paresthesia in the limbs, tremor.

From the digestive system: diarrhea, constipation, nausea, heartburn rarely (with prolonged use of the drug) - dry mouth, flatulence, intrahepatic cholestasis, increased activity of hepatic transaminases in some cases - gingival hyperplasia, gingivitis, anorexia.

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

From the urinary system: increased daily diuresis rarely - impaired 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), change in body weight, galactorrhea.

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

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

Overdose

Symptoms: marked arterial hypotension, tachycardia, chest pain (angina pectoris), headache, collapse, loss of consciousness, nodal or ventricular extrasystole due to suppression of sinusocardial node activity, sinusocardial node. In severe cases, disorders of consciousness with a coma transition, hyperkalemia, metabolic alkalosis, hypoxia, cardiogenic shock with pulmonary edema are possible.

Treatment: Given the absence of a specific antidote, in cases of early detoxification, gastric lavage with activated charcoal is performed. If necessary, it is possible to do the washing of the small intestine, which is more appropriate in the case of overdose of controlled release drugs. When prescribing laxatives, it should be borne in mind that taking slow calcium channel blockers suppresses intestinal motility to full atony.

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

Symptomatic therapy is shown. Symptoms of cardiac arrhythmias with bradycardia can be eliminated by administration of beta-adrenomimetics and / or atropine. For life-threatening bradycardia, an artificial rhythm driver should be used. With a marked decrease in blood pressure, infusion of normal doses of norepinephrine (norepinephrine) or epinephrine (adrenaline) is shown, dopamine (maximum dose of 25 μg / kg body weight / min), dobutamine (maximum dose 15 μg / kg body weight / min), isoprenaline and 10% calcium gluconate solution (10-20 ml I / O). In the development of symptoms of heart failure, it is recommended that / in the introduction of fast-acting cardiac glycosides.

Deystvuyuschee substances

nifedipine

Form of Treatment

tablets