Cordaflex prolonged action tablets p/o 20mg №60

Name:
Cordaflex tab. No. 60 in a pack. No. 1
Description:
Long-acting tablets, film-coated, brownish-purple, round, biconvex, with a matte or slightly shiny surface, odorless or with a slight characteristic odor; at the break – yellow with a narrow strip of brownish-violet color along the edges. The main active ingredient Nifedipine Release form Long-acting tablets, film-coated brownish-purple, round, biconvex, with a matte or slightly shiny surface, odorless or with a slight characteristic odor; at the break – yellow with a narrow strip of brownish-violet color along the edges. 1 tab. Active substance: nifedipine 20 mg; Excipients: microcrystalline cellulose – 99 mg, lactose monohydrate – 30 mg, croscarmellose sodium – 26 mg, copolymer of methyl methacrylate and ethyl acrylate 1: 2 – 1.9 mg, talc – 2 mg, magnesium stearate – 0.6 mg, hyprolose – 0.5 mg. Shell composition: hypromellose – 5.26 mg, titanium dioxide – 1.64 mg, iron dye red oxide (E172) – 0.48 mg, iron dye black oxide (E172) – 0.12 mg, magnesium stearate – 0.5 mg. 30 pcs. – jars of dark glass (1) – packs of cardboard. 60 pcs. – jars of dark glass (1) – packs of cardboard. Dosage 20mg per vial No. 60 in a pack. No. 1 Special instructions Should not be used to relieve an attack of angina pectoris. Particular caution is necessary when prescribing Kordaflex® to patients with significant arterial hypotension (systolic blood pressure below 90 mm Hg). The antihypertensive effect of Cordaflex® is enhanced with hypovolemia. In kidney disease, the dose of nifedipine does not need to be adjusted. A decrease in pressure in the pulmonary artery and hypovolemia after dialysis can enhance the effects of Cordaflex®, and therefore a reduction in its dose is recommended. Despite the absence of a withdrawal syndrome in Cordaflex®, a gradual reduction in doses is recommended before stopping treatment. The regularity of treatment is important, regardless of how you feel, since the patient may not feel the symptoms of arterial hypertension. The simultaneous appointment of beta-blockers should 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 phenomena of heart failure. It is not recommended to simultaneously carry out intravenous therapy with β-adrenergic blockers and intracoronary administration of nifedipine. During treatment, positive results are possible when performing a direct Coombs test and laboratory tests for antinuclear antibodies. If during therapy the patient requires surgery under general anesthesia, it is necessary to inform the anesthesiologist about the nature of the therapy being carried out. Caution should be exercised in elderly patients due to the greatest likelihood of age-related renal dysfunction. Caution is required when using Cordaflex® in patients with liver disease. With portal hypertension and cirrhosis of the liver, the dose should be reduced. In rare cases, at the beginning of the course of treatment with nifedipine or with an increase in its dose shortly after taking the drug, chest pain (angina pectoris due to paradoxical ischemia) may occur. If a causal relationship is found between the use of Cordaflex® and angina pectoris, the drug should be discontinued. Patients with diabetes need careful medical supervision during the use of the drug Cordaflex®. During the course of treatment with the drug, alcohol should be avoided. Each tablet contains 30 mg of lactose monohydrate, so the drug should not be prescribed to patients with lactase deficiency, lactose intolerance, glucose-galactose malabsorption. Influence on the ability to drive vehicles and control mechanisms During the period of treatment, care must be taken when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions. Pharmacological action Selective blocker of slow calcium channels, a derivative of 1.4-dihydropyridine. 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. Uncouples the processes of excitation and contraction in the smooth muscles of blood vessels mediated by calmodulin. 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 OPSS, reduces afterload and myocardial oxygen demand. At the same time, it improves the blood supply to ischemic areas of the myocardium without the development of the “steal” syndrome, and also increases the number of functioning collaterals. Nifedipine has practically no effect on the sinoatrial and AV nodes and has no antiarrhythmic effect. 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. Pharmacokinetics Absorption When taken orally, it is rapidly and almost completely (90%) absorbed from the gastrointestinal tract. Bioavailability – 40-60%. Eating increases bioavailability. It undergoes the effect of “first pass” through the liver. After ingestion 1 tab. prolonged action of 20 mg, the therapeutic concentration of nifedipine in plasma is reached after 1 hour and remains at a constant level for up to 6 hours (prolonged-release plateau), and gradually decreases over the next 30-36 hours. Distribution Plasma protein binding (albumin) is 94-97%. Penetrates through the BBB and the placental barrier, 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. Excretion T1 / 2 – 3.8-16.9 hours. 60-80% of the ingested dose of the drug is excreted in the urine in the form of inactive metabolites, the rest – with bile and feces. Pharmacokinetics in special groups of patients In patients with hepatic insufficiency, the 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 Arterial hypertension; IHD: for the prevention of attacks in various forms of angina pectoris, incl. angiospastic (Prinzmetal’s angina); Raynaud’s syndrome. Dosage and administration The drug is taken orally. Tablets should be swallowed whole, without chewing, with a small amount of water. The recommended initial dose of the drug is 1 tab. (20 mg) 2 times / day. If necessary, the daily dose can be increased to 2 tab. 2 times/day The maximum daily dose of nifedipine should not exceed 120 mg. It is recommended to divide the daily dose into 2 doses at 12-hour intervals. In patients with impaired liver function, the drug is used with caution under the control of liver function, with severe violations of liver function, it is necessary to reduce the dose. In patients with impaired renal function, dose adjustment is not required. In elderly patients, the metabolism of nifedipine is reduced during the “first pass” through the liver, and there is also a higher likelihood of deterioration in cerebral blood flow due to possible sharp peripheral vasodilation, therefore, at the beginning of treatment, the dose of Kordaflex® is reduced by about 2 times. The drug should be discontinued gradually, especially after high doses. Use during pregnancy and lactation Cordaflex® tablets of prolonged action is contraindicated for use before the 20th week of pregnancy. Controlled studies of the use of the drug Kordaflex® in pregnant women have not been conducted. Based on the available clinical data, no specific prenatal risk can be judged. However, there is evidence of an increase in the likelihood of perinatal asphyxia, caesarean section, premature birth and intrauterine growth retardation. It is not clear whether these cases are due to the underlying disease (arterial hypertension), ongoing treatment, or a specific effect of nifedipine. The available information is insufficient to exclude the possibility of side effects that are dangerous to the fetus and newborn. Therefore, the use of Kordaflex® after the 20th week of pregnancy requires a careful individual assessment of the risk-benefit ratio for the patient, fetus and / or newborn and can only be considered in cases where other methods of therapy are contraindicated or ineffective. Careful monitoring of blood pressure in pregnant women should be carried out when using Kordaflex® simultaneously with the intravenous administration of magnesium sulfate due to the possibility of an excessive decrease in blood pressure, which is dangerous for both the mother and the fetus and / or newborn. Since nifedipine is excreted in breast milk, you should refrain from prescribing Cordaflex® during lactation, or stop breastfeeding during treatment with the drug. Precautions Cordaflex® should be used with caution in chronic heart failure, severe liver and / or kidney dysfunction, severe cerebrovascular accident, diabetes mellitus, malignant arterial hypertension, bradycardia, in patients on hemodialysis (due to the risk of severe arterial hypotension ). Interaction with other drugs Rifampicin is a powerful inducer of the CYP3A4 isoenzyme. With simultaneous use with rifampicin, the bioavailability of nifedipine is significantly reduced and, accordingly, its effectiveness is reduced. The use of nifedipine in conjunction with rifampicin is contraindicated. Because rifampicin and phenytoin, through enzyme induction, significantly reduce the plasma concentration of nifedipine, a similar effect of barbiturates and carbamazepine cannot be excluded. When taken simultaneously with other antihypertensive drugs (ACE inhibitors, diuretics, etc.), nitrates, psychotropic drugs and drugs containing magnesium, the hypotensive effect may increase. Simultaneous use with beta-blockers enhances the hypotensive and antianginal effects, which is generally favorable, however, the use of such a combination of drugs requires special care due to the possibility of an excessive decrease in blood pressure, the development of arterial hypotension and heart failure. When combined with prazosin, severe orthostatic hypotension may occur. The combined use of nifedipine with digoxin may lead to an increase in plasma concentrations of digoxin. With simultaneous use with theophylline, the concentration of theophylline in plasma may increase. The use of nifedipine concomitantly with quinidine requires special care, since with simultaneous administration, the concentration of quinidine in plasma may decrease, and with the abolition of nifedipine, it may increase. The simultaneous use of these drugs can lead to the occurrence of malignant ventricular arrhythmia (abnormal increase in the QT interval on the ECG). Diltiazem increases plasma concentrations of nifedipine. Nifedipine may increase the anticoagulant effect of coumarin derivatives. Since nifedipine is metabolized by the CYP3A4 isoenzyme, any inhibitor or inducer of this enzyme can alter the metabolism of nifedipine: grapefruit juice, erythromycin, azole antifungals (eg, ketoconazole), some fluoroquinolones, norfloxacin, ciprofloxacin, progestogen-containing oral contraceptives, and HIV protease inhibitors (eg, indinavir, ritonavir) may inhibit the metabolism of nifedipine and increase its effect. Similarly, co-administration of nifedipine and cimetidine increases its plasma concentration and thus the action of nifedipine, but co-administration of ranitidine does not significantly increase plasma levels of nifedipine. Cyclosporine is also a substrate for the CYP3A4 isoenzyme, therefore, when taken simultaneously, the duration of action of both drugs may increase. Simultaneous administration of nifedipine with weak and moderate inhibitors of the CYP3A4 isoenzyme requires regular monitoring of blood pressure and, if necessary, a dose reduction of nifedipine. These drugs include antibiotics of the macrolide group (azithromycin, which belongs to the macrolide group, is not an inhibitor of the CYP3A4 isoenzyme). Nifedipine reduces the excretion of vincristine, thus increasing its side effects. The need to reduce the dose of vincristine should be considered. Simultaneous administration of cisapride and nifedipine may lead to an increase in plasma concentrations of nifedipine. Blood pressure should be monitored and, if necessary, the dose of nifedipine should be reduced. The simultaneous use of quinupristin / dalfopristin and nifedipine may lead to an increase in the concentration of nifedipine in the blood plasma. Blood pressure should be monitored and, if necessary, the dose of nifedipine should be reduced. Clinical studies of the interaction of nifedipine with valproic acid have not been conducted. Since valproic acid has been shown to increase plasma concentrations of nimodipine, which is structurally similar to nifedipine, BCCA nimodipine by inhibiting microsomal liver enzymes, the possibility of an increase in plasma concentrations of nifedipine cannot be ruled out. The following drugs do not affect the pharmacokinetics of nifedipine: aymalin, benazepril, debrisoquine, doxazosin, irbesartan, omeprazole, orlistat, pantoprazole, ranitidine, rosiglitazone, talinolol, triamterene/hydrochlorothiazide, acetylsalicylic acid and candesartan. Contraindications Acute myocardial infarction (in the first 4 weeks); SSSU; cardiogenic shock; severe arterial hypotension (systolic blood pressure below 90 mm Hg); severe aortic or mitral stenosis, hypertrophic obstructive cardiomyopathy (risk of a pronounced decrease in blood pressure); chronic heart failure IV functional class according to NYHA; concomitant use of rifampicin; pregnancy up to 20 weeks; lactation period (breastfeeding); children and adolescents up to 18 years of age; lactase deficiency, lactose intolerance, glucose-galactose malabsorption syndrome (the drug contains lactose monohydrate); hypersensitivity to nifedipine and other components of the drug; hypersensitivity to other dihydropyridine derivatives. The drug should not be used to relieve angina attacks. Cordaflex® should be used with caution in chronic heart failure, severe liver and / or kidney dysfunction, severe cerebrovascular accident, diabetes mellitus, malignant arterial hypertension, bradycardia, in patients on hemodialysis (due to the risk of severe arterial hypotension) . Composition Active substance: nifedipine 20 mg; Excipients: microcrystalline cellulose – 99 mg, lactose monohydrate – 30 mg, croscarmellose sodium – 26 mg, copolymer of methyl methacrylate and ethyl acrylate 1: 2 – 1.9 mg, talc – 2 mg, magnesium stearate – 0.6 mg, hyprolose – 0.5 mg. Shell composition: hypromellose – 5.26 mg, titanium dioxide – 1.64 mg, iron dye red oxide (E172) – 0.48 mg, iron dye black oxide (E172) – 0.12 mg, magnesium stearate – 0.5 mg. Overdose Symptoms: depending on the severity of intoxication – a pronounced decrease in blood pressure, tachycardia, chest pain, fainting and loss of consciousness due to cardiac arrhythmias (sinus node depression, bradycardia, prolongation of AV conduction, ventricular premature beats), inhibition of insulin secretion. In more severe cases, confusion leading to coma, hyperkalemia, metabolic acidosis, hypoxia, and cardiogenic shock with pulmonary edema may occur. Treatment: there is no specific antidote, therefore, first of all, measures should be taken to eliminate nifedipine and maintain the function of the cardiovascular system. In case of an overdose, the first therapeutic measure should be gastric lavage, activated charcoal; if necessary, with colonic lavage. Complete removal of unabsorbed nifedipine by gastric and colonic lavage is especially important in the event of an overdose of sustained release drugs in order to prevent further absorption. Laxatives can be prescribed, however, in the case of slow calcium channel blockers, inhibition of intestinal motility up to atony should be taken into account. Nifedipine is not excreted by dialysis, therefore, hemodialysis is ineffective, however, plasmapheresis is recommended (given the high percentage of nifedipine binding to plasma proteins and the relatively small Vd). As a symptomatic treatment of bradycardia, atropine and / or beta-agonists can be prescribed. For life-threatening bradycardia, a temporary pacemaker should be placed. With a pronounced decrease in blood pressure due to cardiogenic shock and arterial vasodilation, calcium (1-2 g calcium gluconate IV drip), dopamine (maximum 25 μg/kg body weight/min), dobutamine (maximum 15 μg/kg body weight/min) should be prescribed. ) and epinephrine or norepinephrine. The dose of these drugs should be determined according to the response of the patient. Serum calcium may be normal or slightly elevated. Additional fluid administration should be carried out with caution under the control of hemodynamic parameters to prevent cardiac overload. Side effect The frequency of side effects is aligned with the following categories: very often (? 1/10); often (?1/100 – <1/10); infrequently (?1/1000 - <1/100); rarely (?1/10,000 - <1/1000); very rarely (<1/10,000); unknown (it is impossible to establish the frequency from the available data). From the nervous system: often - dizziness, headache, drowsiness; infrequently - insomnia, anxiety, paresthesia, dizziness; rarely - hypesthesia, tremor, sleep disturbances, mood changes. On the part of the organ of vision: rarely - blurred vision, pain in the eyes. From the side of the cardiovascular system: often - a feeling of palpitations, symptoms of vasodilation (reddening of the skin of the face, a feeling of heat), swelling; infrequently - fainting, tachycardia, marked decrease in blood pressure, orthostatic hypotension; very rarely - in some cases, myocardial infarction may develop, although this is most likely a consequence of the underlying disease. From the respiratory system: infrequently - shortness of breath; rarely - nosebleeds; very rarely - allergic reactions with swelling of the vocal cords, in extreme cases, bronchospasm with life-threatening shortness of breath, which appears after discontinuation of treatment. From the gastrointestinal tract: infrequently - diarrhea, dryness of the oral mucosa, bloating, nausea, constipation; rarely - vomiting, anorexia, belching, gingivitis, hypertrophic gingivitis; very rarely - esophagitis, intestinal obstruction, ulcerative lesions of the intestine. From the side of the liver and biliary tract: rarely - impaired liver function (increased GGT activity), very rarely - jaundice, hepatitis. On the part of the hematopoietic system: very rarely - anemia, leukopenia, thrombocytopenia or thrombocytopenic purpura, agranulocytosis. From the endocrine system: very rarely - transient hyperglycemia. From the genitourinary system: infrequently - nocturia, polyuria; rarely - dysuria, impotence; very rarely - a temporary deterioration in kidney function is possible while taking nifedipine in patients with renal insufficiency. From the side of the skin and subcutaneous tissues: often - redness of the skin of the face, accompanied by a feeling of heat; infrequently - itching, skin rash; rarely - angioedema, maculo-papular, pustular, vesicular and bullous rash, edema, urticaria; very rarely - hypersensitivity reactions, exfoliative dermatitis may occur. Photodermatitis may occur under the influence of sunlight or ultraviolet light. From the musculoskeletal system: myalgia, rarely - pain in the joints and muscles, very rarely - arthritis. Other: infrequently - pain (in the abdomen, chest, legs), weakness; rarely - allergic reactions, chest pain, chills, fever, gynecomastia (especially in elderly patients and against the background of long-term use of the drug - the condition always returns to normal after stopping treatment), cardiac sphincter insufficiency, swelling of the joints, muscle cramps. Angina attacks may appear at the very beginning of therapy, or in patients with a history of angina attacks, the frequency, duration and severity of attacks may increase. With hypertension or coronary artery disease, sudden withdrawal of nifedipine can provoke a hypertensive crisis or myocardial ischemia (withdrawal syndrome). Storage conditions The drug should be stored out of the reach of children at a temperature not exceeding 30 ° C. Buy Cordaflex prolonged-release tablets p/o 20mg No. 60 The price of Cordaflex prolonged-release tablets p/o 20mg No. 60