Cordaflex tablets p/o 10mg №100 №1

Name:
Kordaflex tabl 10mg in vial No. 100
Description:
of yellow coated tablets, matte or slightly shiny, round, biconvex, with a slight characteristic odor. The main active ingredient Nifedipine Release form Tablets, coated yellow, matte or slightly shiny, round, biconvex, with a slight characteristic odor. 1 tab. Active substance: nifedipine 10 mg; Excipients: microcrystalline cellulose – 46 mg, lactose monohydrate – 15 mg, croscarmellose sodium – 13 mg, hydroxypropylcellulose – 4 mg, polyvinyl butyral (B 30T) – 0.7 mg, talc – 1 mg, magnesium stearate – 0.3 mg. Shell composition: hypromellose – 2.63 mg, titanium dioxide (CI77891 EEC171) – 0.82 mg, yellow iron oxide (CI77492 EEC172) – 0.3 mg, magnesium stearate – 0.25 mg. 100 pieces. – brown glass bottles (1) – packs of cardboard. Dosage 10mg per vial №100 Special instructionsThe antihypertensive effect of Cordaflex is enhanced by hypovolemia. The decrease in pressure in the pulmonary artery and hypovolemia after dialysis can also enhance the effects of the drug, and therefore a reduction in its dose is recommended. In rare cases, at the beginning of the course of treatment with Cordaflex 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 between taking the drug and angina pectoris is found, treatment should be discontinued. Patients with diabetes need careful medical supervision during Cordaflex therapy. With arterial hypertension or coronary artery disease, abrupt withdrawal of nifedipine can cause a hypertensive crisis or myocardial ischemia (the “rebound” phenomenon). If during therapy the patient requires surgical intervention under general anesthesia, it is necessary to inform the anesthesiologist about the ongoing Cordaflex therapy. During course treatment with Cordaflex, the use of alcoholic beverages is not recommended due to the risk of an excessive decrease in blood pressure. Influence on the ability to drive vehicles and control mechanisms In the initial, individually determined period of application of Cordaflex, driving vehicles and engaging in other potentially hazardous 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’s response to the drug. 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. 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 total peripheral resistance, 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 atrioventricular 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 (more than 90%) absorbed from the gastrointestinal tract. Absolute bioavailability – 40-70%. After oral administration of Cordaflex, Cmax in the blood is reached 0.5-1 hour after ingestion. Distribution Plasma protein binding (albumin) is 94-97%. Unbound nifedipine is distributed in all organs and tissues. Penetrates through the BBB (less than 5%), through the placental barrier, excreted in breast milk. There is no cumulative effect. Metabolism Nifedipine is extensively metabolized during the “first pass” through the liver (40-60%). Completely metabolized to inactive metabolites. The elimination T1 / 2 of nifedipine is approximately 2 hours. 60-80% of the ingested dose of the drug is excreted in the urine as inactive metabolites, the rest is excreted in the bile and feces. Indications for use Arterial hypertension, including hypertensive crises; IHD: stable angina (angina), angiospastic angina (Prinzmetal’s angina). Dosage and administration The dosing regimen is set individually, depending on the severity of the disease and the patient’s response to therapy. The drug is taken orally before meals, washed down with a small amount of water, without chewing. Cordaflex® 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 action of the drug at the beginning of the development of an attack of angina pectoris or a 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 long-acting film-coated tablets, 20 mg. In elderly patients, the pharmacokinetics of nifedipine changes, and therefore, lower doses may be required to maintain a therapeutic effect. In case of impaired liver or kidney function, the drug is recommended to be used with caution in the same doses as in normal liver and kidney function (tolerance may develop). With severe liver dysfunction, the maximum daily dose should not exceed 40 mg. Application during pregnancy and lactation The use of Cordaflex in pregnant women is indicated when it is impossible to use other drugs that do not have restrictions. Since nifedipine is excreted in breast milk, Cordaflex should be avoided during lactation or breastfeeding should be stopped during drug treatment. Precautions With caution: severe mitral valve stenosis, hypertrophic obstructive cardiomyopathy, chronic heart failure, severe cerebrovascular accident, SSS, severe tachycardia, advanced age, age up to 18 years, renal or hepatic insufficiency (especially patients on hemodialysis – a high risk of excessive and unpredictable decrease in blood pressure), lactose intolerance. Interaction with other drugs Rational in terms of enhancing the antihypertensive and antianginal action is the combination of Cordaflex with beta-blockers, diuretics, ACE inhibitors, nitrates. All of the above combinations in most clinical situations are safe and effective, because they lead to summation or potentiation of effects, however, in some cases there is a risk of a pronounced decrease in blood pressure and an increase in symptoms of heart failure. The combination of Cordaflex with clonidine, methyldopa, octadine, prazosin is possible, according to indications, but can cause severe orthostatic hypotension. Strengthening of the hypotensive effect is also observed in combination therapy with cimetidine, ranitidine and tricyclic antidepressants. Nifedipine increases the concentration of digoxin and theophylline in blood plasma, and therefore the clinical effect and / or the content of digoxin and theophylline in blood plasma should be monitored. Procaine, quinidine and other drugs that cause QT interval prolongation increase the negative inotropic effect and increase the risk of QT interval prolongation. Under the influence of nifedipine, the concentration of quinidine in the blood serum is significantly reduced, which, apparently, is due to a decrease in its bioavailability, as well as the induction of enzymes that inactivate quinidine. With the abolition of nifedipine, a transient increase in the concentration of quinidine (approximately 2 times) is observed, which reaches a maximum level at 3-4 days. Caution should be exercised when using such combinations, especially in patients with impaired left ventricular function. Nifedipine can displace drugs with a high degree of binding from protein binding (including indirect anticoagulants – coumarin and indandione derivatives, NSAIDs), as a result, their plasma concentrations may increase. With simultaneous appointment with rifampicin, phenytoin and calcium preparations, the effect of nifedipine is weakened. Nifedipine inhibits the excretion of vincristine from the body and may increase the side effects of vincristine, if necessary, reduce the dose of vincristine. Diltiazem inhibits the metabolism of nifedipine in the body, if necessary, reduce the dose of nifedipine. Grapefruit juice, erythromycin and azole antifungals (fluconazole, itraconazole, ketoconazole) can 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, 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 can affect the metabolism of nifedipine. Cyclosporine is also a substrate of the CYP3A4 isoenzyme; therefore, with the combined use of cyclosporine and nifedipine, each can increase the duration of the effect of the other. Contraindications Acute myocardial infarction (first 4 weeks); severe arterial hypotension (systolic blood pressure below 99 mm Hg); severe aortic stenosis, idiopathic hypertrophic subaortic stenosis; chronic heart failure in the stage of decompensation; unstable angina; hypersensitivity to nifedipine and other components of the drug, other derivatives of 1,4-dihydropyridine. With caution: severe mitral valve stenosis, hypertrophic obstructive cardiomyopathy, chronic heart failure, severe cerebrovascular accident, SSSU, severe tachycardia, advanced age, age up to 18 years, renal or hepatic insufficiency (especially patients on hemodialysis – a high risk of excessive and unpredictable decrease in blood pressure), lactose intolerance. Composition Active substance: nifedipine 10 mg; Excipients: microcrystalline cellulose – 46 mg, lactose monohydrate – 15 mg, croscarmellose sodium – 13 mg, hydroxypropylcellulose – 4 mg, polyvinyl butyral (B 30T) – 0.7 mg, talc – 1 mg, magnesium stearate – 0.3 mg. Shell composition: hypromellose – 2.63 mg, titanium dioxide (CI77891 EEC171) – 0.82 mg, yellow iron oxide (CI77492 EEC172) – 0.3 mg, magnesium stearate – 0.25 mg. Overdose Symptoms: severe arterial hypotension, tachycardia, chest pain (angina pectoris), headache, collapse, loss of consciousness, nodal or ventricular extrasystole due to inhibition of the sinus node, bradycardia, fainting. In severe cases, disturbances of consciousness with a transition to a coma, 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 is performed with the appointment of activated charcoal. If necessary, small bowel lavage can be done, which is more appropriate in case of an overdose of controlled release drugs. When prescribing laxatives, it should be borne in mind that taking blockers of slow calcium channels suppresses intestinal motility to complete atony. Since nifedipine is highly protein bound, hemodialysis is not effective, and plasmapheresis may be effective. Symptomatic therapy is shown. Symptoms of cardiac arrhythmia with bradycardia can be eliminated by the introduction of beta-agonists and / or atropine. For life-threatening bradycardia, an artificial pacemaker should be used. With a pronounced decrease in blood pressure, infusion of the 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 IV). With the development of symptoms of heart failure, intravenous administration of fast-acting digitalis digitalis glycosides is recommended. Side effects From the side of the cardiovascular system: flushing of the skin of the face, severe arterial hypotension, peripheral edema, tachycardia; rarely – the appearance of angina attacks (drug withdrawal is required), heart failure, syncope. From the side of 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 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 – deterioration of kidney function in patients with chronic renal failure, nighttime urination. From the musculoskeletal system: myalgia; very rarely – arthritis, arthralgia. 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, pruritus; very rarely – photodermatitis. Other: feeling of heat; very rarely – weakness, sweating, fever, chills. Storage conditions The drug should be stored in a place protected from light and out of the reach of children at a temperature of 15 ° to 25 ° C. Buy Cordaflex tablets p/o 10mg №100 №1 Price for Kordaflex tablets p/o 10mg №100 №1