Corinfar retard coated pills 20mg N50
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Active ingredients
Nifedipine
Release form
Pills
Composition
Nifedipine 20 mg adjuvants: lactose monohydrate - 31.6 mg, potato starch - 31.4 mg, microcrystalline cellulose - 31 mg, povidone K25 - 5.4 mg, magnesium stearate - 0.6 mg film composition: hypromellose - 5.188 mg, macrogol 6000 - 0.861 mg, macrogol 35000 - 0.393 mg, quinoline yellow (e104) dye - 0.143 mg, titanium dioxide (e171) - 1.377 mg, talc - 1.038 mg.
Pharmacological effect
Selective slow calcium channel blocker (BMCC), a derivative of 1.4-dihydropyridine. It has antianginal and hypotensive effects. Reduces the current of extracellular Ca2 + into the cardiomyocytes and smooth muscle cells of the coronary and peripheral arteries; in high doses inhibits the release of Ca2 + from intracellular depots. In therapeutic doses, it normalizes the transmembrane current of Ca2 +, disturbed in a number of pathological conditions, especially in arterial hypertension. Does not affect the tone of the veins. Enhances coronary blood flow, improves blood supply to ischemic zones of the myocardium without developing the phenomenon of robbery, activates the functioning of collaterals. By expanding the peripheral arteries, it lowers total peripheral vascular resistance, myocardial tone, afterload, and oxygen demand. Virtually no effect on sinoatrial and atrioventricular nodes, has antiarrhythmic activity. Strengthens a renal blood-groove, causes a moderate natriuresis. Negative chrono, dromo and inotropic action is blocked by a reflex activation of the sympathoadrenal system and an increase in heart rate in response to peripheral vasodilation. The time of onset of the clinical effect is 20 minutes, the duration is 12 hours. With long-term administration (2-3 months), tolerance to the drug is developed .
Pharmacokinetics
Absorption and distribution Absorption is high (more than 90%). Bioavailability - 50-70%. Eating increases bioavailability. It has the effect of first passing through the liver. Cmax of nifedipine after a single dose of 1 tablet (20 mg of nifedipine) is reached in 0.9-3.7 h and averages 28.3 ng / ml. Binding to plasma proteins (with albumin) - 95%. Penetrates through blood-brain barrier and placental barrier, is excreted in the thoracic milk. Metabolism and excretion: Fully metabolized in the liver. Excreted by the kidneys as an inactive metabolite (60-80% of the dose taken). 20% - with bile. T1 / 2 is 2-5 hours.The cumulative effect is absent. The pharmacokinetics in special clinical situations. Chronic renal failure, hemodialysis and peritoneal dialysis do not affect the pharmacokinetics. In patients with hepatic insufficiency, the total clearance decreases and T1 / 2 increases.
Indications
- chronic stable stenocardia (angina pectoris); - vasospastic stenocardia (Prinzmetal stenocardia, variant angina); - arterial hypertension.
Contraindications
- hypersensitivity to nifedipine and other 1,4-dihydropyridine derivatives or to other components of the drug - arterial hypotension (systolic pressure below 90 mm Hg); - cardiogenic shock, collapse; - severe aortic stenosis; - chronic heart failure in decompensation stages - unstable stenocardia; - acute myocardial infarction (first 4 weeks); - I trimester of pregnancy; - lactation period; - combined use with rifampicin. C caution: pronounced mitral valve stenosis, hypertrophic obstructive Cardiomyopathy, severe bradycardia or tachycardia, SSS, malignant hypotension, hypotension, severe cerebral circulatory disorders, myocardial infarction with left ventricular failure, gastrointestinal obstruction, renal and hepatic insufficiency, hemodialysis, II and III, and 3 and 3, in a figure and 3, in a figure and figure and 3, if it is triple and trifling , simultaneous reception of beta adrenoblockers, digoxin.
Precautionary measures
During treatment, psoriasis may worsen. During pheochromocytoma, propranolol can only be used after taking an alpha blocker. After a long course of treatment, propranolol should be discontinued gradually, under the supervision of a physician. during anesthesia, you must stop taking propranolol or find a remedy for anesthesia with minimal negative inotropic effects. The impact on the ability to drive vehicles and control mechanisms of patients whose activities require increased attention, the question of the use of propranolol on an outpatient basis should be addressed only after evaluating the individual response of the patient.
Use during pregnancy and lactation
It is contraindicated to apply during pregnancy I trimester and during lactation. With caution: pregnancy (II and III trimesters).
Dosage and administration
Inside, after a meal, without chewing and drinking a sufficient amount of liquid. The doctor selects the dose of the drug individually in accordance with the severity of the disease and the patient's sensitivity to the drug. For patients with concomitant severe cerebrovascular diseases and in elderly patients, the dose should be reduced. Simultaneous food intake delays, but does not decrease, the absorption of the active substance from the gastrointestinal tract. The recommended dosing regimen is intended for adults. Chronic stable and vasospastic angina pectoris The drug is prescribed in 20 mg (1 tab. ) 2 times / day. If the clinical effect is not sufficiently pronounced, the dose of the drug is gradually increased to 40 mg (2 tab.) 2 times / day. The maximum daily dose is 80 mg (4 pills / day). Essential hypertension. The drug is prescribed 20 mg (1 tablet) 2 times / day. If the clinical effect is not sufficiently pronounced, the dose of the drug is gradually increased to 40 mg (2 tab.) 2 times / day. The maximum daily dose is 80 mg (4 tab./day). For 2 times the daily dose of the drug, the interval between doses should be an average of 12 hours. The minimum interval between doses of the drug is at least 4 hours. The duration of treatment is determined by the attending physician. In cases where the drug is used in high doses and / or for a long time, treatment should be stopped gradually in order to avoid withdrawal syndrome.
Side effects
Since the cardiovascular system: tachycardia, arrhythmias, palpitations, peripheral edema (ankles, feet, ankles), manifestations of excessive vasodilation (asymptomatic decrease in blood pressure, development or worsening of heart failure, flushing to the skin of the face, flushing of the skin, feeling hot) , pronounced decrease in blood pressure (rarely), syncope. In some patients, especially at the beginning of treatment or with an increase in dose, the occurrence of angina may occur, and in rare cases - the development of myocardial infarction, which requires discontinuation of the drug. From the nervous system: headache, dizziness, general weakness, increased fatigue, drowsiness. With long-term use of the drug in high doses - limb paresthesia, tremor,extrapyramidal (parkinsonian) disorders (ataxia, mask-like face, shuffling gait, tremor of hands and fingers, difficulty swallowing), depression. On the digestive system: dyspepsia (nausea, diarrhea or constipation), dry mouth, flatulence, increased appetite; rarely - gingival hyperplasia, completely disappearing after drug withdrawal. With long-term admission - abnormal liver function (intrahepatic cholestasis, increased activity of hepatic transaminases). For the musculoskeletal system: arthritis, myalgia, joint swelling. Allergic reactions: rarely - itching, urticaria, exanthema, autoimmune hepatitis, photodermatitis, anaphylactic reactions, exfoliative dermatitis. From the hemopoietic system: anemia, leukopenia, thrombocytopenia, thrombocytopenic purpura, agranulocytosis. From the urinary system: an increase in daily diuresis in the first weeks of Impairment, renal function impairment (in patients with renal insufficiency). Other: rarely - visual impairment (including transient blindness with plasma C nifedipine), gynecomastia (in elderly patients, completely disappearing after withdrawal), galactorrhea, hyperglycemia , pulmonary edema, weight gain.
Overdose
Symptoms: headache, flushing of the skin of the face, prolonged pronounced decrease in blood pressure, depression of the function of the sinus node, bradycardia / tachycardia bradyarrhythmia. In severe poisoning - loss of consciousness, coma. Treatment: conducting symptomatic therapy. In severe poisoning (collapse, depression of the sinus node), gastric lavage (if necessary, small intestine) is performed, activated charcoal is prescribed. An antidote is calcium supplementation, shown in / in the administration of 10% calcium chloride or calcium gluconate, followed by a switch to a long-term infusion. With a marked decrease in blood pressure, a slow intravenous administration of dopamine, dobutamine, epinephrine or norepinephrine is shown. It is recommended to control glucose content (insulin release may decrease) and electrolytes (K +, Ca2 +). With the development of heart failure - in / in the introduction of strophanthin. caution when used in patients with malignant arterial hypertension and irreversible renal failure on hemodialysis, because possible significant drop in blood pressure due to vasodilation.
Interaction with other drugs
With the simultaneous use of other antihypertensive drugs, as well as tricyclic antidepressants, nitrates, cimetidine, inhalation anesthetics, diuretics, the hypotensive effect of nifedipine may be enhanced. Slow calcium channel blockers may further enhance the negative inotropic effect of antiarrhythmics such as amiodarone and quinidine. nitrates increases tachycardia. Diltiazem inhibits nifedipine metabolism in the body, which may require the simultaneous appointment of these reparata dose reduction of nifedipine. Reduces the concentration of quinidine in the plasma. Increases the concentration of digoxin and theophylline in the blood plasma. Rifampicin accelerates the metabolism of nifedipine in the body, it is not recommended joint appointment. If used simultaneously with cephalosporins (eg, cefixime), we can increase the biologic process. Sympathomimetics, NSAIDs (suppression of prostaglandin synthesis in the kidneys and the retention of sodium ions and body fluids), estrogens (fluid retention in the body) reduce hypotension Zivny effect.Nifedipine can displace from the connection with proteins drugs with a high degree of binding (including indirect anticoagulants - derivatives of coumarin and indandion, anticonvulsant drugs, NSAIDs, quinine, salicylates, sulfinpyrazon), as a result, their concentration in the blood plasma may increase. Niphedipine inhibits prazosin and other alpha-adrenergic blockers, which can lead to an increase in the hypotensive effect. the dose of vincristine is reduced because Nifedipine inhibits its excretion from the body, which can cause an increase in adverse reactions. Lithium preparations can increase toxic effects (nausea, vomiting, diarrhea, ataxia, tremor, tinnitus). When given simultaneously, procainamide, quinidine and other drugs that cause the QT interval to lengthen , the risk of a significant lengthening of the QT interval increases. Grapefruit juice inhibits nifedipine metabolism in the body, so it is contraindicated during treatment with nifedipine. Nifedipine is metabolized with the participation of cyto isoenzymes chromium P450 3A, therefore, the simultaneous use of drugs that inhibit this system,may result in the interaction of this drug and nifedipine: for example, macrolides, antiviral drugs (for example, amprenavir, indinavir, nelfinavir, ritonavir, or saquinavir); Antifungal agents of the azoles group (ketocanazole, itraconazole or fluconazole) cause an increase in plasma nifedipine concentration. Taking into account the experience of using Nimodipine BCCS, a similar interaction with nifedipine cannot be ruled out: carbamazepine, phenobarbital can cause a decrease in plasma nifedipine concentration; and valproic acid - an increase in the concentration of nifedipine in the blood plasma.
special instructions
Patients should refrain from taking ethanol during treatment. It is recommended to stop treatment with the drug gradually. It should be borne in mind that angina may occur at the beginning of treatment, especially after the recent abrupt withdrawal of beta-blockers (the latter should be abolished gradually). A simultaneous appointment of beta-blockers is necessary carry out under conditions of careful medical supervision, since this may cause an excessive decrease in blood pressure, and in some cases - an aggravation of heart symptoms In severe heart failure, the drug is dosed with great caution. The diagnostic criteria for prescribing vasospastic angina are: the classical clinical picture, accompanied by an increase in the ST segment, the occurrence of ergonovine-induced angina or spasm of the coronary arteries, the detection of coronary spasm during angiography or the diagnosis of anemia. (for example, at different voltage thresholds or unstable angina, when these electr rocardiograms indicate transient angiospasm). For patients with severe obstructive cardiomyopathy, there is a risk of increased frequency, severity of manifestations and duration of strokes after taking nifedipine; in this case, it is necessary to discontinue the drug. In patients with irreversible renal failure on hemodialysis who have high blood pressure and reduced BCC, the drug should be used with caution, becausepossible a sharp drop in blood pressure. Patients with impaired liver function requires careful monitoring; if necessary, reduce the dosage of the drug and / or use other dosage forms of nifedipine. If necessary, surgery under general anesthesia should inform the anesthesiologist about treating the patient with nifedipine. sperm. In cases in which re-excretory fertilization did not materialize for an unclear reason, the use of BMCA, including nifedipine, can be considered a possible cause of failure. During treatment, a false-positive Coombs direct test and laboratory tests for antinuclear antibodies can be obtained. in urine, nifedipine may be the cause of a falsely elevated result, however, on the results of tests carried out by HPLC, nifedipine influences I do not have to. With caution, simultaneous treatment with nifedipine, disopyramide and flecainamide should be carried out due to a possible increase in the inotropic effect. Impact on the ability to drive vehicles and control mechanisms and the speed of psychomotor reactions.