Corinfar coated pills 10mg N100
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Active ingredients
Nifedipine
Release form
Pills
Composition
Nifedipine 10 mg; excipients: lactose monohydrate - 15.8 mg, potato starch - 15.7 mg, microcrystalline cellulose - 15.5 mg, povidone K25 - 2.7 mg, magnesium stearate - 0.3 mg; film composition: hypromellose - 2.88 mg, macrogol 6000 - 0.48 mg, macrogol 35000 - 0.22 mg, quinoline yellow (e104) dye - 0.27 mg, titanium dioxide (e171) - 0.77 mg, talc - 0.38 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 + inside the cardiomyocytes and smooth muscle cells of the coronary and peripheral arteries; in high doses inhibits the release of Ca2 + from intracellular depots.; At therapeutic doses, 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 the ischemic zones of the myocardium without the development of the “robbery” phenomenon, activates the functioning of collaterals.; Expanding the peripheral arteries, reduces OPS, myocardial tone, afterload and myocardial oxygen demand. Practically does not affect the sinoatrial node and AV node, has weak antiarrhythmic activity.; Enhances renal blood flow, causes moderate natriuresis; Negative chrono-dromo-and inotropic action is blocked by 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 and its duration is 4-6 hours; With long-term use (2-3 months), tolerance to the action of the drug develops.
Pharmacokinetics
Absorption; Absorption - high (more than 90%). Bioavailability - 50-70%. Eating increases bioavailability. It has the effect of "first pass" through the liver. Cmax of nifedipine in the blood plasma after a single oral dose of 2 pills (corresponding to 20 mg of nifedipine) is reached in 1-3 hours and its average value is 28.3 ng / ml; Distribution; Binding to plasma proteins (with albumin) - 95%. ; It penetrates the BBB and placental barrier, is excreted in breast milk.; There is no cumulative effect.; Metabolism and excretion; Fully metabolized in the liver.; T1 / 2 is 2-5 hours.Excreted by the kidneys as an inactive metabolite (60-80% of the dose taken), 20% - with bile.; Pharmacokinetics in special clinical situations; Chronic renal failure, hemodialysis, and peritoneal dialysis do not affect the pharmacokinetics.; In patients with hepatic insufficiency, the overall clearance decreases and increases T1 / 2.
Indications
- Chronic stable angina (exertional angina); - Prinzmetal angina (variant angina); - arterial hypertension.
Contraindications
- arterial hypotension (systolic blood pressure below 90 mm Hg. Art.); - cardiogenic shock, collapse; - chronic heart failure in the stage of decompensation; - severe aortic stenosis; - unstable angina; - acute myocardial infarction (first 4 weeks); - combined use with rifampicin; - I trimester of pregnancy; - lactation period (breastfeeding); - increased sensitivity to nifedipine and other derivatives of 1,4-dihydropyridine derivatives or to other components of the formulation; Precautions: mitral valve stenosis, hypertrophic obstructive cardiomyopathy, bradycardia or tachycardia, sick sinus syndrome, malignant hypertension, hypovolemia, severe cerebrovascular accident, infarct. myocardium with left ventricular failure, gastrointestinal obstruction, renal and hepatic failure, hemodialysis (due to the risk of arterial hypotension), II and I II trimesters of pregnancy, children and adolescents under 18 years of age (efficacy and safety have not been established), simultaneous use of beta-blockers, digoxin.
Use during pregnancy and lactation
The drug is contraindicated in the first trimester of pregnancy and lactation. With caution: the drug should be prescribed in the second and third trimesters of pregnancy.
Dosage and administration
Inside after eating, without chewing and drinking plenty of liquid. The dose of the drug is chosen by the doctor individually in accordance with the severity of the disease and the sensitivity of the patient 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, absorption of nifedipine from the gastrointestinal tract; Chronic stable and vasospastic angina; Initial dose - 10 mg (1 tab.) 2- 3 times / day With insufficiently pronounced clinical effect, the dose of the drug is gradually increased to 2 tab. (20 mg) 1-2 times / day.The maximum daily dose is 40 mg (4 tab. / Day) .; Essential hypertension; The average daily dose is 10 mg (1 tab.) 2-3 times / day. With insufficiently pronounced clinical effect, a gradual increase in the dose of the drug to 20 mg is possible. (2 tab.) 2 times / day. The maximum daily dose is 40 mg (4 pills / day); With a 2-fold prescription, the minimum interval between doses of the drug should be at least 4 hours; The duration of the course of treatment is determined by the attending physician.
Side effects
On the part of the cardiovascular system: tachycardia, palpitations, arrhythmias, peripheral edema (ankles, feet, ankles), manifestations of excessive vasodilation (asymptomatic reduction in blood pressure, development or worsening of heart failure, blood flushes to the skin of the face, hyperemia 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, paresthesia of the extremities, tremor, extrapyramidal (parkinsonian) disorders (ataxia, mask-like face, shuffling gait, tremor of hands and fingers, difficulty swallowing), depression. From the alimentary system: dyspepsia (nausea , diarrhea or constipation), dry mouth, flatulence, increased appetite; rarely - gingival hyperplasia, completely disappearing after drug withdrawal; long-term admission - abnormal liver function (intrahepatic cholestasis, increased activity of hepatic transaminases) .; From the musculoskeletal system: arthritis, myalgia, joint edema, convulsions of the upper and lower extremities.; Allergic reactions: rarely - pruritus, urticaria, exantarms , autoimmune hepatitis, exfoliative dermatitis, photodermatitis, anaphylactic reactions. From the hematopoietic system: anemia, leukopenia, thrombocytopenia, thrombocytopenic purpura, agranulocytosis. From the urinary system : an increase in daily diuresis, impaired renal function (in patients with renal insufficiency); Other: rarely - visual impairment (includingtransient blindness with a maximum concentration of nifedipine in the blood plasma), gynecomastia (in elderly patients, completely disappearing after discontinuation of the drug), galactorrhea, hyperglycemia, pulmonary edema, bronchospasm, weight gain.
Overdose
Symptoms: headache, flushing of the skin of the face, long-term pronounced decrease in blood pressure, depression of sinus node function, 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. Calcium preparations are an antidote, it is shown in / in the administration of 10% calcium chloride or calcium gluconate, with subsequent transfer to a long-term infusion. With a pronounced decrease in blood pressure, a slow intravenous dopamine, dobutamine, adrenaline or norepinephrine is indicated. It is recommended to monitor glucose (may decrease the release of insulin) and electrolytes in the blood (K +, Ca2 +). With the development of heart failure - in / in the introduction of strophanthin. In case of conduction disturbances - atropine, isoprenaline or an artificial pacemaker. Hemodialysis is not effective, plasmapheresis is recommended.
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. tachycardia is enhanced x drugs.; Reduces the concentration of quinidine in the blood plasma.; Increases the concentration of digoxin and theophylline in the blood plasma.; Rifampicin accelerates the metabolism of nifedipine, is not recommended joint appointment. ; 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 the hypotensive effect.; Nifedipine can displace s of the protein products due to the high degree of binding (includingindirect anticoagulants - derivatives of coumarin and indandion, anticonvulsant, NSAIDs, quinine, salicylates, sulfinpirazon), as a result, their plasma concentrations can increase.; Nifedipine inhibits prazosin and other alpha-adrenergic blockers, which can lead to an increase in the hypotensive effect; need to reduce the dose of vincristine, because nifedipine inhibits its excretion from the body, which can cause increased side effects.; lithium preparations can enhance toxic effects (nausea, vomiting, diarrhea, ataxia, tremor, tinnitus) .; If co-administered with procainamide, quinidine and other drugs that cause lengthening QT interval, the risk of 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 by CYP3A isoenzyme, due this simultaneous use of drugs that inhibit this system can lead to the interaction of this drug and nifedipine: for example, macrolides, antiviral drugs (for example, amprenavir, indinavir, nelfinavir, ritonavir, or saquinavir), concentration of nifedipine in the blood plasma.; Taking into account the experience with the use of BMIC nimodipine, similar interactions with nifedipine can not be ruled out: carbamazepine, phenobarbital can cause a decrease in the concentration of nifedipine in the blood plasma, and valproic acid - an increase in the concentration of nifedipine in the blood plasma.
special instructions
During the period of treatment it is necessary to refrain from taking ethanol. It is recommended to stop treatment with the drug. It should be borne in mind that at the beginning of treatment angina may occur, especially after the recent abrupt withdrawal of beta-blockers (the latter should be abolished gradually) .; Simultaneous administration of beta-blockers should be carried out under careful medical supervision, because this may cause an excessive decrease in blood pressure, and in some cases - worsening symptoms of heart failure. In severe heart failure, the drug is dosed with pain. . Oh caution; Diagnostic criteria drug administration for vasospastic angina are classical clinical picture, accompanied by an increase in the segment ST, occurrence ergonovine-induced angina, or coronary artery spasm,detection of coronary spasm during angiography or detection of an angiospastic component without confirmation (for example, at different voltage thresholds or unstable angina, when ECG data indicate transient angiospasm); taking nifedipine; in this case, the abolition of the drug is necessary.; In patients with irreversible renal failure on hemodialysis, with high blood pressure and reduced BCC, the drug should be used carefully, because possible a sharp drop in blood pressure. For patients with impaired liver function, careful observation is established; 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; dysfunction of sperm. In cases in which repeated extracorporal fertilization did not take place for an unclear reason, the use of BCCM, including nifedipine, can be considered a possible cause of failure. Mandelic acid in the urine nifedipine may be the cause of obtaining a falsely overestimated result; however, nifedipine is affected by the results of tests carried out by HPLC. It does not have. With caution should be the simultaneous treatment of nifedipine, disopyramide and flekainid due to a possible increase inotropic effect. Influence on the ability to drive motor vehicles and control mechanisms requiring increased concentration and speed of psychomotor reactions.