Cordipin XL coated pills with a modified release 40mg N20
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Active ingredients
Nifedipine
Release form
Pills
Composition
Nifedipine 40 mg adjuvants: microcrystalline cellulose, cellulose, lactose, hypromellose (methylhydroxypropylcellulose), magnesium stearate, silica colloidal anhydrous. Composition of the shell: hypromellose (methylhydroxypropylcellulose), macroglass 6000, macrogrow, macrogrow, macroglyph, macroglyph, macroglyphogl, maghrod glaze. e171), talc.
Pharmacological effect
Slow calcium channel blocker. Inhibits the flow of calcium ions through the cell membrane of the heart muscle and vascular smooth muscle. The blockade of entry and accumulation of calcium ions inside the cells leads to the expansion of peripheral and coronary vessels, reduces OPSS, reduces afterload on the heart, reduces coronary blood flow and reduces the myocardial oxygen demand. Primarily, at the beginning of therapy, heart rate and cardiac output can decrease as a result of activation of the baroreceptor reflex. With long-term therapy with nifedipine, heart rate and cardiac output return to the values that were available before the start of therapy. In patients with arterial hypertension, more its pronounced decrease AD.Effekt drug lasts 24 hours, however it is sufficient a single destination per day.
Pharmacokinetics
Absorption and distribution The release of nifedipine from cordipin CL pills is slow and almost linear, i.e. release occurs at a constant level. After release, nifedipine is rapidly and almost completely absorbed. Cssmin is reached after taking the first dose of cordipin CL (after 24 hours), Cssmax of nifedipine in the blood is noted after 5.0 ± 2.7 hours. Nifedipine binds to plasma proteins - 94-99%. Metabolism and elimination of Nipedipine is practically fully metabolized. T1 / 2 is 14.9 ± 6 hours. Less than 1% of the dose is excreted in the urine unchanged, 70-80% of the dose is excreted in the urine as metabolites. Pharmacokinetics in special clinical situations In cases of impaired renal function, the release of nifedipine may be delayed.
Indications
- arterial hypertension; - stable angina (exertional angina); - angiospastic (vasospastic) angina.
Contraindications
- cardiogenic shock (risk of myocardial infarction); - acute period of myocardial infarction (during the first 4 weeks); -severe aortic stenosis; - chronic heart failure (in the decompensation stage); - severe arterial hypotension (systolic blood pressure below 90 mm Hg); - porphyria; - I trimester of pregnancy; - lactation period; - age up to 18 years (efficacy and safety have not been established); - lactase deficiency, galactosemia, malabsorption syndrome; - hypersensitivity to nifedipine and other components of the drug; - hypersensitivity to other dihydropyridine derivatives; Caution should be taken when using the drug Hinnom stenosis of aortic or mitral valve, hypertrophic obstructive cardiomyopathy, bradycardia and tachycardia, sick sinus syndrome, malignant hypertension, myocardial infarction with left ventricular failure, congestive heart failure, unstable angina pectoris, obstruction of the gastrointestinal tract, in the II and III trimester of pregnancy, mild or moderate arterial hypotension, severe cerebrovascular accident, abnormal liver and / or kidney function, hemodialysis (risk of arteries noy hypotension); simultaneously with beta-blockers, cardiac glycosides, rifampicin; in elderly patients.
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
The purpose of the drug cordipin CL in the first trimester of pregnancy is contraindicated. In the II and III trimesters, use is possible only if the intended benefit of therapy for the mother outweighs the potential risk to the fetus. Nifedipine is excreted in breast milk, so if you need to use the drug during lactation you should stop breastfeeding.
Dosage and administration
Set individually. The drug is prescribed in an average dose of 40 mg (1 tab.) 1 time per day, both at the beginning of therapy and with prolonged treatment. If necessary, increase the dose to a maximum of 80 mg (2 pills) per day in 1 or 2 doses. In case of skipping the next dose, the next dose should not be doubled. The drug should be taken after a meal. Tablets are taken whole, without breaking and not chewing, with a glass of water.
Side effects
On the part of the cardiovascular system: manifestations of excessive vasodilation (asymptomatic decrease in blood pressure, flushing of the skin of the face, flushing of the skin of the face, feeling of heat), tachycardia, palpitations, arrhythmia, peripheral edema, development or aggravation of heart failure (often aggravation of already having), chest pains; seldom - excessive decrease in blood pressure, fainting; in some cases (especially at the beginning of treatment) - angina attacks (withdrawal of the drug is required); in rare cases - myocardial infarction. For the central nervous system and peripheral nervous system: headache, dizziness, fatigue, weakness, drowsiness; with long-term use in high doses - paresthesias in the limbs, depression, anxiety, extrapyramidal (parkinsonian) disorders (ataxia, mask-like face, shuffling gait, stiffness of arm and leg movements, tremor of hands and fingers, difficulty swallowing). On the part of the digestive system : dry mouth, decreased appetite, dyspepsia (nausea, diarrhea or constipation); rarely - gingival hyperplasia (bleeding, soreness, swelling); with long-term use - abnormal liver function (intrahepatic cholestasis, increased activity of hepatic transaminases). From the side of hematopoietic organs: anemia, asymptomatic agranulocytosis, thrombocytopenia, thrombocytopenic purpura, leukopenia. From the side of musculoskeletal system: arthritis; rarely - arthralgia, swelling of the joints, myalgia, convulsions of the upper and lower extremities. From the urinary system: an increase in daily diuresis, deterioration of kidney function (in patients with renal insufficiency). From the respiratory system: rarely - difficulty breathing, cough; very rarely - pulmonary edema, bronchospasm. For the senses: very rarely - visual impairment (includingtransient blindness with the maximum concentration of nifedipine in the blood plasma). From the endocrine system: very rarely - gynecomastia (in elderly patients, it completely disappears after discontinuation of the drug), galactorrhea. From the metabolic side: very rarely - hyperglycemia, weight gain. Allergic reactions: rarely - pruritus, exfoliative dermatitis; very rarely - autoimmune hepatitis. Dermatological reactions: rarely - exanthema, photodermatosis.
Overdose
Symptoms: the drug causes peripheral vasodilation with severe and possibly prolonged arterial hypotension: headache, flushing of the skin of the face, prolonged marked decrease in blood pressure, depression of the sinus node, bradycardia and / or tachycardia, bradyarrhythmia. In severe poisoning - loss of consciousness, coma. Treatment: standard measures aimed at removing the drug from the body (the appointment of activated carbon, gastric lavage), stabilization of hemodynamic parameters; careful control of the heart, lungs and excretory system. Calcium preparations are antidote. It is shown in / in the introduction of a 10% solution of calcium chloride or calcium gluconate, followed by switching to a long-term infusion. Due to the high degree of binding to plasma proteins, hemodialysis is not effective. It is recommended to control blood glucose (release of insulin can decrease) and electrolytes (potassium , calcium). Clearance of nifedipine is increased in patients with liver failure.
Interaction with other drugs
The severity of BP reduction increases with simultaneous use of cordipin CL with other antihypertensive drugs, beta-blockers, nitrates, cimetidine (to a lesser extent with ranitidine), inhalation anesthetics, diuretics, tricyclic antidepressants. More from the group of slow calcium channel blockers can more negative inotropic effects of antiarrhythmic agents such as amiodarone and quinidine. Nifedipine causes a decrease in the concentration of quinidine in the blood plasma, p nifedipine follows cancellation may occur drastic increase in the concentration hinidina.Nifedipin increases plasma concentrations of digoxin and theophylline (for a play required clinical effect and control the concentration of digoxin and theophylline in blood plasma) .Induktory microsomal liver enzymes (includingrifampicin) reduce the concentration of nifedipine in the blood plasma. Simultaneous use with nitrates increases tachycardia. The hypotensive effect reduces sympathomimetics, NSAIDs, estrogens, calcium preparations. Nifedipine is able to displace highly binding drugs (including indirect antioxidants). coumarin and indandion, anticonvulsants, NSAIDs, quinine, salicylates, sulfinpirazon), as a result, it is possible to increase their concentrations in the blood plasma. Nyphedipine retardation It does not excrete vincristine from the body and may cause increased side effects of vincristine (with this combination, if necessary, reduce the dose of vincristine). Lithium preparations may increase the side effects of nifedipine (nausea, vomiting, diarrhea, ataxia, tremor, tinnitus). the appointment of cephalosporins (for example, cefixime) and nifedipine increased the bioavailability of cephalosporin by 70%. Nyphedipine inhibits the metabolism of prazozin and other alpha-blockers, as a result, hypotensive Effect. Procainamide, quinidine and other drugs that prolong the QT interval increase the negative inotropic effect and may increase the risk of significant prolongation of the QT interval. Grapefruit juice inhibits nifedipine metabolism, therefore its use is contraindicated during treatment with Cordipin HL.
special instructions
Stop treatment with cordipin CL is recommended gradually. It should be borne in mind that at the beginning of treatment may develop angina, especially after the recent abrupt withdrawal of beta-blockers (the latter should be abolished gradually). Simultaneous prescription of beta-adrenergic blockers should be carried out under close medical supervision, since this may result in an excessive decrease in blood pressure, and in some cases - worsening of heart failure symptoms. Diagnostic criteria for prescribing the drug for angiospastic angina are: a classic clinical picture, accompanied by an increase in the ST segment, the appearance ergonovin-induced angina or coronary artery spasm,detection of coronary spasm during angiography or detection of an angiospastic component without confirmation (for example, with a different voltage threshold or unstable angina, when ECG data indicate transient angiospasm). nifedipine; in this case, it is necessary to cancel the drug. In patients on hemodialysis, with high blood pressure and irreversible renal failure with a reduced BCC, the drug should be used with caution, because a sharp drop in blood pressure may occur. It is necessary to carefully monitor the condition of patients with impaired liver function and, if necessary, reduce the dose of the drug and / or apply other dosage forms of nifedipine. therapy. During the treatment, positive results are possible when carrying out a direct Coombs reaction and laboratory tests for antinuclear antibodies. The drug should be administered simultaneously with Disopyramide and Flecainamide. Influencing the ability to drive vehicles and control mechanisms. Some patients, especially at the beginning of treatment, can cause dizziness, which reduces the ability to drive a car or other mechanisms. In the future, the degree of restriction is determined depending on the individual tolerance of the drug.