Name:
Cardilopin tab. 10mg in bl. in pack. No. 10х3
Description:
Tablets of white, almost white or yellowish-white color, round, flat, with a bevel, with an engraving in the form of the letter “E” on one side and the number “253” on the other. The main active ingredient Amlodipine Release form Tablets are white, almost white or yellowish-white, round, flat, beveled, engraved in the form of the letter “E” on one side and the number “253” on the other. 10 pieces. – blisters (1) – packs of cardboard. Dosage 10mg in bl. in pack. No. 10×3 Special instructions Studies in patients with heart failure II and III functional class according to the NYHA classification while taking amlodipine did not reveal a decrease in exercise tolerance, left ventricular ejection function, or worsening of clinical symptoms. The results of clinical studies in patients with heart failure III-IV functional class according to the NYHA classification showed that amlodipine does not increase the incidence of cardiovascular events or mortality when combined with ACE inhibitors, diuretics or digoxin. During the treatment period, it is necessary to maintain dental hygiene and visit the dentist (to prevent soreness, bleeding and gum hyperplasia). The dosage regimen for the elderly is the same as for patients of other age groups. When increasing the dose, careful monitoring of elderly patients is necessary. The vasodilating effect of amlodipine develops gradually. Therefore, acute arterial hypotension after its use is very rare, however, before stopping treatment, a gradual reduction in doses is recommended. Amlodipine does not affect plasma concentrations of potassium, glucose, triglycerides, total cholesterol, LDL, uric acid, creatinine and uric acid nitrogen. Influence on the ability to drive vehicles and control mechanisms There were no reports of the effect of amlodipine on driving or working with mechanisms. However, in some patients, drowsiness and dizziness may occur mainly at the beginning of treatment. When they occur, the patient must take special precautions when driving and working with mechanisms. Pharmacological action Calcium channel blocker. Amlodipine inhibits the transmembrane inward current of calcium ions into the smooth muscle cells of the heart and blood vessels by blocking slow calcium channels. The antihypertensive effect of amlodipine is due to a direct relaxing effect on vascular smooth muscle cells, which leads to a decrease in peripheral vascular resistance. The mechanism of antianginal action is not entirely clear, however, most likely it is associated with the following two effects: 1. Expansion of peripheral arterioles reduces peripheral vascular resistance, i. afterload. Since amlodipine does not cause reflex tachycardia, myocardial energy and oxygen consumption is reduced. 2. The expansion of large coronary arteries and coronary arterioles improves the supply of oxygen to both normal and ischemic areas of the myocardium. Thanks to these effects, the supply of oxygen to the myocardium improves, even with spasm of the coronary arteries (Prinzmetal’s angina or unstable angina pectoris). In patients with arterial hypertension, taking the drug 1 time / day causes a clinically significant decrease in blood pressure in the supine position and standing throughout the entire 24-hour interval between doses of the drug. Due to the slow development of the effect, the drug does not cause acute arterial hypotension. In patients with angina pectoris, taking the drug 1 time / day increases the total time to perform possible physical activity before the development of an angina attack and the time to a significant decrease in the ST interval, and also reduces the frequency of angina attacks and the need for sublingual nitroglycerin. No negative effect of amlodinine on metabolism was found. The drug does not affect the levels of lipids, glucose and uric acid in the blood serum. Safe for patients with bronchial asthma. Pharmacokinetics Absorption After oral administration, amlodipine is well absorbed from the gastrointestinal tract; while Cmax of amlodipine in plasma is observed after 6-12 hours. Simultaneous food intake does not change the absorption of amlodipine. Absolute bioavailability is approximately 64-80%. Distribution Apparent Vd – 21 l / kg. Plasma protein binding is 93-98%. Css is reached on the 7-8th day of taking the drug and is 5-15 ng / ml. Metabolism and excretion Amlodipine is extensively metabolized in the liver. Approximately 90% of the dose taken is converted into inactive pyridine derivatives. The total clearance is 7 ml / min / kg (25 l / h for a patient weighing 60 kg). It is excreted mainly in the form of metabolites: 60% – with urine, 20-25% – with feces, about 10% is excreted unchanged in the urine. T1 / 2 – 30-35 hours (which allows you to prescribe the drug 1 time / day). Pharmacokinetics in special clinical situations The pharmacokinetic parameters of amlodipine do not change in renal failure. In the elderly, the total clearance is approximately 19 l / h, other parameters do not change. With a decrease in clearance in patients with hepatic insufficiency, the drug should be prescribed in smaller doses. Indications for use – arterial hypertension (in the form of monotherapy or, if necessary, in combination therapy with other antihypertensive agents); – stable angina pectoris (in the form of monotherapy or as part of combination therapy with other antianginal drugs); – angiospastic angina (Prinzmetal’s angina) (in the form of monotherapy or as part of combination therapy with other antianginal drugs). Dosage and Administration For the treatment of arterial hypertension or angina pectoris, the usual initial dose is 5 mg 1 time / day (preferably at the same time). Taking into account the patient’s response, the initial dose can be increased to 10 mg 1 time / day. The dose of Cardilopin is not changed in the case of its simultaneous use with diuretics from the group of thiazides, beta-blockers or ACE inhibitors. In renal insufficiency and in elderly patients, correction of the dosing regimen is not required. When prescribing Cardilopin to patients with impaired liver function, the recommended dose is 2.5 mg / day, because in these patients, T1 / 2 of the drug increases. Use during pregnancy and lactation Given the lack of clinical experience with the use of amlodipine during pregnancy and lactation, the drug should not be prescribed to pregnant women, as well as women of reproductive age who do not use effective contraceptive methods, unless the therapeutic benefit of the drug justifies the possible risk. If necessary, the use of the drug during lactation should stop breastfeeding. Precautions The drug should be prescribed with caution in case of impaired liver function, SSSU (severe bradycardia, tachycardia), chronic heart failure in the stage of decompensation, mild or moderate arterial hypotension, aortic stenosis, mitral stenosis, hypertrophic obstructive cardiomyopathy, acute myocardial infarction (and during 1 month after), diabetes mellitus, elderly patients. Interaction with other drugs It is possible to simultaneously use amlodipine with thiazide diuretics, beta-blockers, long-acting nitrates, sublingual nitroglycerin preparations, NSAIDs, antibiotics and oral hypoglycemic agents. Thiazide and “loop” diuretics, beta-blockers, verapamil, ACE inhibitors and nitrates increase the antianginal and hypotensive effects of amlodipine. Amiodarone, quinidine, alpha1-blockers, antipsychotic drugs (neuroleptics) and slow calcium channel blockers may increase the hypotensive effect of amlodipine. Calcium preparations can reduce the effect of slow calcium channel blockers (including amlodipine). Inhibitors of microsomal oxidation, increasing the concentration of amlodipine in blood plasma, increase the risk of side effects, and inducers of microsomal liver enzymes – reduce. The hypotensive effect of amlodipine is weakened by NSAIDs, especially indomethacin (due to sodium retention and blockade of prostaglandin synthesis by the kidneys), alpha-agonists, estrogens (due to sodium retention), sympathomimetics. Procainamide, quinidine and other drugs that cause QT interval prolongation enhance the negative inotropic effect of amlodipine and may increase the risk of significant QT interval prolongation. Cimetidine does not affect the pharmacokinetics of amlodipine. Amlodipine does not affect the pharmacokinetic parameters of digoxin and warfarin. Grapefruit juice may slightly increase the level of amlodipine in the blood serum, but this does not lead to significant changes in blood pressure. Contraindications – unstable angina; – clinically significant aortic stenosis; – severe arterial hypotension; – children and adolescents under 18 years of age (due to lack of clinical experience); – pregnancy; – lactation period (breastfeeding); – hypersensitivity to amlodipine and other components of the drug. Composition In 1 tab. amlodipine besilate 13.9 mg, which corresponds to the content of amlodipine 10 mg OverdoseSymptoms: pronounced decrease in blood pressure, tachycardia, excessive peripheral vasodilation. Treatment: the patient should be given a horizontal position with raised legs. Carry out gastric lavage, administration of activated charcoal, maintenance of the function of the cardiovascular system, monitoring of indicators of heart and lung function, control of BCC and diuresis. Conduct intensive symptomatic therapy. To restore vascular tone, the use of vasoconstrictor drugs is indicated (in the absence of contraindications to their use); to eliminate the consequences of blockade of calcium channels – in / in the introduction of calcium gluconate. Hemodialysis is not effective. Side effects From the nervous system: headache, dizziness, excessive fatigue, drowsiness, mood changes, convulsions; rarely – loss of consciousness, hypesthesia, paresthesia, tremor, asthenia, malaise, insomnia, nervousness, depression, unusual dreams, anxiety; very rarely – ataxia, apathy, agitation, amnesia. From the digestive system: nausea, abdominal pain; rarely – hyperbilirubinemia, jaundice, increased activity of hepatic transaminases, dry mouth, anorexia, vomiting, constipation or diarrhea, dyspepsia, flatulence, gingival hyperplasia; very rarely – taste perversion, gastritis, increased appetite, pancreatitis. From the side of the cardiovascular system: palpitations, swelling of the ankles and feet, shortness of breath, flushing of the face; rarely – rhythm disturbances (bradycardia, ventricular tachycardia, atrial flutter), chest pain, excessive decrease in blood pressure, orthostatic hypotension; very rarely – the development or aggravation of heart failure, extrasystole, migraine. From the genitourinary system: rarely – pollakiuria, painful urge to urinate, nocturia, sexual dysfunction (including decreased potency); very rarely – dysuria, polyuria. From the respiratory system: rarely – dyspnea; very rarely – cough, rhinitis. From the senses: rarely – blurred vision, conjunctivitis, diplopia, eye pain, disturbance of accommodation, xerophthalmia, tinnitus. From the musculoskeletal system: rarely – arthralgia, arthrosis, myalgia (with prolonged use), back pain; very rarely – myasthenia gravis. On the part of the skin: very rarely – xeroderma, alopecia, dermatitis, purpura. Allergic reactions: pruritus, rash (including erythematous, maculo-papular rash, urticaria). Others: rarely – gynecomastia, feeling hot, chills, weight gain, epistaxis, increased sweating, thirst; very rarely – cold sticky sweat, parosmia, hyperglycemia. Storage conditions The drug should be stored in a place protected from light, out of reach of children at a temperature of 15 ° to 25 ° C. Buy Cardilopin tablets 10 mg No. 10×3 Price for Cardilopin tablets 10 mg No. 10×3
INN | AMLODIPINE |
---|---|
The code | 63 958 |
Barcode | 5 995 327 149 165 |
Dosage | 10mg |
Active substance | Amlodipine |
Manufacturer | Egis Pharmaceuticals PLC, Hungary |
Importer | IOOO Interfarmaks 223028 Minsk region, Minsk district, Zhdanovichsky s / s, ag. Zhdanovichi, st. Star, 19a-5, room. 5-2 |
Reviews
There are no reviews yet.