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Cardilopin tablets 10 mg No. 10x3
Name
Cardilopin tablet. 10 mg per bl. in pack №10x3
Description
The tablets are white, off-white or yellowish-white, round, flat, bevelled, engraved with the letter “E” on one side and the number “253” on the other.
Main active ingredient
Amlodipine
Release form
The tablets are white, off-white or yellowish-white, round, flat, bevelled, engraved with the letter “E” on one side and the number “253” on the other. 10 pieces. - blisters (1) - cardboard packs.
Dosage
10 mg per bl. in pack №10x3
special instructions
Studies in patients with heart failure of functional class II and III according to the NYHA classification when taking amlodipine did not reveal a decrease in exercise tolerance, left ventricular ejection function or worsening of clinical symptoms. The results of clinical studies involving patients with heart failure of 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 pain, 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 dosage is recommended. Amlodipine does not affect plasma concentrations of potassium, glucose, triglycerides, total cholesterol, LDL, uric acid, creatinine and uric acid nitrogen. Effect on the ability to drive vehicles and operate machinery There have been no reports of the effect of amlodipine on driving or operating machinery. However, some patients may experience drowsiness and dizziness, primarily at the beginning of treatment. If they occur, the patient must take special precautions when driving and operating machinery.
pharmachologic effect
Calcium channel blocker. Amlodipine suppresses the transmembrane incoming 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. Dilatation of peripheral arterioles reduces peripheral vascular resistance, i.e. afterload. Since amlodipine does not cause reflex tachycardia, myocardial energy and oxygen consumption is reduced. 2. Dilatation of large coronary arteries and coronary arterioles improves oxygen supply to both normal and ischemic areas of the myocardium. Thanks to these effects, the supply of oxygen to the myocardium is improved, even with spasm of the coronary arteries (Prinzmetal's angina or unstable angina). In patients with arterial hypertension, taking the drug once a day causes a clinically significant decrease in blood pressure in the supine and standing positions 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 per day increases the total time of possible physical activity before the development of an angina attack and the time until a significant decrease in the ST interval, and also reduces the frequency of angina attacks and the need for sublingual nitroglycerin. No negative effects of amlodinine on metabolism were found. The drug does not affect serum lipid, glucose and uric acid levels. Safe for patients with bronchial asthma.
Pharmacokinetics
Absorption After taking the drug orally, amlodipine is well absorbed from the gastrointestinal tract; in this case, the Cmax of amlodipine in blood 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 achieved on the 7-8th day of taking the drug and is 5-15 ng/ml. Metabolism and elimination Amlodipine undergoes extensive metabolism 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% in urine, 20-25% in feces, about 10% is excreted unchanged in 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 elderly people, the total clearance is approximately 19 l/h, other parameters do not change. If clearance is reduced in patients with liver failure, the drug should be prescribed in lower doses.
Indications for use
- arterial hypertension (in the form of monotherapy or, if necessary, as part of combination therapy with other antihypertensive drugs); - stable angina (as monotherapy or as part of combination therapy with other antianginal drugs); - angiospastic angina (Prinzmetal's angina) (as monotherapy or as part of combination therapy with other antianginal drugs).
Directions for use and doses
For the treatment of arterial hypertension or angina pectoris, the usual starting dose is 5 mg 1 time / day (preferably at the same time). Taking into account the patient's reaction, the initial dose can be increased to 10 mg 1 time / day. The dose of Cardilopin is not changed in case of its simultaneous use with diuretics from the thiazide group, beta-blockers or ACE inhibitors. In case of renal failure and in elderly patients, no dosage adjustment is 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 insufficient 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 methods of contraception, unless the therapeutic benefit of the drug justifies the possible risk. If it is necessary to use the drug during lactation, breastfeeding should be stopped.
Precautionary measures
The drug should be prescribed with caution in cases of liver dysfunction, 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 within 1 months after), diabetes mellitus, elderly patients.
Interaction with other drugs
The simultaneous use of amlodipine with thiazide diuretics, beta-blockers, long-acting nitrates, sublingual nitroglycerin preparations, NSAIDs, antibiotics and oral hypoglycemic agents is possible. Thiazide and loop diuretics, beta-blockers, verapamil, ACE inhibitors and nitrates enhance the antianginal and hypotensive effects of amlodipine. Amiodarone, quinidine, alpha1-blockers, antipsychotic drugs (neuroleptics) and slow calcium channel blockers may enhance the hypotensive effect of amlodipine. Calcium supplements may reduce the effect of slow calcium channel blockers (including amlodipine). Inhibitors of microsomal oxidation, increasing the concentration of amlodipine in the blood plasma, increase the risk of side effects, and inducers of microsomal liver enzymes reduce it. The hypotensive effect of amlodipine is weakened by NSAIDs, especially indomethacin (due to sodium retention and blockade of prostaglandin synthesis by the kidneys), alpha-adrenergic agonists, estrogens (due to sodium retention), and sympathomimetics. Procainamide, quinidine and other drugs known to prolong the QT interval enhance the negative inotropic effect of amlodipine and may increase the risk of significant prolongation of the QT interval. Cimetidine does not affect the pharmacokinetics of amlodipine. Amlodipine has no effect on the pharmacokinetic parameters of digoxin and warfarin. Grapefruit juice may slightly increase serum amlodipine levels, 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.
Compound
In 1 tab. amlodipine besilate 13.9 mg, which corresponds to the content of amlodipine 10 mg Excipients: microcrystalline cellulose - 253.6 mg, sodium carboxymethyl starch (type A) - 8 mg, magnesium stearate - 3 mg, colloidal anhydrous silicon dioxide - 1.5 mg.
Overdose
Symptoms: marked decrease in blood pressure, tachycardia, excessive peripheral vasodilation. Treatment: the patient should be placed in a horizontal position with raised legs. Gastric lavage, administration of activated charcoal, maintenance of cardiovascular system function, monitoring of heart and lung function indicators, monitoring of blood volume and diuresis are carried out. Intensive symptomatic therapy is carried out. 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 - intravenous administration of calcium gluconate. Hemodialysis is not effective.
Side effect
From the nervous system: headache, dizziness, excessive fatigue, drowsiness, mood changes, convulsions; rarely - loss of consciousness, hypoesthesia, 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 liver transaminases, dry mouth, anorexia, vomiting, constipation or diarrhea, dyspepsia, flatulence, gingival hyperplasia; very rarely - taste perversion, gastritis, increased appetite, pancreatitis. From 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 - development or worsening 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, impaired accommodation, xerophthalmia, ringing in the ears. From the musculoskeletal system: rarely - arthralgia, arthrosis, myalgia (with long-term use), back pain; very rarely - myasthenia. From the skin: very rarely - xeroderma, alopecia, dermatitis, purpura. Allergic reactions: skin itching, rash (including erythematous, maculopapular rash, urticaria). Other: rarely - gynecomastia, feeling of heat, chills, weight gain, nosebleeds, 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.