Amlodipine tablets 5mg №10×3

NameAmlodipine tabl. Tablets 10 mg white or almost white, ploskotsilindrichesky form, with a facet and risk. The main active ingredient Amlodipine Release form Tablets Dosage 5 mg Pharmacotherapeutic group Selective calcium channel blockers with a predominant effect on blood vessels. dihydropyridine derivatives. It has antihypertensive and antianginal effects. After oral administration, amlodipine is rapidly and completely absorbed, reaching maximum plasma concentrations 6-12 hours after ingestion. Simultaneous food intake does not affect the absorption of amlodipine. The half-life is 35-50 hours, which allows you to prescribe amlodipine 1 time per day. Steady-state plasma concentration is reached after 7-8 days of constant intake of amlodipine. Indications for use Arterial hypertension (including as part of combination therapy); chronic stable angina pectoris; vasospastic angina (Prinzmetal’s angina) (including as part of combination therapy). Route of administration and doses The risk on tablets is intended solely for facilitating the intake of one tablet (by breaking the tablet into two halves), and not for dividing the tablet into two doses. The usual starting dose for hypertension and angina pectoris is 5 mg/day, preferably at the same time of day. Depending on the patient’s individual response to therapy, it is possible to increase the dose to 10 mg / day. With the simultaneous use of thiazide diuretics, 0-blockers and angiotensin-converting enzyme inhibitors, dose adjustment is not required. Elderly people, people with low body weight and patients with impaired liver function can be given a dose of 2.5 mg. The same dose can be given when amlodipine is combined with other antihypertensive agents. The dose of the drug should be chosen taking into account the individual needs of the patient. Typically, dose selection (titration) is carried out from 7 to 14 days, which allows the doctor to evaluate the patient’s response to each dose. In stable and vasospastic angina, the recommended dose is 5-10 mg, a low dose is recommended for the elderly and patients with impaired liver function. To obtain an adequate effect, most patients need a dose of 10 mg. The recommended dose interval for patients with coronary artery disease is 5-10 mg per day. Use in children: The safety and efficacy of amlodipine when used in children has not been established (see section “Contraindications”). Use in patients with impaired liver function: see section “Precautions”. Use in Renal Insufficiency: Amlodipine can be used in the usual doses for the treatment of such patients. Changes in the concentration of amlodipine in plasma do not correlate with the degree of impaired renal function. Amlodipine is not removed during dialysis. The use of this drug is possible only after consulting a doctor! If you forget to take AMLODIPINE, take the tablet as soon as possible before your next dose is due. If it is time for your next dose of medication, do not take the missed dose. You can not double the dosage of the drug to compensate for the missed! Further, the drug is used according to the recommended dosing regimen. Do not stop taking AMLODIPINE without first talking to your doctor. Use during pregnancy and lactation If you are pregnant or breastfeeding, if you suspect that you are pregnant or do not exclude the possibility of pregnancy, inform your doctor. Pregnancy: The use of amlodipine during pregnancy is recommended only in cases where there is no safer alternative and the risk associated with the disease itself outweighs the possible harm to the mother and fetus. Breastfeeding: When deciding whether to continue/stop breastfeeding or continue/withdrawal of amlodipine therapy, the benefits of breastfeeding for the baby and the benefits of amlodipine for the mother should be considered. Fertility: Reversible biochemical changes in the head of the spermatozoa have been observed in some patients with the use of calcium channel blockers. Influence on the ability to drive vehicles and other mechanisms Amlodipine may moderately affect the ability to drive a car or work with mechanisms. In some patients, while taking amlodipine, dizziness, headache, weakness, nausea may develop, which may impair the reaction rate. Precautions The safety and efficacy of amlodipine in hypertensive crisis has not been evaluated. Patients with heart failure. In this category of patients, amlodipine should be used with caution. In a long-term, placebo-controlled study in patients with severe heart failure (NYHA class III and IV), amlodipine had a higher incidence of pulmonary edema compared with placebo, but this effect was not associated with an exacerbation of heart failure. Patients with impaired liver function. The elimination half-life of amlodipine is increased in patients with hepatic impairment, but dosing recommendations have not yet been developed. Therefore, this category of patients should be used with caution. Elderly patients. Increasing the dose of the drug in this category of patients should be done with caution. Patients with renal insufficiency. In this category of patients, the usual doses of the drug should be used. Changes in the concentration of amlodipine in plasma do not correlate with the degree of impaired renal function. Amlodipine is not removed by dialysis. Amlodipine does not affect the results of laboratory tests. Use caution with amlodipine in patients with aortic stenosis who are at risk of developing hypotension. In patients with coronary atherosclerosis, at the beginning of the use or with an increase in the dose of amlodipine, the risk of worsening the course of angina pectoris and the development of acute myocardial infarction increases. The appointment of amlodipine does not prevent beta-blocker withdrawal syndrome. It is not recommended to use amlodipine together with grapefruit or grapefruit juice, since in some patients the bioavailability may be increased, which will lead to an increase in the hypotensive effect of the drug. Patients with low body weight, short stature and patients with severe liver dysfunction may require a lower dosage of amlodipine. It is necessary to maintain dental hygiene and frequent visits to the dentist (to prevent soreness, bleeding and gum hyperplasia). Amlodipine does not affect plasma concentrations of K +, glucose, triglycerides, total cholesterol, LDL, uric acid, creatinine and uric acid nitrogen, therefore it can be used with caution in patients with bronchial asthma, diabetes mellitus and gout. Use 10 mg tablets with caution in case of metabolic disorders: congenital galactosemia, lactase deficiency, malabsorption of glucose and galactose. Interaction with other drugs If you are currently or have recently taken other drugs, tell your doctor. Effect of other medicinal products on amlodipine. Compatible with the main groups of antihypertensive drugs (diuretics, ACE inhibitors, beta-blockers), nitrates and hypoglycemic drugs. Means for inhalation anesthesia (derivatives of hydrocarbons), amiodarone, quinidine and other calcium antagonists can enhance the effect. NSAIDs (especially indomethacin) reduce the hypotensive effect (inhibit the synthesis of prostaglandins in the kidneys and natriuresis). Strong inhibitors of CYP3A4 (protease inhibitors (ritonavir), azole antifungals (ketoconazole, itraconazole), macrolides (such as erythromycin or clarithromycin), verapamil or diltiazem) can lead to a significant increase in amlodipine exposure, which in turn will lead to an increased risk development of hypotension. It is necessary to monitor the presence of symptoms of hypotension and peripheral edema while prescribing amlodipine with CYP3A4 inhibitors. At present, there is no information on the quantitative effects of CYP3A4 inducers on the pharmacokinetics of amlodipine, however, it is necessary to carefully monitor blood pressure indicators while prescribing amlodipine with CYP3A4 inducers. Effect of amlodipine on other medicinal products. The hypotensive effect of amlodipine potentiates the hypotensive effect of other drugs. Tacrolimus: When taking amlodipine in combination with tacrolimus, there is an increased risk of tacrolimus-induced hypertension, but the pharmacokinetic effect of this drug interaction is not well understood. Thus, when prescribing amlodipine to patients treated with tacrolimus, to reduce the toxicity of the latter, it is necessary to monitor the concentrations of tacrolimus in the blood, and, if necessary, change the dose of tacrolimus. Cyclosporine: The study of drug interactions of cyclosporine and amlodipine was performed only on the population of patients with kidney transplantation. In this case, an increase in the highly variable residual concentration of cyclosporine was noted (0-40% on average). Therefore, monitoring of ciclosporin levels in kidney transplant patients treated with amlodipine and, if necessary, dose reduction of ciclosporin should be recommended. Simvastatin: Co-administration of multiple doses of amlodipine 10 mg and simvastatin 80 mg resulted in a 77% increase in simvastatin exposure compared to simvastatin alone. In patients receiving amlodipine, the dose of simvastatin should be limited to 20 mg/day. In clinical interaction studies, amlodipine did not affect the pharmacokinetics of atorvastatin, digoxin, or warfarin. Contraindications Severe arterial hypotension, shock (including cardiogenic shock), left ventricular outflow obstruction (decompensated aortic stenosis), hemodynamic instability after acute myocardial infarction, hypersensitivity to amlodipine and other dihydropyridine derivatives or to any other component that is part of this drug, unstable angina, pregnancy and lactation, children under 18 years of age (no clinical experience). Composition Each tablet contains: active substance: amlodipine (in the form of besylate) – 5.0 mg or 10.0 mg; excipients: sodium starch glycolate (type A), calcium hydrogen phosphate dihydrate, magnesium stearate, microcrystalline cellulose. Overdose Symptoms: a pronounced decrease in blood pressure with the possible development of reflex tachycardia and excessive peripheral vasodilation (there is a possibility of severe and persistent arterial hypotension, including with the development of shock and death). Treatment: the appointment of activated charcoal (especially in the first 2 hours after an overdose), gastric lavage, giving an elevated position to the limbs, active maintenance of the function of the cardiovascular system, monitoring of heart and lung function, control of circulating blood volume and diuresis. To restore vascular tone and blood pressure, if there are no contraindications, it is possible to use vasoconstrictor drugs. Use in / in the introduction of calcium gluconate. Since amlodipine is largely bound to serum proteins, hemodialysis is ineffective. Undesirable reactions When using amlodipine, undesirable effects were registered with the following frequency: very often – 1/10 or more; often from 1/100 to 1/10; infrequently – from 1/1000 to 1/100; rarely – from 1/10,000 to 1/1000); very rarely – less than 1/10000. Blood and lymphatic system disorders: Very rare: leukopenia, thrombocytopenia. Immune system disorders: Very rare: allergic reactions. Metabolic and nutritional disorders: Very rare: hyperglycemia. Psychiatric disorders: Uncommon: insomnia, mood changes (including panic), depression. Rare: confusion. Nervous system disorders: Often: drowsiness, dizziness, headache (especially at the beginning of treatment). Infrequently: tremor, taste disturbances, syncope, hyperesthesia, paresthesia. Very rare: increased muscle tone, peripheral neuropathy. On the part of the organ of vision: Infrequently: visual disturbances (including diplopia). Hearing and labyrinth disorders: Uncommon: tinnitus. Cardiac disorders: Often: palpitations. Uncommon: arrhythmia (including bradycardia, ventricular tachycardia and atrial fibrillation). Very rare: myocardial infarction. Vascular disorders: Common: flushing. Infrequently: arterial hypotension. Very rare: vasculitis. Respiratory, thoracic and mediastinal disorders Common: dyspnoea. Uncommon: cough, rhinitis. Gastrointestinal disorders: Common: Abdominal pain, nausea, dyspepsia, bowel movements (including diarrhea and constipation). Uncommon: Vomiting, dry mouth. Very rare: pancreatitis, gastritis, hyperplasia. Liver and biliary tract disorders: Very rare: hepatitis, jaundice, elevated liver enzymes. Skin and subcutaneous tissue disorders: Uncommon: alopecia, hemorrhagic rash, discoloration of the skin, increased sweating, pruritus, rash, exanthema, urticaria. Very rare: angioedema, exudative erythema multiforme, exfoliative dermatitis, Stevens-Johnson syndrome, angioedema, photosensitivity. Musculoskeletal and connective tissue disorders: Common: Ankle edema, muscle cramps. Uncommon: arthralgia, myalgia, back pain. Renal and urinary disorders: Uncommon: micturition disorder, nocturia, pollakiuria. Genital and breast disorders: Uncommon: impotence, gynecomastia. General disorders and disorders at the injection site: Very often: edema. Often: increased fatigue, asthenia. Uncommon: chest pain, pain, malaise. Influence on the results of laboratory and instrumental studies: Infrequently: weight gain, weight loss. If any adverse reactions occur, please inform your doctor. This applies to all possible adverse reactions, including those not described in this leaflet for the use of the medicinal product. Storage conditions In a place protected from moisture and light at a temperature not exceeding 25 ° C. Keep out of the reach of children. 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