Amlodipine Hemofarm pills 10 mg N20
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Active ingredients
Amlodipine
Release form
Pills
Composition
Amlodipine (in the form of besylate) 10 mg
Pharmacological effect
Amlodipine, a dihydropyridine derivative, is a blocker of the “slow” calcium channels (BMCC) of the II generation, has antianginal and hypotensive effects. By binding to dihydropyridine receptors, it blocks calcium channels, reduces the transmembrane transition of ions, calcium into the cell (to a greater extent in vascular smooth muscle cells than in cardiomyocytes). expanding peripheral arterioles, reduces total peripheral vascular resistance; reduces preload on the heart, myocardial need for oxygen. Expands the main coronary arteries and arterioles in the unchanged and ischemic areas of the myocardium, increases the supply of oxygen to the myocardium (especially with vasospastic angina); prevents the development of spasm of the coronary arteries (including caused by smoking). In patients with angina, a single daily dose increases exercise tolerance, retards the development of another attack of stenocardia and "ischemic" depression of the ST segment; reduces the frequency of strokes and consumption of nitroglycerin. Amlodipine has a long dose-dependent hypotensive effect, which is caused by a direct vasodilating effect on vascular smooth muscle. With arterial hypertension, a single daily dose of amlodipine provides a clinically significant reduction in blood pressure (BP) for 24 hours (in the patient's position "lying" and "standing."). It has no effect on myocardial contractility and conductivity, inhibits platelet aggregation, increases the glomerular filtration rate, has a weak natriuretic effect. In diabetic nephropathy does not increase the severity of microalbuminuria. It does not adversely affect the metabolism and plasma lipid concentration. The onset of the therapeutic effect is 2-4 hours, the duration is 24 hours.
Indications
Arterial hypertension (monotherapy or in combination with other antihypertensive drugs). Stable angina of exertion. Prinzmetal's angina pectoris (monotherapy or in combination with other antianginal drugs).
Contraindications
Hypersensitivity to amlodipine, other dihydropyridine derivatives, other components of the drug. Severe arterial hypotension (systolic blood pressure less than 90 mm Hg) Collapse. Cardiogenic shock. Unstable angina (with the exception of Prinzmetal angina). (efficacy and safety have not been established). Lactose intolerance, lactase deficiency or glucose-galactose malabsorption. Pregnancy. Lactation period. With caution, use the drug for: impaired liver function. and, sick sinus syndrome (severe bradycardia, tachycardia), chronic heart failure of non-ischemic etiology of III-IV functional class according to NYHA classification, aortic stenosis, mitral stenosis, hypertrophic obstructive cardiomyopathy, acute myocardial infarction (and for 1 month after myocardium, and for 1 month after),) age
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 teratogenicity of amlodipine was not detected in an animal study, but there is no clinical experience with its use during pregnancy and lactation. Therefore, amlodipine should not be prescribed for pregnant women and during lactation, as well as for women of childbearing age, if they do not use reliable methods of contraception.
Dosage and administration
Inside, regardless of the meal. For the treatment of arterial hypertension and the prevention of attacks of angina pectoris and vasospastic angina: the initial dose of Amlodipine is 5 mg 1 time per day. If necessary, the daily dose may be increased to a maximum of -10 mg (1 time per day).
Side effects
on the side of the cardiovascular system: often - heartbeat, peripheral edema (swelling of the ankles and feet); infrequently - excessive decrease in blood pressure, orthostatic hypotension, vasculitis; rarely - the development or aggravation of chronic heart failure; very rarely - rhythm disturbances (bradycardia, ventricular tachycardia, atrial fibrillation), myocardial infarction, chest pain, migraine. From the side of the central nervous system: often - headache, dizziness, increased fatigue; infrequently - malaise, fainting, asthenia neuropsychic, hypesthesia, paresthesia, peripheral neuropathy, tremor, insomnia, emotional lability, unusual dreams, nervousness, depression, anxiety; rarely - convulsions, apathy, agitation; very rarely - ataxia, amnesia. From the side of hematopoietic organs: very rarely - thrombocytopenia, leukopenia, thrombocytopenic purpura. On the part of the respiratory system: infrequently - shortness of breath, rhinitis; very rarely - cough. From the digestive tract: often - nausea, abdominal pain; infrequently - vomiting, change of the mode of defecation (including constipation, flatulence), dyspepsia, diarrhea, anorexia, dryness of the oral mucosa, thirst; rarely - gingival hyperplasia, increased appetite; very rarely - gastritis, pancreatitis, hyperbilirubinemia, jaundice (usually cholestatic), increased activity of “liver” transaminases, hepatitis. From the genitourinary system: rarely - pollakiuria, painful urination to urinate, nocturia, impotence; very rarely - dysuria, polyuria. From the side of the skin: rarely - increased sweating; very rarely - cold sticky sweat, xerodermia, alopecia, dermatitis, purpura, discoloration of the skin. Allergic reactions: infrequently - pruritus, rash; very rarely - angioedema, erythema multiforme, urticaria. On the part of the musculoskeletal system: infrequently - arthralgia, muscle cramps, arthrosis,myalgia (with prolonged use), back pain; rarely - myasthenia. Others: infrequently - alopecia, tinnitus, gynecomastia, weight gain / loss, visual impairment, diplopia, accommodation disorder, xerophthalmia, conjunctivitis, eye pain, taste perversion, chills, nasal bleeding, increased sweating; rarely - dermatitis; very rarely - cold sticky sweat, parosmia, impaired skin pigmentation, hyperglycemia.
Overdose
Symptoms: marked reduction in blood pressure with possible development of reflex tachycardia and excessive peripheral vasodilation (risk of severe and persistent arterial hypotension, including the development of shock and death). Treatment: gastric lavage, the appointment of activated carbon (especially in the first 2 hours after overdose ), maintaining the function of the cardiovascular system, monitoring indicators of the function of the heart and lungs, Trendelenburg posture, monitoring the volume of circulating blood and diuresis. To restore vascular tone - the use of vasoconstrictor drugs (in the absence of contraindications to their use); to eliminate the effects of calcium channel blockade, intravenous administration of calcium gluconate. Hemodialysis is not effective.
Interaction with other drugs
Inhibitors of microsomal oxidation can increase the concentration of amlodipine in the blood plasma, increasing the risk of side effects, and inducers of microsomal liver enzymes can reduce this indicator. Unlike other BMCC, amlodipine has no clinically significant interaction with nonsteroidal anti-inflammatory drugs, especially with indomethacin. Thiazide and “loop” diuretics, beta-blockers, verapamil, ACE inhibitors and nitrates enhance the antianginal or hypotensive effects of amlodipine. myodarone, quinidine, alpha 1 -blockers, antipsychotics (neuroleptics) and isoflurane may enhance the hypotensive effect of amlodipine. Calcium preparations may reduce the effect of BMCC. When combined with amlodipine and lithium preparations, the manifestations of neurotoxicity of the latter may be increased (nausea, vomiting, diarrhea, diarrhea, diarrhea, diarrhea, diarrhea, diarrhea tremor, tinnitus). Amlodipine does not affect the pharmacokinetic parameters of digoxin and warfarin. Cimetidine does not affect the pharmacokinetics of amlodipine. Antiviral drugs (ritonavir) contribute to the increase in concentrations of BCCA (including amlodipine) in the blood plasma.
special instructions
Application for violations of liver function: Amlodipine is prescribed with caution in patients with impaired liver function as an antihypertensive agent, in an initial dose of 2.5 mg, as an antiangial agent - 5 mg. Use for renal failure: no dose change is required in patients with renal insufficiency. In elderly patients: T1 / 2 can increase and creatinine clearance (CC) decreases. Changes in doses are not required, but more careful monitoring of patients is needed. It is not necessary to change the dose while prescribing with thiazide diuretics, beta-blockers and angiotensin-converting enzyme inhibitors (ACE). During the period of treatment with Amlodipine, control of the patient's body weight and the amount of sodium salt consumed is necessary ; appropriate low-salt diet is prescribed. It is necessary to maintain dental hygiene and regular visits to the dentist (to prevent pain, bleeding and gingival hyperplasia). The dosage of Amlodipine in elderly patients is similar to that in patients of other age groups. Increasing the dose requires careful monitoring of elderly patients. Despite the absence of "withdrawal" syndrome in BMCA, a gradual decrease in dose is recommended before stopping treatment. Amlodipine does not affect plasma concentrations of potassium ions, glucose, triglycerides, total cholesterol, low density lipoproteins, uric acid, creatinine and urea nitrogen in the blood. Abrupt withdrawal of the drug should be avoided due to the risk of worsening of the course of angina. Amlodipine pills are not recommended for hypertensive crises. Patients with low body mass, patients of small stature and patients with severely impaired liver function may require a lower dose. Effect on ability to drive vehicles and control mechanismsNo reports on the effect of Amlodipine on driving or working with mechanisms. However, in some patients, primarily at the beginning of treatment, drowsiness and Dizziness may occur. When they occur, care should be taken when driving vehicles and engaging in potentially hazardous activities that require increased concentration and psychomotor speed.