Properties
- Form
- tableti saghech i
- Dosage mg
- 5მგ+10
- Pack
- 30
What is it?
International Nonproprietary Name: Amlodipine Besylate + Lisinopril Dihydrate Dosage Form: Film-coated tablets. Description: Round, biconvex, red film-coated tablets with the engraving "AMLP" on one side and a score line on the other. Composition: 1 film-coated tablet contains: Active substances: Amlodipine (as besylate) 5 mg, Lisinopril (as dihydrate) 5 mg. Excipients: Corn starch, calcium hydrogen phosphate, lactose, povidone K30, sodium starch glycolate, magnesium stearate. ATC code: C09BB. Pharmacotherapeutic group: Drugs for cardiovascular system diseases. Angiotensin-converting enzyme (ACE) inhibitors in combination with calcium channel blockers. Pharmacological properties: Pharmacodynamics: Amlipin is a combined antihypertensive drug whose pharmacological properties are due to the combination of the properties of amlodipine (selective calcium channel blocker) and lisinopril (ACE inhibitor). By blocking slow calcium channels of the membrane, amlodipine prevents the transmembrane passage of calcium ions into cardiomyocytes and smooth muscle cells of blood vessels. Its action reduces the tone of blood vessels (arterioles) and peripheral vascular resistance. By dilating arterioles and reducing afterload, amlodipine has an antianginal effect. Since it does not cause reflex tachycardia, its use reduces myocardial oxygen demand. Amlodipine dilates both intact and pathologically altered coronary blood vessels, improving myocardial perfusion. Amlodipine has no adverse metabolic effects. Lisinopril lowers plasma levels of angiotensin II and aldosterone, and at the same time increases the level of bradykinin, which has a vasodilating effect. Under the influence of lisinopril, total peripheral vascular resistance, arterial pressure, and pulmonary capillary pressure decrease. Lisinopril does not change heart rate; however, it can increase cardiac output and improve renal blood flow. Lisinopril reduces albuminuria by lowering blood pressure and improving hemodynamics of the glomerular apparatus and its tissues. With prolonged use, hypertrophy of the myocardium and walls of resistant vessels decreases. In patients with hyperglycemia, lisinopril helps restore impaired endothelial function. Pharmacokinetics: After oral administration, amlodipine is slowly and almost completely (90%) absorbed from the gastrointestinal tract, with Cmax reached in 6-10 hours. The half-life is on average 35-50 hours. Lisinopril is well absorbed from the digestive tract, and its absorption is not related to the presence of food in the stomach. Bioavailability is 25-50%. Cmax is reached in 6 hours. The half-life is 12 hours. The long circulation of both active substances in the body allows the drug to be administered once a day. Indications for use: - Arterial hypertension; - Ischemic heart disease (stable angina, Prinzmetal's angina); - Chronic heart failure (as part of complex therapy); - Diabetic nephropathy. Contraindications: - Hypersensitivity to any component of the drug or other dihydropyridine derivatives; - Angioneurotic edema in history, including that associated with the use of other ACE inhibitors; - Hemodynamically significant stenosis of the aortic or mitral valve; - Severe arterial hypotension; - Cardiogenic shock; - Childhood. Special instructions: In patients with impaired liver function, the half-life of amlodipine increases, which requires caution when selecting the daily dose. In patients taking diuretics or with dehydration of other origin (excessive sweating, prolonged vomiting, profuse diarrhea), as well as during heart failure, symptomatic hypotension may develop. In this case, it is recommended to lay the patient down, and if necessary, administer an infusion of 0.9% sodium chloride solution. Before starting treatment, it is necessary to normalize serum sodium levels and restore fluid volume in case of hypovolemia. In renal artery stenosis (especially bilateral stenosis or stenosis of a single renal artery), as well as during dehydration, the use of lisinopril can lead to impaired kidney function, up to acute renal failure, which is usually transient and disappears after discontinuation of the drug. During surgical interventions involving the use of anesthetics that can cause arterial hypotension, lisinopril blocks the formation of angiotensin II. Prevention of hypotension developed by the above mechanism is possible by replenishing circulating blood volume. Special caution is required when determining the dose of the drug for elderly patients. Since the risk of agranulocytosis cannot be completely ruled out, periodic laboratory control of peripheral blood is necessary when using the drug. Effect on ability to drive and operate machinery: Taking the drug (especially at the beginning of treatment) can affect the ability to drive and perform tasks that require special attention, so it is necessary to refrain from such activities until individual reactions are determined. Pregnancy and lactation: Amlipin cannot be used during pregnancy and lactation. Side effects: Side reactions are usually mild and transient, and discontinuation of the drug is rarely necessary. Relatively common: headache, dry cough, and dizziness. Possible: weakness, diarrhea, nausea, vomiting, orthostatic hypotension, skin itching, skin rash, leg edema, facial flushing, chest pain. The frequency of other side effects is less than 1%. In case of hypersensitivity, angioneurotic edema may develop. Dosage and administration: Take orally 1 tablet once a day. It can be taken independently of meals. If necessary, the daily dose can be increased to 2 tablets. Overdose: Symptoms: Vasodilation with a decrease in blood pressure and reflex tachycardia. Treatment: Symptomatic therapy, with control of cardiac function, blood pressure, diuresis, and water-electrolyte balance, with correction if necessary. In case of significant decrease in blood pressure, the patient should be placed in a "horizontal" position with elevated lower extremities. If intravenous fluid replacement is not sufficiently effective, peripheral vasopressors may be required to maintain circulation. Calcium gluconate may be administered intravenously to stop the action of the calcium antagonist. Due to the slow absorption of amlodipine, gastric lavage is performed in individual cases, activated charcoal is used. Lisinopril is excreted by hemodialysis. Interactions with other drugs: Special caution is required to prevent the development of hyperkalemia when prescribing the drug with potassium-sparing diuretics (spironolactone, amiloride, triamterene), as well as in combination with potassium and potassium-containing agents, mainly in case of impaired kidney function. The drug is prescribed after assessing the benefits and risks, with regular monitoring of serum potassium levels and kidney function. Caution is necessary when used with the following agents: - Diuretics (possible sharp decrease in blood pressure); - Other hypotensive agents (additive effect); - NSAIDs (especially indomethacin), as they retain sodium in the body and block prostaglandin synthesis in the kidneys, estrogenic agents and adrenomimetics, sympathomimetics (possible decrease in therapeutic effect); - Lithium (possible worsening of lithium excretion, control of lithium levels in blood plasma is necessary); Amiodarone, quinidine, beta-blockers, antipsychotics (neuroleptics) can enhance the hypotensive effect. Form of release: 10 film-coated tablets in a blister. 3 blisters in a cardboard box with instructions for use. Storage conditions: Store in a dry place, inaccessible to children, at a temperature not exceeding 25°C. Shelf life: 3 years from the date of manufacture. Do not use after the expiry date. Dispensing conditions: By prescription. Manufacturer: Amlipin is a product and trademark of World Medicine (Great Britain). Manufactured by Laboratoires Bailleul-Berna (France) at: Chemin de Neuilly Z.I. de 150 Arpents, 28500 Vernouillet-France under license from Medraik (Great Britain).