Amlotensin capsules 8mg/5mg №10×3

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Amlotensin caps.8mg/5mg in cell.pack No. 10×3
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Hard gelatin capsules No. 1, cylindrical shape with hemispherical ends with a white body and a yellow cap. The main active ingredient Perindopril + Amlodipine Release form Capsules Dosage 8 mg / 5 mg Special instructions and precautions All instructions associated with each of the components separately listed below apply to the fixed combination Amlotsin. Associated with perindopril. Hypersensitivity/Angioedema: There have been rare reports of angioedema of the face, extremities, lips, mucous membranes, tongue, glottis and/or larynx in patients treated with ACE inhibitors, including perindopril. These reactions may occur at any time during therapy. In such cases, the drug should be stopped immediately and the necessary monitoring should be carried out until the symptoms disappear completely. Usually, in cases where the swelling only affected the face and lips, it went away without any treatment, although taking antihistamines helped relieve symptoms. Angioedema, accompanied by swelling of the larynx, can be fatal. If there is swelling of the tongue, glottis, or larynx that is likely to cause airway obstruction, immediate first aid should be given, which may include administering epinephrine and/or keeping the airway clear. The patient should be under close medical supervision until the complete and final disappearance of symptoms. An increased risk of angioedema when taking an ACE inhibitor exists in patients who have had angioedema that is not associated with taking ACE inhibitors. In rare cases, intestinal edema has been reported in patients treated with ACE inhibitors, manifested by abdominal pain, with or without nausea and vomiting. Intestinal edema should be included in the differential diagnosis in patients taking ACE inhibitors and experiencing abdominal pain. Anaphylactoid reactions during low-density lipoprotein (LDL) apheresis procedures: Anaphylactoid reactions may occur in some patients on hemodialysis using high-flux membranes or patients receiving LDL apheresis procedures using dextran sulfate absorption, when ACE inhibitors are prescribed. To prevent – temporary cancellation of the ACE inhibitor each time before apheresis. Anaphylactoid reactions during desensitization: Anaphylactoid reactions have occurred in some patients receiving ACE inhibitors during desensitization therapy (eg, hymenopteric venom). In some patients, these reactions could be avoided by temporarily discontinuing the ACE inhibitor, but they reappeared if the drug was taken carelessly. Neutropenia/Agranulocytosis/Thrombocytopenia/Anemia: Neutropenia/agranulocytosis, thrombocytopenia and anemia have been reported in patients taking ACE inhibitors. In patients with normal liver function and no other complicating factors, neutropenia rarely occurs. When taking perindopril, extreme caution should be exercised in patients with collagen vascular disease, in patients undergoing immunosuppressive therapy, allopurinol or procainamide treatment, or in those who have all these complicating factors, especially in those with pre-existing impaired liver function. Some of these patients developed serious infections. In some cases, intensive antibiotic therapy was unsuccessful. When prescribing perindopril to such patients, it is recommended to periodically monitor the count of leukocytes and instruct patients to report any signs of infection (eg, sore throat, fever). Precautions for taking. Risk of hypotension: ACE inhibitors may cause a drop in blood pressure. Symptomatic hypotension rarely develops in hypertensive patients without comorbidities, it occurs more often in patients with reduced circulating blood volume (taking diuretics, on a diet with limited salt intake, patients on dialysis, patients suffering from diarrhea or vomiting) or in patients with severe renin dependent hypertension. Patients at increased risk of symptomatic hypotension treated with Amlotensin should be closely monitored for blood pressure, renal function, and serum potassium levels. In the event of hypotension, it is necessary to put the patient on his back and, if necessary, replenish the BCC by intravenous administration of 0.9% sodium chloride solution (9 mg / ml). Transient hypotension is not a contraindication to further use of the drug, which can usually be safely continued after blood pressure has risen again due to an increase in circulating blood volume. Aortic and mitral valve stenosis/hypertrophic cardiomyopathy: As with other ACE inhibitors, perindopril should be used with extreme caution in patients with mitral valve stenosis and left ventricular outflow tract obstruction, such as aortic stenosis or hypertrophic cardiomyopathy. Renal insufficiency: in case of renal insufficiency (creatinine clearance < 60 ml/min.), individual dose titration of the individual components is recommended. In patients with renal insufficiency, routine medical examination should include monitoring of potassium and creatinine levels. In some patients with bilateral renal arterial stenosis or stenosis of the artery to a single kidney, treated with ACE inhibitors, there have been cases of increased blood urea and serum creatinine, which were reversible upon discontinuation of therapy. This is most likely in patients with renal insufficiency. In renovascular hypertension, there is also an increased risk of severe hypotension and renal failure. In some hypertensive patients without apparent renal vascular disease, an increase in blood urea and serum creatinine concentrations was noted, usually it was of a minor and transient nature, especially with the combined use of perindopril and a diuretic. This is most likely in patients already suffering from renal insufficiency. Liver failure: In rare cases, ACE inhibitors have been associated with a syndrome that begins with cholestatic jaundice and progresses to fulminant hepatic necrosis and (sometimes) ends in death. The mechanism of this syndrome is not yet understood. Patients receiving ACE inhibitors who develop jaundice or markedly elevated liver enzymes should stop taking the ACE inhibitor and undergo a thorough medical evaluation. Cough: Cases of cough have been reported during therapy with ACE inhibitors. Characterized by unproductive, persistent cough, passing with the cessation of therapy. An ACE inhibitor-induced cough should be considered as part of the differential diagnosis of cough. Surgery/Anesthesia: During surgery or during anesthesia with drugs that cause hypotension, Amlotensin may block the formation of angiotensin II, as a consequence of the compensatory release of renin. It is recommended to stop treatment the day before surgery. With the onset of hypotension, presumably associated with this mechanism of action, the BCC should be increased. Hyperkalemia: In some patients treated with ACE inhibitors, including perindopril, there have been cases of elevated serum potassium levels. Risk factors for the development of hyperkalemia: renal failure, deterioration of renal function, age (> 70 years), diabetes mellitus, incidental events such as dehydration, acute cardiac decompensation, metabolic acidosis, concomitant use of potassium-sparing diuretics (spironolactone, eplerenone, triamterene or amiloride ), potassium supplements, or potassium-containing salt substitutes, and other drugs that cause an increase in serum potassium levels (eg, heparin). The use of potassium supplements, potassium-sparing diuretics and potassium-containing salt substitutes, especially in patients with impaired liver function, can lead to a significant increase in serum potassium levels. Hyperkalemia can cause serious, sometimes fatal, arrhythmias. If necessary, the concomitant appointment of perindopril and the above drugs, their administration should be carried out with caution and with regular monitoring of the content of potassium in the blood serum. Patients with diabetes: Patients with diabetes taking oral antidiabetic drugs or insulin should have careful glycemic control during the first month of treatment with an ACE inhibitor. Dual blockade of the renin-angiotensin-aldosterone system is associated with an increased risk of hypotension, hyperkalemia, and renal dysfunction (including acute renal failure) compared with monotherapy. Dual RAAS blockade with ACE inhibitors, AT II receptor blockers (ARB II) or Aliskiren cannot be recommended in any patient, especially in patients with diabetic nephropathy. In some cases, when the combined use of ACE inhibitors and ARB II is absolutely indicated, careful observation of a specialist and mandatory monitoring of kidney function, water and electrolyte balance, and blood pressure are necessary. This refers to the use of candesartan or valsartan as add-on therapy to ACE inhibitors in patients with chronic heart failure. Conducting a double blockade of the RAAS under the close supervision of a specialist and mandatory monitoring of kidney function, water and electrolyte balance and blood pressure is possible in patients with chronic heart failure with intolerance to aldosterone antagonists (spironolactone), who have persistent symptoms of chronic heart failure, despite other adequate therapy. associated with amlodipine. Precautions for taking. The safety and efficacy of amlodipine in hypertensive crisis has not been established. Use in patients with hepatic insufficiency: in patients with impaired liver function, the half-life is prolonged and the AUC values are higher, recommended doses have not been established, therefore, it is necessary to start with caution, from the lowest doses of the dosage scale and also be careful when increasing the dose. Patients with severe hepatic impairment require slow dose titration and close monitoring. Patients with heart failure: The treatment of patients with heart failure requires caution. In a long-term placebo-controlled study in patients with severe heart failure (NYHA class III and IV), the incidence of pulmonary edema was higher in patients in the amlodipine group than in the placebo group. Calcium channel blockers, including amlodipine, should be used with caution in patients with congestive heart failure, as they may be at increased risk of cardiovascular events and future mortality. Use in Elderly Patients: Increasing the dosage in elderly patients should be done with caution. Use in patients with renal insufficiency: the use of amlodipine can be used at usual doses. Changes in the concentration of amlodipine in plasma does not correlate with the degree of renal failure, amlodipine is not excreted by dialysis. During treatment with the drug, it is recommended to exclude the use of alcoholic beverages. When using Amlotensin, it is necessary to use adequate contraceptive measures. This medicinal product contains lactose monohydrate and should not be used in patients with rare hereditary problems of galactose intolerance, hereditary lactase deficiency or glucose-galactose malabsorption syndrome. Pharmacotherapeutic group: ACE inhibitors and calcium channel blockers. Indications for use Amlotensin is indicated for the treatment of essential hypertension and/or stable coronary artery disease requiring treatment with perindopril and amlodipine. Method of administration and doses For oral administration. Take one capsule 1 time per day (preferably in the morning) before meals. The fixed dose combination is not intended to initiate antihypertensive therapy. If therapeutically necessary, the dose of the drug can be changed based on the individual selection of doses of individual components. Patients with renal insufficiency and elderly patients. In these categories of patients, the excretion of perindoprilat is slowed down. Therefore, in such patients, it is necessary to regularly monitor the concentration of creatinine and potassium in the blood plasma. Amlotensin can be administered to patients with CC? 60 ml / min and is not suitable for patients with CC < 60 ml / min. Such patients are recommended individual selection of doses of perindopril and amlodipine. In elderly patients, the usual regimen is recommended, but dose increases should be carried out with caution. The change in the concentration of amlodipine in the blood plasma does not correlate with the severity of renal failure. Patients with liver failure. Caution should be exercised when prescribing Amlotensin to patients with hepatic insufficiency due to the lack of dosage recommendations for the drug in such patients. In patients with severe hepatic insufficiency, the drug should be administered with the lowest doses and slowly titrated. Children and teenagers up to 18 years old. The drug should not be prescribed due to the lack of data on the efficacy and safety of the use of perindopril and amlodipine in these groups of patients, both as monotherapy and as a combination therapy. Application during pregnancy and lactation Amlotensin is contraindicated for use during pregnancy and lactation (breastfeeding). Use in children It is not recommended to prescribe the drug to children under 18 years of age, due to the lack of data on the efficacy and safety of use in children. Influence on the ability to drive vehicles or potentially dangerous mechanisms If it is necessary to drive vehicles and work with mechanisms during the use of the drug, the possibility of dizziness or fatigue should be considered. Interaction with other drugs Associated with perindopril. In patients taking diuretic drugs, especially in patients with a decrease in volume and / or salt deficiency, after the start of treatment with an ACE inhibitor, a marked decrease in blood pressure may be observed. When a diuretic is discontinued, an increase in BCC or salt intake before starting treatment, as well as the appointment of low initial doses of perindopril and their gradual increase reduces the risk of hypotension. In some patients taking perindopril, hyperkalemia may occur, although usually the potassium content remains within the normal range. The combination of perindopril with potassium-sparing diuretics (eg, spironolactone, triamterene or amiloride), potassium supplements and potassium-containing salt substitutes is not recommended due to the possible significant increase in serum potassium levels. If the simultaneous use of these drugs is necessary due to severe hypokalemia, then when taking them, special care should be taken and frequent monitoring of the content of potassium in the blood serum should be carried out. With the simultaneous administration of lithium and ACE inhibitors, there have been cases of a reversible increase in serum lithium concentrations and cases of toxicity. Concomitant use of thiazide diuretics may increase the risk of lithium toxicity and increase the already increased risk of lithium toxicity due to the use of ACE inhibitors. The combination of perindopril and lithium is not recommended, but if combined administration is necessary, then careful monitoring of serum lithium levels should be carried out. The use of non-steroidal anti-inflammatory drugs (NSAIDs), including aspirin? 3 g/day may reduce the hypotensive effect of ACE inhibitors. NSAIDs and ACE inhibitors have an additive effect on the increase in plasma potassium, which can lead to deterioration of kidney function. These effects are reversible. In rare cases, renal failure may develop, especially in patients with impaired renal function, for example, in elderly patients or when the body is dehydrated. Concomitant use of antihypertensive and vasodilator drugs may lead to an increase in the hypotensive effect of perindopril. Simultaneous use of nitroglycerin and other nitrates or other vasodilators may lead to a further decrease in blood pressure. The combined use of ACE inhibitors and antidiabetic drugs (insulins, oral hypoglycemic drugs) can lead to an increase in the effect of lowering blood glucose levels with the risk of hypoglycemia occurring in the first weeks of combined treatment and in patients with impaired renal function. Dual RAAS blockade with ACE inhibitors, AT II receptor blockers (ARB II) or Aliskiren cannot be recommended in any patient, especially in patients with diabetic nephropathy. In patients with diabetes mellitus or moderate/severe renal insufficiency (GFR < 60 ml/min/1.73 m2), concomitant use of Aliskiren with ACE inhibitors or ARBs II is contraindicated. In some cases, when the combined use of ACE inhibitors and ARB II is absolutely indicated, careful observation of a specialist and mandatory monitoring of kidney function, water and electrolyte balance, and blood pressure are necessary. Concomitant use of ACE inhibitors with certain anesthetics, tricyclic antidepressants and antipsychotics (neuroleptics) may further lower blood pressure and increase the risk of orthostatic hypotension. When used together with sympathomimetics, the hypotensive effect of ACE inhibitors may decrease. Perindopril may be administered simultaneously with acetylsalicylic acid (use as a thrombolytic), with thrombolytics, beta-blockers and/or nitrates. Antacids and tetracyclines reduce the rate and completeness of perindopril absorption from the gastrointestinal tract. Rarely, nitritoid reactions (including flushing, nausea, vomiting, and hypotension) have been observed with simultaneous use with injections of gold (sodium aurothiomalate) and ACE inhibitors. Alcohol enhances the hypotensive effect of ACE inhibitors. associated with amlodipine. Not recommended combinations: Dantrolene (infusion). In animals, when receiving verapamil and dantrolene intravenously, ventricular fibrillation and cardiovascular collapse associated with hyperkalemia, leading to death, were observed. Due to the risk of hyperkalemia, it is recommended to avoid combinations with calcium channel blockers such as amlodipine in patients prone to malignant hyperthermia and in the treatment of malignant hyperthermia. Combinations requiring caution: CYP3A4 inducers: There are no data on the effect of CYP3A4 inducers on amlodipine. Simultaneous administration of CYP3A4 inducers (rifampicin, Hypericum perforatum (St. John's wort)) with amlodipine may lead to a decrease in the plasma concentration of amlodipine. Amlodipine concomitantly with CYP3A4 inducers should be used with caution. CYP3A4 inhibitors: Concomitant use of amlodipine with strong or moderate CYP3A4 inhibitors (protease inhibitors, azole antifungals, macrolides such as erythromycin or clarithromycin, verapamil or diltiazem) may result in a significant increase in amlodipine exposure. The clinical effect of these changes may be more pronounced in older patients. In such cases, clinical monitoring and dose adjustment may be necessary. The effect of amlodipine to reduce pressure complements the effect of other antihypertensive drugs. In clinical interaction studies, amlodipine did not affect the pharmacokinetics of atorvastatin, digoxin, warfarin, or cyclosporine. Taking amlodipine with grapefruit or grapefruit juice is not recommended, as in some patients the bioavailability of amlodipine may increase, which may lead to an increase in the blood pressure lowering effect. Related to Amlotensin. Combinations that require special care: Baclofen. Enhances the severity of the hypotensive effect. Monitor blood pressure and renal function and, if necessary, adjust the dose of antihypertensive drug. Combinations that require caution: antihypertensive drugs (such as beta-blockers) and vasodilators: the combined use of these drugs may lead to an increase in the hypotensive effect of perindopril and amlodipine. The combined use of nitroglycerin, other nitrates or vasodilators can lead to a further decrease in blood pressure and, therefore, should be administered with caution; corticosteroids, tetracosactide: reduce the hypotensive effect (salt and water retention caused by the action of corticosteroids); alpha-blockers (prazosin, alfuzosin. doxazosin, tamsulosin, terazosin): increased hypotensive effect and increased risk of orthostatic hypotension; amifostine: possible increased hypotensive effect of amlodipine; tricyclic antidepressants / antipsychotics / anesthetics: increased hypotensive effect and increased risk of orthostatic hypotension. Contraindications Associated with perindopril: Hypersensitivity to perindopril or other ACE inhibitors. History of angioedema associated with previous therapy with ACE inhibitors. Hereditary or idiopathic angioedema. Pregnancy and lactation. One temporary use of angiotensin-converting enzyme inhibitors or AT II receptor blockers with Aliskiren in patients with diabetes mellitus or moderate / severe renal insufficiency (glomerular filtration rate less than 60 ml / min / 1.73 m2). Associated with amlodipine: Severe hypotension. Hypersensitivity to amlodipine or other dihydropyridines. Shock, including cardiogenic shock. Left ventricular outflow tract obstruction (eg, in severe aortic stenosis). Heart failure after acute myocardial infarction (during the first 28 days). separately, also apply to the fixed combination of perindopril/amlodipine. Hypersensitivity to the auxiliary components of the drug. Hereditary galactose intolerance, lactase deficiency, or malabsorption of glucose / galactose. Composition 1 capsule of Amlotensin 8 mg / 5 mg contains: active substances: perindopril tert-butylamine - 8 mg; amlodipine (in the form of besylate) - 5 mg .Excipients: sodium starch glycolate type A; sodium stearyl fumarate; lactose monohydrate. Composition of a hard gelatin capsule: for a dosage of 8 mg / 5 mg: orange yellow (E110), quinoline yellow (E104), titanium dioxide (E 171), gelatin. Overdose There is no information on overdose of Amlotensin in humans. Symptoms. An overdose of amlodipine has been reported to result in excessive vasodilation and possible reflex tachycardia. Treatment. Clinically significant hypotension caused by amlodipine overdose requires support for cardiovascular parameters, including regular monitoring of cardiac and respiratory function, limb elevation, and control of circulating blood volume and urine output. Vasoconstrictor drugs, if there are no contraindications to taking them, can help restore vascular tone and blood pressure, intravenous calcium gluconate can help eliminate the effects of calcium channel blockade. Due to the high ability of amlodipine to bind to proteins, dialysis is ineffective. Symptoms of an overdose of perindopril, as with all ACE inhibitors, may include hypotension, circulatory shock, electrolyte imbalance, renal failure, hyperventilation, tachycardia, palpitations, bradycardia, dizziness, anxiety, cough. Treatment: Intravenous infusion with normal saline is recommended. If hypotension develops, the patient should be placed on their back. If possible, treatment with angiotensin II in the form of infusion and/or intravenous catecholamines should be considered. Perindopril is removed from the systemic circulation by hemodialysis. With therapy-resistant bradycardia, pacing is indicated. Vital signs, electrolytes and serum creatinine should be constantly monitored. Side effects When taking perindopril or amlodipine, there is a possibility of developing adverse reactions - see the instructions! Storage conditions In a place protected from moisture and light at a temperature not exceeding 25 ° C. Keep out of the reach of children. Buy Amlotensin capsules 8mg/5mg No. 10x3