Perindopril-LF capsules 8mg №10×3

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Perindopril-LF caps. 8 mg in a cell. pack No. 10×3
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Hard gelatin capsules, No. 1, cylindrical in shape with hemispherical ends, with a white body and a red cap. The contents of the capsules are powder from white to white with a yellowish tint, odorless. The presence of lumps and the formation of a column is allowed. The main active ingredient is Perindopril. Release formCapsules. Dosage 8 mg Warnings and precautions 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 for any patient, especially those 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. Stable ischemic heart disease If an episode of unstable angina (pronounced or not) develops during the first month of treatment with perindopril, the balance between benefit and risk should be carefully assessed before continuing treatment. Arterial hypotension ACE inhibitors can cause a decrease in blood pressure. In patients with uncomplicated hypertension, severe hypotension is rare; it is more common in patients with hypovolaemia, that is, those who take diuretics, limit salt intake, are on hemodialysis, as well as in patients with diarrhea or vomiting, and in patients with severe renin-dependent hypertension. Clinically significant hypotension has been reported in patients with symptomatic heart failure with or without concomitant renal failure. It is likely in patients with more severe heart failure, reflected by the use of high doses of loop diuretics, hyponatremia, or functional kidney damage. Patients with an increased risk of developing clinically significant hypotension need careful observation at the beginning of therapy and dose adjustment. Similar requirements apply to patients with coronary artery disease or cerebrovascular disease, in whom an excessive decrease in blood pressure can lead to the development of myocardial infarction or acute cerebrovascular accident. With the development of arterial hypotension, the patient should be placed in a horizontal position and, if necessary, prescribe intravenous saline. Transient hypotension is not a contraindication to continued treatment, which can usually be restored without complications after an increase in blood pressure due to an increase in circulating blood volume. In some patients with congestive heart failure and normal or low blood pressure, treatment with perindopril may lead to an additional decrease in systemic blood pressure. This effect is expected and is not a reason to stop treatment. In the case of clinically pronounced arterial hypotension, a dose reduction or discontinuation of treatment with perindopril may be required. Aortic and mitral valve stenosis/hypertrophic cardiomyopathy As with other ACE inhibitors, perindopril should be used cautiously in patients with mitral valve stenosis and left ventricular outflow tract stenosis, in particular aortic stenosis or hypertrophic cardiomyopathy. Impaired renal function In case of impaired renal function (creatinine clearance <60 ml / min), the initial dose of perindopril should be adjusted according to the patient's creatinine clearance and depending on the patient's response to treatment. Usually, such patients are monitored for potassium and creatinine levels in a planned manner. In patients with symptomatic heart failure, the development of hypotension after initiation of treatment with ACE inhibitors may lead to some deterioration in renal function. In a similar situation, AKI was described, which was usually irreversible. In some patients with bilateral renal artery stenosis or stenosis of the artery to a solitary kidney treated with ACE inhibitors, an increase in serum urea and creatinine has been detected, usually of a slightly reversible nature after discontinuation of treatment. This is especially likely in patients with impaired renal function. In the case of renovascular hypertension, there is an increased risk of severe hypotension and renal failure. In such patients, treatment should be started under close medical supervision with low doses followed by careful dose selection. Since treatment with diuretics may be a favorable factor in the development of the above phenomena, diuretics should be discontinued in the first weeks of treatment with perindopril, while monitoring renal function. Some patients with hypertension and no obvious signs of previous renal vascular disease developed an increase in serum urea and creatinine, which was usually minor and transient, especially with the simultaneous use of perindopril with diuretics. These manifestations are more likely to develop in patients with previous kidney damage. Dose reduction and/or discontinuation of diuretic and/or perindopril treatment may be required. Patients Receiving Hemodialysis In patients receiving dialysis on high-flow membranes and receiving concomitant treatment with ACE inhibitors, the development of anaphylactic reactions has been observed. For patients, consideration should be given to using a different type of dialysis membrane or a different class of antihypertensive drug. Kidney transplantation There is no experience with the use of perindopril in patients with recent kidney transplantation. Hypersensitivity/angioneurotic edema Rarely, patients treated with ACE inhibitors, including perindopril, may develop angioedema of the face, extremities, lips, mucous membranes, tongue, vocal cords and/or larynx. This phenomenon can develop at any time during treatment. In such cases, treatment with perindopril should be stopped immediately and appropriate monitoring of the condition should begin, which is carried out until the complete cessation of symptoms. In cases where swelling of only the face or lips was observed, it usually disappeared without treatment, although antihistamines were used to relieve symptoms. Angioedema combined with laryngeal edema can lead to death. In the case of swelling of the tongue, vocal cords and larynx with a high probability of airway obstruction, urgent therapy should be prescribed immediately. This may include administering epinephrine and/or maintaining an airway. The patient should be under close medical supervision until complete and sustained cessation of symptoms. Patients with this history of angioedema not associated with ACE inhibitors may have an increased risk of such edema when treated with ACE inhibitors. Anaphylactoid reactions during low-density lipoprotein (LDL) apheresis (LDL) Rarely, patients taking ACE inhibitors during low-density lipoprotein (LDL) apheresis with dextran sulfate have developed life-threatening anaphylactoid reactions. These reactions can be avoided by temporarily withholding ACE inhibitor treatment before each apheresis. Anaphylactic reactions during desensitization Patients receiving ACE inhibitors during desensitization (for example, to hymenoptera venom: wasps, bees, and other insects) developed anaphylactoid reactions. These reactions in these patients can be avoided by temporary discontinuation of ACE inhibitors, however, with accidental repeated administration, these reactions reappear. Liver failure In rare cases, treatment with ACE inhibitors is accompanied by a syndrome that begins with cholestatic jaundice and progresses to the development of fulminant hepatic necrosis, sometimes death. The mechanism by which this syndrome develops is unknown. If jaundice develops during treatment with ACE inhibitors or liver enzymes rise significantly, the ACE inhibitor should be discontinued and appropriate further medical supervision instituted. Neutropenia / agranulocytosis / thrombocytopenia / anemia Patients receiving ACE inhibitors develop neutropenia / agranulocytosis, thrombocytopenia and anemia. In patients with normal renal function and without other complicated factors, neutropenia rarely develops. Perindopril should be used with great caution in patients with collagenoses, immunosuppressive therapy, treatment with allopurinol or procainamide, or a combination of these complicated factors, especially in the case of previous renal dysfunction. Some of these groups of patients develop serious infections, which in a significant number of cases do not respond to active antibiotic therapy. When prescribing perindopril to such patients, periodic monitoring of the level of leukocytes is recommended. Patients should be instructed to report any signs of infection to their doctor. Race ACE inhibitors are more likely to cause angioedema in blacks than in patients of other races. Similar to other ACE inhibitors, perindopril is less effective in lowering blood pressure in blacks than in patients of other races; a possible explanation is the widespread prevalence of low levels of renin in representatives of the black race with hypertension. Cough Cough may develop during treatment with ACE inhibitors. Characterized by unproductive persistent cough, which stops after discontinuation of treatment. In the differential diagnosis of cough, an ACE inhibitor-induced cough should be considered. Surgery / Anesthesia During major surgery or during anesthesia with drugs that cause hypotension, perindopril may block the formation of angiotensin II due to compensatory renin release. Treatment should be stopped the day before surgery. With the development of hypotension associated with this mechanism, it can be corrected with fluid therapy. Hyperkalemia An increase in potassium levels has been observed in some patients during treatment with ACE inhibitors, including perindopril. Patients at risk of developing hyperkalemia include those with renal insufficiency, uncontrolled diabetes mellitus, those taking potassium-sparing diuretics, potassium supplements or salt substitutes containing potassium, and other drugs that increase potassium levels (eg, heparin). If concomitant use of these drugs is necessary, regular monitoring of potassium levels is recommended. Patients with diabetes In patients with diabetes taking oral antidiabetic drugs or insulin, glycemic levels should be carefully monitored during the first month of treatment with an ACE inhibitor. Lithium preparations In general, the combination of lithium and perindopril is not recommended. Potassium-sparing diuretics, potassium supplements, and potassium-containing salt substitutes In general, combinations of perindopril and potassium-sparing diuretics, potassium supplements, and potassium-containing salt substitutes are not recommended. Pregnancy ACE inhibitors should not be given during pregnancy. If continuation of hypertension therapy is deemed necessary, patients planning pregnancy should be given alternative antihypertensive treatment with drugs that have an established safety profile for use in pregnancy. If pregnancy is diagnosed, treatment with ACE inhibitors should be stopped immediately and, if necessary, alternative therapy should be started. Excipients Since the drug contains lactose, it should not be prescribed to patients with rare hereditary diseases: congenital galactosemia, lactase deficiency, glucose / galactose malabsorption syndrome. Indications for use Hypertension: Treatment of hypertension. Heart failure: Treatment of symptomatic heart failure. Stable coronary artery disease: Reduced risk of cardiovascular complications in patients with a history of myocardial infarction and/or with revascularization. Dosage and administrationCapsules for oral administration. It is recommended to take once a day in the morning before meals, the capsule should be swallowed whole without chewing. The recommended dose of perindopril tert-butylamine is taken once a day, in the morning before meals with sufficient liquid (eg water). The dose should be individualized according to the patient's profile and changes in blood pressure levels. Hypertension Perindopril tert-butylamine may be used alone or in combination with other classes of antihypertensive agents. The recommended starting dose is 4 mg once daily in the morning. In patients with severe activation of the renin-angiotensin-aldosterone system (especially renovascular hypertension, decreased blood volume, cardiac decompensation or severe hypertension), an excessive decrease in blood pressure may develop after the initial dose of the drug. In such patients, an initial dose of 2 mg is recommended, treatment should be initiated under the supervision of a physician. The dose may be increased to 8 mg once daily after one month of treatment. After the start of treatment with perindopril, clinically significant hypotension may develop, the likelihood of which is higher in patients with concomitant treatment with diuretics. Such patients are advised to take the drug carefully because of the possible decrease in circulating blood volume and / or electrolyte deficiency. If possible, diuretics should be canceled 2-3 days before the start of treatment with perindopril. In patients with hypertension who cannot stop diuretics, treatment with perindopril should be started with a dose of 2 mg. It is necessary to monitor kidney function and the level of potassium in the blood. Subsequent doses of perindopril should be adjusted according to the blood pressure response. If necessary, diuretic treatment can be restored. In elderly patients, treatment should begin with a dose of 2 mg, after a month it can be increased to 4 mg, and then, if necessary, to 8 mg, depending on renal function (see table below). Symptomatic heart failure Perindopril is often combined with non-potassium-sparing diuretics and/or digoxin and/or beta-blockers; in such cases, the drug should be taken under close medical supervision, starting with the recommended starting dose of 2 mg in the morning. If tolerated normally after at least 2 weeks, this dose may be increased by 2 mg to 4 mg once daily. Dose selection should be based on the clinical response of the individual patient. In severe heart failure and other patients at high risk (in patients with impaired renal function and a tendency to electrolyte disturbances, while taking diuretics and / or vasodilators), the start of treatment should take place under close medical supervision. Before starting treatment with perindopril in patients at high risk of developing clinically significant hypotension (i.e., in patients with electrolyte loss with / without hyponatremia, with hypovolemia, or in patients with concomitant active diuretic therapy), these conditions should be corrected if possible. Before and during treatment with perindopril, blood pressure, kidney function and serum potassium levels should be monitored. Stable ischemic heart disease The drug should be administered at a dose of 4 mg once a day for two weeks, then increase the dose to 8 mg once a day (depending on renal function and provided that the 4 mg dose is well tolerated). Elderly patients should be given 2 mg once daily for one week followed by 4 mg once daily for the next week before increasing the dose to 8 mg once daily, depending on renal function (see Table 1: Dose adjustment for impaired renal function). The dose should only be increased if the previous dose was well tolerated. Dose Adjustment in Renal Insufficiency Dosing in patients with renal insufficiency should be based on creatinine clearance as indicated in Table 1 below: Table 1: Dose Adjustment in Renal Insufficiency Creatinine Clearance (mL/min) (ClCR) / Recommended Dosage 60/4 mg per day 30 < ClCR < 60/2 mg per day 15 < ClCR < 30/2 mg per day every other day Hemodialysis patients with ClCR < 15/2 mg per day of dialysis Perindoprilat clearance during dialysis is 70 ml/min . Patients on hemodialysis should receive this dose after a hemodialysis session. Dose Adjustment in Hepatic Insufficiency No dose adjustment is necessary in patients with hepatic impairment. Children and adolescents Perindopril tert-butylamine is not recommended for use in children and adolescents due to a lack of safety and efficacy data. Use during pregnancy and lactation Pregnancy The use of ACE inhibitors is not recommended during the first trimester of pregnancy. The use of ACE inhibitors is contraindicated in the second and third trimesters of pregnancy. Epidemiological evidence suggesting a risk of teratogenic effects of ACE inhibitors in the first trimester of pregnancy has not been conclusive, but a small increase in risk cannot be ruled out. If continued therapy for hypertension is deemed necessary, patients planning pregnancy should be switched to alternative antihypertensive agents that have an established safety profile for use during pregnancy. If pregnancy is diagnosed, treatment with ACE inhibitors should be stopped immediately and, if necessary, alternative therapy should be initiated. It is known that treatment with ACE inhibitors during the second and third trimesters is accompanied by fetotoxicity for the pregnant woman (decrease in kidney function, oligohydramnios, delayed skull ossification), as well as toxicity of the newborn (renal failure, arterial hypotension, hyperkalemia). If exposure to ACE inhibitors has occurred since the second trimester of pregnancy, ultrasound examination of kidney and skull function is recommended. Infants whose mothers have taken ACE inhibitors should be closely monitored for hypotension. Lactation There is no information regarding the use of perindopril during breastfeeding, it is not recommended to take perindopril during lactation and alternative treatments are recommended with a better safety profile during breastfeeding, especially when feeding a newborn or premature baby. Influence on the ability to drive vehicles and control mechanisms No studies have been conducted on the effect on the ability to drive a car and work with mechanisms. If you need to drive vehicles and work with mechanisms during the use of the drug, you should consider the possibility of dizziness or fatigue. Interaction with other drugs Diuretics During treatment with diuretics, especially in patients with electrolyte loss and / or hypovolemia, after the start of treatment with an ACE inhibitor, an excessive decrease in blood pressure may develop. The possibility of hypotensive effects can be reduced by discontinuing diuretic therapy, increasing BCC or salt intake before starting treatment with low doses of perindopril and doses gradually increasing. Potassium-sparing diuretics, potassium preparations, and potassium-containing salt substitutes Although serum potassium levels are usually maintained within the normal range, hyperkalemia may develop in some patients during treatment with perindopril. Potassium-sparing diuretics (eg, spironolactone, triamterene, or amiloride), potassium supplements, or potassium-containing salt substitutes can cause a significant increase in potassium levels. For this reason, the combination of perindopril with the above drugs is not recommended. If the simultaneous use of these drugs is intended in connection with the development of hypokalemia, they should be used with caution, regularly monitoring the level of potassium. Lithium preparations With the simultaneous use of lithium preparations with ACE inhibitors, a reversible increase in serum lithium concentration and toxicity was observed. Concomitant use of thiazide diuretics may increase the risk of lithium toxicity and exacerbate the already increased risk of lithium toxicity during concomitant use of ACE inhibitors. The combined use of perindopril with lithium preparations is not recommended, however, if such a combination is necessary, careful monitoring of serum lithium levels should be carried out. Non-steroidal anti-inflammatory drugs (NSAIDs), including acetylsalicylic acid at a dose > 3 g / day The appointment of non-steroidal anti-inflammatory drugs may reduce the hypotensive effect of ACE inhibitors. In addition, NSAIDs and ACE inhibitors have the additive effect of increasing potassium levels and may lead to worsening of kidney function. Usually these effects are reversible. In rare cases, acute renal failure may develop, especially in patients with impaired renal function (in the elderly or in patients with dehydration). Antihypertensive drugs and vasodilators The simultaneous use of these drugs may enhance the hypotensive effect of perindopril. Concomitant use of nitroglycerin and other nitrates or other vasodilators may further lower blood pressure. Antidiabetic drugs Epidemiological studies have shown that the combined use of ACE inhibitors and antidiabetic drugs (insulins, oral hypoglycemic agents) can cause an increase in the hypoglycemic effect with a risk of hypoglycemia. It has been shown that this phenomenon is more likely to develop during the first weeks of combined treatment in patients with impaired renal function. Acetylsalicylic acid, thrombolytics, beta-blockers, nitrates Perindopril can be administered simultaneously with acetylsalicylic acid (when used as a thrombolytic), thrombolytics, beta-blockers and/or nitrates. Tricyclic antidepressants / antipsychotics / anesthetics Simultaneous use of certain anesthetics, tricyclic antidepressants and antipsychotics with ACE inhibitors may lead to an additional decrease in blood pressure. Sympathomimetics Sympathomimetics may reduce the hypotensive effects of ACE inhibitors. Gold preparations Nitroid reactions (symptoms including facial flushing, nausea, vomiting and hypotension) have been reported in patients treated with injectable gold preparations (sodium aurothiomalate) and concomitant treatment with an ACE inhibitor, including perindopril. Antacids may reduce the bioavailability of perindopril. Dual blockade of the renin-angiotensin-aldosterone system Dual blockade of the RAAS with ACE inhibitors, AT II receptor blockers (ARB II) or Aliskiren cannot be recommended for any patient, especially 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. Contraindications Hypersensitivity to perindopril, or any other ACE inhibitor, or to any of the components of the drug. History of angioedema (hereditary/idiopathic or related to previous treatment with ACE inhibitors). Pregnancy and lactation. Hereditary galactose intolerance, lactase deficiency, or glucose/galactose malabsorption. Simultaneous 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). Composition Each capsule contains: active substance: perindopril tert-butylamine - 8 mg (which corresponds to perindopril - 6.676 mg), excipients: potato starch, magnesium stearate, lactose monohydrate. composition of the shell of a hard gelatin capsule: for a dosage of 8 mg: cap: azorubine (E122), crimson 4 R (E124), quinoline yellow (E104), titanium dioxide (E 171), gelatin; body: titanium dioxide (E171), gelatin. Overdose Limited data are available on overdose in humans. Symptoms associated with an overdose of ACE inhibitors: hypotension, circulatory shock, electrolyte disturbances, renal failure, hyperventilation, tachycardia, palpitations, bradycardia, dizziness, restlessness and cough. Treatment: intravenous administration of saline. If arterial hypotension develops, the patient should be transferred to a horizontal position, raise the lower limbs. If possible, treatment with angiotensin II infusion and/or catecholamine administration should be considered. Perindopril and perindoprilat can be removed from the general circulation by hemodialysis. If bradycardia develops that is resistant to conservative therapy, the installation of a pacemaker is indicated. Vital signs, serum electrolytes and creatinine should be continuously monitored. Side effects During treatment with perindopril, the following side effects were observed, which were distributed according to frequency as follows: very often (> 1/10); often (> 1/100, <1/10); infrequently (> 1/1000, <1/100); rare (> 1/10000, <1/1000), very rare (<1/10000), unknown (frequency cannot be estimated from existing data). See the table in the instructions. Investigations Possible increase in plasma urea and creatinine levels, as well as hyperkalemia, which disappeared upon discontinuation of treatment, especially in patients with renal insufficiency, severe heart failure and renovascular hypertension. There have been rare cases of increased levels of liver enzymes and serum bilirubin. Clinical trials In the randomized period of the EUROPA study, only serious adverse events were collected. Few patients experienced serious side effects: 16 (0.3%) of 6122 patients taking perindopril and 12 (0.2%) of 6107 patients taking placebo. In patients taking perindopril, arterial hypotension was observed in 6 patients, Quincke's edema in 3 patients and sudden cardiac arrest in 1 patient. The majority of patients had cough, hypotension or other intolerance to perindopril than in the placebo group, 6.0% (n = 366) compared with 2.1% (n = 129), respectively. 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 Perindopril-LF capsules 8mg №10x3 Price for Perindopril-LF capsules 8mg №10x3