Index of drugs

Hypertension. Symptomatic heart failure. Reducing the risk of cardiac events in patients with a history of myocardial infarction and / or revascularization.

1 tabl contains 4 mg or 8 mg Perindopril with tert-butylamine. The drug contains lactose.

Angiotensin converting enzyme inhibitor I for angiotensin II. Suppression of ACE activity results in a decrease in angiotensin II concentration in the plasma, which leads to increased plasma renin activity, decreased aldosterone secretion and increased circulating activity as well as local kallikrein-kinin systems. The maximum antihypertensive effect occurs after 4-6 h after a single dose and persists for at least 24 h. After oral administration, perindopril is rapidly absorbed from the gastrointestinal tract and reaches a maximum blood concentration after 1 h. The bioavailability is 65-70%. About 20% of the total amount of perindopril absorbed is converted into perindoprilat, the active metabolite. T_0,5 perindopril is 1 hour. The maximum concentration of perindoprilat in the blood is reached within 3-4 h. Food reduces the bioavailability of perindopril. Perindoprilat is excreted in the urine and T_0,5 the free fraction is 3-5 h, whereas the bound fraction is 25 h. When repeatedly administered, steady state is achieved within 4 days. Elimination of perindoprilat is slower in the elderly and in patients with heart or kidney failure. Perindoprilat is removed from the circulation by dialysis.

Hypersensitivity to Perindopril, other ACE inhibitors or other components of the preparation. History of angioneurotic edema associated with previous treatment with ACE inhibitors. Congenital or idiopathic angioedema. II and III trimester of pregnancy.

If episodes of unstable angina (severe or not) occur during the first month of treatment with perindopril, the benefit-risk of continuing treatment should be considered. Symptomatic hypotension is more common in dehydrated patients, eg due to the use of diuretics, low-sodium diets, dialysis when vomiting or diarrhea occurs, in patients with severe hypertensive renal hypertension, severe heart failure, following high-dose loop diuretics, hyponatremia or impaired renal function. Symptomatic hypotension has been observed in patients with symptomatic heart failure, with or without co-existing renal insufficiency. In patients with an increased risk of symptomatic hypotension, initiation of therapy and dose adjustment should be closely monitored. The above remarks also apply to patients with ischemic heart disease or cerebrovascular disease, in whom excessive reduction of blood pressure may result in a myocardial infarction or cerebrovascular accident. It should be used with caution in patients with mitral valve stenosis and narrowing of the left ventricle outflow tract (such as with aortic valve stenosis or hypertrophic cardiomyopathy). In patients with renal insufficiency, potassium and creatinine should be monitored. Caution should be used in patients with bilateral renal artery stenosis or stenosis of the artery of the sole kidney. In patients with concomitant vascular hypertension, there is an increased risk of severe hypotension and renal failure - the treatment should be started under close medical supervision, small doses and carefully increased. In dialysis patients with dialysis membranes of high permeability and simultaneously treated with ACE inhibitors, anaphylactoid reactions have been observed - consideration should be given to the use of other types of dialysis membranes or antihypertensive agents from other groups. There is no experience regarding the use of perindopril in patients who have recently undergone kidney transplantation.The preparation should be discontinued before LDL-apheresis with dextran sulphate or before the start of desensitization due to the risk of anaphylactoid reactions. Perindopril should be used with extreme caution in patients with vascular collagen, treated with immunosuppressants, Allopurinol or procainamide, or when these factors are present, especially if there have been renal dysfunctions; some of these patients have experienced severe infections that have been resistant to intensive antibiotic treatment in some cases - periodic white blood cell counts should be monitored and patients should be advised to report any signs of infection. ACE inhibitors are more likely to cause angioneurotic edema in black patients than in non-black patients. Perindopril may be less effective in lowering blood pressure in black patients. Treatment with the preparation should be discontinued 1 day before the planned surgery. The risk of hyperkalaemia is greater in patients with renal insufficiency, worsening of renal function, diabetes, in elderly patients, with concomitant conditions, particularly dehydration, acute cardiac decomposition, metabolic acidosis and in patients simultaneously taking potassium sparing diuretics, potassium supplements or salt substitutes. containing potassium and patients taking other medicines that increase the level of potassium in the blood. In patients with diabetes, Glucose should be frequently monitored during the first month of treatment with ACE inhibitors. In patients receiving ACE inhibitors who develop jaundice or a marked increase in liver enzymes, ACE inhibitors should be discontinued. The efficacy and safety of the preparation in children has not been established - the use in this group of patients is not recommended. The drug contains lactose - should not be used in patients with galactose intolerance, lactase deficiency (Lapp type) or malabsorption of glucose-galactose.

Perindopril is not recommended during the first trimester of pregnancy. The drug is contraindicated in the second and third trimester of pregnancy. Administration of the preparation during the second and third trimester of pregnancy results in renal dysfunction, oligohydramnios, skull ossification retardation and renal failure, hypotension and hyperkalemia in the newborn. In the case of exposure to perindopril, starting from the second trimester of pregnancy, ultrasound examination of the kidneys and skull is recommended. Newborns whose mothers have taken ACE inhibitors should be monitored for hypotension. It is not recommended to use the product during breastfeeding.

Common: pain and dizziness, paresthesia; blurred vision; tinnitus; hypotension and symptoms associated with hypotension; cough, shortness of breath; nausea, vomiting, abdominal pain, taste disturbances, indigestion, diarrhea and constipation; rash, pruritus; muscle cramps; asthenia. Uncommon: mood disorders or sleep disorders; bronchial spasm; dryness of the oral mucosa; swelling of the face, limbs, lips, mucous membranes, tongue, glottis or larynx, urticaria; renal failure; impotence; excessive sweating. Very rare: confusion; arrhythmia, angina, myocardial infarction and stroke (probably secondary to increased hypotension in high-risk patients); eosinophilic pneumonia, rhinitis; inflammation of the pancreas; cytolytic or cholestatic hepatitis; erythema multiforme; acute renal failure; decreases in hemoglobin and hematocrit, thrombocytopenia, leukopenia, neutropenia, cases of agranulocytosis or pancytopenia, cases of hemolytic anemia in patients with congenital G-6-PD deficiency. Frequency unknown: hypoglycaemia, vasculitis. Increases in urea and creatinine in the blood may occur as well as hyperkalemia which resolves after discontinuation of therapy, especially in patients with renal insufficiency, severe heart failure, and renovascular hypertension. Rarely, the use of ACE inhibitor is associated with the onset of syndrome starting with cholestasis jaundice developing into fulminant hepatic necrosis, sometimes leading to death. Increased liver enzymes and bilirubin in the blood were rarely observed.

Orally. Adults.Hypertension. The preparation can be used as monotherapy or in combination with other antihypertensive medicines. The recommended starting dose is 4 mg once a day in the morning. Patients with high activity of the renin-angiotensin-aldosterone system (in particular with renovascular hypertension, salt and / or fluid deficiency, cardiac distension or severe hypertension) may experience an excessive decrease in blood pressure after the initial dose - in these patients the recommended starting dose is 2 mg and treatment should be started under close medical supervision. After a month of treatment, the daily dose can be increased to 8 mg once a day. Concomitant use of diuretics: if possible, diuretic therapy should be discontinued 2-3 days before commencing therapy with perindopril; in patients who can not discontinue diuretic therapy, the treatment should be started with a dose of 2 mg, renal function and potassium levels should be monitored. The further dosage of perindopril should be adjusted to changes in blood pressure in response to treatment. If necessary, treatment with diuretics can be restarted. In elderly patients, treatment should be started with a dose of 2 mg, which can be gradually increased to 4 mg after the first month of treatment and, if necessary, to 8 mg, depending on renal function.Symptomatic heart failure. It is recommended to start treatment with perindopril, generally given in combination with a diuretic, non-potassium and / or Digoxin and / or β-blocker, under close medical supervision from an initial dose of 2 mg once a day in the morning. If this dose is well tolerated, it may be increased by 2 mg, not earlier than after 2 weeks, up to 4 mg once a day. The dose should be adjusted depending on the clinical response of the patient. In patients with severe heart failure or in other high-risk patients (patients with impaired renal function and with a tendency to electrolyte disturbances, patients treated concomitantly with diuretics and / or vasodilators), treatment should be started under close medical supervision . Patients with a high risk of symptomatic hypotension (eg patients with electrolyte depletion with or without hyponatraemia, dehydrated patients or patients undergoing intensive diuretic treatment should have these disorders discharged prior to commencing treatment with perindopril.Stable coronary heart disease. Treatment with perindopril should be started with 4 mg once a day for 2 weeks, and then increased to 8 mg once a day, depending on kidney function and on condition that the 4 mg dose is well tolerated. Elderly patients should receive 2 mg once a day for 1 week, followed by 4 mg once a day for the Next week. The dose may be increased to 8 mg once a day depending on your kidney function. The dose can only be increased if the previous lower dose is well tolerated.
In patients with renal insufficiency, the dosage should be adjusted based on the creatinine clearance: creatinine clearance ≥60 ml / min - the recommended dose of 4 mg / day; clearance 30-60 ml / min - 2 mg / day; clearance 15-30 ml / min - 2 mg every other day, clearance <15 ml / min - 2 mg on the day of dialysis. No dosage adjustment is necessary in patients with hepatic impairment.
It is recommended to take the product in the morning before a meal.