Index of drugs

Table. powl. 5 mg and tabl. powl. 20 mg: treatment of hypertension; supportive therapy in congestive heart failure (NYHA class II-IV).Table. powl. 10 mg: treatment of hypertension; supportive therapy for congestive heart failure (NYHA class II-IV); progressive chronic renal failure (creatinine clearance 30 to 60 ml / min).

1 tabl powl. contains 5 mg, 10 mg or 20 mg benazepril hydrochloride.

Benazepril hydrochloride is a precursor to the active substance - benazeprilat, which is an inhibitor of angiotensin convertase. It inhibits all reactions caused by angiotensin II, i.e. vasoconstriction, stimulation of aldosterone secretion, and increases cardiac output. In addition, it inhibits the breakdown of bradykinin, which is probably important for the hypotensive effect. It lowers blood pressure in all periods of hypertension, regardless of body position. The onset of antihypertensive effect occurs about 1 hour after oral administration, maximum effect after 2-4 h, action persists for at least 24 h after drug administration. During repeated use, the maximum reduction in blood pressure usually occurs within a week and persists during long-term treatment. Abrupt discontinuation of the preparation does not lead to a sharp rise in blood pressure. After oral administration, about 37% of the dose is absorbed, then the precursor is quickly converted into a pharmacologically active metabolite. About 95% of benazepril and benazeprilat are bound to proteins, mainly albumin. Benazepril is extensively metabolised, the major metabolite is benazeprilat. Benazepril is eliminated mainly as a result of biotransformation, benazeprilat is excreted in the urine and bile. In patients with severe renal impairment, the kinase of benazeprilat is significantly altered.

Hypersensitivity to benazepril, derivative compounds or other ingredients of the preparation. Hypersensitivity to other ACE inhibitors or sulfonamide derivatives. Angioedema after administration of ACE inhibitors. Hereditary or idiopathic angioneurotic edema. Pregnancy. Concomitant use with aliskiren in patients with diabetes mellitus or renal impairment (glomerular filtration rate, GFR <60 ml / min / 1.73 m²).

Particularly cautiously use in patients with impaired renal function; impaired liver function or liver disease; hypovolaemia or excessive salt loss (caused by long-term use of diuretics, low-sodium diet, dialysis, diarrhea or vomiting); severe heart failure, ischemic heart disease or cerebrovascular disease (treatment should be started under the supervision of a physician at the hospital, general condition to be monitored for the first 2 weeks of treatment, and the dose of benazapril and / or diuretic should be changed under strict medical supervision); in patients with bilateral renal artery stenosis or stenosis of the artery of the sole kidney, especially at renovascular hypertension (starting with low doses and increasing the dose after close medical supervision, checking the renal function during the first weeks of treatment); with aortic stenosis or other stenosis of the left ventricle outflow path; in patients with vascular collagenosis treated with immunosuppressants, Allopurinol or procainamide, especially with a history of renal dysfunction (regular leukocyte counts should be checked). Fluid deficiencies and / or excessive loss of salt should be corrected before starting treatment with the preparation. The use of benazapril in the case of cardiogenic shock and haemodynamically significant narrowing of the outflow should be avoided. Caution in patients undergoing major surgery or under general anesthesia with hypotensive agents; in patients with diabetes. It is not recommended for use in patients with primary hyperaldosteronism. Due to the lack of data on the use of benazepril in patients with recent kidney transplantation, it is not recommended to use the product.Due to the risk of anaphylactoid reactions in hemodialysis patients using highly permeable polyacrylonitrile membranes, during apheresis of low density lipoproteins using dextran sulphate or during desensitisation treatment (eg hymenoptera venom), the preparation should not be used at the same time. In black patients, the effectiveness of the preparation may be less and the angioedema may be more frequent. There are no data on the safety and efficacy of the medicine in children. The concomitant use of ACE inhibitors, angiotensin II receptor antagonists or aliskiren increases the risk of hypotension, hyperkalaemia and renal dysfunction (including acute renal failure) - therefore, dual blocking of the RAA system is not recommended by concomitant use of ACE inhibitors, angiotensin II receptor antagonists or aliskiren. If the use of a dual RAA blockade is absolutely necessary, it should only be carried out under the supervision of a specialist, and the vital parameters of the patient, such as kidney function, electrolyte concentration and blood pressure should be closely monitored. In patients with diabetic nephropathy, ACE inhibitors and angiotensin II receptor antagonists should not be used concurrently. Due to the lactose content, patients with rare hereditary galactose intolerance, Lapp lactase deficiency or malabsorption of glucose-galactose should not be used.

The drug is contraindicated in pregnancy. The use of ACE inhibitors in the second and third trimester of pregnancy may cause developmental disorders in the fetus and newborn, including hypotension, hypoplasia of the skull, anuria, renal failure, oligohydramnios and death. It is not recommended to use the product during breastfeeding.

Common (≥1 / 10): palpitations, orthostatic symptoms, nonspecific gastrointestinal disturbances, rash, flushing, pruritus, photosensitivity, frequent urination, cough, respiratory symptoms, headache and dizziness, feeling fatigue, decrease in hemoglobin, hematocrit, leukocytes and platelets. Rare (≥1 / 10,000, <1/1000): orthostatic hypotension, chest pain, angina pectoris, arrhythmia, diarrhea, constipation, nausea and vomiting, abdominal pain, pemphigus, urticaria, hepatitis (mainly cholestatic), jaundice cholestatic, increased urea and creatinine in the blood, drowsiness, insomnia, nervousness, paresthesia, angioneurotic edema, swelling of the lips or face, joint pain, arthritis, myalgia. Very rare (<1 / 10,000): myocardial infarction, ischemic heart episode, pancreatitis, intestinal obstruction, Stevens-Johnson syndrome, renal impairment, tinnitus, taste disturbances, haemolytic anemia, thrombocytopenia. There are few reports of the occurrence, in patients using ACE inhibitors, of a syndrome starting with cholestasis jaundice that develops into fulminant hepatic necrosis, sometimes leading to death.

Orally.Hypertension. In patients not using thiazide diuretics, the initial dose is 10 mg once a day, this dose can be increased to 20 mg a day, usually after 1-2 weeks. In some patients, the hypotensive effect may be reduced at the end of the dose interval, then drug in 2 doses. The maximum recommended daily dose is 40 mg in 1-2 doses. If you do not achieve sufficient blood pressure reduction, you can use another hypotensive medicine, such as a thiazide diuretic or blocking Calcium channel (initially in small doses). In the event of prior diuretic therapy, the diuretic should be discontinued 2-3 days before the start of treatment with the preparation and then administered if necessary; if it is not possible to stop the administration of diuretics, the initial dose should be reduced to 5 mg daily. In renal insufficiency with a creatinine clearance <30 ml / min, the starting dose is 5 mg, which can be increased to a maximum of 10 mg per day; in order to reduce blood pressure more strongly, a diuretic should be used other than thiazide or another antihypertensive drug.Congestive heart failure. The recommended starting dose is 2.5 mg once a day (due to the risk of a sudden decrease in blood pressure at the first dose, patients taking the product for the first time should be monitored very carefully); if after 2-4 weeks there is no satisfactory improvement in heart failure, the dose may be increased to 5 mg once a day (provided that there is no orthotopic hypotension or other significant adverse reactions), depending on the response, the dose may be increased to 10 mg or up to 20 mg once a day at appropriate intervals. Some patients respond better when using the drug twice a day. Controlled clinical trials indicate that patients with NYHA Class IV heart failure usually require lower doses than mild or moderate patients (NYHA class II or III). For patients with a creatinine clearance <30 ml / min, the daily dose may be increased to 10 mg, but a low initial dose (2.5 mg / day) may be optimal.Progressive chronic renal failure (with or without hypertension). To slow down the development of long-term use of the drug in a dose of 10 mg once a day. If an additional blood pressure reduction is necessary, other antihypertensive drugs may be used in combination with the preparation.
Table. 5 mg are divisible.