Index of drugs

Treatment of hypertension. Treatment of symptomatic heart failure. Short-term treatment (6 weeks) of haemodynamically stable patients 24 h after acute myocardial infarction. Treatment of kidney disease in patients with hypertension, type 2 diabetes and initial nephropathy.

1 tabl contains 10 mg or 20 mg lisinopril (as lisinopril dihydrate).

ACE inhibitor (an enzyme that catalyzes the conversion of angiotensin I to vasopressor angiotensin II, as well as the breakdown of bradykinin). ACE inhibition leads to a decrease in angiotensin II concentration, and thus a reduction in vasoconstriction and aldosterone secretion. Decreased aldosterone secretion may lead to increased levels of potassium in the blood. Approximately 25% of the intestinal tract is absorbed (with interindividual variability of 6-60%) of the orally administered dose of lisinopril. Meal intake does not affect absorption. The maximum concentration in the blood occurs after approx. 7 hours. Lisinopril is not metabolised and is excreted unchanged in the urine. T_0,5 is about 12 hours.

Hypersensitivity to lisinopril, other ACE inhibitors or any of the excipients. History of angioneurotic edema associated with previous treatment with ACE inhibitor. Hereditary or idiopathic angioedema. II and III trimester of pregnancy.

Blood pressure and renal function should be monitored at the beginning as well as during treatment with lisinopril. Particularly cautiously used in patients with highly stimulated renin-angiotensin-aldosterone system, due to the risk of significant hypotension (medical supervision is necessary and treatment should be started at a low dose, very carefully increased) - this applies to patients: with reduced fluid volume ( e.g. as a result of therapy with diuretics, low-salt diet, dialysis, diarrhea or vomiting); with severe renin-dependent hypertension; with heart failure, with or without renal impairment; with renal arterial hypertension (with bilateral renal artery stenosis or stenosis of the artery of the sole kidney). Similar recommendations should be used in patients with ischemic heart disease or cerebrovascular disease in whom excessive hypotension may result in a myocardial infarction or cerebrovascular episode. Caution should also be exercised in patients undergoing major surgery or under general anesthesia with hypotensive agents (hypotension can be compensated by increasing fluid volume). If hypotension occurs during treatment with lisinopril, the patient should be placed in the supine position and, if necessary, given a saline infusion of physiological saline. Transient hypotension is not a contraindication to the administration of subsequent doses of lisinopril, which can usually be administered without difficulty when the blood pressure increases after increasing the volume of fluids. If hypotension during treatment with lisinopril becomes symptomatic, it may be necessary to reduce the dose or discontinue treatment with lisinopril. Since the use of diuretics may contribute to the occurrence of hypotension, it may be necessary to reduce the dose and / or discontinue diuretic therapy. Do not start treatment with lisinopril in patients with acute myocardial infarction if there is a risk of further severe haemodynamic deterioration following the use of a vasodilator (for patients with systolic blood pressure ≤ 100 mmHg or in cardiogenic shock). Caution should be exercised when administering lisinopril to patients with mitral stenosis and impaired left ventricular outflow, such as aortic stenosis or hypertrophic cardiomyopathy. In patients with impaired renal function (creatinine clearance <80 ml / min), potassium and creatinine should be monitored during treatment with lisinopril.In patients with heart failure and concomitant renal insufficiency, initiation of treatment with ACE inhibitors may cause further deterioration of renal function, in some cases acute renal failure (usually reversible) has been observed. In patients with bilateral renal artery stenosis or stenosis of the artery supplying blood to a single kidney treated with an ACE inhibitor, an increase in serum urea and creatinine was observed (these changes were generally transient after discontinuation of the drug); this particularly applies to patients with renal failure. In acute myocardial infarction, treatment with lisinopril should not be initiated in patients with renal failure (creatinine> 177μmol / l and / or proteinuria> 500 mg / 24 h); if the kidney disorder worsens during treatment (creatinine> 265 μmol / l or doubling pre-treatment values) discontinuation of lisinopril should be considered. Special care should be taken in patients with collagenosis, using immunosuppressants, taking Allopurinol or procainamide, or in patients who coexist with these factors, in particular coexistence of renal impairment (regular monitoring of the number of white blood cells is recommended). In diabetic patients treated with oral antidiabetic agents or insulin, blood Glucose monitoring should be closely monitored during the first month of treatment with an ACE inhibitor. Exercise caution in patients at risk of hyperkalemia: renal failure, diabetes, and if concomitant use of potassium sparing diuretics, potassium supplements or other blood potassium potentiating agents (eg heparin) - if co-administered with control the potassium concentration. Co-administration of lisinopril and lithium is not recommended. In patients undergoing dialysis treatment with high permeability (eg AN69) there is a high probability of anaphylactoid reactions - consideration should be given to using an antihypertensive agent from another group or other type of dialysis membranes. In patients requiring venom desease desensitization or LDL-apheresis treatment with dextran sulphate, it is recommended to temporarily discontinue ACE inhibitors due to the risk of life-threatening anaphylactoid reactions. In patients who develop angioneurotic edema of the face, limbs, lips, tongue, mucous membranes, glottis and or larynx, the drug should be immediately discontinued, appropriate therapy should be instituted and the patient monitored until the signs of edema have completely resolved (fatal angioedema has been observed associated with laryngeal or tongue swelling). The black patients are more likely to have angioedema. Black patients lisinopril may be less effective. In case of jaundice or a significant increase in liver enzymes, the use of lisinopril should be discontinued and appropriate treatment should be given. In the differential diagnosis of cough, cough induced by ACE inhibitors should be considered. The use of lisinopril in children other than hypertension is not recommended; the use of lisinopril in children aged <6 years is not recommended.

The use of the preparation in the first trimester of pregnancy is not recommended (there is a risk of teratogenic effect). Use in the second and third trimester of pregnancy is contraindicated. Lisinopril used in the second and third trimester of pregnancy is toxic to fetal development (deterioration of renal function, oligohydramnios, delayed ossification of the skull) and newborn (renal failure, hypotension, hyperkalemia) - when exposure to the drug occurred from the second trimester of pregnancy, it is recommended an ultrasound examination of the fetus skull and kidneys; children whose mothers took the drug during pregnancy should be closely monitored for hypotension. The drug is not recommended during breast-feeding.

Common: dizziness, headache, orthostatic symptoms (including hypotension), cough, diarrhea, vomiting, renal dysfunction. Uncommon: mood changes, paresthesia, taste disturbances, sleep disturbances, myocardial infarction or cerebrovascular episode (probably secondary to excessive hypotension in high-risk patients), palpitations, tachycardia, Raynaud's phenomenon, rhinitis, nausea, abdominal pain, indigestion , rash, pruritus, hypersensitivity and / or angioneurotic edema (angioneurotic edema of the face, limbs, tongue, glottis and / or larynx), impotence, fatigue, weakness, increase in serum urea, increase in serum creatinine, increase in enzyme activity liver, hyperkalemia.Rare: hemoglobin decrease, hematocrit reduction, mental confusion, olfactory disorders, dry mouth, urticaria, alopecia, psoriasis, uremia, acute renal failure, gynecomastia, increased serum bilirubin, hyponatremia. Very rare: bone marrow suppression, anemia, thrombocytopenia, leukopenia, neutropenia, agranulocytosis, haemolytic anemia, generalized lymphadenopathy, autoimmune diseases, hypoglycaemia, bronchospasm, sinusitis, allergic alveolitis and / or eosinophilic pneumonia, inflammation pancreas, angioneurotic edema, parenchymal or cholestatic hepatitis, jaundice, hepatic impairment, profuse sweating, pemphigus, toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme, oliguria / anuria. Frequency unknown: symptoms of depression, syncope, abnormal secretion of antidiuretic hormone. A complex syndrome that may include one or more of the following symptoms has been reported: fever, vasculitis, myalgia, joint pain and / or arthritis, the occurrence of antinuclear antibodies (ANA), increased rate of red blood cell count (ESR), eosinophilia and leukocytosis , rash, hypersensitivity to light and other dermatological symptoms. In very rare cases, a syndrome occurred that started with cholestasis, and then led to fulminant liver cirrhosis and sometimes to death. The safety profile of lisinopril in children is comparable to the safety profile in adults.

Orally. The dose should be adjusted individually depending on the patient's response and the value of blood pressure.Hypertension. Lisinopril can be used alone or in combination with other antihypertensive agents. The recommended starting dose is 10 mg. In patients with highly stimulated renin-angiotensin-aldosterone system (especially with renovascular hypertension, salt and / or dehydrated deficiency, heart failure or severe hypertension), the starting dose should be reduced to 2.5-5 mg and the treatment should be started under close medical supervision. The usual maintenance dose is 20 mg / day. If the desired effect is not achieved within 2-4 weeks, the dose can be increased. The maximum dose used in long-term, controlled clinical trials was 80 mg / day. In patients concomitantly treated with diuretics, if possible, the diuretic should be discontinued 2-3 days before treatment with lisinopril. For patients who can not take their diuretic, treatment with lisinopril should be started at a dose of 5 mg. Renal function and blood potassium should be monitored. If necessary, treatment with a diuretic may be resumed. Subsequent doses of lisinopril should be determined based on the pressure value.Heart failure. Lisinopril should be supplemented by diuretic therapy and, if appropriate, digitalis preparations or β-blockers. The starting dose is 2.5 mg once a day, which should be given under close medical supervision. The dose should be increased gradually, by no more than 10 mg once, no more frequently than every 2 weeks. The highest tolerated dose is 35 mg once a day.Acute myocardial infarction. Patients should receive standard treatment, i.e. thrombolytics, Acetylsalicylic acid, β-blockers; together with lisinopril, Nitroglycerin can be administered intravenously or transdermally. Treatment with lisinopril should be started within 24 hours after the onset of infarction symptoms. Treatment should not be started if the systolic blood pressure is <100 mmHg. The initial dose of lisinopril is 5 mg, followed by 5 mg after 24 h, 10 mg after 48 h and then 10 mg once a day. Patients with a systolic blood pressure ≤ 120 mmHg should receive a lower dose of 2.5 mg at the beginning of therapy or within the first 3 days after the infarction. The maintenance dose is 10 mg / day. If hypotension (systolic blood pressure ≤ 100 mmHg) occurs, 5 mg can be given as a daily maintenance dose, temporarily reducing it by 2.5 mg if necessary. In the case of prolonged hypotension (systolic blood pressure <90 mmHg for over 1 hour), the preparation should be discontinued.Treatment should be continued for 6 weeks, and then reassess the patient's condition. Patients who develop symptoms of heart failure should continue treatment with lisinopril.Impaired renal function in the course of diabetes mellitus. In patients with hypertension, type 2 diabetes and initial nephropathy, the dose is 10 mg once a day and can be increased to 20 mg once a day to achieve diastolic blood pressure <90 mmHg.Special groups of patients. In patients with renal insufficiency, the dose should be determined according to creatinine clearance (CCr) - 31-80 ml / min: 5-10 mg / day; 10-30 ml / min: 2.5-5 mg / day; <10 ml / min (including dialysis patients): 2.5 mg / day. The dose can be increased gradually until the blood pressure is properly controlled or a maximum dose of 40 mg / day is achieved. Treatment with lisinopril is not recommended in patients after kidney transplantation. In elderly patients, renal function should be taken into account, and the dosage of lisinopril adjusted to a tensile response.Children. Hypertension in children and adolescents from 6 to 16 years of age. Children about the month of 20 to <50 kg: starting dose of 2.5 mg once a day, the dose should be increased to a maximum dose of 20 mg / day. Children about the month of ≥ 50 kg: starting dose of 5 mg once a day, the dose should be increased to a maximum dose of 40 mg / day. The dosage> 0.61 mg / kg has not been studied. (or> 40 mg) in children and adolescents. In children with impaired renal function, a lower starting dose or prolonged dose interval should be considered. The use of lisinopril in children with severe renal impairment is not recommended (GFR <30 ml / min / 1.73 m²).
The drug should be taken once a day, at about the same time of the day. Meal intake does not affect the absorption of lisinopril.