Index of drugs

Treatment of hypertension. Treatment of symptomatic heart failure. Short-term (6 weeks) treatment of hemodynamically stable patients within the first 24 hours after the onset of acute myocardial infarction. Treatment of kidney disease in patients with hypertension and type II diabetes with initial stage nephropathy.

1 tabl contains 5 mg, 10 mg or 20 mg lisinopril.

Lisinopril is an inhibitor of peptidyl dipeptidase. It inhibits the activity of an angiotensin converting enzyme (ACE). Inhibition of ACE results in a decrease in angiotensin II concentration, leading to reduced vasoconstrictor effect and decreased aldosterone secretion. The latter effect is small, but may cause a small increase in serum potassium. It is believed that the pressure reduction action is mainly based on the inhibition of the renin-angiotensin-aldosterone system, however, lisinopril also has antihypertensive activity in patients with low plasma renin activity. The average absorption of lisinopril is approximately 29%. The food has no effect on the absorption of the drug. The maximum serum concentration is reached within approx. 7 hours. Lisinopril does not bind to plasma proteins in addition to angiotensin convertase. Lisinopril is not metabolised in the body and is excreted unchanged in the urine, and the effective half-life in the accumulation phase, after repeated administration was 12.6 hours. In patients with circulatory insufficiency increases the AUC, but decreases the absorption of the preparation. Elderly patients have increased absorption and AUC.

Hypersensitivity to lisinopril, other ingredients of the preparation or other ACE inhibitors. Occurrence of angioedema in the past due to the use of ACE inhibitor. Hereditary or idiopathic angioneurotic edema. II and III trimester of pregnancy.

The probability of hypotension in patients with hypertension is more frequent in the case of reduced volume of fluids (as a result of diuretic therapy, salt-restricted diet, use of dialysis, diarrhea, vomiting), severe renin-dependent hypertension. In patients with or without heart failure, with or without renal failure, symptomatic hypotension was observed. Hypotension is more commonly observed in patients with a more severe degree of heart failure as a result of high-dose loop doses of diuretics, hyponatremia or functional renal failure. Starting therapy and adjusting the dose should be closely monitored in patients with an increased risk of symptomatic hypotension and in patients with ischemic heart disease or cerebrovascular disease or disease in which excessive depression may cause a myocardial infarction or a cerebrovascular event. In some patients with heart failure, with normal or low blood pressure, there may be an additional reduction in blood pressure after administration of lisinopril; if hypotension becomes symptomatic, it may be necessary to reduce the dose or discontinue treatment with lisinopril. 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 mm HG or cardiogenic shock). Caution should be exercised when administering lisinopril to patients with mitral valve stenosis and blocked left ventricular outflow, i.e. with aortic stenosis or hypertrophic cardiomyopathy. 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); the appearance of such changes is particularly likely in patients with renal insufficiency. There is an increased risk of severe hypotension and renal failure with concomitant hypertension of vasospastic origin; in these patients, treatment should be started under close medical supervision, starting with small doses, which should be carefully increased. Since the use of diuretics may contribute to these side effects, these should be discontinued and renal function monitored in the first weeks of treatment with lisinopril. In some hypertensive patients with no pre-existing overt kidney disease, serum urea and creatinine levels, usually mild and transient, may increase, especially when lisinopril and diuretic are used concomitantly; in this case, it is necessary to reduce the dose of lisinopril and / or discontinuation of the diuretic. 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 renal impairment worsens during treatment, withdrawal of lisinopril should be considered. In patients with angioedema 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 (fatalities associated with laryngeal edema have been observed and language). The black patients are more likely to have angioedema. Patients on dialysis with high permeability membranes (eg AN 69) have reported anaphylactic reactions; in these patients, other dialysis membranes or other antihypertensive agents should be used. Anaphylactoid reactions have been reported in patients during LDL aferase with dextran sulfate or during desensitisation (eg after bites from hymenoptera); in these patients, lisinopril should be temporarily discontinued. If jaundice or a significant increase in liver enzymes occur, the use of lisinopla should be discontinued and appropriate treatment should be given. 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 black patients, the drug may be less effective. In patients treated with lisinopril, during general anesthesia with antihypertensive agents, there is a greater risk of hypotension. An increased risk of hyperkalemia occurs in patients with renal insufficiency, diabetes mellitus as well as in the case of concomitant use of potassium-sparing diuretics, potassium supplements or potassium salts, drugs that increase the concentration of potassium (eg heparin); if you need to use these medicines at the same time, you should check the potassium levels. Simultaneous use of lithium is not recommended. Use in children and adolescents <18 years is not recommended due to lack of data on efficacy and safety in this age group.

Use in the first trimester of pregnancy is not recommended. The preparation is contraindicated in the second and third trimester of pregnancy. In women planning pregnancy, an alternative antihypertensive treatment should be started with an established safety profile during pregnancy. If during treatment it turns out that the patient is pregnant, the drug should be discontinued immediately and, if necessary, alternative therapy should be started. Prolonged use in the second and third trimester of pregnancy may cause toxic effects in the fetus (renal dysfunction, oligohydramnios, skull ossification delay) and toxicity in infants (renal failure, hypotension, hypercalcemia). If administered in the second trimester of pregnancy, a renal ultrasound examination is recommended and fetal skulls. Infants whose mothers take lisinopril for hypotension should be monitored. Breastfeeding is not recommended.

Common: headache and dizziness; cough (dry and persistent, disappears after discontinuation of treatment); diarrhea, vomiting; kidney problems; orthostatic effects (including hypotension) Uncommon: increased urea and creatinine in the blood, increased liver enzymes, hyperkalemia; mood changes, paresthesia, peripheral dizziness, taste disorders, sleep disorders; myocardial infarction (probably secondary to severe hypotension in high-risk patients, palpitations, tachycardia, paresthesia, dysgeusia, possible cerebrovascular events, probably secondary to hypotension in high-risk patients, rhinitis, nausea, abdominal pain , indigestion, rash, pruritus, angioneurotic edema (face, limbs, lips, tongue, glottis and / or larynx, Raynaud's syndrome, fatigue weakness, hypersensitivity, including angioneurotic edema, impotence, mood disorders.) Rare: decrease in hemoglobin , decrease in hematocrit value, confusion, dry mouth, uremia, acute renal failure, urticaria, alopecia, psoriasis, gynecomastia, disorder Very rarely bone marrow suppression, anemia, thrombocytopenia, leukopenia, neutropenia, agranulocytosis, hemolytic anemia, generalized node enlargement absorbent, auto disease immunological; bronchospasm, sinusitis, allergy / eosinophilic alveolitis; pancreatitis, intestinal swelling, hepatitis - hepatocellular or congestive, jaundice, biliary cirrhosis; oliguria, anuria; profuse sweating, pemphigus, toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme, pseudoarthrosis; hypoglycemia. Frequency unknown: depressive symptoms. A complex syndrome that may include one or more of the following symptoms has been reported: fever, vasculitis, myalgia, arthritis pain and inflammation, positive anti-nuclear antibody titers, accelerated blood cell depletion, eosinophilia, leukocytosis, rash, photodermatitis, 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.

Orally. The dose should be adjusted individually depending on the patient's response and the value of blood pressure.Hypertension (the drug can be used alone or in combination with other antihypertensive agents). The usual starting dose is 10 mg. In patients with high activity of the renin-angiotensin-aldosterone system (especially with renovascular hypertension, salt and / or dehydrated insufficiency, 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 (the drug can be used in combination with diuretics, digitalis glycosides and 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, intravenous or transdermal administration of glycerol trinitrate. 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 orally, followed by 5 mg after 24 h, 10 mg after 48 h and then 10 mg once a day. Patients with systolic blood pressure ≤120 mmHg at the beginning of treatment during the first 3 days after the infarction should receive 2.5 mg orally. The maintenance dose is 10 mg / day. If hypotension occurs (systolic blood pressure ≤100 mmHg), 5 mg can be given as a daily maintenance dose or 2.5 mg temporarily. In case of prolonged hypotension (systolic blood pressure <90 mmHg for more than 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.Impaired renal function in the course of diabetes mellitus. In hypertensive patients, type II diabetes mellitus and nephropathy starting 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.
In patients with renal insufficiency, the dose should be determined according to the creatinine clearance: creatinine clearance 31-80 ml / min 5-10 mg per day; clearance 10-30 ml / min 2.5-5 mg per day; clearance below 10 ml / min (including dialysis patients) 2.5 mg daily. The dose can be gradually increased until you can control pressure or up to a maximum dose of 40 mg. In patients who have recently received a kidney surgery, treatment is not recommended.
Use once a day, every day at the same time. Food does not affect the absorption of the drug.