Lisinoton, 20 mg, tablets, 28 pcs.

Lisinoton

Arterial hypotension

Most often, a pronounced decrease in blood pressure occurs with a decrease in circulating blood volume (CBV) caused by diuretic therapy, a decrease in sodium chloride in food, dialysis, diarrhea or vomiting. In patients with CHF and with or without renal failure, a pronounced decrease in blood pressure is possible. Under strict medical supervision, lisinopril should be prescribed to patients with coronary heart disease, cerebrovascular insufficiency, in whom a sharp decrease in blood pressure can lead to myocardial infarction or stroke. Transient arterial hypotension is not a contraindication for taking the next dose of the drug.

When using lisinopril, some patients with chronic heart failure, but with normal or low blood pressure, may experience a decrease in blood pressure, which is usually not a reason to discontinue treatment.

Before starting treatment with lisinopril, if possible, serum sodium levels should be normalized and/or circulating blood volume should be replenished, and patients at increased risk of developing symptomatic hypotension should be carefully monitored at the beginning of treatment and during dose adjustment.

In case of renal artery stenosis (especially with bilateral stenosis or in the presence of stenosis of the artery of a single kidney), as well as with circulatory failure due to a lack of sodium ions and/or fluid, the use of lisinopril can lead to impaired renal function, acute renal failure, which usually turns out to be irreversible even after discontinuation of the drug.

Acute myocardial infarction

The use of Lisinoton in patients with acute myocardial infarction is not recommended if systolic blood pressure does not exceed 100 mmHg. Art. Lisinopril can be used in conjunction with intravenous administration or with the use of therapeutic transdermal nitroglycerin systems.

Surgical interventions / general anesthesia

Before surgery (including dental surgery), the doctor/anesthesiologist should be informed about the use of an ACE inhibitor. During extensive surgical interventions, as well as when using other drugs that cause a decrease in blood pressure, lisinopril, by blocking the formation of angiotensin II, can cause a pronounced, unpredictable decrease in blood pressure. If arterial hypotension develops, it should be corrected by increasing the volume of blood volume.

Dual blockade of the renin-angiotensin-aldosterone system (RAAS)

Cases of hypotension, syncope, stroke, hyperkalemia and renal dysfunction (including acute renal failure) have been reported in susceptible patients, especially when multiple drugs that affect the RAAS are used concomitantly.

The simultaneous use of ACE inhibitors with medicinal products containing aliskiren is contraindicated in patients with diabetes mellitus and/or with moderate or severe renal impairment (GFR less than 60 ml/min/1.73 m2 body surface area) and is not recommended in other patients.

Concomitant use of ACE inhibitors with angiotensin II receptor antagonists is contraindicated in patients with diabetic nephropathy and is not recommended in other patients.

In cases where the simultaneous administration of two drugs acting on the RAAS is necessary, their use should be carried out under the supervision of a physician with extreme caution and with regular monitoring of renal function, blood pressure and electrolyte levels in the blood plasma.

Renal dysfunction

In patients with impaired renal function (creatinine clearance less than 80 ml/min), the initial dose of lisinopril should be changed in accordance with the clinical clearance (see section "Dosage and Administration"). Regular monitoring of potassium levels and creatinine concentrations in blood plasma is a mandatory treatment strategy for such patients.

In patients with CHF, arterial hypotension can lead to deterioration of renal function. Cases of acute renal failure, usually reversible, have been reported in such patients.

Hemodialysis using high-flow membranes

Anaphylactoid reactions may occur during simultaneous hemodialysis using high-flow membranes (including AN69®). A different type of dialysis membrane or a different antihypertensive agent should be considered.

Mitral stenosis / aortic stenosis / hypertrophic obstructive cardiomyopathy

Lisinopril, like other ACE inhibitors, should be used with caution in patients with left ventricular outflow tract obstruction (aortic stenosis, hypertrophic obstructive cardiomyopathy), as well as in patients with mitral stenosis.

Anaphylactoid reactions during low-density lipoprotein apheresis (LDL apheresis)

In patients taking ACE inhibitors, anaphylactoid reactions may develop during LDL apheresis using dextran sulfate. The development of these reactions can be prevented by temporarily discontinuing the ACE inhibitor before each LDL apheresis procedure.

Anaphylactoid reactions during desensitization with an allergen from Hymenoptera venom

In patients taking ACE inhibitors during desensitization with Hymenoptera (hymenoptera) venom, it is extremely rare that a life-threatening anaphylactoid reaction may occur. It is necessary to temporarily stop treatment with an ACE inhibitor before starting a course of desensitization.

The use of ACE inhibitors should be avoided in patients receiving bee venom immunotherapy.

Hypersensitivity reactions/angioedema

Angioedema of the face, extremities, lips, tongue, epiglottis and/or larynx has been reported rarely in patients treated with ACE inhibitors, including lisinopril. Angioedema may occur at any time during treatment. In such cases, the drug Lisinoton should be immediately discontinued, appropriate treatment should be prescribed, and medical supervision should be provided until complete regression of symptoms. Even in cases of tongue swelling not accompanied by respiratory failure, patients may require long-term observation as treatment with antihistamines and corticosteroids may not be sufficient.

Angioedema, accompanied by swelling of the larynx, can be fatal. Swelling of the tongue, vocal folds, or larynx can lead to airway obstruction. When such symptoms appear, emergency treatment is required: administration of epinephrine (0.3-0.5 ml of epinephrine (adrenaline) solution 1:1000 subcutaneously, administration of glucocorticosteroids, antihistamines) and/or ensuring free patency of the airways. The patient should be under medical supervision until symptoms disappear completely and permanently.

In rare cases, intestinal edema (angioedema of the intestine) develops during therapy with ACE inhibitors. In this case, patients experience abdominal pain as an isolated symptom or in combination with nausea and vomiting, in some cases without previous angioedema of the face and with normal levels of C1-esterase.

Diagnosis is made using abdominal computed tomography, ultrasound, or surgery. Symptoms disappeared after stopping the ACE inhibitors. The possibility of developing intestinal edema must be taken into account when carrying out the differential diagnosis of abdominal pain in patients taking ACE inhibitors.

Patients with a history of angioedema not associated with ACE inhibitors may be at greater risk of developing angioedema during ACE inhibitor therapy.

In black patients taking ACE inhibitors, angioedema was observed more often than in representatives of other races.

An increased risk of angioedema was observed in patients concomitantly taking ACE inhibitors and drugs such as mTOR inhibitors (temsirolimus, sirolimus, everolimus), dipeptidyl peptidase type IV inhibitors (sitagliptin, saxagliptin, vildagliptin, linagliptin), estramustine, neutral endopeptidase inhibitors (racecadotril). , sacubitril) and tissue plasminogen activators

Cough

A dry cough has been reported when using ACE inhibitors. The cough is dry and prolonged, which disappears after stopping treatment with an ACE inhibitor. In the differential diagnosis of cough, cough caused by the use of an ACE inhibitor must also be taken into account.

Neutropenia / agranulocytosis / thrombocytopenia / anemia

While taking ACE inhibitors, neutropenia/agranulocytosis, thrombocytopenia and anemia may occur. In patients with normal renal function and in the absence of other aggravating factors, neutropenia rarely develops. Neutropenia and agranulocytosis are reversible and disappear after discontinuation of the ACE inhibitor.

Lisinopril should be used with extreme caution in patients with systemic connective tissue diseases, while taking immunosuppressants, allopurinol or procainamide, especially in patients with impaired renal function. Some patients developed severe infections, and in some cases, resistant to intensive antibiotic therapy. When using lisinopril in such patients, periodic monitoring of the leukocyte content in the blood (blood test with leukocyte count) is recommended. Patients should be warned to report any signs of infectious disease (eg, sore throat, fever) to their physician.

Ethnic differences

It should be taken into account that patients of the Negroid race have a higher risk of developing angioedema. Like other ACE inhibitors, lisinopril is less effective in lowering blood pressure in black patients. This effect may be associated with a pronounced predominance of low-renin status in black patients with arterial hypertension.

Diabetes

When using lisinopril in patients with diabetes mellitus receiving oral hypoglycemic agents or insulin, blood glucose concentrations should be regularly monitored during the first month of therapy.

Liver dysfunction

In rare cases, while taking ACE inhibitors, a syndrome of development of cholestatic jaundice with transition to fulminant liver necrosis, sometimes with death, was observed. The mechanism of development of this syndrome is unclear. If jaundice or a significant increase in the activity of liver enzymes occurs while taking ACE inhibitors, you should stop taking the drug, and the patient should be under appropriate medical supervision.

Hyperkalemia

Hyperkalemia may develop during therapy with ACE inhibitors, including lisinopril. Risk factors for the development of hyperkalemia are renal failure, old age (over 65 years), diabetes mellitus, some concomitant conditions (dehydration, decreased blood volume, acute heart failure in the stage of decompensation, metabolic acidosis), simultaneous use of potassium-sparing diuretics (such as sironolactone, eplerenorm, triamterene or amiloride), as well as potassium preparations, potassium-containing table salt substitutes and other drugs that increase the level of potassium in the blood plasma (for example, heparin).

The use of potassium supplements/preparations, potassium-sparing diuretics, and potassium-containing table salt substitutes can lead to a significant increase in potassium levels in the blood, especially in patients with significantly reduced renal function. Hyperkalemia can lead to serious, sometimes fatal, heart rhythm problems.

If simultaneous use of lisinopril and the drugs listed above containing potassium or increasing the potassium content in the blood plasma is necessary, caution should be exercised and the potassium content in the blood serum should be regularly monitored.

Elderly age

In elderly patients, the use of standard doses of lisinopril results in higher plasma concentrations of lisinopril. Therefore, special care is required when determining the dose, despite the fact that no differences in the antihypertensive effect of lisinopril were identified in elderly and young patients.

Lisinoton, 28 pcs., 5 mg, tablets

Symptomatic hypotension.

Most often, a pronounced decrease in blood pressure occurs with a decrease in fluid volume caused by diuretic therapy, reducing the amount of salt in food, dialysis, diarrhea or vomiting. In patients with chronic heart failure with or without simultaneous renal failure, a pronounced decrease in blood pressure is possible. It is more often detected in patients with severe chronic heart failure, as a result of the use of large doses of diuretics, hyponatremia or impaired renal function. In such patients, treatment with Lisinoton should be started under the strict supervision of a physician (with caution in selecting the dose of the drug and diuretics). Similar rules must be followed when prescribing to patients with coronary artery disease and cerebrovascular insufficiency, in whom a sharp decrease in blood pressure can lead to myocardial infarction or stroke. A transient hypotensive reaction is not a contraindication for taking the next dose of the drug. When using Lisinoton, some patients with chronic heart failure, but with normal or low blood pressure, may experience a decrease in blood pressure, which is usually not a reason to stop treatment. Before starting treatment with Lisinoton, if possible, the sodium concentration should be normalized and/or the lost volume of fluid should be replenished, and the effect of the initial dose of Lisinoton on the patient should be carefully monitored. In case of renal artery stenosis (especially with bilateral stenosis, or in the presence of stenosis of the artery of a single kidney), as well as with circulatory failure due to lack of sodium and/or fluid, the use of Lisinoton can also lead to impaired renal function, acute renal failure, which usually turns out to be irreversible after discontinuation of the drug.

In acute myocardial infarction.

The use of standard therapy (thrombolytics, acetylsalicylic acid, beta-blockers) is indicated. Lisinotone can be used in conjunction with intravenous administration or with the use of therapeutic transdermal nitroglycerin systems.

Surgery/general anesthesia.

During extensive surgical interventions, as well as when using other drugs that cause a decrease in blood pressure, lisinopril, by blocking the formation of angiotensin II, can cause a pronounced, unpredictable decrease in blood pressure.

In elderly patients

the same dose leads to a higher concentration of the drug in the blood, so special care is required when determining the dose, although no differences in the antihypertensive effect of Lisinoton have been identified between elderly and young people. Since the potential risk of agranulocytosis cannot be excluded, periodic monitoring of the blood picture is required. When using the drug under dialysis conditions with a polyacrylonitrile membrane, anaphylactic shock may occur, so either a different type of dialysis membrane or the prescription of other antihypertensive drugs is recommended.

There is no data on the effect of lisinopril, used in therapeutic doses, on the ability to drive vehicles and machines, however, it must be borne in mind that dizziness may occur, so caution should be exercised.