Lisinoton pills 10mg, 28pcs

Composition

Tablets are round, biconvex, white in color, with a notch.

Active ingredient:

• Lisinopril (in the form of dihydrate) 10 mg in 1 tablet.

Auxiliary substances:

• Mannitol.
• Calcium hydrophosphate dihydrate.
• Pre-gelatinized corn starch.
• Sodium croscarmellose.
• Magnesium stearate.

Pharmacological action

Lysinotone is an ACE inhibitor that reduces the formation of angiotensin II from angiotensin I. A decrease in angiotensin II leads to a direct decrease in the release of aldosterone. Reduces the degradation of bradykinin and increases the synthesis of prostaglandins.

Reduces OPSS, blood pressure, preload, pressure in the pulmonary capillaries, causes an increase in the minute volume of blood and increased myocardial tolerance to stress in patients with chronic heart failure. Dilates the arteries to a greater extent than the veins.

Some of the effects are attributed to effects on the tissue renin-angiotensin system. With prolonged use, hypertrophy of the myocardium and arterial walls of the resistive type decreases. Improves blood supply to the ischemic myocardium.

ACE inhibitors prolong life expectancy in patients with chronic heart failure, slow the progression of left ventricular dysfunction in patients who have suffered a myocardial infarction without clinical manifestations of heart failure.

After a single dose of the drug, the antihypertensive effect develops in 1 hour, reaches a maximum in 6-7 hours and persists for 24 hours. The duration of the effect also depends on the amount of the dose taken. With arterial hypertension, the effect is noted in the first days after the start of treatment, a stable effect develops after 1-2 months.

When the drug was abruptly discontinued, no significant increase in blood pressure was observed.

Lysinotone reduces albuminuria. In patients with hyperglycemia, it helps to normalize the function of damaged glomerular endothelium. It does not affect the concentration of glucose in the blood in patients with diabetes mellitus and does not lead to an increase in cases of hypoglycemia.

Indications

• Arterial hypertension (as monotherapy or in combination with other antihypertensive drugs).
• Chronic heart failure (as part of a combination therapy for the treatment of patients taking digitalis preparations and / or diuretics).
• Early period of acute myocardial infarction (in the first 24 hours) with stable hemodynamic parameters (to maintain hemodynamic parameters and prevent left ventricular dysfunction and heart failure).

Use during pregnancy and lactation

The use of Lysinotone during pregnancy is contraindicated. Lisinopril passes through the placenta. If pregnancy is established, the drug should be discontinued as soon as possible.

Taking ACE inhibitors in the second and third trimesters of pregnancy has an adverse effect on the fetus (a pronounced decrease in blood pressure, renal failure, hyperkalemia, cranial hypoplasia, and intrauterine death are possible).

There are no data on the negative effects of the drug on the fetus when used in the first trimester. For newborns and children who have been exposed to intrauterine ACE inhibitors, it is recommended to establish careful monitoring for the timely detection of a pronounced decrease in blood pressure, oliguria, hyperkalemia.

There are no data on the penetration of Lisinopril into breast milk. If it is necessary to prescribe the drug during lactation, breastfeeding should be discontinued.

Contraindications

• Angioedema in the anamnesis (including when using ACE inhibitors).
• Hereditary angioedema.
• Age up to 18 years (efficacy and safety have not been established).
• Hypersensitivity to lisinopril or other ACE inhibitors.

With caution, the drug should be prescribed for severe renal dysfunction, bilateral renal artery stenosis or stenosis of the artery of a single kidney with progressive azotemia, condition after kidney transplantation, renal failure, azotemia, hyperkalemia, aortic stenosis, hypertrophic obstructive cardiomyopathy, primary hyperaldosteronism, arterial hypotension, cerebrovascular diseases (including cerebral circulatory failure), ischemic disease heart failure, coronary insufficiency, autoimmune systemic connective tissue diseases (including scleroderma, systemic lupus erythematosus), bone marrow hematopoiesis suppression, hypovolemic conditions (including as a result of diarrhea, vomiting); patients on a sodium-restricted diet, elderly patients.

Side effects

From the cardiovascular system: often-orthostatic hypotension, chest pain (1-3%); rarely (From the central nervous system: often – dizziness, headache (5-6%), weakness; rarely (From the digestive system: often – nausea, vomiting, diarrhea; rarely (From the respiratory system: often (3%) – dry cough. From the hematopoietic system: possibly-leukopenia, neutropenia, agranulocytosis, thrombocytopenia, with long-term treatment-a slight decrease in the concentration of hemoglobin and hematocrit, erythrocytopenia. From the immune system: (0.1%) angioedema (face, lips, tongue, larynx or epiglottis, upper and lower extremities); rarely (From the urinary system: rarely (Dermatological reactions: often – skin rash; rarely (Laboratory parameters: hyperkalemia, azotemia, hyperuricemia, hyperbilirubinemia, increased activity of liver enzymes (especially if there is a history of kidney disease, diabetes mellitus and renovascular hypertension). Other: rare (

Interaction

When used concomitantly with diuretics, lisinopril reduces the excretion of potassium.

With extreme caution, Lysinotone should be prescribed simultaneously with potassium-sparing diuretics (spironolactone, triamterene, amiloride), potassium, salt substitutes containing potassium, because the risk of hyperkalemia increases, especially with impaired renal function.

Therefore, these combinations should be prescribed only on the basis of an individual decision of the attending physician, with regular monitoring of serum potassium levels and renal function.

When used concomitantly with diuretics and other antihypertensive drugs, an additive antihypertensive effect develops.

When used concomitantly with NSAIDs (including Indometacin), estrogens, and adrenostimulants, the antihypertensive effect of lisinopril decreases.

When used concomitantly with lithium, the excretion of lithium may decrease, so you should regularly monitor the concentration of lithium in the blood serum.

When used concomitantly with antacids and colestyramine, the absorption of lisinopril from the gastrointestinal tract decreases. When used concomitantly, ethanol enhances the effect of lisinopril.

How to take, course of use and dosage

The drug is taken orally.

With arterial hypertension, patients who do not receive other antihypertensive agents are prescribed 5 mg 1 time/day. In the absence of an effect, the dose is increased every 2-3 days by 5 mg to an average therapeutic dose of 20-40 mg / day (an increase in the dose of more than 40 mg / day usually does not lead to a further decrease in blood pressure). The usual daily maintenance dose is 20 mg. The maximum daily dose is 40 mg.

The full effect usually develops in 2-4 weeks from the start of treatment, which should be taken into account when increasing the dose. If the clinical effect is insufficient, the drug can be combined with other antihypertensive agents.

If the patient has received prior treatment with diuretics, then their use should be stopped 2-3 days before the start of Lysinotone use. If diuretics cannot be discontinued, the initial dose of Lysinotone should not exceed 5 mg / day.

In this case, after taking the first dose, medical monitoring is recommended for several hours (the maximum effect is reached in about 6 hours), since a pronounced decrease in blood pressure may develop.

In patients with renovascular hypertension or other conditions with increased RAAS activity, it is also advisable to prescribe a lower initial dose of 2.5-5 mg / day under increased medical supervision (control of blood pressure, renal function, and serum potassium concentration). The maintenance dose should be determined depending on the dynamics of blood pressure.

In renal insufficiency, due to the fact that lisinopril is excreted by the kidneys, the initial dose should be determined depending on creatinine clearance, then a maintenance dose should be established in accordance with the reaction in conditions of frequent monitoring of renal function, serum potassium and sodium concentrations.

With persistent arterial hypertension, long-term maintenance therapy with the drug at a dose of 10-15 mg/day is indicated.

In patients with chronic heart failure, the initial dose is 2.5 mg 1 time / day, followed by an increase in the dose by 2.5 mg after 3-5 days to the usual maintenance daily dose of 5-20 mg. The daily dose should not exceed 20 mg.

Elderly patients often have a more pronounced long-term hypotensive effect, which is associated with a decrease in the rate of elimination of lisinopril. Therefore, in this category of patients, it is recommended to start treatment with a dose of 2.5 mg / day.

In acute myocardial infarction (as part of combination therapy),5 mg is prescribed on the first day, then 5 mg every other day,10 mg every two days, and then 10 mg 1 time/day. In patients with acute myocardial infarction, the drug should be used for at least 6 weeks. At the beginning of treatment or during the first 3 days after acute myocardial infarction in patients with low systolic blood pressure (≤120 mm Hg), the drug should be prescribed at a dose of 2.5 mg.

If blood pressure decreases (systolic blood pressure < 100 mm Hg) while taking Lysinotone, the daily dose of 5 mg can be temporarily reduced to 2.5 mg.

In case of a long-term pronounced decrease in blood pressure (systolic blood pressure

Overdose

Symptoms: marked decrease in blood pressure, dry mouth, drowsiness, urinary retention, constipation, anxiety, increased irritability (occur when taking a single dose of 50 mg).

Treatment: if necessary, symptomatic therapy is performed (intravenous fluid use, control and normalization of blood pressure, water and electrolyte balance).

Lisinopril is eliminated from the body by hemodialysis.

Special instructions

Most often, a marked decrease in blood pressure occurs with a decrease in fluid volume caused by diuretic therapy, a decrease in salt in food, dialysis, diarrhea or vomiting.

In chronic heart failure with or without concomitant renal failure, a marked decrease in blood pressure is possible. More often, a pronounced decrease in blood pressure is detected in patients with severe chronic heart failure, as a result of the use of high-dose diuretics, hyponatremia or impaired renal function.

In such patients, treatment with Lysinotone should be started under the strict supervision of a doctor (with caution, select the dose of the drug and diuretics).

Similar rules should be followed when prescribing Lysinotone to patients with coronary heart disease, cerebrovascular insufficiency, in which 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 Lysinotone in some patients with chronic heart failure, but with normal or low blood pressure, there may be a decrease in blood pressure, which is usually not a reason to stop treatment.

Before starting treatment with Lysinotone, 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 Lysinotone on the patient should be carefully monitored.

In the 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 and/or fluid, the use of Lysinotone can 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. It is possible to use Lysinotone together with intravenous use or with the use of therapeutic transdermal nitroglycerin systems.

With extensive surgical interventions, as well as with the use of other drugs that cause a decrease in blood pressure, lisinopril, blocking the formation of angiotensin II, can cause a pronounced unpredictable decrease in blood pressure.

In elderly patients, the use of standard doses leads to a higher concentration of the drug in the blood, so special care is required when determining the dose, despite the fact that there are no differences in the antihypertensive effect of Lysinotone in elderly and young patients.

Since the potential risk of agranulocytosis cannot be excluded, periodic monitoring of the blood picture is required.

When using the drug in a polyacrylonitrile membrane dialysis setting, anaphylactic shock may occur, so either a different type of dialysis membrane is recommended, or other antihypertensive agents are prescribed.

Influence on the ability to drive motor vehicles and manage mechanisms

There are no data on the effect of lisinopril on the ability to drive vehicles and mechanisms, but it should be borne in mind that dizziness may occur, so caution should be exercised.

Form of production

Pills.

Storage conditions

At a temperature not exceeding 25 °C

Shelf life

3 years

Active ingredient

Lisinopril

Conditions of release from pharmacies

By prescription

Dosage form

Tablets