Lisinopril tablets for oral administration 10 mg. Lisinopril: indications, contraindications, side effects. Use for renal impairment

Cardiovascular diseases hold the lead in the list of life-threatening dangers. Scientists are looking for methods to contain the onslaught of sinister CVDs and are creating new drugs. Among the drugs that prolong life and improve well-being is lisinopril. His appearance was triumphant. Lisinopril immediately began to be used intensively.

Lisinopril - an antihypertensive bastion for the heart

The drug is popular and in demand by patients. In our country alone, several pharmaceutical companies produce it.

Lisinopril is also produced by foreign corporations.

Instructions for use of the drug lisinopril

Name active substance And tradename for lisinopril they are the same. In Latin it is Lisinopril. International generic name also lisinopril.

Release form: tablets. The color and shape of the tablets vary: manufacturers design them in different corporate styles.
Alsi Pharma. The Moscow "Alsi Pharma" produces lisinopril tablets in white, they have a chamfer - a corner cut (rounding) at the transition of wide planes to the side surface, and a line - a transverse line.

The line is applied to facilitate dosing when breaking: along it the tablet will split exactly in half. “Alsi Pharma” applies risk on tablets in dosages of 10 and 20 mg - they are divided if necessary. The third, five-milligram, dosage is provided in tablets without risks - this dose of lisinopril is minimal and does not need to be divided. Regardless of the dosage, the tablet shape is round.

"Vertex". This St. Petersburg company produces lisinopril tablets - also white. But they are flat-cylindrical and round in shape. There is a chamfer on everyone, the risk is only on the maximum, 20 mg, dosage of the active substance. And all three types are produced: from the minimum - 5, to the maximum dose accepted for the drug - 20 mg.

"Northern Star", Moscow. The shape is flat-cylindrical, the tablets are white, there is only a chamfer, there are no marks. In production - all three accepted dosages for this drug (5, 10, 20 - in milligrams).

ALKALOID-AO, Macedonia. Lisinopril tablets from this company look more varied. You can easily recognize them by their color:

• Light yellow, 10 mg;
• Creamy pink, 20 mg.

The tablets are round, biconvex in shape. The mark is applied only on one side.

The ATC code for all manufacturers of this medicine is the same: . This is the code international classification drugs for their use in medicine. Instructions for use may refer to this code for lisinopril and other drugs with similar letters, with only one difference: ATC.

The letters are Latin; in Latin the classification is designated: Anatomical Therapeutic Chemical, and in Russian it is anatomical-therapeutic-chemical. Which is identical.

Pharmacotherapeutic group

Lisinopril is part of the group of ACE inhibitors (angiotensin-converting enzyme). The group is actively used by medicine to stabilize, bring to normal, increased blood pressure.

Pharmacodynamics

Lisinopril, by inhibiting the angiotensin-converting enzyme, prevents the conversion of angiotensin I to another form: angiotensin II. These substances are blood pressure regulators.

When ACE stimulates the process of chemical transformation of the former into the latter, the following occurs:

Lisinopril affects the preservation of bradykinin and reduces its breakdown. Bradykinin is a synthesis of almost a dozen amino acids, a substance with a strong vasodilator effect. By protecting it, lisinopril promotes vasodilation, which is important for those suffering from hypertension.

Improves bradykinin and capillary permeability, stimulating metabolic processes. For peripheral circulatory system This is especially important, where blood supply and metabolism are often disrupted.

Under the influence of lisinopril tablets, the rate of prostaglandin synthesis increases. These substances regulate almost all processes occurring in the body. Their balance, equilibrium state is the key to good health.

By reducing pressure and preload, ACE inhibitors protect the myocardium. The drug is prolonged. Lisinopril begins to act after an hour from administration, the maximum effect is after seven hours. One tablet works for a day.

You need pills that help with blood pressure - lisinopril can help. The effect is noticeable already in the first days of treatment. After a month, the effect is stable.

This medicine can be stopped abruptly if necessary. Cancellation does not cause pressure surges.

Pharmacokinetics

A quarter of the medication taken is absorbed into the gastrointestinal tract. The timing of meals does not affect absorption. Bioavailability – 30%.

The blood-brain barrier and the placental barrier, too, almost do not let through active substance drug. Lisinopril almost does not bind to blood proteins and is not metabolized. The kidneys excrete the active substance unchanged.

In patients with different diagnoses and individual characteristics, as well as - different ages, the kinetic properties of the drug lisinopril may also differ.

In chronic heart failure, bioavailability is reduced due to difficult absorption of the substance. It is only 16% - half of the usual one.

If an ACE inhibitor is prescribed to a person suffering from renal failure, its concentration in the bloodstream is several times higher than usual. This creates an increased risk side effects from taking lisinopril.

In the elderly, the concentration is twice as high as when taking the medicine - by young patients.

If the liver is affected by cirrhosis, lisinopril becomes less available - by a third. And the release of the body, its cleansing of the drug (clearance) is twice as slow.

Indications for the use of lisinopril tablets

The drug is prescribed for diagnoses:

1. Arterial hypertension. The stage of the disease and the body’s response will help the doctor decide what is preferable: monotherapy or complex therapy, with other medications together.

2. Chronic heart failure. A combined application scheme is needed here. Lisinopril is usually added to cardiac glycosides, and diuretics can be added.

Minute blood volume (abbreviation - MV) under the influence of lisinopril increases, peripheral vascular resistance (the letter O means total) decreases. The pressure decreases: arterial and even in the pulmonary capillaries. Cardiovascular and respiratory system directly interconnected, when it’s easier for both, it’s easier for the whole body.

The drug acts on all blood vessels; arteries react to lisinopril with greater dilation than veins. The heart ends up in better conditions, can bear the load more easily, even with such a diagnosis.

ACE inhibitors are system controllers (RAAS). The one that contains “rebellious” hormones – aldosterone, angiotensin. By inhibiting their activity, lisinopril contributes to a rare phenomenon. When taken for a long time, the condition improves coronary arteries, their end sections, responsible for the power of cardiac output, become more elastic. Myocardial hypertrophy decreases. Areas with ischemia gradually return to normal structure, gaining proper blood supply.

3. Acute myocardial infarction. Lisinopril has direct indications for use in the early phase of a heart attack. While hemodynamics are stable, this drug is needed in the first hours; it will help maintain hemodynamic parameters within optimal limits. This will prevent the development of heart failure and left ventricular dysfunction. This is a real extension of people's lives.

4. Diabetic nephropathy. The kidneys are the target of diabetes, it always hits it. When prescribing lisinopril tablets, the cardiologist and nephrologist know what they help with. The medicine reduces the degree of albuminuria (pathological excretion of protein in the urine) in people with diabetes. In this case, the indication for use of the drug lisinopril may be diabetes, even with normal blood pressure, if it is type 1.

Type 2 diabetes is usually accompanied by varying degrees of increased blood pressure, and lisinopril will help the kidneys here too. At the same time, removing the load, and the heart. When glucose increases, which is always characteristic of diabetes, the kidney glomeruli and other organ structures suffer. The glomerular (renal) endothelium is damaged. Lisinopril helps him recover and normalize his functions.

Having a beneficial effect on tissues affected by diabetes, the medicine does not cause fluctuations in glucose and does not affect its content in the blood. While protecting against the consequences of diabetes, the drug does not provoke hypoglycemia.

Contraindications for use

When turning to a therapist or cardiologist for help, tell the doctor about all the diagnoses, not just what is bothering you now. To prescribe treatment, your doctor must consider what the patient can and cannot do.

Lisinopril is good, but has contraindications. They are:

Use with caution

Use lisinopril with caution for diagnoses:

Application and dosage

Given the duration of action, lisinopril should be used once a day. The medicine will work until the next dose, 24 hours. The therapeutic effect is achieved by competent selection of the dose and timely adjustment (if necessary).

How to take lisinopril depends on the diagnosis, plus a number of other reasons.

The dose is determined by the doctor. This is creative work: everything must be taken into account - the patient’s condition, age, list of diseases, reaction to medications, even the patient’s weight.

Hypertension (arterial hypertension). Treated with lisinopril alone (monotherapy) if light form, not running. Or combined or combined therapy with a complex of drugs is carried out.

Treatment with lisinopril for blood pressure begins with 10 mg. If good tolerability and normalization of blood pressure are observed, stop at this dosage. Sometimes adaptation to the medicine occurs actively: the first days show a significant decrease in blood pressure. But then the optimal value may be established: slightly higher than at the beginning.

If the blood pressure decreases insufficiently, they look for options:

Usually the initial or double (20 mg) dose is sufficient. The maximum daily dose is 40 mg of lisinopril. Increase slowly, at two-week (minimum) intervals.

It is better not to combine with diuretics, especially potassium-sparing ones. They are canceled in advance. Lisinopril is started after three days. In situations where discontinuation of the diuretic is impossible, lisinopril is taken in a minimal dose - only 5 mg. Even this intake can sharply “drop” the blood pressure - the patient is observed by a doctor until the peak of the effect of the ACE inhibitor lisinopril - 7 hours.

Control is necessary and then laboratory testing (tests). This will show the condition of the kidneys, the content of potassium in the blood plasma.

At renal failure take into account the slow withdrawal of the drug, reduce the dosage. Renal failure will require a dose that is half the accepted minimum. This is 2.5 mg.

If it is provoked by another disease and becomes pronounced when the RAAS is activated, the dosage is also half the minimum. Starting from 2.5 mg, they increase - traditionally at two-week intervals.

Chronic heart failure. The same dose is taken as the initial dose when treating chronic heart failure with lisinopril. Gradual increase in general scheme. The daily maximum for this disease is 20 mg.

Myocardial infarction. The acute phase of a heart attack begins to be treated by prescribing 5 mg of lisinopril. Repeat after one day. After another two days, they give 10 mg, and then continue with this dose every day. You shouldn’t cancel before one and a half months.

If the diagnosis is acute heart attack, and the systolic (upper) pressure is not higher or lower than the tonometer mark - 120, then 5 mg is too much, half the dose should be prescribed - 2.5 mg. When, even with this regimen, the pressure continues to decrease, less than 90 millimeters of mercury is recorded, and does not increase within an hour, lisinopril should be discontinued.

Lisinopril is combined with a complex of medications taken in the treatment of this condition. Beta-blockers, aspirin, and blood clot-dissolving drugs (thrombolytics) administered to the patient are well supplemented with lisinopril. It is also compatible with nitrates.

Diabetic nephropathy. There are differences in lisinopril therapy for type 1 and type 2 diabetes. The dosage is the same - 10 mg, maximum - 20. And also - once a day. But it is customary to focus on diastolic pressure. The significant indicator in this case is in the “sitting” position. For patients with the first type, a value below 75 is achieved, with type 2 - below 90 millimeters of mercury.

In a significant proportion of patients, lisinopril affects diastolic pressure, with little effect on systolic pressure. In the case of diabetes, this property of the drug is very valuable. Diastolic blood pressure is reduced little by most medications.

Side effects

Side effects from taking lisinopril, according to test statistics, are infrequent. But they, like any other medicinal substances, happen. This:

Overdose

Symptoms characteristic of an overdose of lisinopril:

Treat overdose symptomatically. Mandatory health care, intravenously replenish the lack of fluid, administer medicinal solutions. Control the pressure.

Lisinopril can be removed by dialysis, since it is not bound to blood proteins.

Drug interactions

special instructions

Such diseases are treated by trying to prevent a sharp drop in blood pressure; it is this fact that common reason occurrence of myocardial infarction or ischemic stroke. With low pressure, sclerotic vessels cannot provide blood (nutrition) in the required volume, neither the heart nor the brain can. If the condition drags on, the danger increases. This is the main reason to be careful in treatment.

If CHF is not accompanied by arterial hypertension, initially taking lisinopril may slightly lower blood pressure. This is normal, there is no need to stop taking the medicine.

Renal artery stenosis is a good reason to weigh all factors and make thoughtful treatment decisions. Taking lisinopril sometimes leads to the development of acute renal failure in such patients. This condition is irreversible; stopping the drug will not help correct it. The same result is often obtained from the use of lisinopril by people with circulatory failure due to hypovolemia.

Surgery requires prior withdrawal of lisinopril. It is capable of uncontrollably lowering blood pressure during surgery.

Patients undergoing dialysis should not combine the drug with the use of a polyacrylic-nitrile membrane during dialysis. Shock reactions from such interactions occur. You need to either stop the drug or use a different membrane.

Lisinopril analogues

In Russia, many pharmaceutical companies produce lisinopril, its price is affordable: 10 mg tablets, 30 pieces - 66 rubles. And in the instructions for its use, this dose, 10 mg, is usually recommended more often for lisinopril, and the price is low.

This dosage is supportive in the treatment of diseases treated by the drug. The price of lisinopril varies little in pharmacies across Russia; it is available everywhere. Yes, and twice the dose - 20 mg, is also inexpensive, the price of lisinopril is about 100 rubles. It's even more profitable than buying.

Lisinopril is an antihypertensive, vasodilating drug. Instructions for use recommend taking tablets 2.5 mg, 5 mg, 10 mg, 20 mg when various forms arterial hypertension, diabetic nephropathy, as well as as part of combination therapy for early treatment acute myocardial infarction and chronic heart failure. Reviews from patients and doctors explain what pressure this medicine helps with.

Release form and composition

Lisinopril is supplied in tablets of 2.5 mg, 5 mg, 10 mg, 20 mg. The composition includes the active substance of the same name and auxiliary elements.

pharmachologic effect

Lisinopril increases peripheral vascular tone and promotes the secretion of aldosterone by the adrenal glands. Thanks to the use of tablets, the vasoconstrictor effect of the hormone angiotensin is significantly reduced, while a decrease in aldosterone is noted in the blood plasma.

Taking the drug helps lower blood pressure, regardless of body position (standing, lying down). Lisinopril avoids the occurrence of reflex tachycardia (increased heart rate).

A decrease in blood pressure while taking the medication occurs even with a very low level of renin in the blood plasma (a hormone produced in the kidneys).

Properties of the drug

Effect this drug becomes noticeable within an hour after taking it orally. The maximum effect of Lisinopril is observed 6 hours after administration, and this effect continues to persist throughout the day.

Abruptly stopping this drug does not cause a rapid increase in blood pressure; the increase may be small compared to the level before starting therapy.

If Lisinopril is used by patients suffering from heart failure in parallel with digitalis and diuretic therapy, it has the following effects: reduces peripheral vascular resistance; increases stroke and minute blood volume (without increasing heart rate); reduces the load on the heart; increases the body's tolerance to physical activity.

The drug significantly improves intrarenal dynamics. Absorption of this drug occurs from gastrointestinal tract, while its maximum concentration in the blood is observed in the interval from 6 to 8 hours after administration.

What does Lisinopril help with?

Indications for use of the drug include:

• diabetic nephropathy (reduction of albuminuria in insulin-dependent patients with normal blood pressure and non-insulin-dependent patients with arterial hypertension);
• chronic heart failure (as part of combination therapy for the treatment of patients taking digitalis and/or diuretics);
• arterial hypertension (in monotherapy or in combination with other antihypertensive drugs);
• early treatment of acute myocardial infarction (in the first 24 hours with stable hemodynamic parameters to maintain these parameters and prevent left ventricular dysfunction and heart failure).

At what pressure should I take it?

Lisinopril is prescribed for blood pressure above 140/90.

Instructions for use

Lisinopril (indications involve taking various doses of the drug) is available in tablets containing 2.5 mg, 5 mg, 10 mg and 20 mg of the active substance. The instructions recommend taking Lisinopril once a day, preferably at the same time.

You should start using the medication for essential hypertension with 10 mg per day, followed by a transition to a maintenance dose of 20 mg per day, while, in extreme cases, a maximum daily dose of 40 mg is allowed.

Reviews about Lisinopril indicate that the full therapeutic effect of the drug can develop 2-4 weeks after the start of treatment. If after use maximum doses the drug did not achieve the expected results, additional use of other antihypertensive drugs is recommended.

Patients taking diuretics should stop taking them 2-3 days before starting Lisinopril. If for some reason it is not possible to discontinue diuretics, daily dose Lisinopril should be reduced to 5 mg.

In conditions with increased activity the renin-angiotensin-aldosterone system, which regulates blood volume and blood pressure, the instructions recommend using Lisinopril in a daily dose of 2.5-5 mg. The maintenance dose of the drug for such diseases is set individually depending on the value of blood pressure.

How to take for illnesses

In case of renal failure, the daily dose of lisinopril depends on creatinine clearance and can vary from 2.5 to 10 mg per day.

Persistent arterial hypertension requires taking 10-15 mg per day for a long time.

Taking the drug for chronic heart failure starts with 2.5 mg per day, and after 3-5 days increases to 5 mg. The maintenance dose for this disease is 5-20 mg per day.

For diabetic nephropathy, Lisinopril instructions recommend taking 10 mg-20 mg per day.

Use for acute myocardial infarction involves complex therapy and is carried out according to the following scheme: on the first day - 5 mg, then the same dose - once a day, after which the amount of the drug is doubled and taken once every two days, the final stage - 10 mg once a day. Lisinopril, indications determine the duration of treatment; for acute myocardial infarction, it is taken for at least 6 weeks.

Contraindications

Side effects

• alopecia;
• angioedema(face, lips, tongue, larynx or epiglottis, upper and lower extremities);
• anorexia;
• anuria;
• asthenic syndrome;
• stomach ache;
• chest pain;
• pronounced decrease in blood pressure;
• headache;
• dizziness;
• diarrhea;
• dyspepsia;
• taste changes;
• myocardial infarction;
• skin rash;
• skin itching;
• hives;
• mood lability;
• leukopenia, neutropenia, agranulocytosis, thrombocytopenia;
• fever;
• myalgia;
• fetal development disorder;
• renal dysfunction;
• renal dysfunction;
• heart rhythm disturbances;
• oliguria;
• orthostatic hypotension;
• acute renal failure;
• increased fatigue;
• increased sweating;
• heartbeat;
• weakness;
• decreased potency;
• drowsiness;
• confusion;
• convulsive twitching of the muscles of the limbs and lips;
• dry cough;
• dry mouth;
• tachycardia;
• nausea, vomiting;
• cardiopalmus;
• cerebrovascular stroke in patients with an increased risk of the disease due to a pronounced decrease in blood pressure.

Children, pregnancy and breastfeeding

The drug is not prescribed to persons under 18 years of age. Contraindicated during pregnancy and breastfeeding.

special instructions

In acute myocardial infarction, the medicine is used against the background complex therapy with the use of thrombolytics, beta-blockers and acetylsalicylic acid.

Before performing surgery, the doctor should be warned about taking Lisinopril. Sick diabetes mellitus Regular monitoring of sugar levels is required.

Drug interactions

In combination with drugs containing lithium, the removal of the latter from the body is disrupted. With this combination it is required constant control the concentration of lithium in the blood.

Lisinopril enhances the effect of ethanol. Non-steroidal anti-inflammatory drugs, estrogens and acetylsalicylic acid reduce the antihypertensive effect of the drug.

Analogues of the drug Lisinopril

Analogues are determined by structure:

1. Liten.
2. Lisinoton.
3. Prinivil.
4. Lizonorm.
5. Sinopril.
6. Lisinopril dihydrate.
7. Dapril.
8. Lysigamma.
9. Lisinopril Grindeks (Stada, Pfizer, Teva, OBL, Organica).
10. Listril.
11. Irumed.
12. Lizoril.
13. Rileys Sanovel.
14. Lizacard.
15. Diropress.

In combination with Hydrochlorothiazide:

1. Copril plus.
2. Liten N.
3. Listril Plus.
4. Iruzid.
5. Rileys Sanovel plus.
6. Co-Diroton.
7. Lysoretic.
8. Zonixem ND.
9. Lisinoton N.
10. Zonixem NL.

In combination with Amlodipine:

1. Equator.
2. Equacard.

Vacation conditions and price

The average price of Lisinopril (10 mg tablets No. 30) in Moscow is 44 rubles. In Kyiv you can buy medicine for 45 hryvnia, in Kazakhstan - for 1498 tenge. In Minsk, pharmacies offer medicine for 2-3 bel. ruble Dispensed from pharmacies with a prescription.

Official medical instructions on the use of the manufacturer Lisinopril is shown in the photo (click to enlarge):

Lisinopril photo 1

Description

Tablets are white, flat-cylindrical, with a chamfer and a score. Tablets with a dosage of 5 mg are engraved “5”.

Compound

One tablet contains: active substance– lisinopril 5 mg and 10 mg; Excipients : potato starch, microcrystalline cellulose, stearic acid, povidone, lactose monohydrate.

Pharmacotherapeutic group

Medicines that affect the renin-angiotensin system. Angiotensin-converting enzyme inhibitors.
ATX code– С09AA03.

Pharmacological properties"type="checkbox">

Pharmacological properties

Pharmacodynamics
An ACE inhibitor, reduces the formation of angiotensin II from angiotensin I. A decrease in the content of angiotensin II leads to a direct decrease in the release of aldosterone. Reduces the degradation of bradykinin and increases the synthesis of prostaglandins. Reduces total peripheral vascular resistance, blood pressure (BP), preload, pressure in the pulmonary capillaries, causes an increase in minute blood volume and an increase in myocardial tolerance to stress in patients with chronic heart failure. Dilates arteries in to a greater extent than veins. Some effects are explained by effects on tissue renin-angiotensin systems. With long-term use, hypertrophy of the myocardium and the walls of resistive arteries decreases. Improves blood supply to ischemic myocardium.
The duration of the effect also depends on the dose. The onset of action is after 1 hour. The maximum effect is determined after 6–7 hours. The action lasts 24 hours. In case of arterial hypertension, the effect is observed in the first days after the start of treatment, a stable effect develops after 1–2 months.
In patients with chronic heart failure, Lisinopril, by reducing total peripheral vascular resistance, reduces afterload on the heart, increases stroke and cardiac output without increasing heart rate, and increases tolerance to physical activity. In addition, Lisinopril reduces preload, helps reduce pressure in the pulmonary circulation and in the right atrium, and causes regression of myocardial hypertrophy.
Two large randomized trials, ONTARGET and VA NEPHRON-D, examined the combination of ACE inhibitors and angiotensin II receptor blockers in patients with cerebrovascular disease and type 2 diabetes mellitus with end-organ damage or diabetic nephropathy. These studies did not reveal significant benefits for patients in terms of preservation of renal function, cardiovascular outcomes and mortality, but, at the same time, were accompanied by an increased incidence of renal dysfunction and hypotension compared with monotherapy. Given the similar characteristics of all ACE inhibitors, the results of these studies can be extended to the entire group of drugs.
The ALTITUDE trial examined the addition of aliskiren to ACE inhibitor or angiotensin II receptor blocker therapy in patients with type 2 diabetes mellitus and renal or cardiac disease. The study was stopped early due to a high incidence of adverse outcomes (risk cardiovascular mortality or stroke were higher in the aliskiren group). The study also found an increased incidence of adverse effects in the aliskiren group (hyperkalemia, hypotension and renal dysfunction).
Pharmacokinetics
Suction
After oral administration, lisinopril is absorbed from the gastrointestinal tract. Cmax of lisinopril in plasma is achieved within 6–8 hours. Eating does not affect the absorption of the drug. Absorption averages 30%, bioavailability - 29%.
Distribution
Does not bind to plasma proteins. Css of lisinopril during a course of taking the drug is established after 3 days. Permeability through the blood-brain and placental barrier is low.
Metabolism
Lisinopril is not biotransformed in the body.
Removal
It is excreted unchanged by the kidneys. The half-life is 12 hours.
Pharmacokinetics in special clinical situations
In patients with severe renal impairment, an increase in the time to reach Cmax and Css of lisinopril was noted; The dosage regimen for this category of patients must be adjusted taking into account creatinine clearance.

Indications for use

Arterial hypertension (including symptomatic);
- chronic heart failure (as part of combination therapy);
- acute myocardial infarction (in the first 24 hours as part of combination therapy). See also sections “Contraindications”, “ special instructions", "Interaction with others medicines", "Pharmacodynamics".

Contraindications

(see also sections “Interaction with other drugs and other forms of interaction”, “Pharmacological properties”)
- hypersensitivity to lisinopril;
- angioedema (local swelling of the skin, subcutaneous tissue and/or mucous membranes in combination with or without urticaria) in history, including when using ACE inhibitors;
- simultaneous use of angiotensin-converting enzyme inhibitors or ATII receptor blockers with aliskiren in patients with diabetes mellitus or moderate/severe renal failure (GFR)< 60 мл/мин/1,73 м 2) противопоказано;
- hereditary Quincke's edema;
- childhood up to 6 years;
- pregnancy;
- breast-feeding.

Directions for use and doses

Lisinopril is recommended to be taken orally once a day, at approximately the same time. Eating does not affect the absorption of lisinopril tablets. The dose should be determined individually according to the patient's response and blood pressure.
Arterial hypertension
Lisinopril can be used as monotherapy and in combination with other antihypertensive drugs. See also sections “Contraindications”, “Special instructions”, “Interaction with other drugs”, “Pharmacodynamics”.
Initialdosa. For patients with arterial hypertension, the recommended starting dose is 10 mg.
Patients with a very active renin-angiotensin-aldosterone system (particularly renovascular hypertension, increased salt excretion and/or decreased interstitial fluid volume, heart failure, or severe hypertension) may experience a significant decrease in blood pressure after taking the initial dose. For such patients, the recommended dose is 2.5–5 mg, and initiation of treatment should take place under the direct supervision of a physician. A reduction in the initial dose is also recommended in case of renal failure (see table below).
Maintenance dose. The usual recommended maintenance dose is 20 mg once daily. If this dose does not provide a sufficient therapeutic effect within 2–4 weeks, it can be increased. The maximum daily dose is 80 mg.
Treatment of arterial hypertension in children aged 6–16 years
The recommended starting dose is 2.5 mg once daily in patients weighing 20 to<50 кг и 5 мг для пациентов с массой тела ≥50 кг. Дозировка должна подбираться индивидуально до максимальной суточной 20 мг для детей с массой тела от 20 до <50 кг и максимальной суточной 40 мг для пациентов с массой тела ≥50 кг. Отсутствуют данные о применении у детей дозы выше 0,61 мг/кг (выше 40 мг). У детей со сниженной функцией почек требуется назначение более низкой начальной дозы и увеличение интервала между приемами препарата.
Patients taking diuretics
Symptomatic hypotension may occur after initiation of treatment with lisinopril. This is likely for patients taking diuretics while being treated with lisinopril. Such patients are advised to take the drug with caution due to the likelihood of increased salt excretion from the body and/or a decrease in the volume of intercellular fluid. If possible, it is necessary to stop diuretic treatment 2-3 days before starting Lisinopril therapy. For patients with arterial hypertension who cannot stop treatment with diuretics, therapy should be started with a dose of 5 mg. It is necessary to monitor kidney function and serum potassium levels. Subsequent doses of lisinopril should be adjusted according to blood pressure response. If necessary, diuretic therapy can be resumed.
Dosage for patients with renal failure should be based on QC, as shown in the table below.
Table. Dose selection for patients with renal failure.

* - dosage and/or frequency of administration must be calculated based on blood pressure response.
The dose can be gradually increased until blood pressure normalizes or until a maximum dose of 40 mg per day is reached.
Chronic heart failure
Patients with symptomatic heart failure should take lisinopril as an adjuvant therapy to diuretics, digitalis, or beta-blockers. Therapy with Lisinopril can be started with a dose of 2.5 mg 1 time per day, the drug must be taken under the supervision of a physician to identify the initial effect of the drug on blood pressure.
Lisinopril dosage must be increased:
increasing the dose by no more than 10 mg;
intervals between dose increases should be at least 2 weeks;
up to the highest dose tolerated by the patient, up to a maximum of 35 mg once daily.
Dose selection should be based on the clinical response of each individual patient.
Patients who are at high risk for symptomatic hypotension, such as patients with increased salt excretion with or without hyponatremia, patients with hypovolemia, or patients who have received intensive diuretic therapy, should improve their condition, if possible, before initiating lisinopril therapy. It is necessary to monitor kidney function and serum potassium levels.
Acute myocardial infarction
Depending on the circumstances, the patient should undergo standard recommended therapy, such as treatment with thrombolytics, aspirin and beta-blockers. Along with this, nitroglycerin can be used (including transdermally).
Initial dose(the first 3 days after a heart attack).
Treatment with lisinopril can be started within the first 24 hours after the first symptoms appear. Treatment should not be started if systolic blood pressure is less than 100 mmHg. Art. The starting dose of lisinopril is 5 mg orally, followed by 5 mg every 24 hours, 10 mg every 48 hours, and 10 mg daily. Patients with systolic pressure not exceeding 120 mmHg. Art., before starting or during therapy in the first 3 days after a heart attack, treatment should begin with a low dose of 2.5 mg.
In case of renal failure (creatinine clearance<80 мл/мин) начальную дозу лизиноприла необходимо подбирать в соответствии с показателями клиренса креатинина пациента (см. таб.).
Maintenance dose. The recommended maintenance dose is 10 mg 1 time per day. In case of arterial hypotension (systolic pressure less than 100 mm Hg), the maintenance daily dose should not exceed 5 mg; if necessary, this dose can be reduced to 2.5 mg. If, after taking Lisinopril, prolonged arterial hypotension is observed (systolic pressure remains less than 90 mm Hg for more than 1 hour), Lisinopril therapy should be discontinued. Therapy is recommended for 6 weeks, after which the patient's condition must be re-evaluated. Patients with symptoms of heart failure must continue treatment.
Elderly patients
In clinical trials, there were no age-related changes in the effectiveness or safety of the drug.
However, reaching a certain age is associated with a decrease in renal function; the initial dose of lisinopril must be selected in accordance with the instructions given in the table. After this, the dose should be adjusted according to response and blood pressure.

Side effects

When using Lisinopril, like other ACE inhibitors, a number of side effects may occur with the following frequency: very common (1/10), common (1/100<1/10), нечастые (1/1000<1/100), редкие (1/10000 <1/1000), очень редкие (<1/10000), неизвестные (не могут быть оценены на основании доступных данных).
Disorders of the blood and lymphatic system: rare - decreased hemoglobin, decreased hematocrit, very rare - bone marrow suppression, anemia, thrombocytopenia, leukopenia, neutropenia, agranulocytosis, hemolytic anemia, lymphadenopathy, autoimmune diseases.
Nutritional and metabolic disorders: very rare – hypoglycemia.
Nervous system and mental disorders: common – dizziness, headache, uncommon – mood swings, paresthesia, dizziness, taste disorder, sleep disorder, rare – confusion, olfactory disorders, frequency unknown – symptoms of depression, loss of consciousness.
Heart and vascular disorders: common - orthostatic effects, including hypotension, uncommon - myocardial infarction or cerebrovascular disorders, possible development of secondary hypotension in high-risk patients, palpitations, tachycardia, Raynaud's phenomenon.
Respiratory and chest disorders: common – cough, uncommon – rhinitis, very rare – bronchospasm, sinusitis, allergic alveolitis/eosinophilic pneumonia.
Gastrointestinal disorders: common – diarrhea, vomiting, uncommon – nausea, abdominal pain, dyspepsia, rare – dry mouth, very rare – pancreatitis, intestinal angioedema, hepatitis – either hepatocellular or cholestatic, jaundice and liver failure.
Disorders of the skin and subcutaneous tissue: uncommon – redness, itching, hypersensitivity/angioedema (angioedema of the face, lips, tongue, pharynx and/or larynx), rare – urticaria, alopecia, psoriasis, very rare – sweating, pemphigus, toxic necrolysis of the epidermis, Stevens syndrome- Johnson, erythema multiforme, cutaneous pseudolymphoma. There is a report of a symptom complex including one or more of the following symptoms: fever, vasculitis, myalgia, arthralgia/arthritis, antinuclear antibodies, increased ESR, eosinophilia and leukocytosis, skin rash, photosensitivity of the skin and other skin manifestations.
Kidney and urinary tract disorders: common – renal dysfunction, rare – uremia, renal failure, very rare – oliguria/anuria.
Endocrine disorders: frequency not known - inadequate secretion of antidiuretic hormone.
Disorders of the reproductive system and mammary glands: uncommon – impotence, rare – gynecomastia.
General and administration site disorders: infrequent – ​​fatigue, asthenia.
Laboratory research: uncommon – increased blood urea, increased serum creatinine, increased activity of liver enzymes, hyperkalemia, rare – increased serum bilirubin, hyponatremia.

Interaction with other drugs

Diuretics. When using the drug simultaneously with diuretics, a sharp decrease in blood pressure is possible; with other antihypertensive drugs, an additive effect is observed (with combination therapy, caution is required).
Potassium supplements, potassium-sparing diuretics. When used simultaneously with potassium-sparing diuretics (spironolactone, triamterene, amiloride), potassium preparations, salt substitutes and dietary supplements containing potassium, hyperkalemia may develop, especially in patients with impaired renal function. When using such combinations, regular monitoring of potassium levels in the blood and kidney function is required.
Lithium. Reversible increases in serum lithium concentrations and toxicity have been reported during concomitant use of lithium with ACE inhibitors. Concomitant use of thiazide diuretics with ACE inhibitors may further increase the risk of lithium toxicity. Concomitant use of lisinopril with lithium is not recommended, but if such a combination is necessary, careful monitoring of serum lithium levels is necessary.
Nonsteroidal anti-inflammatory drugs (NSAIDs), including acetylsalicylic acid 3 g/day. When ACE inhibitors are used concomitantly with non-steroidal anti-inflammatory drugs (for example, acetylsalicylic acid in anti-inflammatory dosing regimens, COX-2 inhibitors and non-selective NSAIDs), a weakening of the antihypertensive effect may occur. Concomitant use of ACE inhibitors and NSAIDs may result in an increased risk of deterioration of renal function, including the possibility of acute renal failure, as well as increased serum potassium concentrations, especially in patients with impaired renal function. These effects are usually reversible. Combinations of ACE inhibitors and NSAIDs should be prescribed with caution, especially in the elderly. Patients should maintain adequate fluid balance; After a course of therapy, it is necessary to check kidney function.
Gold preparations. Nitrate-like reactions (symptoms of vasodilation, including hot flashes, nausea, dizziness and hypotension, which can be very severe) are more likely to develop when ACE inhibitors are co-administered with injectable gold preparations.
Other antihypertensive drugs. The simultaneous use of these drugs may increase the hypotensive effect of lisinopril.
Concomitant use with nitroglycerin and other nitrates or other vasodilators, may further lower blood pressure.
Tricyclic antidepressants/neuroleptics/anesthetics. Concomitant use of certain anesthetics, tricyclic antidepressants and antipsychotics with ACE inhibitors may lead to a further decrease in blood pressure.
Sympathomimetics. Sympathomimetics may reduce the antihypertensive effect of ACE inhibitors.
Antidiabetic drugs. Epidemiological studies have shown that the simultaneous use of ACE inhibitors and antidiabetic drugs (insulin, oral hypoglycemic agents) may enhance the hypoglycemic effect of the latter with the risk of developing hypoglycemia. This effect is more likely to occur during the first weeks of combination treatment and in patients with renal impairment.
Acetylsalicylic acid, thrombolytics, beta blockers, nitrates. Lisinopril can be used simultaneously with acetylsalicylic acid (in dosages that provide an antiplatelet effect), thrombolytics, beta blockers and/or nitrates.
Double blockade of the renin-angiotensin-aldosterone system (RAAS).
Based on the available data, dual blockade of the RAAS with an ACEI, ARB II, or aliskiren cannot be recommended in any patient, especially in patients with diabetic nephropathy.
In patients with diabetes mellitus or moderate/severe renal impairment (GFR< 60 мл/мин/1,73 м2) одновременное применение алискирена с иАПФ или БРА II противопоказано.
In some cases, when the combined use of ACE inhibitors and ARB II is absolutely indicated, careful supervision by a specialist and mandatory monitoring of renal function, water and electrolyte balance, and blood pressure are necessary.

special instructions

Symptomatic hypotension is more likely to occur in patients with more severe heart failure, those receiving high doses of loop diuretics, hyponatremia, or impaired renal function. In patients at increased risk of symptomatic hypotension, initiation of therapy and dose adjustment should be carefully monitored. Similar measures apply to patients with coronary heart disease or cerebrovascular disease, in whom an excessive decrease in blood pressure can lead to myocardial infarction or stroke.
Often, hypotension, especially after the first dose, can develop in patients with severe forms of heart failure; this should be taken into account when prescribing lisinopril. If hypotension occurs, the patient should be placed on his back and, if necessary, given an infusion of 9 mg/ml sodium chloride solution. A transient hypotensive reaction is not a contraindication to further doses, which can usually be administered without difficulty once effective blood volume has been restored and the transient hypotensive reaction has subsided.
Arterial hypotension in acute myocardial infarction. In acute myocardial infarction, treatment with lisinopril should not be started if there is a risk of further serious hemodynamic disturbances due to prior use of vasodilators. This applies to patients with a systolic blood pressure of 100 mm Hg. Art. or less, or cardiogenic shock. During the first 3 days after myocardial infarction, the dose of the drug must be reduced if the systolic pressure does not exceed 120 mmHg. Art. If the systolic blood pressure is equal to or less than 100 mmHg. Art., the selected doses must be reduced to 5 mg or temporarily to 2.5 mg. If, after taking Lisinopril, prolonged arterial hypotension is observed (systolic pressure remains less than 90 mm Hg for more than 1 hour), it is necessary to discontinue treatment with Lisinopril.
Aortic and mitral valve stenosis/hypertrophic cardiomyopathy. As with other ACE inhibitors, lisinopril should be used cautiously in patients with mitral valve stenosis or left ventricular ejection obstruction, such as aortic stenosis or hypertrophic cardiomyopathy.
Renal dysfunction. In case of renal failure (creatinine clearance<80 мл/мин), начальную дозу Лизиноприла необходимо скорректировать в соответствии с показателем клиренса креатинина пациента (см. таблицу), а затем – в зависимости от реакции больного на лечение. У этих пациентов необходимо ежедневно контролировать уровень калия в сыворотке крови и клиренс креатинина.
In patients with heart failure, hypotension after initiation of treatment with ACE inhibitors may lead to further deterioration of renal function. In such cases, the development of acute renal failure, usually reversible, has been reported.
In some patients with bilateral renal artery stenosis or renal artery stenosis of a solitary kidney who took ACE inhibitors, serum urea and creatinine levels increased, usually returning to normal after discontinuation of therapy. Levels increased more often in patients with renal failure. In the presence of renovascular hypertension, the risk of developing severe arterial hypotension and renal failure increases. Treatment of such patients should begin under medical supervision, with low doses and careful selection. Since diuretic therapy may contribute to all of the above, diuretic therapy should be discontinued and renal function monitored during the first weeks of treatment with lisinopril.
In some patients with arterial hypertension without obvious renal vascular disease, taking Lisinopril, especially against the background of diuretics, causes an increase in the level of urea in the blood and creatinine in the blood serum. These changes are usually minor and transient. More often in patients with a history of renal failure. In this case, it may be necessary to reduce the dose of the drug and/or stop taking the diuretic and/or Lisinopril.
Treatment of acute myocardial infarction with Lisinopril is not indicated in patients with signs of renal dysfunction, in which there is an increased serum creatinine level > 177 μmol/L and/or proteinuria > 500 mg/day. If renal failure develops during treatment with lisinopril (serum creatinine concentration > 265 µmol/L or an increase of 2 times the pre-treatment value), then the doctor may consider stopping lisinopril.
Hypersensitivity/angioedema. In very rare cases, angioedema of the face, extremities, lips, tongue, glottis and/or larynx has been reported in patients treated with ACE inhibitors. During treatment, angioedema may occur at any time. In such cases, the drug should be stopped immediately, appropriate therapy should be initiated and observation should be established to ensure complete resolution of symptoms. In cases where the swelling is localized in the tongue area, which does not lead to breathing problems, the patient may require long-term observation, since therapy with antihistamines and corticosteroids may not be sufficient.
Anaphylactic reactions in patients undergoing hemodialysis. Anaphylactic reactions have been reported in patients undergoing hemodialysis using high-flux membranes (eg, AN 69) and concomitantly treated with ACE inhibitors. These patients should be offered to change their dialysis membranes to a different type of membrane or use a different class of antihypertensive drug.
Desensitization. Patients taking ACE inhibitors during desensitization therapy (for example, to hymenoptera venom) develop persistent anaphylactoid reactions. These reactions were avoided in such patients by temporarily stopping the use of ACE inhibitors, but after careless re-use of the drug, the reactions were restored.
Liver failure. Very rarely, ACE inhibitors have been associated with a syndrome that begins with cholestatic jaundice and rapidly progresses to necrosis and (sometimes) death. The mechanism of this syndrome has not been identified. Patients who develop jaundice or significant elevations in liver enzymes while taking lisinopril should discontinue the drug and receive appropriate medical attention.
Neutropenia/agranulocytosis. Cases of neutropenia/agranulocytosis, thrombocytopenia and anemia have been reported in patients receiving ACE inhibitors. In patients with normal renal function and in the absence of other complicating factors, neutropenia is rare. After stopping the ACE inhibitor, neutropenia and agranulocytosis are reversible. Lisinopril should be used with extreme caution in patients with collagen vascular disease, as well as in patients receiving immunosuppressive therapy, treatment with allopurinol or procainamide, or a combination of these complicating factors, especially in the presence of impaired renal function. When using the drug in such patients, it is recommended to periodically monitor the number of leukocytes in the blood and warn the patient to report any signs of infection.
Cough. Cough may occur after using ACE inhibitors. Usually the cough is non-productive and stops after discontinuation of therapy. Cough caused by ACE inhibitors should be considered in the differential diagnosis of cough as one of the possible options.
Surgical interventions/anesthesia. In patients undergoing general surgery or anesthesia with agents that cause hypotension, lisinopril may block the formation of angiotensin II following compensatory renin secretion. If arterial hypotension occurs due to this mechanism, it is necessary to adjust the level of blood volume.
Hyperkalemia. Several cases of increased serum potassium levels have been reported in patients treated with ACE inhibitors, including lisinopril. Patients at high risk of developing hyperkalemia include those with renal insufficiency, diabetes mellitus, or those concomitantly using potassium supplements, potassium-sparing diuretics or potassium-containing salt substitutes, or patients taking other drugs that increase serum potassium levels (eg, heparin). If concomitant use of these drugs is considered appropriate, regular monitoring of serum potassium levels is recommended.
Patients with diabetes mellitus. In diabetic patients taking oral antidiabetic agents or insulin, careful glycemic control should be exercised during the first month of ACE inhibitor therapy.
Anaphylactoid reactions occurring during low-density lipoprotein (LDL) apheresis. Since the use of ACE inhibitors during LDL apheresis with dextran sulfate can lead to anaphylactic reactions that can be life-threatening, ACE inhibitors should be temporarily discontinued before each use.
Race. ACE inhibitors may cause more severe angioedema in dark-skinned patients than in Caucasian patients. Also, in this group of patients, the hypotensive effect of lisinopril is less pronounced due to the predominance of low renin fractions.
Lithium. The combination of lithium and lisinopril is not recommended.
Dual blockade of the renin-angiotensin-aldosterone system (RAAS). Dual blockade of the RAAS is associated with an increased risk of hypotension, hyperkalemia and renal dysfunction (including acute renal failure) compared with monotherapy. Dual blockade of the RAAS using an ACEI, ARB II, or aliskiren cannot be recommended in any patient, especially in patients with diabetic nephropathy.
In some cases, when the combined use of ACE inhibitors and ARB II is absolutely indicated, careful supervision by a specialist and mandatory monitoring of renal function, water and electrolyte balance, and blood pressure are necessary. This also applies to the prescription of candesartan or valsartan as additional therapy to ACE inhibitors in patients with heart failure. Carrying out double blockade of the RAAS under the careful supervision of a specialist and mandatory monitoring of renal function, water-electrolyte balance and blood pressure is possible in patients with chronic heart failure with intolerance to aldosterone antagonists (spironolactone), who have persistence of symptoms of chronic heart failure, despite other measures adequate therapy.

Release form: Solid dosage forms. Pills.

General characteristics. Compound:

Pharmacological properties:

Indications for use:

Important! Get to know the treatment

Directions for use and dosage:

Features of application:

Side effects:

Interaction with other drugs:

Contraindications:

Overdose:

Storage conditions:

List B. In a dry place, protected from light, at a temperature not exceeding 25 °C. Keep out of the reach of children. Shelf life: 2 years. You should not take the drug after the expiration date.

Vacation conditions:

On prescription

Package:

Tablets of 5, 10 or 20 mg. 10 tablets per blister pack made of polyvinyl chloride film and aluminum foil; 20 or 30 tablets in a light-protective glass jar or in a polymer jar or in a polymer bottle; Each jar or bottle or 1, 2 or 3 blisters along with instructions for use are placed in a cardboard pack.

10 pcs in blister; in a cardboard pack there are 3, 5 or 10 blisters; or in a blister 14 pcs.; There are 2 blisters in a cardboard pack.

Description of the dosage form

Round, biconvex tablets of white color with a dividing notch in the middle on both sides and an imprint on the top, respectively: “2.5”, “5”, “10” and “20”.

Lisinopril: Indications

Arterial hypertension, chronic heart failure (as an adjuvant in case of insufficient effectiveness of potassium-sparing diuretics or, if necessary, in combination with digitalis preparations), acute myocardial infarction with stable cardiovascular parameters (patients with stable hemodynamic parameters with SBP above 100 mm Hg. Art., serum creatinine level below 177 µmol/l (2 mg/dl) and proteinuria less than 500 mg/day) in addition to standard treatment of myocardial infarction, preferably in combination with nitrates.

Lisinopril: Contraindications

Hypersensitivity to lisinopril, other components of the drug or other ACE inhibitors; renal artery stenosis, bilateral or unilateral with a solitary kidney; predisposition to facial edema (hereditary/idiopathic angioedema and angioedema as a result of treatment with ACE inhibitors in history, see “Precautions”; condition after kidney transplantation; severe renal impairment (severe renal failure: creatinine Cl less than 30 ml/min) ; hemodialysis; aortic or mitral stenosis or other disorder of blood outflow from the left side of the heart, including hypertrophic cardiomyopathy, with significant circulatory disorders; unstable cardiovascular parameters (hemodynamically unstable state) after acute myocardial infarction; SBP 100 mm Hg. century or lower before starting lisinopril therapy; cardiogenic shock; breastfeeding; pregnancy; concomitant use of poly(acrylonitrile, sodium 2-methylallyl sulfonate) high-flux membranes (eg AN 69) during emergency dialysis, due to the risk of life-threatening increased reaction sensitivity (anaphylactic reaction) up to shock.

The combination of lisinopril with poly(acrylonitrile sodium 2-methylallyl sulfonate) should be avoided by using other drugs (non-ACE inhibitors) for the treatment of hypertension, heart failure or other dialysis membranes.

Use during pregnancy and breastfeeding

Use during pregnancy is contraindicated. Before starting treatment, women of childbearing age should ensure that they are not pregnant. During treatment, women should take precautions against pregnancy. If pregnancy does occur during treatment, it is necessary, in accordance with the doctor’s recommendations, to replace the drug with another one that is less dangerous for the child, since the use of Lisinopril Stada tablets, especially in the last 6 months of pregnancy, can harm the fetus.

ACE inhibitors can be excreted in breast milk. Their effect on breastfed children has not been studied. Therefore, breastfeeding should be stopped during treatment.

Directions for use and doses

Inside, as a rule, once in the morning, regardless of meals, with a sufficient amount of liquid (for example, a glass of water).

Arterial hypertension: initial dose - 5 mg/day, in the morning. Dose selection is carried out until optimal blood pressure is achieved. The dose of the drug should not be increased earlier than after 3 weeks. Usually the maintenance dose is 10–20 mg 1 time per day. It is allowed to take a single dose - 40 mg 1 time per day.

For renal dysfunction, heart failure, intolerance to diuretic withdrawal, hypovolemia and/or salt deficiency (for example, as a result of vomiting, diarrhea or diuretic therapy), severe or renovascular hypertension, as well as for elderly patients, a low initial dose of 2.5 mg 1 time is required per day in the morning.

Heart failure (can be used in combination with diuretics and digitalis preparations): initial dose - 2.5 mg 1 time per day in the morning. The maintenance dose is selected in stages, increasing the dose by 2.5 mg. The dose is increased slowly, depending on the patient's individual response. The interval between dose increases should be at least 2, preferably 4 weeks. The maximum dose is 35 mg.

Acute myocardial infarction when hemodynamically stable (should be given in addition to nitrates, such as IV or skin patches, and in addition to the usual standard treatment for myocardial infarction): Lisinopril should be started within 24 hours of the onset of symptoms provided that the patient’s hemodynamic parameters are stable. The first dose is 5 mg, then another 5 mg after 24 hours and 10 mg after 48 hours, then at a dose of 10 mg/day. With low SBP (<120 мм рт. ст.) на начальном этапе терапии или в первые 3 дня после инфаркта следует назначать пониженную дозу - 2,5 мг.

In case of arterial hypotension (SBP below 100 mm Hg), the daily maintenance dose should not exceed 5 mg and, if necessary, can be reduced to 2.5 mg. If, despite reducing the daily dose to 2.5 mg, arterial hypotension (SBP below 90 mm Hg for more than 1 hour) persists, lisinopril should be discontinued.

The duration of maintenance therapy is 6 weeks. The minimum maintenance daily dose is 5 mg. For symptoms of heart failure, lisinopril therapy is not canceled.

Lisinopril is compatible with concomitant IV or cutaneous (patch) administration of nitroglycerin.

Dosage for moderately reduced renal function (creatinine clearance 30–70 ml/min) and for elderly patients (over 65 years): initial dose - 2.5 mg/day, in the morning; maintenance dose (depending on the adequacy of blood pressure control) - 5–10 mg/day. The maximum daily dose should not exceed 20 mg.

To facilitate individual selection of the dose of Lisinopril Stada 2.5 tablets; 5; 10 and 20 mg have a dividing notch (for the convenience of dividing the tablets into 2 or 4 equal parts).

The duration of treatment is determined by the attending physician.

Lisinopril: Side effects

The cardiovascular system: sometimes, especially at the beginning of therapy or when increasing the dose of lisinopril and/or diuretics, an excessive decrease in blood pressure is possible. This is most likely in patients with salt or fluid deficiency after treatment with diuretics, in patients with heart failure and severe or renovascular hypertension. Symptoms include dizziness, general weakness, blurred vision and (sometimes) loss of consciousness (fainting).

There are isolated reports of the following side effects of ACE inhibitors associated with a severe drop in blood pressure: tachycardia, palpitations, arrhythmia, chest pain, angina pectoris, myocardial infarction, transient decrease in cerebral circulation, stroke.

When lisinopril is prescribed to patients with acute myocardial infarction, especially in the first 24 hours, 2nd or 3rd degree AV block and/or severe arterial hypotension and/or renal failure, and in rare cases, cardiogenic shock may develop.

During therapy with ACE inhibitors, isolated cases of increased vascular spasms in Raynaud's syndrome have been noted.

Kidneys: development or intensification of symptoms of renal failure, in some cases - up to acute renal failure. Rare cases of proteinuria have been reported, sometimes in combination with deterioration of renal function.

Respiratory system: dry cough, sore throat, hoarseness and bronchitis; Difficulty breathing, sinusitis, rhinitis, bronchospasm/asthma, pulmonary infiltration, stomatitis, glossitis and dry mouth are rarely observed. The cough is usually persistent, without mucus, and goes away after stopping the drug. In isolated cases, angioedema of the larynx, throat and/or tongue led to narrowing of the airways with a fatal outcome (see “Precautions”). There are isolated reports of cases of alveolitis (chronic eosinophilic pneumonia).

Gastrointestinal tract/liver: nausea, stomach pain, rarely - vomiting, diarrhea, constipation, loss of appetite.

During therapy with ACE inhibitors, a syndrome has occasionally been observed that begins with cholestatic jaundice, progressing to liver necrosis, which can be fatal. The mechanism of this syndrome is unknown. If jaundice occurs during therapy with ACE inhibitors, discontinuation of the drug and medical monitoring of the patient's condition are necessary.

During therapy with ACE inhibitors, isolated cases of liver dysfunction, hepatitis, liver failure, pancreatitis and intestinal obstruction have been reported.

Skin, blood vessels: allergic skin reactions (rash, rarely - urticaria, itching, as well as angioedema of the face, lips and/or limbs). There have been isolated reports of severe skin reactions, including pemphigus, erythema multiforme, exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis (Lyell's syndrome).

Skin reactions may be accompanied by fever, myalgia, arthralgia, vasculitis and changes in a number of laboratory parameters (eosinophilia, leukocytosis and/or positive test for antinuclear antibodies).

If a severe skin reaction is suspected, immediate consultation with a specialist and discontinuation of lisinopril is necessary.

During therapy with ACE inhibitors, isolated cases of psoriasis-like skin reactions, photosensitivity reactions, flushing, increased sweating, hair loss, and nail detachment (onycholysis) have been reported.

CNS: headache and fatigue, less commonly - drowsiness, depression, sleep disturbance, impotence, tingling sensation, peripheral neuropathy (including paresthesia, imbalance and muscle cramps), increased nervousness, confusion, tinnitus, blurred vision and disturbance (dysgeusia) or temporary loss (ageusia) of taste sensitivity.

Laboratory test data (urine, blood): decrease in hemoglobin level, hematocrit, white blood cell count or platelet count. In rare cases (mainly in patients with reduced renal function, connective tissue diseases or receiving allopurinol, procainamide or some immunosuppressants) - anemia, thrombocytopenia, neutropenia, eosinophilia, in rare cases - agranulocytosis or pancytopenia.

There are isolated reports of hemolytic anemia in patients with congenital deficiency of glucose-;6-phosphate dehydrogenase.

In rare cases, mainly in patients with renal dysfunction, severe heart failure and renovascular hypertension, there may be an increase in the level of urea, creatinine and potassium ions and a decrease in the level of sodium ions in the blood serum. In patients with diabetes mellitus, hyperkalemia is possible.

In special cases, increased proteinuria may occur (see "Precautions").

There are isolated reports of increased levels of liver enzymes and bilirubin.

Overdose

Symptoms: severe arterial hypotension, shock, bradycardia, electrolyte imbalance and renal failure.

If you suspect an overdose, consult a doctor immediately.

Treatment: if the overdose has occurred recently, then in the first 30 minutes measures should be taken to prevent the absorption of the drug, for example, gastric lavage, administration of a drug that binds the active substance (absorbent), and sodium sulfate. The usual treatment is the administration of saline, possibly hemodialysis. After an overdose, the patient's condition must be carefully monitored, preferably in an intensive care unit. Serum electrolyte and creatinine concentrations should be measured frequently.

Interaction

Antihypertensive drugs, especially diuretics, enhance the hypotensive effect (in patients receiving diuretics, especially if treatment with diuretics has been started recently, with the additional administration of lisinopril, a drop in blood pressure is sometimes possible).

Potassium-sparing diuretics may further increase potassium levels, especially in patients with reduced renal function. Potassium-sparing diuretics, such as spironolactone, triamterene, or amiloride, potassium supplements, or potassium-containing dietary supplements may significantly increase serum potassium ion concentrations (if such medications are associated with preexisting hypokalemia, they should be used with caution and serum potassium levels should be carefully monitored). ACE inhibitors reduce the excretion of potassium ions from the body caused by diuretics.

Painkillers and NSAIDs (acetylsalicylic acid, indomethacin) may weaken the hypotensive effect of lisinopril.

Lisinopril and other drugs that increase the excretion of sodium ions from the body may reduce the excretion of lithium (when treated with lithium salts, careful monitoring of the concentration of lithium in the blood serum is necessary).

Anesthetic and hypnotic drugs, narcotic substances enhance the hypotensive effect of lisinopril (it is necessary to inform the anesthesiologist about taking Lisinopril Stada tablets).

Sympathomimetics may reduce the hypotensive effect of ACE inhibitors.

Concomitant use of allopurinol, drugs that inhibit the body's defense response (cytostatics, immunosuppressants, systemic glucocorticoids) and procainamide increases the risk of developing leukopenia.

ACE inhibitors may increase blood sugar levels, reducing the effect of antidiabetic drugs, especially during the first week of combination therapy.

Antacids may reduce the bioavailability of ACE inhibitors.

ACE inhibitors enhance the effects of alcohol. Alcohol enhances the hypotensive effect of ACE inhibitors.

Sodium chloride reduces the effectiveness of lisinopril in arterial hypertension and heart failure.

Precautionary measures

Treatment with lisinopril for chronic heart failure should be started in a hospital setting with combination therapy with diuretics or diuretics in high doses (for example, more than 80 mg of furosemide), fluid or salt deficiency (hypovolemia or hyponatremia: serum sodium less than 130 mmol/l), low blood pressure , unstable heart failure, reduced renal function, therapy with high doses of vasodilators, patient age over 70 years.

The concentration of electrolytes and creatinine in the blood serum and blood cell counts should be monitored, especially at the beginning of therapy and in risk groups (patients with renal failure, connective tissue diseases), as well as with the simultaneous use of immunosuppressants, cytostatics, allopurinol and procainamide.

Arterial hypotension. The drug can cause a sharp decrease in blood pressure, especially after the first dose. Symptomatic hypotension in patients with high blood pressure without complications is rare. Symptomatic hypotension occurs more often in patients with electrolyte or fluid deficiency, receiving diuretics, following a low-salt diet, after vomiting or diarrhea, or after hemodialysis. Symptomatic hypotension has been observed primarily in patients with chronic heart failure with or without resulting renal failure, as well as in patients receiving high doses of loop diuretics, hyponatremia or impaired renal function. In such patients, therapy should be initiated under strict medical supervision, preferably in a hospital setting, with low doses and dosage adjustments should be made with caution. At the same time, monitoring of renal function and serum potassium levels is necessary. If possible, treatment with diuretics should be discontinued.

Caution is also necessary in patients with angina or cerebral vascular disease, in whom an excessive decrease in blood pressure can lead to myocardial infarction or stroke.

The risk of symptomatic hypotension during lisinopril therapy can be reduced by discontinuing the diuretic before starting lisinopril treatment.

If arterial hypotension occurs, the patient should be placed down, given fluids, or given intravenous fluid (fluid replacement). Atropine may be required to treat associated bradycardia. After successful elimination of arterial hypotension caused by taking the first dose of the drug, there is no need to abandon the subsequent careful increase in dose. If arterial hypotension in a patient with heart failure becomes systematic, a dose reduction and/or discontinuation of the diuretic and/or lisinopril may be required. If possible, diuretic treatment should be discontinued 2–3 days before starting lisinopril therapy.

Arterial hypotension in acute myocardial infarction. In acute myocardial infarction, therapy with lisinopril should not be initiated if, due to previous treatment with vasodilators, there is a risk of further serious deterioration of hemodynamic parameters. This applies to patients with SBP 100 mmHg. Art. and below or with cardiogenic shock. With SBP 100 mm Hg. Art. and below the maintenance dose should be reduced to 5 mg or 2.5 mg. In acute myocardial infarction, taking lisinopril can lead to severe arterial hypotension. In case of persistent arterial hypotension (SBP less than 90 mm Hg for more than 1 hour), lisinopril therapy should be discontinued.

In patients with chronic heart failure after acute myocardial infarction, lisinopril should be prescribed only if hemodynamic parameters are stable.

Renovascular hypertension/renal artery stenosis (see “Contraindications”). In renovascular hypertension and bilateral (or unilateral in the case of a solitary kidney) renal artery stenosis, the use of lisinopril is associated with an increased risk of excessive reduction in blood pressure and renal failure. This risk may be exacerbated by the use of diuretics. Even in patients with unilateral renal artery stenosis, renal failure may be accompanied by only minor changes in serum creatinine levels. Therefore, treatment of such patients should be carried out in a hospital under close medical supervision, starting with a low dose, and increasing the dose should be gradual and careful. During the first week of therapy, diuretic treatment should be interrupted and renal function monitored.

Renal dysfunction. Use with caution in patients with reduced renal function. Such patients require a lower dose or a longer interval between doses (see "Dosage and Administration").

Reports of an association between lisinopril therapy and renal failure relate to patients with chronic heart failure or existing renal dysfunction (including renal artery stenosis). With timely diagnosis and proper treatment, renal failure associated with lisinopril therapy is usually reversible.

In some patients with arterial hypertension without obvious renal dysfunction, an increase in blood urea and creatinine was observed during simultaneous therapy with lisinopril and diuretics. In this situation, it may be necessary to reduce the dose of the ACE inhibitor or discontinue the diuretic, and the possible presence of undiagnosed renal artery stenosis should also be considered.

Lisinopril therapy for acute myocardial infarction should not be prescribed to patients with signs of renal dysfunction: serum creatinine concentration more than 177 µmol/l (2 mg/dl) and/or proteinuria more than 500 mg per day. Lisinopril should be discontinued if renal dysfunction develops during therapy (serum creatinine Cl<30 мл/мин или удвоение уровня креатинина в сыворотке крови по сравнению с его уровнем до лечения).

Elevated serum potassium levels (hyperkalemia). Lisinopril therapy may lead to increased levels of potassium ions in the blood serum (hyperkalemia), especially in the presence of existing renal or heart failure. Prescribing additional therapy with potassium-sparing diuretics or potassium supplements is undesirable, because this can cause a significant increase in serum potassium ion levels. However, if therapy is considered appropriate, regular monitoring of serum potassium levels is necessary during treatment.

Elderly patients. In elderly patients, the effect of ACE inhibitors may be more pronounced than in younger patients. Therefore, treatment of elderly patients should be carried out with caution. For patients over 65 years of age, an initial dose of lisinopril of 2.5 mg/day is recommended, as well as monitoring of blood pressure and renal function.

Children. The effectiveness and safety of lisinopril in children has not been sufficiently studied, so its use is not recommended.

Primary hyperaldosteronism. In primary aldosteronism, antihypertensive drugs whose action is based on inhibition of the renin-angiotensin system are usually ineffective, so the use of lisinopril is not recommended.

Proteinuria. Rare cases of proteinuria have been reported, especially in patients with reduced renal function or after taking sufficiently high doses of lisinopril. For clinically significant proteinuria (more than 1 g/day), the drug should be used only after careful comparison of the expected benefits and potential risks and with regular monitoring of clinical and laboratory parameters.

LDL pheresis/desensitization. During LDL pheresis using dextran sulfate, concomitant therapy with ACE inhibitors can lead to life-threatening anaphylactic reactions. These reactions (for example, a drop in blood pressure, difficulty breathing, vomiting, allergic skin reactions) are also possible when lisinopril is prescribed against the background of desensitizing therapy for insect bites (for example, bees or wasps).

If LDL pheresis or desensitization therapy for insect bites is necessary, lisinopril should be temporarily replaced with another drug (but not an ACE inhibitor) for the treatment of hypertension or heart failure.

Tissue swelling/angioedema (see “Contraindications”). There are rare reports of angioedema of the face, extremities, lips, tongue and nasopharynx in patients receiving ACE inhibitors, including lisinopril. Edema can develop at any stage of therapy, which in such cases should be stopped immediately and the patient's condition monitored.

If the swelling is limited to the face and lips, it usually goes away without treatment, although antihistamines may be used to relieve symptoms.

The risk of developing angioedema during therapy with ACE inhibitors is higher in patients who have a history of angioedema not associated with the use of ACE inhibitors.

Angioedema of the tongue and nasopharynx is life-threatening. In this case, emergency measures are indicated, including immediate subcutaneous administration of 0.3–0.5 mg of epinephrine or slow intravenous administration of 0.1 mg of epinephrine while monitoring ECG and blood pressure. The patient must be hospitalized. Before discharge, the patient should be observed for at least 12–24 hours until all symptoms disappear completely.

Aortic stenosis/hypertrophic cardiomyopathy. ACE inhibitors should be prescribed with caution to patients with obstruction of blood outflow from the left ventricle. In case of hemodynamically significant obstruction, lisinopril is contraindicated.

Neutropenia/agranulocytosis. Rare cases of neutropenia or agranulocytosis have been reported in patients with arterial hypertension receiving ACE inhibitors. They were rarely observed in uncomplicated arterial hypertension, but were more common in patients with renal failure, especially with concomitant lesions of vascular or connective tissues (for example, systemic lupus erythematosus or dermatosclerosis) or with simultaneous therapy with immunosuppressants. Regular monitoring of blood leukocytes is indicated for such patients. After discontinuation of ACE inhibitors, neutropenia and agranulocytosis disappear.

If there is an increase in body temperature, enlarged lymph nodes and/or sore throat during treatment, you should immediately consult a doctor and determine the concentration of leukocytes in the blood.

Surgical interventions/general anesthesia. In patients undergoing major surgery and receiving general anesthesia with drugs that lower blood pressure, lisinopril blocks the formation of angiotensin II due to compensatory secretion of renin. If arterial hypotension develops as a result, it can be corrected by replenishing fluid volume (see “Interactions”).

In case of malignant hypertension or chronic heart failure, the initiation of therapy, as well as dose changes, should be done in a hospital setting.

If you take the drug at a dose lower than prescribed or skip a dose of the drug, it is unacceptable to double the dose at the next dose. Only a doctor can increase the dose.

In case of temporary interruption or cessation of therapy in patients with heart failure, symptoms may reappear. Do not interrupt treatment without consulting your doctor.

There are no studies of the effect of this drug on the ability to drive vehicles. However, one should take into account the possibility of impaired ability to drive vehicles and machinery, as well as to work without reliable support due to dizziness and increased fatigue that sometimes occur.