Vitopril 5 mg tablets № 30

Vitopril (VITOPRIL) user manual

Composition

active ingredient: lisinopril dihydrate;

1 tablet 2.5 mg contains lisinopril dihydrate 2.723 mg in transfers to lisinopril 2.5 mg 1 tablet 5 mg contains lisinopril dihydrate 5.445 mg in terms of lisinopril 5 mg 1 tablet 10 mg contains lisinopril dihydrate 10,890 mg, calculated on lisinopril 10 mg 1 tablet of 20 mg contains lisinopril dihydrate 21,780 mg in terms of lisinopril 20 mg
excipients: calcium hydrophosphate, corn starch, corn starch, silicon dioxide colloid, magnesium stearate, mannit (E 421).

Dosage form

Pills.

Basic physical and chemical properties:

white, round, biconvex with embossed "2.5" or "5", or "10", or "20" on the one hand according to dosing and incision on both sides (for dosages of 2.5 mg or 5 mg) and crosswise notching on both sides (for dosages of 10 mg or 20 mg).

Pharmacological group

ACE inhibitors (ACE), monocomponent. The ATX code is C09A A03.

Pharmacological properties

Pharmacodynamics.

Lizinopril reduces the level of angiotensin-II and aldosterone in the blood plasma, while simultaneously increasing the concentration of the bradykinin vasodilator. Lizinopril causes a decrease in peripheral vascular resistance and arterial pressure, the minute volume of the heart can increase at a constant heart rate, and kidney blood flow may also increase.

The arterial pressure begins to decrease after 1:00 after ingestion, the maximum hypotensive effect is reached at 6:00.The duration of action of lisinopril (about 24 hours) depends on the dose. With long-term treatment, the effectiveness of the drug is not reduced. With a sharp cessation of treatment, large changes in blood pressure (withdrawal syndrome) does not occur.

Although the primary action of lisinopril is associated with the renin-angiotensin-aldosterone system, the drug is also effective in hypertension, which occurs with a low content of renin.

In addition to a direct reduction in blood pressure, lisinopril reduces albuminuria due to changes in the histology and hemodynamics of the glomerular renal apparatus. In the course of controlled trials, no changes in blood sugar level or an increase in hypoglycemia were observed in patients with diabetes mellitus.

It plays a positive role in restoring the function of damaged endothelium in patients with hyperglycemia.

Pharmacokinetics.

Suction

When oral lisinopril is taken, the maximum serum concentration is reached at 7:00. Judging by the amount excreted in the urine, the average rate of absorption of lisinopril is approximately 25% when taking a dose of 5-80 mg. The variability of indicators between patients can be from 6% to 60%. The bioavailability of lisinopril decreases to about 16% in patients with NYHA class II-IV heart failure. Eating does not affect the absorption of lisinopril.

Distribution

In addition to binding with ACE, lisinopril does not bind to other blood plasma proteins. As studies on animals show, lisinopril in a small amount penetrates the blood-brain barrier.

Conclusion

Lizinopril is not metabolized and is excreted exclusively by the kidneys in unchanged form. After increasing the dose, the effective half-life is 12.6 hours. The clearance of lisinopril is approximately 50 ml / min in healthy volunteers. After the withdrawal of a significant amount of the free active, the slower removal of the fraction associated with the ACE follows.

Impaired liver function

In patients with cirrhosis of the liver, suction of lisinopril is slowed by approximately 30% (as determined in urinary excretion) depending on the liver function disorder. On the other hand, its withdrawal is reduced and leads to an increase in the effectiveness of lisinopril by 50%.

Impaired renal function

Violation of kidney function reduces the excretion of lisinopril, which is excreted by the kidneys. This decrease is of clinical significance only when the level of glomerular filtration is less than 30 ml / min. If the creatinine clearance is 30-80 ml / min, the average area under the curve increases only by 13%. If the creatinine clearance is from 5 to 30 ml / min, despite this, the average area under the curve increases 4.5 times compared with the norm. Lizinopril can be removed by dialysis.

Heart failure

In the presence of heart failure, the effect of lisinopril increases (AUC increases by about 25%). On the other hand, the bioavailability of lisinopril is reduced to about 16% in patients with heart failure.

Children

The pharmacokinetic profile of lisinopril was studied in 29 patients aged 6 to 16 years suffering from hypertension and in whom the glomerular filtration rate is less than 30 ml / min / 1.73 m 2. When taking a dose of 0.1 to 0.2 mg / kg, the constant concentration of lisinopril in the blood plasma, reached within 6:00, and the degree of absorption based on excretion in the urine, were approximately 28%. The value differed from the values obtained in adult patients. The values of AUC and C max in children in this study coincide with the values obtained in adults.

Elderly patients

In elderly patients, the level of lisinopril is usually higher due to a violation of kidney function AUC approximately 60% higher than in younger patients.

Indications

• Arterial hypertension.
• Symptomatic heart failure.
• Short-term (6 weeks) treatment as a part of combined therapy of acute myocardial infarction (in the first 24 hours) with stable hemodynamics.
• Treatment of initial nephropathy in patients with type II diabetes, arterial hypertension.

Contraindications

• Hypersensitivity to lisinopril or other ACE inhibitors, or one of the constituents of the drug
• angioedema in history, including after the use of ACE inhibitors, idiopathic and hereditary edema Quincke
• primary hyperaldosteronism;
• after kidney transplantation;
• cardiogenic shock
• hypovolemia;
• acute myocardial infarction with unstable hemodynamics (systolic pressure below 90 mm Hg);
• bilateral stenosis of the renal artery or stenosis of the artery of a single kidney
• acute renal failure with increased blood pressure;
• severe heart failure
• severe arterial or renovascular hypertension
• aortic or mitral stenosis or hypertrophic cardiomyopathy with severe hemodynamic disturbances;
• patients with a serum creatinine level ≥ 220 μmol / l;
• simultaneous application of the preparation and high-permeability membranes with polyacrylonitrile sodium-2-methylosulfonate (eg AN 69) in case of urgent dialysis;
• the period of pregnancy and lactation, women planning pregnancy (see the section "Use during pregnancy or lactation").

Interaction with other drugs and other interactions

Diuretics

As a rule, the use of diuretics compatible with Vitopril increases the antihypertensive effect of Vitopril. Especially in those patients for whom diuretic therapy was started recently, there is sometimes a decrease in blood pressure. The risk of symptomatic hypotension during treatment with lisinopril can be reduced by canceling diuretics before starting Vitopril therapy.

It should be very carefully prescribed simultaneously with diuretics, especially patients with kidney disease and elderly people. During treatment, you need to monitor blood pressure and monitor the level of electrolytes (potassium, sodium, chlorine, calcium) and functional renal blood plasma tests in a timely manner.

Potassium-sparing diuretics or potassium preparations

After applying potassium-sparing diuretics, the level of potassium continues to increase, especially in patients with impaired renal function. ACE inhibitors slow the excretion of potassium caused by diuretics. Potassium-sparing diuretics like spironolactone, triamterene or amiloride, as well as potassium preparations and nutritional supplements containing potassium, can significantly increase the level of potassium in the blood serum. In case of need of application of the above-mentioned remedies with available hypokalemia should be carried out with extreme caution and under constant control of potassium level in blood serum.

Antihypertensive drugs

With the simultaneous use of lisinopril with other antihypertensive agents (α-, ß-adrenoreceptor blockers, calcium ion antagonists, angiotensin II receptor blockers), the hypotensive effect of the drug is potentiated.

When combined with other antihypertensive drugs, it is necessary to begin treatment with lisinopril from low doses and carefully monitor blood pressure and pulse (at least 3 times a day) and / or under medical supervision.

Between different representatives of the ACE inhibitor group, cross-sensitivity is possible.

Non-steroidal anti-inflammatory drugs (NSAIDs) (including acetylsalicylic acid ≥ 3 g per day).

Long-term use of NSAIDs may weaken the hypotensive effect of lisinopril. NSAIDs and ACE inhibitors additively affect the increase in potassium in the serum, which can lead to impaired renal function. In some cases, acute renal failure may occur, especially in patients with dehydration, elderly patients.

Analgesics and anti-inflammatory drugs (acetylsalicylic acid, indomethacin, thrombolytics, ß-blockers, nitrates).

Lizinopril can be used simultaneously with acetylsalicylic acid (in cardiac doses), thrombolytic agents, ß-blockers and / or nitrates.

Thrombolytics

When used together with thrombolytic agents (streptokinase, metalase, actilysis), there is a risk of developing arterial hypotension. It is necessary to carefully prescribe lisinopril to patients who received thrombolytic for 6-12 hours after the administration of the latter.

Oral hypoglycemic agents (sulfonylurea derivatives - metformin, biguanides - glibenclamide) and insulin when combined with lisinopril may increase the hypotensive effect in the first weeks of combined therapy.

With simultaneous use with estrogens due to fluid retention in the body, the antihypertensive effect of the drug may decrease.

Lithium preparations

Therapy with lithium preparations and other agents that accelerate the elimination of sodium can lead to a delay in lithium removal. So, when using lithium drugs, the concentration of serum lithium should be under constant control.

Ethanol

ACE inhibitors potentiate the effect of ethanol. Ethanol raises blood pressure, reducing the effect of ACE inhibitors.

Anesthetics, narcotic and hypnotics

When using lisinopril with funds for anesthesia, muscle relaxants with hypotensive effect, narcotic analgesics, hypnotics and antidepressants, the hypotensive effect of the drug increases.

In case of simultaneous use with anesthetics that have an antihypertensive effect, during anesthesia, lisinopril can block the formation of angiotensin II, increasing the (secondary) activity of renin of the blood plasma, which leads to significant fluctuations in blood pressure during the operation. If after taking lisinopril it took less than 72 hours and the need for anesthesia, in the preoperative period or during the operation it is necessary to increase the BCC by assigning salt colloidal, crystalloidal and plasmazamine solutions.

Sympathomimetics

May weaken the hypotensive effect of ACE inhibitors.

Simultaneous use of allopurinol, drugs that suppress the protective reaction of the body (cytostatics, immunosuppressants, systemic glucocorticoids) and procainamide increases the risk of developing leukopenia.

Antidiabetic drugs.

ACE inhibitors can increase the hypoglycemic effect of antidiabetics (insulin, oral hypoglycemic agents) with a risk of hypoglycemia, especially during the first week of joint therapy and in patients with renal insufficiency.

Antacid agents

The intake of antacid agents, colestramine, sorbents reduce the absorption of lisinopril from the gastrointestinal tract, which can reduce the hypotensive effect of the drug. If it is necessary to use sorbents and antacid agents, the latter should be taken 1.5-2 hours before the use of lisinopril.

Sodium chloride

Reduces the hypotensive effect of Vitopril and such that it facilitates heart failure.

Preparations of gold

When using injectable forms of gold (for example, sodium aurothiomalate), nitrioid reactions may occur (symptoms of vasodilation, including redness, nausea, dizziness, hypotension).

Cytotoxic agents

When used with agents, have a myelosuppressive effect, the risk of developing neutropenia and / or agranulocytosis increases.

Allopurinol, cytostatics, immunosuppressants, GCS, procainamide with simultaneous application with lisinopril may lead to the development of leukopenia.

Dialysis

When dialysis therapy and simultaneous use of lisinopril, there is a risk of anaphylactoid reactions when using high-flow polyacrylonitrile metal sulfonate membranes (for example, AN 69).

Other

Lizinopril can be used with glyceroltrinitrate for intravenous or transdermal use.

With simultaneous use of lisinopril with digoxin and nitrates, clinically significant adverse reactions have not been reported.

Application features

To begin therapy Vitoprilum in occasion of a chronic heart failure in stationary conditions is recommended to such categories of patients:

• with combined therapy of diuretics, especially in high doses (eg, furosemide at a dose of 80 mg)
• with saline or deficiency (with hyponatremia with a sodium level of less than 130 mmol / l or with hypovolemia)
• available arterial hypotension;
• with unstable heart failure,
• with decreased renal function

when therapy with high doses of vasodilators;

• patients aged 70 years.

It is necessary to regularly monitor the concentration of serum electrolytes and creatinine, and also periodically perform a blood test at the beginning of therapy and in patients at high risk (with renal failure and in patients with diffuse diseases), as well as in patients taking immunosuppressants, cytostatics, allopurinol and procainamide.

Symptomatic hypotension

Vitopril is able, especially immediately after administration, to cause a sharp drop in blood pressure. Symptomatic hypotension is rarely seen in patients with uncomplicated hypertension, but more often occurs in patients with salt or deficiency caused by diuretic therapy, salt-free diet, vomiting, diarrhea, or dialysis. Symptomatic hypotension is noted mainly in patients with severe heart failure in combination with renal insufficiency resulting from or without it, as well as in patients receiving high doses of loop diuretics with hyponatremia or impaired renal function.

Vitopril should be administered to these patients under the constant supervision of a physician, preferably in a hospital setting, in low doses and with careful dosage adjustment. At the same time, kidney function and serum potassium levels should be monitored. It is recommended, if possible, to stop diuretic therapy.

This fully applies to patients with angina and cerebral angiopathy, in whom a sharp decrease in blood pressure threatens myocardial infarction or stroke.

In case of hypotension, the patient should be placed in a horizontal position and, if possible, orally or corrected by the water balance. In the case of development associated with hypotension, bradycardia shows the use of atropine. After the successful treatment of hypotension caused by the first dose, there remains a need for careful correction of the dose of the drug. If acute arterial hypotension in patients with heart failure symptomatic, there may be a need to reduce the dose and / or cancel therapy with diuretics or Vitopril. If possible, diuretic therapy should be discontinued 2-3 days before Vitopril therapy begins.

The development of symptomatic arterial hypotension is possible in patients with reninvascular hypertension, heart failure or severe arterial hypertension after taking the initial dose of lisinopril.

Transient arterial hypotension is not a contraindication for the treatment with lisinopril, however, it may be necessary to temporarily stop the drug or reduce its dose.

Hypotension with acute myocardial infarction

In case of acute myocardial infarction, Vitopril therapy should not be started, if through preliminary treatment with vasodilator drugs there is a risk of further serious deterioration of hemodynamic parameters. This applies to patients with systolic blood pressure of 100 mm Hg. Art. and below or in the presence of cardiogenic shock. During the first 3 days after the infarction, dosing should be reduced for patients with a systolic blood pressure of 120 mm Hg. Art. or lower.With a systolic blood pressure of 100 mm Hg. Art. or lower the maintenance dose should be reduced to 5 mg or temporarily to 2.5 mg.In acute myocardial infarction receiving Vitoprila may cause severe hypotension. When sustained hypotension (systolic blood pressure less than 90 mmHg. Cm. For more than 1:00) lisinopril treatment should cease.

Patients with severe heart failure after acute myocardial infarction receiving the drug should be administered only when the stability of hemodynamic status.

Aortic stenosis and mitral stenosis / hypertrophic cardiomyopathy

It should be used with caution in patients with ACE inhibitors prevents the outflow of blood from the left ventricle. If hemodynamically significant obstruction Vitopril contraindicated.

Renal insufficiency

For patients with severe renal failure (creatinine levels below 30 ml / min) and the patients who are on dialysis, the drug is contraindicated. Lisinopril used with caution in patients with impaired renal function. Patients in this group require dose reduction or increase in the interval between doses.

On the development of renal failure during therapy Vitoprilom reported mainly in patients with severe cardiac insufficiency or existing renal dysfunction (including renal artery stenosis). With early detection and proper treatment induced renal failure Vitoprilom therapy has temporary reversible.

Some patients with hypertension, uncomplicated symptomatic renal dysfunction, marked increase in the level of urea and creatinine, caused by joint use of Vitoprila and diuretics. In this case may require dose reduction or abolition of ACE inhibitor diuretics, as well as consideration of the possible presence of the identified stenosis of the renal artery.

Treatment of acute myocardial infarction Vitoprilom not indicated for patients with signs of renal dysfunction in which there is increased levels of serum creatinine (above 177 umol / L (2.0 mg / dl) and / or proteinuria of over 500 mg / day. With the development of renal dysfunction during therapy Vitoprilom (creatinine clearance less than 30 mL / min or twice increased levels of serum creatinine when determining to treatment), the drug should be canceled.

There are isolated cases of proteinuria in patients, especially those with reduced kidney function or after administration of high doses of lisinopril. In the case of clinically significant proteinuria (greater than 1 g / day) lisinopril should be applied only after evaluating the therapeutic benefits and the potential risks and with constant monitoring of clinical and biochemical parameters.

If the kidney function (creatinine clearance <80 mL / min) initial dose of lisinopril must be chosen depending on the performance of creatinine clearance (see. Section "Dosage and Administration") and clinical response to treatment. For such patients it is recommended constant monitoring of the concentration of potassium, and creatinine in the blood.

Primary hyperaldosteronism

Patients with primary hyperaldosteronism ACE inhibitors are ineffective, so the use of lisinopril is not recommended.

Edema tissue / angioedema

There have been reports of cases of angioneurotic edema of the face, extremities, lips, tongue, glottis and / or larynx in patients treated with ACE inhibitors, including the drug. Edema may develop at any time during the course of therapy. In such cases, you should immediately stop taking the drug, and the patient should be under constant medical supervision. Edema bounded face and lips, to stabilize the patient's condition and starts in the absence of treatment, but we recommend the use of antihistamines to facilitate symptomatology.

Patients with a history of angioedema not associated with ACE inhibitor therapy, characterized by an increased risk of angioedema with ACE inhibitor therapy.

Angioneurotic edema, tongue, glottis or larynx may be the nature of that life threatening. Immediate measures include subcutaneous administration of 0.3-0.5 mg epinephrine or slow injection of 0.1 mg epinephrine (according to the instructions for use) with constant monitoring ECG and blood pressure. The patient to be hospitalized. For at least 12-24 hours, the patient should be kept under constant supervision until the moment when confidence will complete disappearance of symptoms.

Arterial renal vascular hypertension / renal artery stenosis

In patients with renovascular hypertensive and available unilateral or bilateral renal artery stenosis Vitoprila application leads to the risk of abrupt reduction in blood pressure and renal failure risk is increased in the combined use of diuretics. Even in patients with unilateral renal artery stenosis renal failure may be accompanied by only a slight change in serum creatinine. Therefore, treatment of these patients should be performed in a hospital under close medical supervision, starting with a low dose and a dose increase should be gradual and cautious. In the first week of therapy should be discontinued diuretic treatment and monitoring of renal function.

Anaphylactoid reactions in patients on hemodialysis

Patients on long-term hemodialysis Vitopril contraindicated. When the joint application Vitoprila and field (acrylonitrile, sodium-2-metilalilsulfonat) -vysokoprotochnyh membrane (eg 69 AN) during dialysis or hemofiltration there is the risk of a hypersensitivity reaction (reaction psevdoanafilakticheskoy) until the development of the shock. One of the earliest manifestations of anaphylaxis - swelling of the face, skin flushing, hypotension, and dyspnea. Symptoms develop within minutes after initiation of hemodialysis. We recommend the use of membranes for dialysis or the use of drugs to treat hypertension or heart failure infarction.

LDL-apheresis desensitization

With apheresis low density lipoprotein (LDL) with dextran sulfate. ACE inhibitors can cause anaphylactic reactions which may be life threatening. Anaphylactic reactions, life-threatening (e.g., lowering blood pressure, dizziness, vomiting, allergic skin reaction) can also develop when using Vitoprila background desensitization to insect stings (e.g., bees and wasps).

When the need for LDL - apheresis or desensitization insect bites, the drug must be temporarily replaced with another antihypertensive drug (not ACE inhibitor) which is effective in cardiac insufficiency.

Liver failure

Very rarely, ACE inhibitors is associated with the development of cholestatic jaundice, progressive in fulminant necrosis and (sometimes) death. The mechanism of this disease is unknown. With the development of jaundice or increasing the level of liver enzymes in patients who used the treatment Vitoprilom, discontinue the use of this drug and to conduct appropriate treatment.

Neutropenia / agranulocytosis

Patients receiving ACE inhibitors, noted neutropenia / agranulocytosis, thrombocytopenia and anemia. Neutropenia rarely occurs in patients with normal renal function and no other complicating factors. Neutropenia and agranulocytosis back cases ACE inhibitor. Lisinopril should be used with caution in patients with one or more of the following factors: patients with collagen diseases, with immunosuppressive therapy, patients who receive allopurinol or procainamide, especially in the early stages of renal dysfunction. In some of these patients developed serious infections, which are not always subjected to intensive antibiotic therapy. In applying these patients lisinopril recommended periodic monitoring of white blood cellsand patients should be warned of the need to inform the doctor about any signs of infection.

Ethnicity

ACE inhibitors can cause more pronounced angioedema patients with darker skin than Caucasoid patients. Also in this group of patients hypotensive effect Vitoprila less pronounced predominance of low fractions due to renin.

Cough

There have been cases of occurrence of cough in patients who used the treatment Vitoprilom. It is usually nonproductive cough, persistent and disappears after drug withdrawal. Cough caused by ACE inhibitors, should be considered in the differential diagnosis of cough.

Surgical interventions / anesthesia

Patients in operation and anesthesia agents lowering blood pressure taking the drug blocks the formation of angiotensin II compensation due renin secretion. If hypotension is the result of this mechanism, it should be corrected by the replenishment fluid volume.

The increased potassium level in serum (hyperkalaemia)

In patients with existing kidney or heart failure treatment Vitoprilom can cause hyperkalemia. Treatment of potassium-sparing diuretics or potassium supplements is not recommended because it can lead to a significant increase in the level of potassium in the blood serum. However, if the therapy is shown by these drugs, potassium levels should be monitored regularly during the entire course of therapy.

Elderly patients

Reaction to therapy with ACE inhibitors in elderly patients have been found to exceed those of younger patients. For patients aged 65 years and below the recommended initial dose ( 2.5 mg) Vitoprila with constant control of blood pressure and renal function.

Diabetics

Diabetics take oral antidiabetic medication or insulin, should be carefully monitored blood glucose level for the entire period of treatment with ACE inhibitors.

Lithium

Not recommended for use Vitopril in combination with lithium.

Warning

Patients at high risk group (with the saline and / or aqueous deficiency, for example after dialysis, vomiting, diarrhea accompanying diuretic therapy, and in patients with heart failure or renal hypertension) may develop severe hypotension.

Thus, the compensation recommended salt and volume deficiency before treatment Vitoprilom and / or discontinuation of diuretic therapy for 2-3 days prior to initiation of therapy with ACE inhibitors. In these patients therapy should be started with the lowest dose - 2.5 mg lisinopril once daily 1 in the morning.

must be continuously monitored in these patients is not less than 8:00 - mainly in hospital after the first dose, and after each dose escalation Vitoprila and / or diuretics to avoid uncontrollable sharp decrease in blood pressure. This also applies to patients with angina pectoris or cerebrovascular accident, in which a sharp decrease in blood pressure is fraught with the development of myocardial infarction or stroke.

For patients with malignant hypertension or severe heart failure Vitoprilom begin therapy should be in a hospital.

In case of interruption or discontinuation of the drug in patients with hypertension, blood pressure can rise again, and in patients with heart failure symptoms can recover failure.

Use during pregnancy and lactation

The drug should not be used for pregnant women or women trying to conceive. If during drug treatment confirmed the pregnancy, its use must be stopped immediately and replaced with another drug approved for use for pregnant women.

The ability to influence the reaction rate when driving vehicles or other mechanisms

Study of the effect of the drug on the ability to drive vehicles or other potentially dangerous machinery is not performed. However, we must remember that the ability to drive vehicles or other potentially dangerous machinery or to work without a solid support may be impaired due to dizziness and fatigue.

Dosing and Administration

Vitopril recommended 1 times a day, preferably at the same time. Food does not affect the absorption of lisinopril, however DRUG can be used regardless of the meal. Dosage individual, it should be selected for each individual patient depending on the blood pressure values.

Vitopril 2.5 mg and 5 mg can be broken into two equal parts, Vitopril 10 mg and 20 mg can be broken into four equal parts.

Lisinopril may be used as monotherapy, or in combination with other antihypertensive agents.

Arterial hypertension

The initial dose. Patients with hypertension is recommended to begin treatment with a dose of 10 mg per day. In patients with renovascular hypertension, congestive heart failure or severe hypertension blood pressure can significantly decrease after receiving the initial dose. For such patients, the recommended initial dose of lisinopril is 2.5-5 mg per day and the therapy should be initiated under constant medical supervision. Use of the drug in patients with renal insufficiency should start with small doses.

Supportive dose. The usual effective maintenance dose is 20 mg, taken once a day. Some patients need 2 to 4 weeks of therapy to achieve optimal blood pressure. In the event that a satisfactory therapeutic effect is not achieved, the dose should be gradually increased. The maximum daily dose of lisinopril used in long-term clinical trials was 80 mg.

Dosage for patients taking diuretics

At the beginning of treatment with lisinopril, symptomatic arterial hypotension may occur, usually more often in patients taking diuretics. If possible, the diuretic should be discontinued 2-3 days before the start of treatment with lisinopril.Patients who can not stop using diuretics, treatment with lisinopril should begin with a dose of 5 mg per day. In this case, after taking the first dose, it is recommended that the doctor be observed for several hours (the maximum effect is reached after about 6:00), since symptomatic arterial hypotension may occur. The further dose should be selected depending on blood pressure. If necessary, you can start using the diuretic again.

Dosage for patients with impaired renal function

Dosage for patients with impaired renal function should be selected based on the values of creatinine clearance, as indicated in the table.

CK, ml / min	Initial dose, mg / day
31-80	5-10
10-30	2.5-5
<10 (including patients on dialysis)	2.5 *

* The dose and frequency of application should be adjusted depending on blood pressure.

The maintenance dose depends on the clinical response and is selected with regular monitoring of renal function, potassium and sodium concentrations in the blood.

The maximum daily dose of lisinopril is 40 mg.

Chronic heart failure

Patients with symptomatic heart failure lisinopril should be taken with diuretics, if necessary - with digitalis or ß-blockers.

The initial dose, which must be taken under the supervision of a physician to determine the initial effect on blood pressure, is 2.5 mg per day.

In the future, the dose of the drug should be gradually increased within 2-4 weeks to the usual maintenance dose, most often 5-20 mg 1 time per day, depending on the individual reaction of the patient. The maximum daily dose of lisinopril is 35 mg.

Patients with a high risk of symptomatic hypotension, that is, those who have hyponatremia, or those who took large doses of diuretics, treatment with lisinopril should be performed under the control of kidney function and the level of potassium and sodium in the serum.

Acute myocardial infarction

Patients should receive, according to the situation, standard recommended treatment, such as thrombolytics, aspirin and ß-blockers. Together with lisinopril, intravenous or transdermal nitroglycerin can be used.

The initial dose (the first 3 days after a heart attack). Treatment with lisinopril can begin within 24 hours after the onset of symptoms in the complex therapy of myocardial infarction. Lizinopril can not be taken if the systolic pressure ≤ 100 mm Hg.

If lisinopril is necessary in the first 24 hours after a heart attack, the initial dose should be 5 mg per day, after 24 hours re-appoint 5 mg, after 48 hours - 10 mg per day. In the future, the maintenance dose is 10 mg per day. The duration of the course of treatment is 6 weeks.

At a low systolic pressure (≤ 120 mm Hg.) During the first 3 days after a heart attack, a low dose (2.5 mg / day) is indicated, after which, if the patient's condition allows, you can continue treatment with a larger dose.

Indication for cessation of lisinopril treatment is prolonged arterial hypotension, when after 1:00 after application of the drug the systolic pressure remains below 90 mm Hg. Art.

Supportive dose. The maintenance dose is 10 mg once a day. If hypotension occurs (systolic blood pressure is less than or equal to 100 mm Hg.), You can give a daily maintenance dose of 5 mg with a temporary reduction of up to 2.5 mg, if necessary. With prolonged hypotension (systolic blood pressure less than 90 mm Hg for more than 1:00), lisinopril should be discontinued.

Treatment should last 6 weeks, after which the patient should be reassessed. Patients who develop symptoms of heart failure should continue taking lisinopril (see Dosage for Heart Failure).

Kidney complications of diabetes mellitus

The daily dose of lisinopril for patients with type II diabetes with the initial stage of nephropathy suffering from hypertension is 10 mg once a day. If necessary, the dose may be increased to 20 mg once a day to achieve a diastolic pressure level below 90 mm Hg. Art. in the sitting position. In case of impaired renal function (creatinine clearance <80 ml / min), the initial dose of lisinopril should be selected based on the values of creatinine clearance (see the above table).

Patients with a kidney transplant

There is no experience of using lisinopril in patients after kidney transplantation, therefore, the use of lisinopril is not recommended.

Children

Do not use the drug for children.

Overdose

Depending on the severity of the overdose, the following symptoms may develop: severe hypotension, shock, bradycardia, water-electrolyte disorders, renal failure, hyperventilation, tachycardia, increased heart rate, bradycardia, acute vascular insufficiency, dizziness, anxiety and cough.

Usually, the treatment consists of injecting a saline solution. Lizinopril, the active ingredient of Vitopril tablets, is removed from the blood by hemodialysis. The use of a pacemaker is indicated with bradycardia resistant to therapy. After an overdose, the patient should be under constant medical supervision, mainly in the intensive care unit. It is recommended constant monitoring by laboratory indicators (determination of the level of electrolytes and creatinine in the blood serum).If an overdose has occurred recently, measures should be taken to prevent absorption and promote the removal of the drug (gastric lavage, absorption of absorbents and sodium sulfate) within 30 minutes after using lisinopril. Further therapy is symptomatic.

Adverse Reactions

When using the drug, the following side effects are possible.

On the part of the lymphatic system and blood system: a decrease in the concentrations of hemoglobin and hematocrit, oppression of bone marrow hematopoiesis, anemia, thrombocytopenia, leukopenia, neutropenia, agranulocytosis, hemolytic anemia, lymphadenopathy, autoimmune diseases.

From the side of metabolism: hypoglycemia.

From the endocrine system: inadequate secretion of ADH.

From the side of the nervous system: headache, dizziness, mood changes, paresthesia, taste disorders (dysgeusia), balance disorders, sleep disorders, confusion, depression, loss of consciousness, disorientation, tinnitus and visual acuity.

From the cardiovascular system: orthostatic disorders (including hypotension), accompanied by dizziness, weakness, visual impairment and syncope, acute myocardial infarction, cerebrovascular disorders (as a result of a significant decrease in pressure), a feeling of increased heart rate, tachycardia, Raynaud phenomenon, fainting, proteinuria , arterial hypotension (especially after taking the first dose of the drug in patients with sodium deficiency, dehydration, heart failure), myocardial infarction or stroke (possibly, secondary phenomena to excessive hypotension in high-risk patients).

When using lisinopril in patients with acute myocardial infarction, especially in the first 24 hours, blockade II-III degree, severe arterial hypotension and / or renal dysfunction, cardiogenic shock are possible.

On the part of the respiratory system: cough, rhinitis, bronchospasm, sinusitis, allergic alveolitis / eosinophilic pneumonia, bronchitis, glossitis.

On the part of the digestive tract and liver: diarrhea, nausea, vomiting, abdominal pain, indigestion, dry mouth, pancreatitis, intestinal obstruction, hepatitis, cholestatic or hepatocellular jaundice, hepatic insufficiency, angioedema, liver function.

From the skin and subcutaneous tissue: rash, itching, hypersensitivity reactions / angioedema, face, lips, tongue, larynx and / or extremities, urticaria, alopecia, psoriasis, increased sweating, pemphigus, toxic epidermal necrolysis (Lyell's syndrome), Stevens syndrome -Jonson, exudative erythema multiforme, dermal pseudolymphoma, skin reactions accompanied by fever, myalgia, arthralgia, vasculitis, eosinophilia, leukocytosis and / or positive antinuclear antibody analysis (Ana-titre), increased ESR, rashes, photosensitivity.

From the side of the kidneys and urinary tract: kidney dysfunction, uremia, acute renal failure, oliguria / anuria.

On the part of the reproductive system: impotence, gynecomastia.

Common disorders: obesity, asthenia, arthralgia / arthritis, increased fatigue.

Results of biochemical laboratory indicators: increase in the concentration of urea, creatinine, liver and potassium enzymes in the blood serum, increased bilirubin in blood serum, hyponatremia.

Shelf life

3 years. Do not use after the expiration date.

Storage conditions

Store at a temperature of no higher than 25 ° C (for tablets of 2.5 mg), not more than 30 C (for tablets of 5 mg, 10 mg and 20 mg) in the original packaging. Keep out of the reach of children.

Packaging

10 tablets in a blister, 3 blisters in a cardboard box.

Category of leave

On prescription.