Lisinoton, tablets 5 mg 28 pcs

Lysinoton is an ACE inhibitor and reduces the formation of angiotensin II from angiotensin I. Reduction of angiotensin II leads to a direct reduction of aldosterone release. Reduces bradykinin degradation and increases prostaglandin synthesis.

Recreases RPS, BP, preload, pulmonary capillary pressure, causes an increase in the minute blood volume and increases myocardial tolerance to exercise in patients with chronic heart failure. Dilates arteries more than veins.

Some effects are explained by the effect on tissue renin-angiotensin systems. Long-term use reduces myocardial hypertrophy and resistive arterial wall hypertrophy. It improves the blood supply to the ischemic myocardium.

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

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

When the drug is abruptly withdrawn, no pronounced increase in BP was observed.

Lysinoton decreases albuminuria. In patients with hyperglycemia it normalizes the function of the damaged glomerular endothelium. It does not affect the blood glucose concentration in patients with diabetes mellitus and does not lead to increased incidence of hypoglycemia.

Indications

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

Pharmacological effect

Lisinoton is 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 peripheral vascular resistance, blood pressure, 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 more 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.

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

After a single dose of the drug, the antihypertensive effect develops after 1 hour, reaches a maximum after 6-7 hours and persists for 24 hours. The duration of the effect also depends on the size of the dose taken. 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.

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

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

Special instructions

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

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

In such patients, treatment with Lisinoton should be started under the strict supervision of a physician (with caution in selecting the dose of the drug and diuretics).

Similar rules should be followed when prescribing Lisinoton to patients with coronary heart disease or cerebrovascular insufficiency, in whom a sharp decrease in blood pressure can lead to myocardial infarction or stroke.

A transient hypotensive reaction is not a contraindication for taking the next dose of the drug.
When using Lisinoton, some patients with chronic heart failure, but with normal or low blood pressure, may experience a decrease in blood pressure, which is usually not a reason to stop treatment.

Before starting treatment with Lisinoton, if possible, the sodium concentration should be normalized and/or the lost fluid volume should be replaced, and the effect of the initial dose of Lisinoton on the patient should be carefully monitored.

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

In acute myocardial infarction, the use of standard therapy (thrombolytics, acetylsalicylic acid, beta-blockers) is indicated. It is possible to use Lisinoton in conjunction with intravenous administration or with the use of therapeutic transdermal nitroglycerin systems.

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

In elderly patients, the use of standard doses leads to higher concentrations of the drug in the blood, so special care is required when determining the dose, despite the fact that no differences in the antihypertensive effect of Lisinoton were identified in elderly and young patients.

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

When using the drug under dialysis conditions with a polyacryl-nitrile membrane, anaphylactic shock may occur, so either a different type of dialysis membrane or the prescription of other antihypertensive drugs is recommended.

Impact on the ability to drive vehicles and operate machinery

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

Active ingredient

Lisinopril

Composition

The tablets are round, biconvex, white, scored.

Active ingredient:

Lisinopril (dihydrate) 5 mg per tablet.

Excipients:

Mannitol.
Calcium hydrogen phosphate dihydrate.
Pregelatinized corn starch.
Croscarmellose sodium.
Magnesium stearate.

Pregnancy

The use of Lisinoton during pregnancy is contraindicated. Lisinopril crosses the placenta. If pregnancy is established, the drug should be stopped as soon as possible.

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

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

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

Contraindications

History of angioedema (including with the use of ACE inhibitors).
Hereditary Quincke’s edema.
Age up to 18 years (efficacy and safety have not been established).
Hypersensitivity to lisinopril or other ACE inhibitors.

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

Side Effects

From the cardiovascular system: often – orthostatic hypotension, chest pain (1-3%); rarely (<1%) - marked decrease in blood pressure, palpitations, tachycardia, myocardial infarction, cerebrovascular stroke in patients with an increased risk of the disease due to a marked decrease in blood pressure.From the side of the central nervous system: often – dizziness, headache (5-6%), weakness; rarely (<1%) - increased fatigue, drowsiness, convulsive twitching of the muscles of the limbs and lips, asthenic syndrome, mood lability, confusion, decreased potency.From the digestive system: often – nausea, vomiting, diarrhea; rarely (<1%) - dry mouth, anorexia, dyspepsia, taste changes, abdominal pain, pancreatitis, hepatocellular or cholestatic jaundice, hepatitis.From the respiratory system: often (3%) – dry cough.From the hematopoietic system: possible – leukopenia, neutropenia, agranulocytosis, thrombocytopenia, with long-term treatment – a slight decrease in the concentration of hemoglobin and hematocrit, erythrocytopenia.From the immune system: (0.1%) angioedema (face, lips, tongue, larynx or epiglottis, upper and lower extremities); rarely (<1%) - a syndrome that includes accelerated ESR, arthralgia and the appearance of antinuclear antibodies.From the urinary system: rarely (<1%) - impaired renal function, oliguria, anuria, acute renal failure, uremia, proteinuria.Dermatological reactions: often – skin rash; rarely (<1%) - urticaria, increased sweating, itching, alopecia.Laboratory indicators: hyperkalemia, azotemia, hyperuricemia, hyperbilirubinemia, increased activity of liver enzymes (especially if there is a history of kidney disease, diabetes mellitus and renovascular hypertension).Other: rarely (< 1%) - myalgia, fever, impaired fetal development.

Interaction

When used simultaneously with diuretics, lisinopril reduces potassium excretion.

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

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

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

When used simultaneously with NSAIDs (including indomethacin), estrogens, and adrenergic stimulants, the antihypertensive effect of lisinopril is reduced.

When used concomitantly with lithium, the excretion of lithium may be reduced, so the concentration of lithium in the blood serum should be regularly monitored.

When used simultaneously with antacids and cholestyramine, the absorption of lisinopril from the gastrointestinal tract is reduced.
With simultaneous use, ethanol enhances the effect of lisinopril.

Overdose

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

Treatment: if necessary, carry out symptomatic therapy (iv fluid administration, control and normalization of blood pressure, water and electrolyte balance).

Lisinopril is removed from the body by hemodialysis.

Storage conditions

At a temperature not exceeding 25 °C

Shelf life

3 years

Manufacturer

Actavis Ltd, Malta