Diroton, pills 20mg, 56pcs

Composition

One tablet contains:

Active ingredients

-Lisinopril 20 mg.

Auxiliary substances

Magnesium stearate,

talc,

mannitol,

corn starch,

calcium hydrophosphate dihydrate.

Pharmacological action

Diroton tablets are an ACE inhibitor.

Reduces the formation of angiotensin II from angiotensin I. A decrease in angiotensin II leads to a direct decrease in the release of aldosterone. Reduces the degradation of bradykinin and increases the synthesis of prostaglandins.

Reduces OPSS, blood pressure, preload, pressure in the pulmonary capillaries, causes an increase in the minute volume of blood and increased myocardial tolerance to stress in patients with chronic heart failure. Dilates the arteries to a greater extent than the veins. Some of the effects are attributed to effects on the tissue renin-angiotensin system. With prolonged use, hypertrophy of the myocardium and arterial walls of the resistive type decreases. Improves blood supply to the ischemic myocardium.

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

The onset of action of the drug – in 1 hour, reaches a maximum in 6-7 hours and persists for 24 hours. The duration of the effect also depends on the amount of the dose taken. With arterial hypertension, the effect is noted in the first days after the start of treatment, a stable effect develops after 1-2 months. When the drug was abruptly discontinued, no significant increase in blood pressure was observed.

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

Indications

-Arterial hypertension (in the form of monotherapy or in combination with other antihypertensive drugs). – Chronic heart failure (as part of a combination therapy for the treatment of patients taking digitalis preparations and / or diuretics). – Acute myocardial infarction (in the first 24 hours with stable hemodynamic parameters to maintain these indicators and prevent left ventricular dysfunction and heart failure). – Diabetic nephropathy (to reduce albuminuria in patients with insulin-dependent diabetes mellitus with normal blood pressure and in patients with non-insulin-dependent diabetes mellitus with arterial hypertension).

Use during pregnancy and lactation

The use of Diroton during pregnancy is contraindicated. Lisinopril penetrates the placental barrier. If pregnancy is established, the drug should be discontinued as soon as possible.

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

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

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

Contraindications

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

Side effects

The most common side effects were dizziness, headache (5-6%), weakness, diarrhea, dry cough (3%), nausea, vomiting, orthostatic hypotension, skin rash, chest pain (1-3%).

The frequency of other adverse reactions is less than 1%.

From the cardiovascular system: marked decrease in blood pressure, chest pain; rarely-orthostatic hypotension, tachycardia, bradycardia, the appearance of symptoms of heart failure, violation of AV conduction, myocardial infarction.

From the digestive system: nausea, vomiting, abdominal pain, dry mouth, diarrhea, dyspepsia, anorexia, taste disorders, pancreatitis, hepatitis (hepatocellular and cholestatic), jaundice (hepatocellular or cholestatic), hyperbilirubinemia, increased activity of hepatic transaminases.

From the skin: urticaria, increased sweating, photosensitization, pruritus, hair loss.

From the central nervous system: lability of mood, impaired concentration, paresthesia, increased fatigue, drowsiness, convulsive twitching of the muscles of the limbs and lips; rarely-asthenic syndrome, confusion.

From the respiratory system: dyspnoea, dry cough, bronchospasm, apnea.

From the hematopoietic system: leukopenia, thrombocytopenia, neutropenia, agranulocytosis, anemia (decreased hemoglobin concentration, hematocrit, erythrocytopenia), with long – term treatment, a slight decrease in hemoglobin and hematocrit is possible, in some cases-agranulocytosis.

Allergic reactions: angioedema of the face, extremities, lips, tongue, epiglottis and / or larynx, intestinal angioedema, vasculitis, positive reactions to antinuclear antibodies, increased ESR, eosinophilia; in very rare cases – interstitial angioedema (edema of the interstitial lung tissue without transudate entering the alveolar lumen).

From the genitourinary system: uremia, oliguria, anuria, impaired renal function, acute renal failure, decreased potency. Laboratory parameters: hyperkalemia and / or hypokalemia, hyponatremia, hypomagnesemia, hypochloremia, hypercalcemia, hyperuricemia, increased urea and creatinine concentrations in blood plasma, hypercholesterolemia, hypertriglyceridemia, decreased glucose tolerance.

Others: arthralgia, arthritis, myalgia, fever, gout exacerbation.

Interaction

With caution, Diroton should be prescribed simultaneously with potassium-sparing diuretics ( spironolactone, triamterene, amiloride), potassium, salt substitutes containing potassium, because the risk of hyperkalemia increases, especially with impaired renal function. Therefore, these combinations should be prescribed only on the basis of an individual decision of the attending physician, with regular monitoring of serum potassium levels and renal function.

When used concomitantly with diuretics and other antihypertensive drugs, an additive antihypertensive effect develops (the risk of a pronounced decrease in blood pressure).

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

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

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

When used simultaneously, Diroton may enhance the effect of ethanol (alcohol).

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

How to take, course of use and dosage

The drug is taken orally 1 time/day, in the morning, with all indications, before or after meals, always at about the same time of day.

– Use in essential hypertension Patients who do not receive other antihypertensive drugs are prescribed 10 mg 1 time/day. The usual daily maintenance dose is 20 mg. The maximum daily dose is 40 mg. The full effect usually develops in 2-4 weeks from the start of treatment, which should be taken into account when increasing the dose.

If the clinical effect is insufficient, the drug can be combined with other antihypertensive agents. If the patient has received prior treatment with diuretics, then their use should be stopped 2-3 days before the start of Diroton use. If diuretics cannot be discontinued, the initial dose of Diroton should not exceed 5 mg / day. In this case, after the first dose, recommended medical supervision for several hours (a maximum of action is achieved after approximately 6 h), as may develop a marked reduction in blood pressure.

– Application in renovascular hypertension and States with increased activity of the renin-angiotensin-aldosterone system Appropriate to prescribe a lower initial dose of 2.5-5 mg/day under strict medical supervision (monitoring of blood pressure, renal function, potassium concentration in the blood serum). The maintenance dose should be determined depending on the dynamics of blood pressure.

– Use in chronic heart failure, the initial dose is 2.5 mg 1 time/day, which can be increased to the usual daily maintenance dose of 5-20 mg. The daily dose should not exceed 20 mg

. – Use in acute myocardial infarction In combination therapy on the first day is prescribed 5 mg, then 5 mg every other day,10 mg-after two days and then 10 mg 1 time/day. In patients with acute myocardial infarction, the drug should be used for at least 6 weeks. At the beginning of treatment or during the first 3 days after acute myocardial infarction in patients with low systolic blood pressure (~120 mm Hg), the drug should be prescribed at a dose of 2.5 mg. In the case of a decrease in blood pressure (systolic blood pressure ?100 mm Hg) while taking Diroton, the daily dose of 5 mg can be temporarily reduced to 2.5 mg. In the case of a long – term pronounced decrease in blood pressure (systolic blood pressure

-Use in diabetic nephropathy In patients with insulin-dependent diabetes mellitus, Diroton is used at a dose of 10 mg 1 time/day.If necessary, the dose can be increased to 20 mg 1 time / day in order to achieve diastolic blood pressure values below 75 mm Hg in a sitting position. In patients with non-insulin-dependent diabetes mellitus, the drug is prescribed in the same dose, in order to achieve diastolic blood pressure values below 90 mm Hg in a sitting position.

– Use in renal insufficiency Due to the fact that lisinopril is excreted by the kidneys, the initial dose should be determined depending on creatinine clearance, then, in accordance with the reaction, a maintenance dose should be established in conditions of frequent monitoring of renal function, potassium concentration and sodium concentration in the blood serum: Creatinine clearance (ml / min) Initial dose 30-70 5-10 mg 10-30 2.5-5 mg Less than 10 (including patients on hemodialysis) 2.5 mg

For the convenience of dosing, you can use the drug Diroton table 5 mg up. 14 Gideon Richter A or Diroton table 20 mg up. 14 Gideon Richter A.

Overdose

-Symptoms: marked decrease in blood pressure.

– Treatment: If necessary, carry out symptomatic therapy (intravenous fluid use, control and normalization of blood pressure, water-electrolyte balance). Lisinopril can be eliminated from the body by dialysis.

Special instructions

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

Before starting treatment with Diroton, if possible, the sodium concentration should be normalized and / or the lost volume of fluid should be replenished, and the effect of the initial dose of Diroton on the patient’s blood pressure should be carefully monitored.

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

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

– Use in chronic heart failure In chronic heart failure with simultaneous renal failure or without it, 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 high-dose diuretics, hyponatremia or impaired renal function. In such patients, treatment with Diroton should be started under the strict supervision of a doctor (with caution, select the dose of the drug and diuretics). When using Diroton in some patients with chronic heart failure, but with normal or low blood pressure, there may be a decrease in blood pressure, which is usually not a reason to stop treatment. A transient hypotensive reaction is not a contraindication for taking the next dose of the drug.

– Use in ischemic heart disease and cerebrovascular insufficiency The appointment of Diroton in patients with CHD, cerebrovascular insufficiency, may cause a sharp decrease in blood pressure, may lead to myocardial infarction or stroke. In such patients, treatment with Diroton should be started under the strict supervision of a doctor (with caution, select the dose of the drug and diuretics).

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

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

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

– Use of the drug under dialysis conditions When using the drug under dialysis conditions with a polyacrylic-nitrile membrane, anaphylactic shock may occur, so either a different type of dialysis membrane is recommended, or other antihypertensive agents are prescribed.

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

Form of production

Pills.

Storage conditions

At a temperature of 15-30 °C

Shelf life

3 years

Active ingredient

Lisinopril

Conditions of release from pharmacies

By prescription

Dosage form

Tablets

Purpose

For adults as directed by your doctor

Indications

Hypertension, Heart Failure, Myocardial Infarction, Diabetic Nephropathy