Diroton pills 10 mg №28

Active ingredient and dosage form

Pills: 1 pill contains lisinopril 2.5 mg, 5 mg, 10 mg, 20 mg;
Excipients: magnesium stearate, talc, mannitol, corn starch, Calcium phosphate;
14 or 28 pcs. packaged.

Mechanism of action

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

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

The onset of action of the drug - after 1 h, reaches a maximum after 6-7 hours and lasts 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 noted in the first days after the start of treatment, a stable action develops in 1-2 months. With the abrupt cancellation of the drug did not observe a pronounced increase in blood pressure.

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

Indications and usage

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);
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 in patients with normal blood pressure and in patients with insulin-dependent diabetes mellitus with arterial hypertension).

Dosage and administration

The drug is taken orally once a day, in the morning, with all indications, before or after eating, always at about the same time of day.

With essential hypertension patients who do not receive other antihypertensive drugs are prescribed 10 mg once a day. The usual daily maintenance dose is 20 mg. The maximum daily dose is 40 mg.

The full effect usually develops after 2-4 weeks from the start of treatment, which should be considered when increasing the dose. With insufficient clinical effect, it is possible to combine the drug with other antihypertensive drugs.

If the patient has received prior treatment with diuretics, then they should be discontinued 2-3 days before the use of Diroton. If it is impossible to cancel diuretics, then the initial dose of Diroton should not exceed 5 mg / In this case, after taking the first dose, medical monitoring is recommended for several hours (the maximum effect is reached after about 6 hours), because A pronounced decrease in blood pressure may develop.

Renovascular hypertension or other conditions with increased activity of the renin-angiotensin-aldosterone system, it is also advisable to prescribe a lower initial dose of 2.5–5 mg per day under enhanced medical control (control of blood pressure, kidney function, serum potassium concentration). Maintenance dose should be determined depending on the dynamics of blood pressure.

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

In chronic heart failure The initial dose is 2.5 mg once a day, which can be increased to the usual maintenance daily dose of 5-20 mg. The daily dose should not exceed 20 mg.

In acute myocardial infarction (in combination therapy), 5 mg is prescribed on the first day, then 5 mg every other day, 10 mg — in two days, and then 10 mg 1 time per 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 administered at a dose of 2.5 mg. In the case of a decrease in blood pressure (systolic blood pressure <100 mm Hg) while receiving Diroton, a daily dose of 5 mg can be temporarily reduced to 2.5 mg. In the case of a prolonged pronounced decrease in blood pressure (systolic blood pressure <90 mmHg more than 1 hour), treatment with diroton should be stopped.

With diabetic nephropathy in patients with insulin-dependent diabetes mellitus, diroton is used in a dose of 10 mg once a day. If necessary, the dose can be increased to 20 mg 1 time per 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.

Adverse reactions

From the side of the central nervous system: often - dizziness, headache (5-6%), weakness; sometimes - increased fatigue, drowsiness, jerky muscles of the limbs and lips; rarely - asthenic syndrome, mood lability, confusion, decreased potency.
From the digestive system: diarrhea (3%), nausea, vomiting (1-3%), dry mouth, anorexia, dyspepsia, changes in taste, abdominal pain, pancreatitis, hepatocellular or cholestatic jaundice, hepatitis.
Cardiovascular: orthostatic hypotension, chest pain (1-3%); sometimes - a pronounced decrease in blood pressure; heartbeat, tachycardia, myocardial infarction, cerebrovascular stroke in patients with an increased risk of disease, due to a pronounced decrease in blood pressure.
Immune system: (0.1%) angioedema (face, lips, tongue, larynx or epiglottis, upper and lower extremities); rarely, a syndrome involving accelerated erythrocyte sedimentation rate, arthralgia, and the appearance of antinuclear antibodies.
Hemic and lymphatic: sometimes - leukopenia, neutropenia, agranulocytosis, thrombocytopenia, with long-term treatment - a slight decrease in the concentration of hemoglobin and hematocrit, erythrocytopenia.
Respiratory: dry cough (3%).
Urogenital: rarely (<1%) - renal dysfunction, oliguria, anuria, acute renal failure, uremia, proteinuria.
Dermatologic: skin rash (1-3%); rarely (<1%) - urticaria, increased sweating, pruritus, alopecia.
From the laboratory indicators: sometimes (> 1%) - hyperkalemia, azotemia, hyperuricemia, hyperbilirubinemia, increased activity of liver enzymes (especially in the presence of a history of kidney disease, diabetes mellitus and renovascular hypertension).
Other: rarely (<1%) - myalgia, fever, impaired fetal development.

Contraindications

Angioedema in history (including with the use of ACE inhibitors); hereditary angioedema; age up to 18 years (efficacy and safety not established); hypersensitivity to lisinopril or other ACE inhibitors; pregnancy and breastfeeding.

Carefully: in case of marked impaired renal function, bilateral renal artery stenosis or arterial stenosis of the only kidney with progressive azotemia, condition after kidney transplantation, renal failure, azotemia, hyperkalemia, aortic osteoarthritis, hypertrophic obstructive cardiomyopathy, primary hyperaldsterestrostrumstrostrum, isotropystroma, idiopathone, idiopathone, ischemia, hypertrophic obstructive cardiomyopathy including cerebrovascular insufficiency), coronary artery disease, coronary insufficiency, autoimmune systemic diseases of connective th tissue (including scleroderma, systemic lupus erythematosus), inhibition of bone marrow hematopoiesis, hypovolemic states (including as a result of diarrhea, vomiting); patients who are on a sodium-restricted diet, elderly patients.

Most often, a pronounced decrease in blood pressure occurs when a decrease in the volume of fluid caused by diuretic therapy, a decrease in salt content in food, dialysis, diarrhea or vomiting. In chronic heart failure with simultaneous renal failure or without it, a pronounced decrease in blood pressure is possible. A more pronounced decrease in blood pressure is detected in patients with severe stage of 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 physician (carefully select the dose of the drug and diuretics).

Similar rules should be followed when appointing Dyroton to patients with coronary artery disease, cerebrovascular insufficiency, in which a sharp decrease in blood pressure can lead to myocardial infarction or stroke.

Transient hypotensive reaction is not a contraindication for taking the next dose of the drug.

With the use of diroton in some patients with chronic heart failure, but with normal or lowered blood pressure, there may be a decrease in blood pressure, which is usually not a reason to stop treatment.

Before starting treatment with Diroton, if possible, normalize the concentration of sodium and / or fill up the lost volume of fluid, carefully monitor the effect of the initial dose of Diroton on the patient's blood pressure.

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

In acute myocardial infarction, the use of standard therapy (thrombolytics, Acetylsalicylic acid, beta-blockers) is indicated. It is possible to use Diroton together with IV injection or with the use of therapeutic transdermal systems of Nitroglycerin.

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

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

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

When using the drug in dialysis conditions with a polyacrylonitrile membrane, anaphylactic shock may occur, therefore either a different type of dialysis membrane or the appointment of other antihypertensive agents is recommended.

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

Symptoms: pronounced decrease in blood pressure.
Treatment: if necessary, conduct symptomatic therapy (in / in the introduction of fluid, monitoring and normalization of blood pressure, water and electrolyte balance).

Lisinopril can be eliminated from the body through dialysis.

Keep out of the reach of children at a temperature of 15 to 30 ° C.

Diroton