Diroton, pills 10mg, 28pcs

Composition

1 tablet contains

lisinopril 10 mg.

Auxiliary substances:

magnesium stearate,

talc,

mannitol,

corn starch,

calcium hydrophosphate dihydrate.

Pharmacological action

Diroton has pronounced hypotensive (lowers blood pressure) and peripheral vasodilating properties. The Active ingredient of this drug is lisinopril. After application, Diroton begins to act in 60 minutes, the maximum effect is observed in 6-7 hours and persists throughout the day.

Indications

Essential and renovascular arterial hypertension (as monotherapy or in combination with other antihypertensive drugs). Chronic heart failure (as part of combination therapy). 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

Hypersensitivity to lisinopril and other components of the drug, a history of angioedema, including those associated with the use of ACE inhibitors, idiopathic angioedema, hereditary angioedema, age up to 18 years (efficacy and safety have not been established).

Side effects

From the cardiovascular system: possible hypotension, pain behind the sternum. From the central nervous system: dizziness, headache, muscle weakness. From the digestive system: diarrhea, nausea, vomiting. Respiratory system disorders: dry cough. From the hematopoietic system: agranulocytosis, decreased hemoglobin and hematocrit (especially with prolonged use); in some cases, an increase in ESR. From the side of water-electrolyte metabolism: hyperkalemia. From the side of metabolism: increased creatinine, urea nitrogen (especially in patients with kidney diseases, diabetes mellitus, renovascular hypertension). Allergic reactions: skin rash, angioedema. Other: in isolated cases – arthralgia.

Interaction

When used concomitantly with antihypertensive agents, an additive antihypertensive effect is possible. When used concomitantly with potassium-sparing diuretics (spironolactone, triamterene, amiloride), potassium preparations, and dietary salt substitutes containing potassium, the risk of hyperkalemia increases, especially in patients with impaired renal function. Concomitant use of ACE inhibitors and NSAIDs increases the risk of developing impaired renal function, and hyperkalemia is rarely observed. When used concomitantly with loop diuretics, thiazide diuretics, the antihypertensive effect increases. The occurrence of severe hypotension, especially after taking the first dose of a diuretic, is probably due to hypovolemia, which leads to a transient increase in the hypotensive effect of lisinopril. The risk of impaired renal function increases. When used concomitantly with Indometacin, the antihypertensive effect of lisinopril decreases, apparently due to the inhibition of prostaglandin synthesis under the influence of NSAIDs (which are believed to play a role in the development of the antihypertensive effect of ACE inhibitors). When used concomitantly with insulin, hypoglycemic agents and sulfonylureas, hypoglycemia may develop due to increased glucose tolerance. When used concomitantly with clozapine, the concentration of clozapine in the blood plasma increases. When used concomitantly with lithium carbonate, the concentration of lithium in the blood serum increases, accompanied by symptoms of lithium intoxication. A case of severe hyperkalemia in a patient with diabetes mellitus when used concomitantly with lovastatin is described. A case of severe arterial hypotension is described when used concomitantly with pergolide. When used concomitantly with ethanol, the effect of ethanol is enhanced.

How to take, course of use and dosage

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

With essential hypertension, patients who do not receive other antihypertensive drugs are prescribed 10 mg 1 time a 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 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 in about 6 hours), since a pronounced decrease in blood pressure may develop.

In case of 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 increased medical supervision (control of blood pressure, renal function, and serum potassium concentration). The maintenance dose should be determined depending on the dynamics of blood pressure.

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, 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 (as part of combination therapy) on the first day,5 mg is prescribed, then 5 mg every other day,10 mg in two days and then 10 mg once a 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 (

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

Overdose

Symptoms:  marked decrease in blood pressure.

Treatment:  if necessary, symptomatic therapy is performed (intravenous fluid use, control and normalization of blood pressure, water and 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. In chronic heart failure with or without concomitant renal failure, a marked 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).

Similar rules should be followed when prescribing Diroton to patients with CHD, cerebrovascular insufficiency, in which 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 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.

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.

In the 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 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.

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.

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, 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.

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

When using the drug in a polyacrylonitrile membrane dialysis setting, anaphylactic shock may occur, so either a different type of dialysis membrane is recommended, or other antihypertensive agents are prescribed.

There are no data on the effect of lisinopril on the ability to drive vehicles and mechanisms, but 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

Myocardial Infarction, Diabetic Nephropathy, Hypertension, Heart Failure