Diroton, tablets 10 mg 28 pcs

Diroton has pronounced hypotensive (lowers blood pressure) and peripheral vasodilator properties.

Indications

Active ingredient

Composition

1 tablet contains

lisinopril 10 mg.

Auxiliary substances:

magnesium stearate,

talc,

mannitol,

corn starch,

calcium hydrophosphate dihydrate.

How to take, the dosage

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

In patients with essential hypertension who are not receiving other antihypertensive agents, 10 mg once daily is prescribed. 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 beginning of treatment, which should be taken into account when increasing the dose. If the clinical effect is insufficient, it is possible to combine the drug with other hypotensive agents.

If the patient has received prior treatment with diuretics, their use should be stopped 2-3 days before starting Diroton. If diuretics cannot be stopped, the initial dose of Diroton should not exceed 5 mg/ In this case, a physician’s control for several hours after the first dose is recommended (maximum action is reached after about 6 hours), because a pronounced decrease in BP may develop.

In renovascular hypertension or other conditions with increased activity of renin-angiotensin-aldosterone system it is also reasonable to prescribe lower initial dose – 2.5-5 mg per day under increased medical control (BP control, renal function, serum potassium concentration). The maintenance dose should be determined depending on the dynamics of BP.

In patients with renal impairment, because lisinopril is excreted by the kidneys, the initial dose should be determined according to creatinine clearance, then the maintenance dose should be established according to the response with frequent monitoring of renal function, serum potassium and sodium concentrations.

In chronic heart failure, the initial dose is 2.5 mg once daily, 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), 5 mg is prescribed the first day, then 5 mg every other day, 10 mg every other day, and then 10 mg once daily. In patients with acute myocardial infarction, the drug should be used for at least 6 weeks. At the beginning of treatment or within the first 3 days after acute myocardial infarction in patients with low systolic BP (

In diabetic nephropathy in patients with insulin-dependent diabetes mellitus, Diroton is used in a dose of 10 mg once daily. If necessary, the dose can be increased to 20 mg once daily in order to achieve diastolic BP values below 75 mmHg in sitting position. In patients with insulin-independent diabetes mellitus the drug is administered in same dose with aim to reach values of diastolic BP lower than 90 mmHg in sitting position.

Interaction

Special Instructions

A pronounced decrease in BP most often occurs with a decrease in fluid volume caused by diuretic therapy, salt reduction, dialysis, diarrhea, or vomiting. In chronic heart failure with or without concomitant renal failure, a marked decrease in BP may occur. More often a significant BP reduction is detected in patients with a severe stage of chronic heart failure, as a consequence of using high dose diuretics, hyponatremia or impaired renal function. In such patients Diroton treatment should be started under the strict control of a physician (select the dosage of the drug and diuretics with caution).

Similar rules should be followed when prescribing Diroton to patients with CHD, cerebrovascular insufficiency, in whom a sharp decrease in BP may lead to myocardial infarction or stroke.

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

Diroton may decrease BP in some patients with chronic heart failure but with normal or decreased BP, which is usually not a reason to discontinue treatment.

Before treatment with Diroton, if possible, normalize sodium concentration and/or replenish lost fluid volume, carefully monitor the effect of the initial dose of Diroton on the patient’s BP.

In case of renal artery stenosis (especially in bilateral stenosis or in the presence of artery stenosis of the only kidney), as well as in circulatory failure due to lack of sodium and/or fluid, use of Diroton may lead to impaired renal function, acute renal failure, which is usually irreversible after drug withdrawal.

In acute myocardial infarction the use of standard therapy (thrombolytics, acetylsalicylic acid, beta-adrenoblockers) is indicated. It is possible to use Diroton together with IV administration or with the use of therapeutic transdermal nitroglycerin systems.

In major surgical interventions, as well as in the use of other drugs that cause BP reduction, lisinopril, by blocking angiotensin II formation, may cause a significant unpredictable decrease in BP.

In elderly patients, the use of standard doses leads to higher blood concentrations of the drug, so extra caution is required in determining the dose, although no differences in the antihypertensive effect of Diroton have been found in elderly and young patients.

Because the potential risk of agranulocytosis cannot be excluded, periodic monitoring of blood counts is required.

Anaphylactic shock may occur when the drug is used in dialysis with a polyacrylonitrile membrane, so either a different type of dialysis membrane or the administration of other antihypertensive agents is recommended.

There are no data on the effect of lisinopril on the ability to drive and operate vehicles, but it should be taken into account that dizziness may occur, so caution should be exercised.

Contraindications

Side effects

Overdose

Symptoms: pronounced BP decrease.

Treatment: if necessary, symptomatic therapy (intravenous fluid administration, control and normalization of BP, water-electrolyte balance).

Lisinopril may be eliminated from the body by dialysis.

Pregnancy use

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

The use of ACE inhibitors in the II and III trimesters of pregnancy has adverse effects on the fetus (marked BP decrease, renal failure, hyperkalemia, skull hypoplasia, fetal death are possible). There is no data about the negative effect of the drug on the fetus in case of its use in the first trimester.

In newborns and infants who have had intrauterine exposure to ACE inhibitors are recommended to be closely monitored for timely detection of marked BP decrease, oliguria, hyperkalemia.

There are no data on lisinopril penetration into breast milk.

Breast-feeding should be discontinued if it is necessary to prescribe the drug during lactation.

Similarities