Tritace tablets 5mg, No. 28

essential hypertension;

chronic heart failure (as part of combination therapy, in particular, in combination with diuretics);

diabetic or non-diabetic nephropathy preclinical and clinically expressed stages, incl. with severe proteinuria, especially when combined with arterial hypertension;

Reducing the risk of myocardial infarction, stroke, or cardiovascular mortality in patients at high cardiovascular risk:

- in patients with confirmed coronary artery disease, a history of myocardial infarction or without it, including patients who have undergone percutaneous transluminal coronary angioplasty, coronary artery bypass grafting;

- in patients with a history of stroke;

- in patients with peripheral arterial occlusive lesions;

- in patients with diabetes mellitus with at least one additional risk factor (microalbuminuria, arterial hypertension, increased plasma concentrations of TC, decreased plasma concentrations of HDL-C, smoking);

heart failure that developed during the first few days (2Ц9 days) after acute myocardial infarction (see section 'Pharmacodynamics').

Inside, swallowing whole (without chewing) and drinking a sufficient amount (1/2 glass) of water, regardless of meals (i.e. tablets can be taken before, during or after meals). The dose is selected depending on the therapeutic effect and the patient's tolerance of the drug.

Treatment with TritaceЃ is usually long-term, and its duration is determined on a case-by-case basis by the doctor.

Unless otherwise prescribed, the following dosing regimens are recommended for normal kidney and liver function.

With essential hypertension

Usually the initial dose is 2.5 mg once a day in the morning (one table. TritaceЃ 2.5 mg or 1/2 table. TritaceЃ 5 mg scored). If, when taking the drug in this dose for 3 weeks or more, it is not possible to normalize blood pressure, then the dose can be increased to 5 mg of ramipril per day. If the dose of 5 mg is insufficiently effective, after 2-3 weeks it can be doubled to the maximum recommended daily dose of 10 mg / day.

As an alternative to increasing the dose to 10 mg / day with insufficient hypotensive efficacy of a daily dose of 5 mg, it is possible to add other antihypertensive drugs to the treatment, in particular, diuretics or CCBs.

With chronic heart failure

The recommended initial dose is 1.25 mg once a day (1/2 table. TritaceЃ 2.5 mg with a line). Depending on the response to the therapy, the dose may be increased. It is recommended to double the dose at intervals of 1Ц2 weeks. If a daily dose of 2.5 mg or more is required, it can be taken either once a day or divided into 2 doses.

The maximum recommended daily dose is 10 mg.

For diabetic or non-diabetic nephropathy

The recommended initial dose is 1.25 mg 1 time per day (1/2 tab. TritaceЃ 2.5 mg at a risk). The dose may be increased to 5 mg once a day. In these conditions, doses of more than 5 mg once a day in controlled clinical trials have not been adequately studied.

To reduce the risk of myocardial infarction, stroke, or cardiovascular mortality in patients at high cardiovascular risk

The recommended initial dose is 2.5 mg 1 time per day (1 tablet. TritaceЃ 2.5 mg or 1/2 table. TritaceЃ 5 mg with a line).

Depending on the patient's tolerance to the drug, the dose can be gradually increased. It is recommended to double the dose after 1 week of treatment, and over the next 3 weeks of treatment - to increase it to the usual maintenance dose of 10 mg 1 time per day.

Doses exceeding 10 mg have not been adequately studied in controlled clinical trials.

The use of the drug in patients with Cl creatinine less than 0.6 ml / s has not been studied enough.

With heart failure, which developed during the first few days (2-9 days) after acute myocardial infarction

The recommended starting dose is 5 mg per day, divided into 2 single doses of 2.5 mg, one of which is taken in the morning, and the second in the evening (1 tablet.TritaceЃ 2.5 mg or 1/2 tablet.TritaceЃ 5 mg with a risk). If the patient does not tolerate this initial dose (there is an excessive decrease in blood pressure), then it is recommended for him to give 1.25 mg 2 times a day for two days (1/2 table. Tritace 2.5 mg with a risk).

Then, depending on the patient's response, the dose may be increased. It is recommended that the dose be doubled at 1Ц3 day intervals as the dose is increased. Later, the total daily dose, which was initially divided into two doses, may be given as a single dose.

The maximum recommended dose is 10 mg.

Currently, the experience of treating patients with severe heart failure (III Ц IV functional class according to NYHA classification), which arose immediately after acute myocardial infarction, is insufficient. If a decision is made in such patients about treatment with TritaceЃ, it is recommended that treatment begins with the lowest possible dose - 1.25 mg once a day (1/2 table.TritaceЃ 2.5 mg scored) and special care should be taken observe with each dose increase.

The use of the drug TritaceЃ in certain groups of patients

Patients with impaired renal function. When Cl creatinine is from 50 to 20 ml / min / 1.73 m2, the initial daily dose is usually 1.25 mg (1/2 tab. TritaceЃ 2.5 mg with a scored). The maximum allowable daily dose is 5 mg.

Patients with incompletely corrected loss of fluid and electrolytes, patients with severe arterial hypertension, as well as patients for whom an excessive decrease in blood pressure poses a certain risk (for example, with severe atherosclerotic lesions of the coronary and cerebral arteries). The initial dose is reduced to 1.25 mg / day (1/2 table. Tritace 2.5 mg with a line).

Patients with prior diuretic therapy. It is necessary, if possible, to discontinue diuretics 2-3 days (depending on the duration of action of the diuretics) before starting treatment with TritaceЃ, or at least to reduce the dose of diuretics taken. Treatment of such patients should begin with the lowest dose, equal to 1.25 mg of ramipril (1/2 table. Tritace 2.5 mg scored), taken once a day in the morning. After taking the first dose and each time after increasing the dose of ramipril and (or) 'loop' diuretics, patients should be under medical supervision for at least 8 hours to avoid an uncontrolled hypotensive reaction.

Elderly patients (over 65 years old). The initial dose is reduced to 1.25 mg per day (1/2 table. Tritace 2.5 mg with a line).

Patients with impaired liver function. The response of blood pressure to taking the drug TritaceЃ can both increase (by slowing down the elimination of ramiprilat) and decrease (by slowing down the conversion of inactive ramipril into active ramiprilat). Therefore, close medical supervision is required at the beginning of treatment. The maximum permissible daily dose is 2.5 mg (1 tab. TritaceЃ 2.5 mg or 1/2 tab. TritaceЃ 5 mg scored).

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hypersensitivity to ramipril, other ACE inhibitors, or to any of the components of the drug (see section 'Composition and release form');

a history of angioedema (hereditary or idiopathic, as well as after taking ACE inhibitors) - the risk of rapid development of angioedema (see section 'Side effects');

hemodynamically significant renal artery stenosis (bilateral or unilateral in the case of a single kidney);

arterial hypotension (SBP less than 90 mm Hg) or conditions with unstable hemodynamic parameters;

hemodynamically significant stenosis of the aortic or mitral valve or hypertrophic obstructive cardiomyopathy (GOKMP);

primary hyperaldosteronism;

severe renal failure (Cl creatinine less than 20 ml / min / 1.73 m2) (clinical experience is insufficient).

hemodialysis (clinical experience is insufficient);

pregnancy;

lactation period;

nephropathy, which is treated with corticosteroids, NSAIDs, immunomodulators and / or other cytotoxic agents (experience of clinical use is insufficient, see the section 'Interaction');

chronic heart failure in the stage of decompensation (experience of clinical use is insufficient);

age up to 18 years (experience of clinical use is insufficient);

hemodialysis or hemofiltration using certain membranes with a negatively charged surface, such as high-flow polyacrylonitrile membranes (risk of hypersensitivity reactions) (see sections 'Interaction', 'Special instructions');

LDL apheresis with the use of dextran sulfate (risk of hypersensitivity reactions) (see section 'Special instructions');

hyposensitizing therapy for hypersensitivity reactions to insect poisons, such as bees, wasps (see section 'Special instructions').

Additional contraindications when using TritaceЃ in the acute stage of myocardial infarction:

severe heart failure (NYHA functional class IV);

unstable angina;

life-threatening ventricular arrhythmias;

Pulmonary heart.

Carefully:

conditions in which an excessive decrease in blood pressure is especially dangerous (with atherosclerotic lesions of the coronary and cerebral arteries);

conditions accompanied by an increase in the activity of the renin-angiotensin-aldosterone system (RAAS), in which, with ACE inhibition, there is a risk of a sharp decrease in blood pressure with deterioration of renal function:

- severe arterial hypertension, especially malignant arterial hypertension;

- chronic heart failure, especially severe or for which other drugs with hypotensive action are taken;

- hemodynamically significant unilateral renal artery stenosis (in the presence of both kidneys);

- previous intake of diuretics;

- violations of water and electrolyte balance as a result of insufficient intake of liquid and table salt, diarrhea, vomiting, profuse sweating;

dysfunction of the liver (lack of experience of use: it is possible both an increase and a weakening of the effects of ramipril; if patients have cirrhosis of the liver with ascites and edema, a significant activation of the RAAS is possible, see above 'Conditions accompanied by an increase in the activity of the RAAS');

impaired renal function (Cl creatinine more than 20 ml / min / 1.73 m2) due to the risk of developing hyperkalemia and leukopenia;

condition after kidney transplantation;

systemic connective tissue diseases, incl. systemic lupus erythematosus, scleroderma, concomitant therapy with drugs that can cause changes in the picture of peripheral blood (possibly suppression of bone marrow hematopoiesis, the development of neutropenia or agranulocytosis, see the Interaction section);

diabetes mellitus (risk of developing hyperkalemia);

old age (risk of increased hypotensive action);

hyperkalemia.