Hartil - instructions for use, reviews, analogs and formulations (tablets of 1.25 mg, 2.5 mg, 5 mg, 10 mg, D with a diuretic hydrochlorothiazide) for hypertension and pressure reduction in adults, children and pregnancy. Composition

In this article, you can read the instructions for using the drug Hartil. Presented are reviews of visitors to the site - consumers of this medication, as well as opinions of doctors specialists on the use of Hartil in their practice. A big request is to actively add their feedback on the drug: the medicine helped or did not help get rid of the disease, which were observed complications and side effects, possibly not declared by the manufacturer in the annotation. Analogues of Hartil in the presence of existing structural analogs. Use to treat hypertension and reduce blood pressure in adults, children, as well as during pregnancy and lactation. Composition of the preparation.

Hartil - ACE inhibitor.It is a prodrug, from which the active metabolite ramiprilate is formed in the body. It is believed that the mechanism of antihypertensive action is associated with competitive inhibition of ACE activity, which leads to a decrease in the rate of conversion of angiotensin 1 into angiotensin 2, which is a potent vasoconstrictor. As a result of a decrease in the concentration of angiotensin 2, a secondary increase in plasma renin activity occurs due to elimination of negative feedback during the release of renin and a direct decrease in aldosterone secretion. Due to the vasodilator effect reduces OPSS (afterload), wedging pressure in the pulmonary capillaries (preload) and resistance in the pulmonary vessels; increases the minute volume of the heart and tolerance to the load.

In patients with signs of chronic heart failure after a myocardial infarction, Ramipril (active ingredient of the drug Hartil) reduces the risk of sudden death, the progression of heart failure to severe / resistant failure and reduces the number of hospitalizations for heart failure.

It is known that Hartil significantly reduces the incidence of myocardial infarction, stroke and cardiovascular death in patients with increased cardiovascular risk due to vascular disease (CHD, stroke or peripheral vascular disease) or diabetes mellitus, which have at least one additional risk factor (microalbuminuria , hypertension, increased total cholesterol, low HDL, smoking). Reduces the overall mortality and need for revascularization procedures, slows the onset and progression of chronic heart failure. As in patients with diabetes mellitus, and without it, ramipril significantly reduces the existing microalbuminuria and the risk of developing nephropathy. These effects are observed in patients with both elevated and normal BP.

The hypotensive effect of Hartil develops after about 1-2 hours, reaches a maximum within 3-6 hours, lasts at least 24 hours.

Composition

Ramipril + auxiliary substances (Hartil).

Ramipril + Hydrochlorothiazide + excipients (Hartil D).

Pharmacokinetics

When ingested absorption is 50-60%, food does not affect the degree of absorption, but slows absorption. In the liver, it is metabolized to form an active metabolite of ramiprilate (6 times more active inhibits ACE than ramipril), inactive diketopiperazine, and glucuronize. All metabolites formed, with the exception of ramiprilate, have no pharmacological activity. Binding to plasma proteins for ramipril - 73%, ramiprilata - 56%. Bioavailability after oral administration of 2.5-5 mg of ramipril - 15-28%; for ramiprilate - 45%. After a daily intake of ramipril at a dose of 5 mg per day, the steady concentration of ramiprilate in plasma is reached by day 4. The kidneys excrete 60%, through the intestines - 40% (mainly in the form of metabolites). If renal function is impaired, excretion of ramipril and its metabolites slows in proportion to the decrease in QC; when the liver function is impaired, the conversion into ramiprilat is slowed down; with heart failure, the concentration of ramiprilate increases 1.5-1.8 times.

Indications

• arterial hypertension;
• chronic heart failure;
• heart failure, developed in the first few days after an acute myocardial infarction;
• diabetic and nondiabetic nephropathy;
• reduction in the risk of myocardial infarction, stroke, and cardiovascular mortality in patients with high cardiovascular risk, including patients with confirmed coronary artery disease (with or without a history of heart attack), patients undergoing percutaneous transluminal coronary angioplasty, coronary artery bypass grafting, with stroke in history and patients with occlusive lesions of peripheral arteries.

Forms of release

Tablets of 1.25 mg, 2.5 mg, 5 mg and 10 mg (Hartil).

Tablets 2.5 mg + 12.5 mg, 5 mg + 25 mg (Hartil D with diuretic hydrochlorothiazide).

Instructions for use and dosage

Hartil Tablets

Inside, not liquid, squeezed a lot of liquid (about 1 glass), regardless of the time of food intake.

Dosage should be established for each patient individually, taking into account the therapeutic effect and tolerability. Tablets can be divided in half, breaking down the risk.

Arterial hypertension. The recommended initial dose is 2.5 mg 1 time per day (1 tablet Hartil 2.5 mg daily). Depending on the therapeutic effect, the dose can be increased by doubling the daily dose every 2-3 weeks.The usual maintenance dose is 2.5-5 mg per day (1 tablet Hartil 2.5 mg or 1 tablet 5 mg). The maximum daily dose should not exceed 10 mg.

Chronic heart failure. The recommended initial dose is 1.25 mg once a day (daily, 1/2 tablet Hartil 2.5 mg). Depending on the therapeutic effect, the dose can be increased by doubling the daily dose every 2-3 weeks. If you need more than 2.5 mg of the drug, this dose can be taken immediately or divided into 2 divided doses. The maximum daily dose should not exceed 10 mg.

Treatment after myocardial infarction. It is recommended to start taking the drug on the 3rd-10th day after an acute myocardial infarction. The recommended initial dose, depending on the condition of the patient and the time elapsed after an acute myocardial infarction, is 2.5 mg twice a day (1 tablet of Hartil 2.5 mg 2 times a day). Depending on the therapeutic effect, the initial dose can be doubled to 5 mg (2 tablets Hartil 2.5 mg or 1 tablet Hartil 5 mg) 2 times a day. The maximum daily dose should not exceed 10 mg. When intolerance of the drug should reduce the dose.

Nondiabetic or diabetic nephropathy. The recommended initial dose is 1.25 mg once a day (daily, 1/2 tablet Hartil 2.5 mg).Depending on the therapeutic effect, the dose can be increased by doubling the daily dose every 2-3 weeks. If you need more than 2.5 mg of the drug, this dose can be taken immediately or divided into two doses. The recommended maximum daily dose is 5 mg.

Prevention of myocardial infarction, stroke or death from cardiovascular disorders. The recommended initial dose is 2.5 mg once a day. Depending on the tolerability of the drug, after 1 week of taking the dose should be increased by half compared with the initial dose. This dose should be doubled again after 3 weeks of admission. The recommended maintenance dose is 10 mg 1 time per day.

Special patient groups

Elderly patients. The use of ramipril in elderly patients taking diuretics and / or with heart failure, as well as impaired liver or kidney function, requires special attention. Dosage should be set by individual selection of doses depending on the response to the drug.

Dysfunction of the liver. In case of violations of liver function, a reduced or increased effect on the administration of Hartil can be equally often observed, therefore, in the early stages of treatment, patients with impaired liver function needcareful medical supervision. The maximum daily dose in such cases should not exceed 2.5 mg.

In patients receiving diuretic therapy, due to the risk of a significant reduction in blood pressure, consideration should be given to the possibility of temporary cancellation or at least a decrease in the dose of diuretics, not less than 2-3 days (or longer, depending on the duration of diuretics) Hartil. For patients who previously received diuretics, usually the initial dose is 1.25 mg.

Hartil D tablets

Tablets should be taken 1 time per day every morning, washed down with a sufficient amount of liquid. The drug can be taken regardless of food intake. Tablets are not intended to be divided into parts.

For adults, Hartil D should be administered only after individual dosing of each component. The dose can be increased with an interval of at least 3 weeks. The usual initial dose is 2.5 mg of ramipril and 12.5 mg of hydrochlorothiazide. The usual maintenance dose is 2.5 mg of ramipril and 12.5 mg of hydrochlorothiazide or 5 mg of ramipril and 25 mg of hydrochlorothiazide. The recommended maximum daily dose is 5 mg ramipril and 25 mg hydrochlorothiazide.

For elderly patients and patients with QC from 30 to 60 ml / min individual doses of each component (ramipril and hydrochlorothiazide) must be carefully selected before switching to the combined drug Hartil D.

The dose of Hartil D should be as low as possible. The recommended maximum daily dose is 5 mg ramipril and 25 mg hydrochlorothiazide.

Hartil D is contraindicated in patients with severe renal dysfunction (CC less than 30 ml / min / 1.73 m2).

Side effect

• arterial hypotension;
• pain in the chest;
• tachycardia;
• dizziness;
• weakness;
• headache;
• sleep disturbance, mood;
• diarrhea, constipation;
• loss of appetite;
• stomatitis;
• stomach ache;
• pancreatitis;
• cholestatic jaundice;
• dry cough;
• bronchitis;
• sinusitis;
• proteinuria;
• increase in the concentration of creatinine and urea in the blood (mainly in patients with impaired renal function);
• neutropenia, agranulocytosis, thrombocytopenia, anemia;
• skin rash;
• angioedema and other hypersensitivity reactions;
• muscle spasms;
• impotence;
• alopecia.

Contraindications

• marked violations of kidney and liver function;
• bilateral stenosis of the renal arteries or stenosis of the artery of a single kidney;
• condition after kidney transplantation;
• primary hyperaldosteronism;
• hyperkalemia;
• stenosis of the aortic aorta;
• pregnancy;
• lactation (breastfeeding);
• children and adolescents under 18;
• increased sensitivity to ramipril and other ACE inhibitors.

Application in pregnancy and lactation

Hartil is contraindicated for use in pregnancy and lactation (breastfeeding).

Use in children

Contraindicated in children and adolescents under 18 years.

special instructions

In patients with concomitant renal dysfunction, doses are individually selected in accordance with the values ​​of CK. Before starting treatment, all patients need to conduct a study of kidney function. In the process of treatment with ramipril, kidney function, electrolyte blood composition, hepatic enzymes level in the blood, as well as peripheral blood patterns are regularly monitored (especially in patients with diffuse connective tissue diseases, in patients receiving immunosuppressants, allopurinol).Patients who have a deficiency of fluid and / or sodium before treatment should be corrected water-electrolyte disorders. During treatment with ramipril, hemodialysis can not be performed using polyacrylonitrile membranes (the risk of anaphylactic reactions is increased).

Drug Interactions

With simultaneous use of potassium-sparing diuretics (including spironolactone, triamterene, amiloride), potassium drugs, salts and supplements to food substitutes containing potassium may develop hyperkalemia (particularly in patients with impaired renal function), as ACE inhibitors reduce the content of aldosterone, which leads to a delay in potassium in the body against the background of the limitation of the excretion of potassium or its additional intake into the body.

While the use of nonsteroidal anti-inflammatory drugs (NSAIDs) may decrease the antihypertensive effect of ramipril, impaired kidney function.

When used simultaneously with loop or thiazide diuretics, the antihypertensive effect is enhanced. Pronounced arterial hypotension, especially after taking the first dose of a diuretic, appears to be due to hypovolemia,which leads to transient strengthening of the hypotensive effect of ramipril. There is a risk of hypokalemia. Increased risk of impaired renal function.

With simultaneous use with drugs that have an antihypertensive effect, it is possible to intensify the hypotensive effect.

When used simultaneously with immunosuppressants, cytostatics, allopurinol, procainamide, an increased risk of developing leukopenia is possible.

When used simultaneously with insulin, hypoglycemic agents, sulfonylurea derivatives, metformin, hypoglycemia may develop.

When used simultaneously with allopurinol, cytostatics, immunosuppressants, procainamide, the risk of developing leukopenia may be increased.

With the simultaneous use of lithium carbonate, an increase in the concentration of lithium in the blood serum is possible.

Analogues of the drug Hartil

Structural analogs for the active substance:

• Amprilan;
• Vazolong;
• Dilaprel;
• Korpril;
• Pyrimil;
• Ramepress;
• Ramigamma;
• Ramicardium;
• Ramipril;
• Tritace;
• Hartil D.

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