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Indications

  • essential hypertension;
  • Chronic heart failure (in combination therapy, in particular in combination with a diuretic);
  • diabetic or non-diabetic nephropathy, symptomatic or pre-clinical stage, including severe proteinuria, especially when combined with hypertension;
  • reducing the risk of testosterone cypionate vs enanthate  myocardial infarction, stroke or cardiovascular death in patients at high cardiovascular risk:
    • in patients with documented coronary artery disease, myocardial infarction with or without including patients undergoing percutaneous transluminal coronary angioplasty, coronary artery bypass grafting,
    • patients with a history of stroke,
    • in patients with peripheral arterial occlusive disease,
    • in patients with diabetes mellitus with at least one additional risk factor (microalbuminuria, hypertension, elevated plasma concentrations of OX, reduced plasma concentrations of HDL-C, smoking);
  • heart failure, which developed during the first few days (from the second to the ninth day) after acute myocardial infarction (see. “Pharmacodynamics” section).

Contraindications

  • Hypersensitivity to ramipril, other ACE inhibitors or any of the components of the preparation (see “Composition” section.)
  • angioedema (hereditary or idiopathic, and after taking ACE inhibitors), a history – the risk of rapid development of angioedema;
  • hemodynamically significant renal artery stenosis (bilateral or unilateral in the case of a solitary kidney);
  • hypotension (systolic blood pressure (BP) of less than 90 mm Hg) or condition with unstable hemodynamics;
  • hemodynamically significant stenosis of the aortic or mitral valve, or hypertrophic obstructive cardiomyopathy (GOKMP);
  • primary aldosteronism;
  • severe renal impairment (creatinine clearance (CC) of less than 20 ml / min with 1.73 m² body surface area);
  • hemodialysis;
  • pregnancy, lactation;
  • nephropathy, which treatment is corticosteroids, nonsteroidal anti-inflammatory drugs, immunomodulators and / or other cytotoxic agents (see times Affairs “Interaction with other medicinal products.”);
  • Chronic heart failure decompensation (clinical application experience is insufficient);
  • age of 18 years (safety and efficacy have not been studied);
  • LDL apheresis using a dextran sulfate (risk of developing hypersensitivity reactions);
  • hyposensitization therapy with hypersensitivity reactions to poisons of insects, such as bees, wasps;
  • lactose intolerance, lactase deficiency, glucose-galactose malabsorption.

Additional contraindications in applying the drug Dilaprel ® in acute phase of myocardial infarction

  • severe heart failure (IV functional class NYHA classification);
  • unstable angina;
  • life-threatening ventricular cardiac arrhythmias;
  • pulmonary heart.

Carefully

  • a condition in which an excessive fall in blood pressure is especially dangerous (in atherosclerotic lesions of the coronary and cerebral arteries);
  • State, accompanied by increased activity of the renin-angiotensin-aldosterone system (RAAS), in which the inhibition of ACE has a risk of a sharp decrease in blood pressure with deterioration of renal function:
    • severe hypertension, particularly malignant hypertension,
    • chronic heart failure, especially heavy or about which other drugs are taken with antihypertensive effect,
    • hemodynamically significant unilateral renal artery stenosis (if both kidneys)
    • prior to taking diuretics,
    • violations of water-electrolyte balance as a result testosterone cypionate vs enanthate of inadequate intake of fluids and salt, diarrhea, vomiting, excessive sweating;
    • liver dysfunction (failure to use the experience: perhaps as strengthening and weakening effects of ramipril, in the presence of patients of liver cirrhosis with ascites and edema can be a significant activation of the RAAS, see above “state, accompanied by increased activity of the RAAS.”);
    • diabetes (risk of hyperkalemia);
    • renal dysfunction (creatinine clearance 20 mL / min at the body surface 1.73 m2) (risk of hyperkalemia and leukopenia);
    • condition after kidney transplantation; systemic connective tissue diseases including systemic lupus erythematosus, systemic sclerosis, concomitant therapy myelotoxicity of drugs capable of causing changes in picture peripheral blood (possible inhibition of bone marrow hematopoiesis, the development of neutropenia or agranulocytosis);
  • older age (risk of increased antihypertensive effect);
  • hyperkalemia.

Pregnancy and lactation

Dilaprel ® should not be used during pregnancy. Therefore, before starting treatment, make sure that there is no pregnancy.
If the patient becomes pregnant during treatment, you must as soon as possible to replace drug therapy Dilaprelom ® to another therapy. Otherwise there is a risk of disturbance of fetal kidneys, decreased fetal blood pressure and newborn renal dysfunction, hyperkalemia, hypoplasia of the skull bones, oligohydramnios, limb contractures, skull deformation, pulmonary hypoplasia, especially in the I trimester of pregnancy.
If treatment Dilaprelom ® necessary lactation, the breast-feeding should be discontinued.

Dosing and Administration

The capsules must be swallowed whole and washed down with a sufficient amount (1/2 cup) of water, regardless of the meal (ie capsules may be taken both before and during or after a meal). The dosage is selected depending on the therapeutic effect and patient tolerability of the drug.

Hypertension
Inside, the initial dose – 2.5 mg, once in the morning. When taking the drug at this dose for 3 weeks or more can not normalize blood pressure, the dose may be increased up to 5 mg of the preparation Dilaprel ® per day. In inefficiency dose of 5 mg every 2-3 weeks, it can be further doubled to a maximum recommended daily dose – 10 mg per day. As an alternative to increasing the dose to 10 mg per day when there is insufficient anti-hypertensive effect of 5 mg daily dose can be added to the treatment of other antihypertensive drugs, especially diuretics or blockers “slow” calcium channels.

Chronic heart failure
initial dose – 1.25 mg / day *. Depending on the patient’s response to therapy dose can be increased. It is recommended doubling at intervals of 1-2 weeks. Doses of 2.5 mg or more taken once or divided into 2 doses. The maximum daily dose – 10 mg.

In heart failure, advanced in the first few days (from the second to the ninth day) after an acute myocardial infarction
initial dose – 5 mg, divided in 2 doses, 2.5 mg in the morning and evening. If a patient can not tolerate this initial dose (excessive blood pressure reduction observed), then it is recommended for two days to give 1.25 mg 2 times a day. *
Then, depending on patient response, dosage may be increased.
It is recommended that the dose its increase was doubled at intervals of 1-3 days. Later, the total daily dose, which is initially divided into two doses can be given only once.
The maximum recommended daily dose is 10 mg.
At the present time experience in treating patients with severe chronic heart failure (III-IV functional class NYHA classification), which arose immediately after the acute myocardial infarction, is not sufficient.
If such patients, the decision to conduct drug treatment Dilaprel ® , it is recommended that treatment is started with the lowest possible dose – 1.25 mg 1 time per day *. Particular caution should be exercised whenever the dose is increased.

In diabetic or nondiabetic nephropathy
initial dose – 1.25 mg 1 time per day *. The dose may be increased up to 5 mg once per day.
The maximum testosterone cypionate vs enanthate daily dose of – 5 mg.

Use of the drug Dilaprel ® in selected groups of patients

Patients with renal impairment
When CC from 50 to 20 mL / min per 1.73 m² body surface initial daily dose is usually 1.25 mg *.
The maximum daily dose – 5 mg.

Patients with incompletely adjusted loss of fluid and electrolytes, patients with severe hypertension, and patients for whom an excessive fall in blood pressure is a risk (for example, in severe atherosclerotic lesions of the coronary and cerebral arteries)
The initial dose is reduced to 1.25 mg / day * .

Patients with prior treatment with diuretics
is necessary if possible to cancel diuretics 2-3 days (depending on the duration of action of diuretics) before treatment with Dilaprel ® or at least reduce the dose of diuretics. Treatment of such patients should be started with the lowest dose of 1.25 mg ramipril * Take 1 times a day, in the morning. After the first dose and after every increase of the dose of ramipril and (or) loop diuretics, patients should be under medical supervision at least 8 hours in order to avoid uncontrolled hypertensive reactions.

Elderly patients (over 65 years)
The initial dose is reduced to 1.25 mg / day *.

Patients with impaired liver function
reaction of BP to the drug Dilaprel ® can either amplify (by slowing down the excretion ramiprilata) or decrease (by slowing the conversion of less active ramipril active ramiprilat). Therefore, at the beginning of treatment requires careful medical supervision.
Maximum permitted daily dose – 2.5 mg.

* In this case the preparation can be used in other ramipril dosage form: 2.5 mg tablets with Valium.