Index of drugs

Mild to moderate hypertension. Left ventricular dysfunction after acute myocardial infarction.

1 capsule contains 0.5 mg, 1 mg or 2 mg of trandolapril. The preparation contains lactose.

Trandolapril is converted into the active metabolite - trandolaprilat, which is an inhibitor of ACE (angiotensin converting enzyme I to angiotensin II). Suppression of ACE activity results in a decrease in angiotensin II concentration, a reduction in aldosterone secretion and an increase in serum renin activity by inhibition of negative feedback. Inhibition of bradykinin degradation, release of prostaglandins and reduction of sympathetic nervous system activity are other mechanisms of action that may be important for the vasodilating effect of ACE inhibitors. The antihypertensive effect is seen about 1 hour after administration and lasts for at least 24 hours. Trandolapril is absorbed rapidly after oral administration, reaching C_max during 30 min. It is hydrolysed to the active metabolite - trandolaprilat, which reaches C_max 4-6 h after administration of the preparation. The bioavailability of trandolaprilat is approximately 13% after oral trandolapril infusion. Trandolaprilat is more than 80% bound to plasma proteins. Steady state is achieved within 4 days of drug administration. The drug is excreted in about 33% in the urine and 66% in the faeces. T_0,5 Trandolaprilat is 16-24 h.

Hypersensitivity to trandolapril, other ACE inhibitors or other components of the preparation. History of angioneurotic edema associated with prior use of ACE inhibitors. Hereditary or idiopathic angioneurotic edema. II and III trimester of pregnancy. Breastfeeding period.

Use with caution in patients with elevated renin-angiotensin-aldosterone system activity due to the risk of significant decreases in blood pressure and renal function impairment (requires medical supervision, including monitoring of blood pressure, and treatment should be started with a low dose, very carefully increased ) - this applies to patients: dehydrated and sodium deficient (eg as a result of long-term use of diuretics, low-sodium diet, dialysis, diarrhea and vomiting, discontinuation of diuretics and replenish volume and / or sodium deficiency); with renal artery stenosis; with heart failure; with liver cirrhosis and / or ascites. Similar precautions should also be observed in patients with angina and in patients with cerebrovascular disorders due to the risk of cardiac or cerebral ischemia in severe hypotension. If hypotension or renal insufficiency occurs, it may be necessary to reduce the dose or discontinue treatment with trandolapril and / or diuretics. Caution should also be exercised in patients undergoing major surgery or during general anesthesia with drugs that cause hypotension (if treatment with an ACE inhibitor can not be stopped, caution should be taken to correct the volume of intravascular fluid). Particularly cautiously use in patients: with aortic stenosis or narrowing of the left ventricle outflow pathway; with concomitant connective tissue diseases (eg systemic lupus erythematosus, scleroderma) or in patients using immunosuppressants, Allopurinol or procainamide due to the risk of neutropenia; with the risk of hyperkalemia (including patients with renal failure, in the elderly, with diabetes, with metabolic acidosis, with sudden deterioration of heart function, taking potassium sparing diuretics at the same time, potassium supplements or salt substitutes containing potassium or other drugs increasing the concentration potassium in the blood, the use of trandolapril with drugs causing hyperkalemia is not recommended); with hepatic impairment; with impaired renal function; with clinically significant proteinuria (> 1 g / day). There is no experience regarding the use of trandolapril in patients who have recently undergone kidney transplantation - treatment with the preparation is not recommended. Lithium is not recommended.In dialysis patients with dialysis membranes of high permeability and simultaneously treated with ACE inhibitors, anaphylactoid reactions have been observed - consideration should be given to the use of other types of dialysis membranes or antihypertensive agents from other groups. The preparation should be discontinued before LDL-apheresis with dextran sulphate or before the treatment of Hymenoptera sensitizing venom, due to the risk of life-threatening anaphylactoid reactions. ACE inhibitors are more likely to cause angioneurotic edema in black patients than in non-black patients. The drug may be less effective in lowering blood pressure in black patients. The preparation should be discontinued in the event of angioedema and appropriate medical procedures should be instituted. In patients receiving ACE inhibitors who develop jaundice or who have a significant increase in liver enzymes, treatment with an ACE inhibitor should be discontinued. The efficacy and safety of the preparation in children have not been established - do not use in this age group. Due to the lactose content, the preparation should not be used in patients with galactose intolerance, Lapp lactase deficiency or malabsorption of glucose-galactose.

The use of the preparation in the first trimester of pregnancy is not recommended (there is a risk of teratogenic effect). Use in the second and third trimester of pregnancy is contraindicated. Trandolapril used in the second and third trimester of pregnancy is toxic to fetal development (deterioration of renal function, oligohydramnios, delayed ossification of the skull) and newborn (renal failure, hypotension, hyperkalemia) - when exposure to the drug occurred from the second trimester of pregnancy, it is recommended an ultrasound examination of the fetus skull and kidneys; children whose mothers took the drug during pregnancy should be closely monitored for hypotension. The drug is contraindicated during breastfeeding.

Very common: hypotension. Common: headache, dizziness, cough, weakness. Uncommon: palpitations, nausea, pruritus, skin rash, feeling unwell. Rarely or very rarely: throat irritation, watery runny nose, vomiting, abdominal pain, diarrhea, constipation, indigestion, angioneurotic edema, sweating, urticaria, muscle pain, hot flushes, nervousness, sleep disorders, drowsiness. In addition: increased urea and creatinine in the blood, decreased platelet count, increased liver enzymes (including AST and ALT), agranulocytosis, leukopenia, dyspnoea, bronchitis, dry mouth, pancreatitis, functional renal failure, proteinuria , alopecia, hyperkalemia, stroke, fainting, fever, hypersensitivity reactions (including pruritus and rash). There may also be other side effects seen with ACE inhibitors as a group: decrease in hemoglobin and hematocrit, angina pectoris, myocardial infarction, atrioventricular block, bradycardia, cardiac arrest, tachycardia, pancytopenia, sinusitis, rhinitis , inflammation of the tongue, bronchospasm, intestinal obstruction, increased bilirubin in the blood, haemolytic anemia with congenital deficiency of glucose-6-phosphate dehydrogenase, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, psoriasis-like lesions, cerebral haemorrhage, transient ischemia , cholestatic jaundice, hepatitis.

Orally. Adults:HypertensionThe recommended initial dose (in patients who do not receive diuretic therapy, no congestive heart failure and no renal or hepatic impairment) is 0.5 once daily (therapeutic response to a dose of 0.5 mg is observed only in a small number of patients). The dose should be doubled every 2-4 weeks, taking into account the patient's response to the preparation, up to a maximum dose of 4 mg once a day. The maintenance dose is usually 1-2 mg once a day. If the patient's response to a dose of 4 mg per day is unsatisfactory, the preparation should be considered in combination with diuretics and / or Calcium channel blockers.Left ventricular dysfunction after acute myocardial infarction: treatment should start at 3.after the acute myocardial infarction after the necessary conditions have been met (stable haemodynamic status and treatment of residual ischaemia). The starting dose is 0.5 mg once a day. Then the dose should be gradually increased to a maximum dose of 4 mg once a day. When symptomatic hypotension occurs, the dose may be temporarily discontinued. Treatment should be started under hospital conditions under strict control, especially blood pressure. If hypotension occurs, treatment associated with antihypertensive and diuretics should be reviewed and, if possible, their doses reduced. The dose of trandolapril should be reduced only if the recommendations described are ineffective or impossible.Special groups of patients. Patients who previously received diuretics: discontinue diuretic therapy at least 2-3 days before applying 0.5 mg daily trandolapril; if necessary, treatment with diuretics may be continued at a later time. In patients with hypertension, concomitant congestive heart failure, or with or without kidney disease, treatment should be initiated under close medical supervision in a hospital setting of 0.5 mg once a day. Patients with impaired renal function: creatinine clearance 10-30 ml / min - initial dose is 0.5 mg daily, if necessary, the dose can be increased to 1 mg once a day; creatinine clearance <10 ml / min and dialyzed patients - the dose is 0.5 mg once a day. In patients with renovascular hypertension, the starting dose is 0.5 mg per day, then the dose adjusted to blood pressure. In patients with severe hepatic impairment, the starting dose is 0.5 mg per day administered under close medical supervision. In elderly patients with normal renal function no dose adjustment is necessary, it is recommended to start with a low dose and monitor blood pressure and renal function at the beginning of treatment. In elderly patients treated with diuretics, congestive heart failure, renal or hepatic insufficiency, the dose should be adjusted to the blood pressure obtained.
The drug can be taken before, during or after a meal.