Index of drugs

Hypertension. Left ventricular dysfunction (ejection fraction ≤35%) after myocardial infarction with or without heart failure symptoms and / or with residual ischaemia or without ischaemia.

1 capsule contains 2 mg of trandolapril.

A drug from the group of angiotensin converting enzyme I inhibitors into angiotensin II. Trandolapril is a prodrug that is hydrolysed to a potent and long-acting metabolite - trandolaprilat, which is a proper ACE inhibitor. Administration of trandolapril results in a decrease in the concentration of angiotensin II, aldosterone and atrial natriuretic factor as well as an increase in plasma renin activity and angiotensin I concentration. In patients treated with the hypertrophy, improvement of diastolic function and improvement of arterial flexibility have been observed. Treatment with trandolapril reduces overall mortality, cardiovascular mortality, risk of sudden death, and severe or refractory heart failure. After oral administration, it is rapidly absorbed from the gastrointestinal tract (the presence of food does not affect the absorption of the drug), the bioavailability of the drug is about 40-60%. Trandolaprylate reaches maximum plasma concentration after 4-6 h. Maximum trandolapril plasma concentrations occur within 30 minutes of administration. Trandolaprilat is approximately 80% bound to plasma proteins. The effect of the drug persists for approximately 24 hours. The steady state is reached within 4 days. T_0,5 Trandolaprilat is 16-24 h, excretes in about 33% with urine (including 10-15% in unchanged form) and in 66% with faeces.

Hypersensitivity to trandolapril, any of the excipients or any other ACE inhibitor. Angioedema associated with previous treatment with an ACE inhibitor. Hereditary or idiopathic angioneurotic edema. Pregnancy and breast-feeding. Concomitant use with aliskiren in patients with diabetes mellitus or renal impairment (glomerular filtration rate, GFR <60 ml / min / 1.73 m²).

Patients with an increased risk of symptomatic hypotension, with ischemic heart disease or cerebrovascular disorders (risk of myocardial infarction or cerebrovascular accident) should be carefully monitored during the initiation of treatment and adjustment of the dose. Transient hypotension is not a contraindication for further treatment, which can be used without problems as soon as blood pressure increases after increasing the intravascular volume. In patients with heart failure with normal or low blood pressure, additional hypotension may occur after using trandolapril and if hypotension becomes symptomatic, a reduction in dose or discontinuation of trandolapril may be necessary. Do not initiate treatment in patients with acute myocardial infarction who are at risk of further severe deterioration of the haemodynamic status after using a vasodilator (patients with systolic blood pressure ≤100 mmHg and patients in cardiogenic shock). Do not initiate treatment in acute myocardial infarction in patients with renal dysfunction (serum creatinine> 177 μmol / l (or) proteinuria> 500 mg / day) and if renal dysfunction occurs (serum creatinine> 265 μmol) or doubling the pre-treatment value) discontinuation of trandolapril should be considered. Take caution when using trandolapril in patients with aortic stenosis or hypertrophic cardiomyopathy. In haemodynamic cases, no trandolapril should be administered. Use with caution in patients with heart failure (risk of acute renal failure), bilateral renal artery stenosis or renal artery stenosis of one active kidney (risk of severe hypotension and renal failure, initiate treatment under close control with a low dose, discontinue treatment in the first weeks of treatment diuretic and monitor renal function), hypertension (a diuretic and / or a trandolapril may be required to be reduced and / or discontinued). The use of trandolapril is not recommended in patients after kidney transplantation (lack of experience in use) and in patients with primary hyperaldosteronism. The preparation should be discontinued with angioedema (angioneurotic edema is more frequently observed in black patients than in other breeds), jaundice or a marked increase in liver enzymes.Trandolapril may be less effective in lowering blood pressure in black patients than in other breeds, due to the more frequent occurrence of low-renin states in the black population of hypotension. In patients on dialysis with high-throughput dialysis membranes and treated with an ACE inhibitor, another type of dialysis membrane or antihypertensive drug from another group should be considered. The ACE inhibitor should be discontinued before each apheresis of low-density lipoproteins (LDL), and during desensitisation treatment, eg with hymenoptera venom, due to the possibility of anaphylactoid reactions. Exercise caution and monitor patients with impaired hepatic function. Use with extreme caution in patients with collagen diseases receiving immunosuppressant therapy, Allopurinol or prokimide treatment or in whom these coexists, especially in the case of pre-existing renal dysfunction (periodic monitoring of white blood cells is recommended and monitoring of the patient's condition for symptoms of infection). In patients undergoing major surgery or during anesthesia with agents that cause hypotension, if hypotension occurs, they can be compensated by increasing the intravascular volume. Trandolapril may cause hyperkalaemia, the patients most at risk of this side effect include patients with renal insufficiency, diabetes or those taking concomitant diuretic, sparing potassium, potassium supplements or potassium-containing salt substitutes or other drugs that increase serum potassium (eg heparin) ) (regular monitoring of potassium in the blood is recommended). Trandolapril can only be administered after a careful assessment of the risks and benefits of treating patients with clinically relevant proteinuria (more than 1g / day), and clinical and laboratory parameters should be monitored regularly. Combined use of trandolapril and lithium is not recommended. The concomitant use of ACE inhibitors, angiotensin II receptor antagonists or aliskiren increases the risk of hypotension, hyperkalaemia and renal dysfunction (including acute renal failure) - therefore, dual blocking of the RAA system is not recommended by concomitant use of ACE inhibitors, angiotensin II receptor antagonists or aliskiren. If the use of a dual RAA blockade is absolutely necessary, it should only be carried out under the supervision of a specialist, and the vital parameters of the patient, such as kidney function, electrolyte concentration and blood pressure should be closely monitored. In patients with diabetic nephropathy, ACE inhibitors and angiotensin II receptor antagonists should not be used concurrently. The use of the drug in children has not been studied and therefore the administration is not recommended in this age group. The preparation contains lactose - do not use in patients with rare hereditary galactose intolerance, Lapp lactase deficiency or malabsorption of glucose-galactose.

ACE inhibitors are not recommended during the first trimester of pregnancy, and contraindications are contraindicated in the second and third trimesters. The use of trandolapril in the first trimester may be associated with an increased teratogenic risk. Taking the preparation in the second and third trimester may cause toxic effects on the fetus (renal dysfunction, oligohydramnios, delayed ossification of the skull) and the newborn (renal failure, hypotension, hyperkalemia). In the case of exposure to trandolapril from the second trimester, ultrasound examination of the kidneys and skull is recommended. Newborns whose mothers have taken trandolapril should be closely monitored for possible hypotension, oliguria and hyperkalemia. If you are planning or confirming your pregnancy, you should use other treatment as soon as possible. Due to the lack of data on the use of trandolapril during breastfeeding, use is not recommended, especially when breastfeeding a newborn or a premature baby.

Common: central dizziness, headache; orthostatic symptoms (including hypotension), cough; diarrhea, vomiting; kidney problems. Uncommon: mood swings, paresthesia, peripheral dizziness, disturbed taste, sleep disorders; myocardial infarction or cerebrovascular incident, probably secondary to significant hypotension in high-risk patients, palpitations, tachycardia, Raynaud's; shortness of breath, inflammation of the oral mucosa, sore throat, hoarseness; nausea, abdominal pain and indigestion, anorexia; rash, pruritus; impotence; fatigue, weakness, unwellness; increase in blood urea, increase in serum creatinine, increase in liver enzymes, hyperkalemia.Rare: decrease in hemoglobin, decrease in hematocrit; confusional states, drowsiness, depression, balance disorders, muscle convulsions, nervousness, tinnitus, blurred vision; dryness of the oral mucosa, constipation, lack of appetite; hypersensitivity / angioedema of the face, limbs, lips, tongue, glottis and / or larynx, urticaria, alopecia, psoriasis; uremia, acute renal failure, proteinuria; gynecomastia; hot flushes; increase in serum bilirubin, hyponatremia. Very rare: bone marrow suppression, anemia, thrombocytopenia, leukopenia, neutropenia, eosinophilia, agranulocytosis, haemolytic anemia, generalized lymphadenopathy, autoimmune disease; hypoglycemia; bronchospasm, sinusitis, oral mucositis, inflammation of the tongue, lung infarction, allergic alveolitis / eosinophilic pneumonia; pancreatitis, hepatitis (intracellular and cholestatic), jaundice, angioedema of the intestines; sweating, pemphigus, toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme, hypersensitivity to light, redness of the face, separation of the nail from the placenta, severity of Raynaud's disease; oliguria / anemone, bacterial interstitial nephritis. Isolated cases of tachycardia, palpitations, arrhythmia, chest pain, angina, transient ischemic attacks and strokes have been reported. In patients with an acute myocardial infarction, the IIst atrio-ventricular block may occur. or IIIst. and (or) severe hypotension and renal failure as well as cardiogenic shock, especially during the first day. In addition, a syndrome consisting of one or more of the following symptoms may occur: fever, vasculitis, muscle pain, arthralgia, arthritis, positive antinuclear antibody (ANA), accelerated cell death, leukocytosis, rash, photosensitivity and dermatological symptoms.

Orally. Adults.Hypertension: the starting dose is 0.5 once a day; the dose may be doubled every 2 to 4 weeks, depending on the patient's response, 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 4-mg dose is not satisfactory, combination therapy with other antihypertensive medicinal products should be considered.Left ventricular dysfunction after acute myocardial infarction: treatment can be started on the 3rd day, but not later than on the 7th day after acute myocardial infarction; the starting dose is 0.5 mg per day; then the dose should be increased the Next day to 1 mg once daily for 2 days, and then gradually increased to a maximum dose of 4 mg once a day. Increasing the dose may be temporarily interrupted (including if symptomatic hypotension develops). Treatment should be started under hospital conditions under strict control, especially blood pressure. In the event of hypotension, the antihypertensive treatment should be carefully evaluated, with the use of vasodilators, including nitrates and diuretics, and if possible reduce their dose. The dose of trandolapril should be reduced only if the recommendations described are ineffective or impossible. If treatment with trandolapril is well tolerated, the preparation should be taken at least 2 years after myocardial infarction.
Patients who previously received diuretics: diuretics should be discontinued for 2-3 days before the application of trandolapril 0.5 mg daily; if necessary, the diuretic may be resumed later. After the first dose and when the dose is increased and / or the loop diuretic, the patient should be kept under control for at least 6 hours to avoid uncontrolled hypotension. In patients with hypertension and congestive heart failure, with or without co-existing renal insufficiency, treatment should be initiated under close medical supervision in a hospital setting of 0.5 mg once a day. No dose adjustment is necessary for patients with mild to moderate renal impairment.In patients with a creatinine clearance of 10-30 ml / min, the starting dose is 0.5 mg daily, if necessary, the dose may be increased to 4 mg once a day; in patients with a creatinine clearance <10 ml / min and in dialysis patients - treatment should start at 0.5 mg once a day and if necessary increase to a maximum of 2 mg once a day. Doses have not been established in patients with end-stage renal disease and those undergoing hemodialysis. In patients with severe hepatic impairment, the starting dose is 0.5 mg per day administered under close medical supervision and the maximum dose may not exceed 2 mg. In older patients with normal renal and hepatic function, no dose adjustment is necessary. In elderly patients treated with diuretics, congestive heart failure or renal or hepatic insufficiency, the dose should be adjusted to the blood pressure obtained.Way of giving. The capsules can be taken whole regardless of the meal.