Index of drugs

Mild to moderate hypertension. Left ventricular dysfunction after myocardial infarction. Symptomatic heart failure.
Trandolapril has been shown to increase the survival after myocardial infarction in patients with left ventricular dysfunction (ejection fraction ≤35%), with or without heart failure symptoms and / or with residual ischemia. Long-term treatment with trandolapril significantly reduces the overall mortality caused by cardiovascular diseases. It significantly reduces the risk of sudden death and the occurrence of severe or refractory heart failure.

One capsule contains 0.5 mg, 2 mg or 4 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. The antihypertensive effect is evident about one hour after administration and lasts for at least 24 hours, with the maximum effect visible between 8 and 12 hours after administration. Trandolapril is absorbed quickly after oral administration, reaching C_max in 1 hour. It is hydrolysed to the active metabolite - trandolaprilat, which reaches C_max 3-8 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 15-23 h.

Hypersensitivity to trandolapril or other ingredients. History of angioneurotic edema associated with prior use of ACE inhibitors. Hereditary or idiopathic angioneurotic edema. II and III trimester of pregnancy. Concomitant use with aliskiren in patients with diabetes mellitus or renal impairment (glomerular filtration rate, GFR <60 ml / min / 1.73 m²).

Do not use in patients with major stenosis or narrowing of the outflow tract. Caution should be exercised in patients with impaired renal function (monitoring of renal function, dose reduction may be required at a creatinine clearance <30 ml / min), in patients with impaired hepatic function and in the elderly. In patients with renal insufficiency, congestive heart failure, unilateral or bilateral renal artery stenosis, renal artery stenosis of the sole kidney and kidney transplantation there is a risk of renal dysfunction. Due to the increased risk of symptomatic hypotension, after the first dose and during dose escalation, hypovolaemic patients and sodium deficiency due to long-term use of diuretics, dietary sodium, dialysis, diarrhea and vomiting, discontinuation of diuretics and replenish the volume of fluids and (or) sodium deficiency. In patients undergoing surgery, trandolapril may block the production of angiotensin II secondary to the compensatory release of renin. In patients with collagenosis (including Lupus Erythematosus and systemic sclerosis), especially with concomitant renal insufficiency and in the case of concomitant use of corticosteroids and antimetabolites, the number of white blood cells and urine protein should be checked regularly. Angioedema was more frequently observed in black patients than in other breeds. When using ACE inhibitors, the risk of anaphylactoid reactions increases, including insect bites; before starting desensitisation, temporary discontinuation of the preparation should be considered. Due to the risk of anaphylactoid reactions, ACE inhibitors should be avoided in patients on dialysis with polyacrylonitrile membranes with a high ultrafiltration ratio or in patients receiving LDL dextran sulphate.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. Do not use in children. Do not use in patients with rare, hereditary galactose intolerance, Lapp lactase deficiency or malabsorption of glucose-galactose.

The drug is contraindicated during pregnancy and breastfeeding. Before starting treatment, make sure that you are not pregnant. You should also avoid getting pregnant during treatment. Administration of the preparation in the second and third trimester of pregnancy results in renal dysfunction, oligohydramnios and delayed bone ossification of the skull; in the newborn, renal failure, hypotension and hyperkalemia may occur. In the case of exposure to trandolapril, starting from the second trimester of pregnancy, ultrasound examination of the kidneys and skull is recommended. Infants whose mothers have taken ACE inhibitors should be monitored for hypotension.

Common: pain and dizziness, cough, asthenia, hypotension. Uncommon: infection of the upper respiratory tract, insomnia, decreased libido, drowsiness, palpitations, redness of the skin with a feeling of heat (hot flushes), inflammation or congestion of the upper respiratory tract, nausea, diarrhea, constipation, stomach and intestinal pain, gastrointestinal disorders , rash, pruritus, back pain, muscle cramps, limb pain, erectile dysfunction, chest pain, edema, feeling unwell, fatigue. Rare: urinary tract infection, bronchitis, hypersensitivity reactions, hyperglycemia, hyponatremia, hypercholesterolemia, hyperlipidemia, hyperuricemia, gout, lack of appetite or increased appetite, hallucinations, depression, sleep disturbances, anxiety, agitation, apathy, cerebrovascular incident, syncope, muscle convulsions, paresthesia, migraine, taste disorders, blepharitis, eye edema, visual disturbances, eye diseases, tinnitus, myocardial ischemia, angina pectoris, heart failure, tachycardia, bradycardia, hypertension, angiopathy, orthostatic hypotension, peripheral vascular disease, varicose veins, nosebleeds, pharyngitis, sore throat and larynx, cough with excretory secretion, breathing disorders, vomiting (also bloody), gastritis, abdominal pain, indigestion, bloating, winds, dryness oral mucosa, hepatitis , hyperbilirubinemia, angioneurotic edema, psoriasis, hyperhidrosis, eczema, acne, dry skin, skin diseases, bone and joint pain, osteoarthritis, renal failure, azotemia, polyuria, pollakiuria, leukopenia, anemia, decreased platelet count, trauma . After the introduction of the medicine, the following side effects were also reported: agranulocytosis, pancytopenia, transient ischemic attack, cerebral hemorrhage, disturbances of balance, atrioventricular block, cardiac arrest, arrhythmias, bronchospasm, intestinal obstruction, pancreatitis, jaundice, alopecia, urticaria, Stevens-Johnson syndrome, toxic necrotic separation, myalgia, fever, increase in alkaline phosphatase, lactate dehydrogenase, creatinine and urea in the blood, abnormal ECG, hyperkalemia, abnormal liver function tests, decrease in hemoglobin and hematocrit . The use of ACE inhibitors also showed hemolytic anemia, confusion, blurred vision, sinusitis, rhinitis, inflammation of the tongue, erythema multiforme, psoriasis dermatitis and angioedema of the intestines.

Orally. Adults.HypertensionThe recommended starting dose (in patients who do not drink diuretics, no congestive heart failure, and no renal or hepatic impairment) is 0.5-2 mg once a day. A therapeutic response to a 0.5 mg dose is observed only in a small number of patients. In black patients, the starting dose is usually 2 mg. The dose should be doubled every 4 to 4 weeks, taking into account the patient's response to the preparation, up to a maximum dose of 4-8 mg per day; the maintenance dose is usually 1-4 mg once a day. If the patient's response to a dose of 4-8 mg / day is unsatisfactory, the preparation should be considered in combination with diuretics and / or Calcium channel blockers.Left ventricular dysfunction after myocardial infarction: treatment can be started on the 3rd day after a heart attack, once in a single dose of 0.5-1 mg once a day; then the dose should be gradually increased, up to a maximum of 4 mg once a day. When symptomatic hypotension occurs, the dose may be temporarily discontinued. If hypotension occurs, reduce the dose of concomitant vasodilators (including nitrates) and diuretics as much as possible. The dose of trandolapril can be reduced only if the procedure described above has proved ineffective or can not be applied.Heart failure: in patients with concomitant hypertension and congestive heart failure, with or without renal insufficiency, treatment should be initiated at a dose of 0.5-1 mg once a day, under close medical supervision.Special groups of patients. In elderly patients with normal renal function, no dose adjustment is necessary. In patients with a risk of excitation of the renin-angiotensin system (eg in dehydrated and sodium-deprived patients), the diuretic should be discontinued 2-3 days before starting trandolapril 0.5 mg; if necessary, the diuretic may be resumed later. In patients with moderate renal impairment (creatinine clearance 30-70 ml / min), no dosage adjustment is necessary; with a clearance <30 ml / min the starting dose is 0.5 mg, then it can be gradually increased until the desired effect is achieved (these patients should be under strict medical supervision); in patients undergoing dialysis, blood pressure should be carefully monitored and the dose adjusted as necessary. In patients with severe hepatic impairment, the starting dose is 0.5 mg once a day under strict control.