Index of drugs

Treatment of spontaneous hypertension in adults. Reduction in cardiovascular morbidity in patients with overt atherosclerotic disease (ischemic heart disease, stroke or peripheral arterial disease) or with type 2 diabetes with documented end organ damage.

1 tabl contains 40 mg or 80 mg of telmisartan.

Selective angiotensin II receptor antagonist (AT type₁) with high affinity. Selectively binds to the AT receptor₁by blocking the effects of angiotensin II. It has no agonist activity towards the AT receptor₁, does not bind and does not block other AT receptor subtypes. Telmisartan reduces the amount of aldosterone in the blood. It does not inhibit the activity of renin plasma and does not block ion channels. It does not inhibit angiotensin-converting enzyme (kininase II), thanks to which it does not increase the effects of bradykinin-dependent effects. After oral administration, telmisartan is rapidly, but to a different degree absorbed from the gastrointestinal tract. The average absolute bioavailability is about 50%. It is highly bound to plasma proteins (> 99.5%). It is metabolized in the process of coupling to glucuronide derivatives, which do not have pharmacological activity. The drug is almost completely excreted unchanged in the faeces, urinary excretion accounts for less than 1% of the administered dose. T_0,5 is> 20 h.

Hypersensitivity to the components of the preparation. Disorders in the outflow of bile. Severe hepatic failure. 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).

The prepart should not be given to patients with cholestasis, biliary obstructive disorders or severe hepatic impairment. It may be used in patients with mild or moderate hepatic impairment only with caution. There was an increased risk of severe hypotension and renal failure when administering drugs affecting the renin-angiotensin-aldosterone system in patients with bilateral renal artery stenosis or renal artery stenosis for one active kidney. In patients with impaired renal function, periodic monitoring of potassium and creatinine in the blood is recommended. There are no data on the use of the preparation in patients after a recent kidney transplantation. Symptomatic hypotension, especially after the first dose, may occur in patients with decreased intravascular volume and / or reduced sodium concentration as a result of intense diuretic therapy and / or reduced salt intake, diarrhea or vomiting - these disorders should be compensated before administration. 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. In patients whose vascular tone and renal function depend mainly on the activity of the renin-angiotensin-aldosterone system (e.g., patients with severe congestive heart failure or kidney disease, including renal artery stenosis), administration of drugs such as telmisartan affecting on this system, it was associated with a sharp reduction in blood pressure, hyperazotemia, oliguria and rarely with acute renal failure.Patients with primary aldosteronism generally do not respond to treatment with antihypertensive drugs acting through the inhibition of the renin-angiotensin system - the use of telmisartan in these patients is not recommended. Special care should be taken in patients with aortic or bifurcular stenosis or hypertrophic narrowing cardiomyopathy. As with other antihypertensive agents, excessive reduction of blood pressure in patients with cardiomyopathy or coronary heart disease may result in a heart attack or stroke. Due to the risk of hyperkalemia, in patients at risk: elderly, with renal insufficiency, with diabetes, while taking other preparations that may increase the level of potassium in the blood and (or) patients with underlying diseases, in particular such as: dehydration, acute decompensated heart failure, metabolic acidosis, deterioration of renal function, sudden deterioration of renal function (eg in the course of infectious diseases), cell disintegration (eg in acute limb ischemia, striated muscle decay, widespread injury) before deciding on when using preparations acting on the renin-angiotensin-aldosterone system, the benefit-risk ratio should be assessed. In patients at risk for hyperkalemia, blood potassium levels should be monitored in great detail. Angiotensin II receptor antagonists are less effective in the treatment of hypertension in the black population. Telmisartan is not recommended for patients <18 years of age.

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. Telmisartan 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 not recommended during breast-feeding.

Uncommon: infection of the upper respiratory tract (including pharyngitis and sinusitis), urinary tract infections (including cystitis), anemia, hyperkalemia, insomnia, depression, syncope, dizziness, bradycardia, hypotension, orthostatic hypotension, dyspnoea, abdominal pain, diarrhea, dyspepsia, bloating, vomiting, pruritus, sweating, rash, muscle pain, back pain (eg sciatica), muscle cramps, kidney problems (including severe renal failure), chest pain, weakness , increased levels of creatinine in the blood. Rare: thrombocytopenia, hypersensitivity reactions, anxiety, visual disturbances, tachycardia, gastritis, dry mouth, liver dysfunction, erythema, angioedema, drug eruptions, toxic skin eruptions, eczema, joint pain, limb pain, flu-like symptoms , increased levels of uric acid in the blood, increased activity of hepatic enzymes and creatine phosphokinase in the blood, decreased hemoglobin. Not known: sepsis (including fatal outcome), eosinophilia, anaphylactic reaction, urticaria, tendon pain (symptoms imitating tendinitis).

Orally. Adults.Spontaneous hypertension: the usual effective dose is 40 mg once a day. In some patients, improvement may occur after 20 mg. In the absence of a satisfactory blood pressure-lowering effect, the dose of telmisartan may be increased to 80 mg once a day. Alternatively, telmisartan can be used in combination with thiazide diuretics such as hydrochlorothiazide. In the event that a dose increase is considered, it must be taken into account that the maximum pressure-lowering effect is achieved 4-8 weeks after the start of treatment.Prevention of cardiovascular diseasesThe recommended dose is 80 mg once a day. It has not been determined whether doses lower than 80 mg of telmisartan are effective in reducing the incidence of cardiovascular problems.Close blood pressure monitoring is recommended when initiating telmisartan to reduce cardiovascular morbidity and if necessary to adjust the dose of blood-pressure medication.Special groups of patients. Dosage adjustment is not necessary in the elderly and in patients with mild to moderate renal impairment. In patients with severe renal failure or undergoing hemodialysis, it is recommended to start treatment with a 20 mg dose. In the case of mild to moderate hepatic impairment, the dose can not exceed 40 mg once a day.
The drug can be taken regardless of the meal.