Telmisartan-SZ, tablets 80 mg 28 pcs

Antihypertensive drug, angiotensin II receptor antagonist (type AT1). It has a very high affinity to this receptor subtype. By selectively and prolonged binding to the receptors, telmisartan displaces angiotensin II from binding to AT1 receptors. It has no affinity for other AT receptor subtypes.

Indications

Arterial hypertension.

Pharmacological effect

Antihypertensive agent, angiotensin II receptor antagonist (AT1 type). It has a very high affinity for this receptor subtype. By selectively and long-term binding to receptors, telmisartan displaces angiotensin II from its connection with AT1 receptors. Does not show affinity for other AT receptor subtypes.

Special instructions

Telmisartan is used with caution in cases of liver dysfunction, gastric and duodenal ulcers in the acute stage, other gastrointestinal diseases, aortic and mitral valve stenosis, obstructive hypertrophic cardiomyopathy, coronary artery disease, and heart failure.

In patients with bilateral renal artery stenosis or renal artery stenosis of a single functioning kidney, the use of telmisartan increases the risk of severe arterial hypotension and renal failure. Therefore, telmisartan should be used with caution in this category of patients.

During the period of use of telmisartan in patients with impaired renal function, it is necessary to monitor the content of potassium and creatinine in the blood plasma.

There are currently no data on the use of telmisartan in patients with recent kidney transplantation.

In patients with reduced blood volume and/or hyponatremia, symptomatic arterial hypotension may occur, especially after taking the first dose of telmisartan. Therefore, before carrying out therapy, correction of such conditions is necessary.

It is not recommended to use telmisartan in patients with primary aldosteronism, because such patients are insensitive to drugs that affect the renin-angiotensin system.

The use of telmisartan is possible in combination with thiazide diuretics, because This combination provides an additional reduction in blood pressure.

When considering the possibility of increasing the dose of telmisartan, it should be remembered that the maximum hypotensive effect is usually achieved 4-8 weeks after the start of treatment.

Use in pediatrics

There are no data on the safety and effectiveness of telmisartan in children and adolescents.

Impact on the ability to drive vehicles and operate machinery

The question of the possibility of engaging in potentially hazardous activities that require increased attention and rapid psychomotor reactions should be decided only after assessing the individual response to telmisartan.

Active ingredient

Telmisartan

Composition

1 tab.
telmisartan
80 mg

Excipients:

sodium hydroxide – 6.8 mg,

povidone (K-30) – 24 mg,

meglumine – 24 mg,

mannitol – 330.4 mg,

magnesium stearate – 4.8 mg,

talc – 10 mg.

10 pcs. – contour cellular packaging (3) – cardboard packs.

Contraindications

Obstruction of the biliary tract, severe dysfunction of the liver and kidneys, pregnancy, lactation (breastfeeding), hypersensitivity to telmisartan.

Side Effects

From the central nervous system: headache, dizziness, fatigue, insomnia, anxiety, depression, convulsions.

From the digestive system: abdominal pain, dyspepsia, nausea, diarrhea, increased activity of liver transaminases.

From the respiratory system: cough, pharyngitis, upper respiratory tract infections.

From the hematopoietic system: decrease in hemoglobin level.

Allergic reactions: rash; in a single case – angioedema.

From the urinary system: peripheral edema, urinary tract infections, increased uric acid levels, hypercreatininemia.

From the cardiovascular system: marked decrease in blood pressure, palpitations, chest pain.

From the musculoskeletal system: low back pain, myalgia, arthralgia.

Laboratory indicators: hyperkalemia, anemia, hyperuricemia.

Other: influenza-like syndrome.

Interaction

When used simultaneously with antihypertensive drugs, the antihypertensive effect may be enhanced.

When used simultaneously with potassium-sparing diuretics, heparin, dietary supplements, salt substitutes containing potassium, hyperkalemia may develop.

When used simultaneously with lithium preparations, an increase in the concentration of lithium in the blood plasma is possible.

With simultaneous use, it is possible to increase the concentration of digoxin in the blood plasma.

Recommendations for use

For adults, the daily dose is 20-40 mg (1 time/day). In some patients, a hypotensive effect can be achieved with a dose of 20 mg/day. If necessary, the dose can be increased to 80 mg/day.

Patients with impaired renal function, as well as elderly patients, do not require dose adjustment.

For patients with impaired liver function, the daily dose is 40 mg.

Functional features

When taken orally, it is quickly absorbed from the gastrointestinal tract. Bioavailability is 50%. When taken simultaneously with food, the reduction in AUC ranges from 6% (at a dose of 40 mg) to 19% (at a dose of 160 mg). 3 hours after administration, the plasma concentration levels off, regardless of whether it is taken with food or on an empty stomach.

Plasma protein binding is 99.5%. The average values ​​of apparent Vd at the equilibrium stage are 500 l. Metabolized by conjugation with glucuronic acid. Metabolites are pharmacologically inactive.

T1/2 – more than 20 hours. Excreted through the intestines unchanged. Cumulative renal excretion is less than 1%. Total plasma clearance is 1000 ml/min (renal blood flow is 1500 ml/min).

Manufacturer

North Star NAO, Russia