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

Hypertension (high blood pressure)Arterial hypertension.

Active ingredient

Telmisartan

Composition

Associates:

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 cell packs (3) – cardboard boxes.

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Interaction

Concomitant use with antihypertensive drugs may increase the antihypertensive effect.

Concomitant use with potassium-saving diuretics, heparin, dietary supplements, salt substitutes containing potassium may lead to hyperkalemia.

Concomitant use with lithium preparations may increase the concentration of lithium in plasma.

Concomitant use may increase the plasma concentration of digoxin.

Directions for use

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

Patients with impaired renal function and elderly patients do not require dose adjustment.

In patients with hepatic impairment the daily dose is 40 mg.

Special Instructions

With caution telmisartan is used in liver dysfunction, acute gastric and duodenal ulcer, other GI diseases, aortic and mitral valve stenosis, obstructive hypertrophic cardiomyopathy, CHD, heart failure.

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

In patients with impaired renal function, plasma potassium and creatinine should be monitored during telmisartan use.

Telmisartan currently has no data on the use of telmisartan in patients with recent kidney transplantation.

In patients with decreased RBC and/or hyponatremia, symptomatic arterial hypotension may occur, especially after the first dose of telmisartan. Therefore, correction of such conditions is necessary prior to therapy.

The use of telmisartan in patients with primary aldosteronism is not recommended because these patients are insensitive to drugs that act on the renin-angiotensin system.

The use of telmisartan is possible in combination with thiazide diuretics because this combination provides additional BP reduction.

When considering 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.

Pediatric use

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

Impact on ability to drive and operate machinery

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

Synopsis

Tablets are white or almost white, round, flat-cylindrical, beveled and ribbed.

Features

Ingestion is rapidly absorbed from the gastrointestinal tract. Bioavailability is 50%. When taken concomitantly with food, the AUC reduction ranges from 6% (at a dose of 40 mg) to 19% (at a dose of 160 mg). Three hours after intake, plasma concentrations level off, regardless of whether it is taken with food or on an empty stomach.

The binding to plasma proteins is 99.5%. Mean values of apparent V_d in the equilibrium stage are 500L. Metabolized by conjugation with glucuronic acid. Metabolites are pharmacologically inactive.

T_1/2 – more than 20 h. It is excreted through the intestine unchanged. Cumulative renal excretion is less than 1%. Total plasma clearance is 1000 ml/min (renal blood flow is 1500 ml/min).

Contraindications

Biliary obstruction, severe hepatic and renal dysfunction, pregnancy, lactation (breastfeeding), hypersensitivity to telmisartan.

Side effects

CNS disorders: headache, dizziness, fatigue, insomnia, anxiety, depression, seizures.

In the digestive system: abdominal pain, dyspepsia, nausea, diarrhea, increased liver transaminase activity.

Respiratory system disorders: cough, pharyngitis, upper respiratory tract infections.

Hematopoietic system: decrease in hemoglobin levels.

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

Urinary system disorders: peripheral edema, urinary tract infections, increased uric acid level, hypercreatininemia.

Cardiovascular system disorders: marked decrease in BP, palpitations, chest pain.

Muscular system disorders: low back pain, myalgia, arthralgia.

Laboratory disorders: hyperkalemia, anemia, hyperuricemia.

Others: flu-like syndrome.

Similarities

Mycardis, Telsartan, Telzap, Telmista, Telpres, Telmisartan