Telpres tablets 80 mg 28 pcs. (Telmysartan)

Latin name

TELPRES

Pharmacological action of

Angiotensin II receptor antagonist.

Telmisartan is a specific angiotensin II receptor antagonist (type AT1), effective when taken orally. It has a high affinity for the AT1 subtype of angiotensin II receptors, through which the action of angiotensin II is realized. Displaces angiotensin II from the receptor, lacking the action of an agonist with respect to this receptor. Telmisartan binds only to the AT1 subtype of angiotensin II receptors. Communication is long lasting. It has no affinity for other receptors, including the AT2 receptor and other less studied angiotensin receptors. The functional significance of these receptors, as well as the effect of their possible excessive stimulation with angiotensin II, the concentration of which increases with the appointment of telmisartan, has not been studied. It reduces the concentration of aldosterone in the blood, does not inhibit renin in blood plasma and does not block ion channels. Telmisartan does not inhibit the angiotensin converting enzyme (kininase II) (an enzyme that also breaks down bradykinin). Therefore, amplification of the side effects caused by bradykinin is not expected.

In patients with arterial hypertension, telmisartan at a dose of 80 mg completely blocks the hypertensive effect of angiotensin II. The onset of antihypertensive action is noted within 3 hours after the first oral administration of telmisartan. The effect of the drug persists for 24 hours and remains significant up to 48 hours. A pronounced antihypertensive effect usually develops 4 weeks after regular use of the drug.

In patients with arterial hypertension, telmisartan lowers systolic and diastolic blood pressure (BP) without affecting heart rate (HR).

In the case of abrupt cancellation of telmisartan, blood pressure gradually returns to its original level without the development of withdrawal syndrome.

Indications

Hypertension

Decreased cardiovascular morbidity and mortality in patients 55 years of age and older with a high risk of cardiovascular disease.

Contraindications

Hypersensitivity to the active substances or auxiliary components of the drug or other sulfonamide derivatives

Pregnancy

Breastfeeding period

Obstructive biliary tract disease

Severe liver dysfunction Class C 30 ml / min)

Refractory hypokalemia, hypercalcemia

Concurrent use with aliskiren in patients with diabetes mellitus and / or impaired renal function (glomerular filtration rate less than 60 ml / min / 1.73 m2)

Concurrent use of ACE inhibitors in patients with diabetic nephropathy

Lactase deficiency, lactose intolerance, lactose intolerance glucose-galactose malabsorption

Age up to 18 years (efficacy and safety not established).

Precautions:

Bilateral renal artery stenosis or stenosis of a single kidney artery (see Special Instructions)

Impaired liver function (Child-Pugh Class A and B) (see Special Instructions)

Decreased BCC due to prior diuretic therapy , restrictions on the intake of salt, diarrhea or vomiting

Hyperkalemia

Condition after kidney transplantation (no experience with use)

Chronic heart failure III-IV functional class (FC) according to the classification of the New York Cardiology Association

Hypercalcemia

Hypercholesterolemia srdlkrd heart disease hepatic coma)

Stenosis of the aortic and mitral valve

Idiopathic hypertrophic subaortic stenosis (hypertrophic obstruction) uctive cardiomyopathy)

Diabetes mellitus

Primary hyperaldosteronism

Gout, hyperuricemia

Systemic lupus erythematosus

Secondary angle-closure glaucoma (due to the presence of hydrochlorothiazide)

Use in patients of the Negroid race

Experience in the use of patients with impaired kidneys (CC more than 30 ml / min) is limited, but does not confirm the development of side effects from the side renal and dose adjustment not required

Concomitant use with ACE inhibitors or siskl aliskiren Concurrent use with potassium preparations, potassium-sparing diuretics.

Use during pregnancy and lactation

Medicines that directly affect the RAAS can cause serious damage and death of the developing fetus, therefore, when planning or establishing the fact of pregnancy, the drug should be immediately canceled and, if necessary, an alternative antihypertensive therapy should be prescribed that has established safety profile for use during pregnancy. The use of the drug during pregnancy is contraindicated.

In preclinical studies of telmisartan, teratogenic effects were not detected, but fetotoxicity was established. It is known that exposure to angiotensin II receptor antagonists during the second and third trimesters of pregnancy causes fetotoxicity in humans (decreased renal function, oligohydramnios, slowing of ossification of the skull), as well as neonatal toxicity (renal failure, hypotension, hyperkalemia). Patients planning a pregnancy should be prescribed alternative therapy. If treatment with angiotensin II receptor antagonists occurred during the second trimester of pregnancy, ultrasound testing of the kidney function and the condition of the skull in the fetus is recommended.

Newborns whose mothers received angiotensin II receptor antagonists should be closely monitored for hypotension.

Telpres therapy is contraindicated during breastfeeding. Studies of the effect on human fertility have not been conducted.

Special instructions

Liver dysfunction

Telpres is contraindicated in patients with cholestasis, biliary obstruction, or severe liver dysfunction (Child-Pugh class C) (see Contraindications), since telmisartan is mainly excreted in the bile. It is believed that in such patients, hepatic clearance of telmisartan is reduced. In patients with mild or moderate hepatic impairment (Child-Pugh class A and B), Telpres should be used with caution (see section Caution).

Renovascular hypertension

In patients with bilateral arterial stenosis or arterial stenosis of a single functioning kidney, treatment with drugs acting on RAAS increases the risk of severe arterial hypotension and renal failure.

Impaired renal function and kidney transplantation

When using Telpres in patients with impaired renal function, periodic monitoring of potassium and creatinine in blood plasma is recommended. There is no clinical experience with Telpres in patients who have recently undergone kidney transplantation.

Decreased circulating blood volume

Symptomatic arterial hypotension, especially after the first administration of Telpres, may occur in patients with reduced BCC and / or sodium in the blood plasma against the background of previous treatment with diuretics, restriction of sodium chloride, diarrhea or vomiting. Such conditions (fluid and / or sodium deficiency) should be eliminated before taking Telpres.

Double blockade of the renin-angiotensin-aldosterone system

The concomitant use of telmisartan with aliskiren is contraindicated in patients with diabetes mellitus or renal failure (glomerular filtration rate less than 60 ml / min / 1.73 m2) (see section Contraindications).

The simultaneous use of telmisartan and ACE inhibitors is contraindicated in patients with diabetic nephropathy (see section Contraindications).

As a result of inhibition of RAAS, arterial hypotension, fainting, hyperkalemia, and impaired renal function (including acute renal failure) were noted in patients predisposed to this, especially when using several drugs that also act on this system. Therefore, a double blockade of RAAS (for example, while taking telmisartan with other RAAS antagonists) is not recommended.

In cases of dependence of vascular tone and renal function mainly on RAAS activity (for example, in patients with chronic heart failure or kidney disease, including renal artery stenosis or stenosis of a single kidney artery), the appointment of drugs that affect this system may be accompanied by the development of acute arterial hypotension, hyperazotemia, oliguria and, in rare cases, acute renal failure.

Primary aldosteronism

In patients with primary aldosteronism, treatment with antihypertensive drugs, which are carried out by inhibiting RAAS, is usually ineffective.

Aortic and mitral valve stenosis, hypertrophic obstructive cardiomyopathy

Caution should be exercised when using Telpres (as well as other vasodilators) in patients with aortic or mitral stenosis, as well as hypertrophic obstructive cardiomyopathy.

Hyperkalemia

Taking medications acting on the RAAS can cause hyperkalemia. In elderly patients, patients with renal failure or diabetes mellitus, patients also taking medications that increase plasma potassium levels, and / or patients with concomitant diseases, hyperkalemia can be fatal.

When deciding on the concomitant use of drugs acting on the RAAS, it is necessary to assess the risk-benefit ratio.

The main risk factors for hyperkalemia that should be considered are:

- diabetes mellitus, renal failure, age (patients older than 70 years)

- combination with one or more drugs acting on RAAS and / or potassium-containing food additives. Drugs or therapeutic classes of drugs, which can cause hyperkalemia, are salt substitutes containing potassium, potassium-sparing diuretics, ACE inhibitors, angiotensin II receptor antagonists, non-steroidal anti-inflammatory drugs (NSAIDs, including selective COX-2 inhibitors), heparin, immunosuppressants (cyclosporin trimoprimol - intercurrent diseases, especially dehydration, acute heart failure, metabolic acidosis, impaired renal function, cytolysis syndrome (e.g., acute limb ischemia, rhabdomyol s, extensive trauma).

Patients at risk are advised to carefully monitor their potassium in the blood plasma (see Interaction with Other Medicines section).

Ethnic differences

ACE inhibitors, telmisartan and other ARAII, apparently lower blood pressure in patients of the Negroid race less effectively than in representatives of other races, possibly due to a greater predisposition to a decrease in renin activity in the population of these patients.

Other

As with other antihypertensive drugs, an excessive decrease in blood pressure in patients with ischemic cardiomyopathy or coronary heart disease can lead to myocardial infarction or stroke.

Impact on the ability to drive transp. Wed and fur .:

Special clinical studies of the effect of the drug on the ability to drive a car and mechanisms have not been conducted. When driving and working with mechanisms that require increased concentration of attention, care must be taken, since dizziness and drowsiness can rarely occur with telmisartan.

Composition

Active ingredient:

Telmisartan - 80 .00 mg

Help Yelnia substance:

Sodium hydroxide - 6.70 mg Povidone K25

- 21.60 mg

Meglumin -

24.00 mg Mannitol - 327.70 mg Magnesium stearate

- 8.00 mg Crospovidone

- 12.00 mg.

Side effects

In general, the incidence of adverse reactions noted for telmisartan is comparable to that for placebo. The observed cases of side effects did not correlate with the gender, age or race of the patients. Classification of frequency of adverse reactions of the World Health Organization (WHO): very often (> 1/10) often (from> 1/100 to <1/10) infrequently (from> 1/1000 to <1/100) rarely (from> 1 / 10,000 to < 1/1000) very rarely (from <1/10 000) the frequency is unknown (according to available data, it is not possible to establish the frequency of occurrence).

Infectious and parasitic diseases: infrequently: upper respiratory tract infections, including pharyngitis and sinusitis, urinary tract infections (including cystitis) of unknown frequency: sepsis, including fatal sepsis.

Disorders from the blood and lymphatic system: infrequently: anemia rarely: thrombocytopenia of unknown frequency: eosinophilia.

Mental disorders: infrequently: depression rarely: anxiety.

Disorders of the nervous system: infrequently: insomnia, syncope, vertigo rarely: fainting.

Disorders of the organ of vision: rarely: impaired vision.

Heart disorders: infrequently: bradycardia rarely: tachycardia.

Vascular disorders: infrequent: marked decrease in blood pressure *, orthostatic hypotension

* was often observed in patients with controlled blood pressure who received treatment with telmisartan to reduce the risk of cardiovascular mortality in addition to standard treatment.

Disorders of the respiratory system, chest and mediastinal organs: infrequently: shortness of breath, cough.

Disorders of the gastrointestinal tract: infrequently: abdominal pain, diarrhea, dyspepsia, flatulence, vomiting

rarely: upset stomach, discomfort, dry mucous membrane of the oral cavity, impaired liver function / liver disease.

Immune system disorders: rare: hypersensitivity, angioedema (including fatal) of unknown frequency: anaphylactic reactions.

Disorders of the skin and subcutaneous tissue: infrequently: hyperhidrosis, skin itching, rash

rarely: erythema, drug rash, toxic skin rash, eczema, unknown frequency: urticaria.

Disorders of the musculoskeletal system and connective tissue: infrequently: myalgia, back pain (for example, sciatica), muscle spasms rarely: arthralgia, pain in the extremities of an unknown frequency: pain in the tendons (tendon-like symptoms).

Disorders of the kidneys and urinary tract: infrequently: renal failure, including acute renal failure.

Disorders in nutrition and metabolism: infrequently: hyperkalemia.

General disorders: infrequently: chest pain, asthenia (weakness) rarely: flu-like condition.

Influence on the results of laboratory indicators and instrumental studies: infrequently: increased blood creatinine concentration rarely: increased uric acid concentration in the blood, liver enzymes, serum creatine phosphokinase activity, decreased hemoglobin, hypoglycemia (in patients with diabetes mellitus).

Overdose

Information on overdose is limited.

Symptoms: the most significant - a marked decrease in blood pressure and tachycardia, bradycardia, dizziness, and increased serum creatinine concentration and acute renal failure.

Treatment: symptomatic and supportive. Proposed measures include inducing vomiting and / or gastric lavage, taking activated charcoal, and replenishing the lack of fluids and salts. Continuous monitoring of electrolytes and creatinine in blood serum. Hemodialysis is not effective.

Storage conditions

At a temperature not exceeding 25 ° C.

Keep out of the reach of children!

Expiration

2 years.

Do not use after the expiry date.

Deystvuyuschee substances

Telmysartan

Pharmacy vacation

Po

Form of Treatment

tablets



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