Telmista

Telmista®

Liver dysfunction

The use of Telmisartan is contraindicated in patients with cholestasis, biliary obstruction or severe liver failure (Child-Pugh class C) (see section “Contraindications”), since telmisartan is mainly excreted in the bile. It is assumed that in such patients the hepatic clearance of telmisartan is reduced. In patients with mild to moderate hepatic impairment (Child-Pugh classes A and B), Telmista should be used with caution (see section "With caution").

Renovascular hypertension

When treated with drugs that act on the RAAS, the risk of severe arterial hypotension and renal failure increases in patients with bilateral renal artery stenosis or arterial stenosis of a single functioning kidney.

Renal dysfunction and kidney transplantation

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

Decrease in BCC

Symptomatic arterial hypotension, especially after the first dose of Telmista®, may occur in patients with low blood volume and/or low sodium levels in the blood plasma due to previous treatment with diuretics, restriction of salt intake, diarrhea or vomiting. Such conditions (hypovolemia and hyponatremia) must be eliminated before taking Telmista®.

Double blockade of the RAAS

Concomitant use of telmisartan with drugs containing aliskiren is contraindicated in patients with diabetes mellitus and/or with moderate or severe renal impairment (GFR less than 60 ml/min/1.73 m2 body surface area) and is not recommended in other patients.

The simultaneous use of telmisartan and ACE inhibitors is contraindicated in patients with diabetic nephropathy (see section "Contraindications") and is not recommended in other patients.

As a result of inhibition of the RAAS, the following have been observed: arterial hypotension, syncope, hyperkalemia and impaired renal function (including acute renal failure) in predisposed patients, especially with the simultaneous use of several drugs that also act on this system. Therefore, double blockade of the RAAS (for example, while taking telmisartan with other RAAS antagonists) is not recommended.

In cases where vascular tone and renal function depend primarily on the activity of the RAAS (for example, in patients with CHF or kidney disease, including renal artery stenosis or stenosis of the artery of a single kidney), the administration 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 hyperaldosteronism

In patients with primary hyperaldosteronism, treatment with antihypertensive drugs that act by inhibiting the RAAS is usually ineffective. In this regard, the use of Telmista® is not recommended.

Stenosis of the aortic or mitral valve. GOKMP

As with other vasodilators, patients with aortic or mitral stenosis, as well as HOCM, must be especially careful when using Telmista®.

Patients with diabetes mellitus receiving insulin or oral hypoglycemic agents

During treatment with Telmista®, these patients may develop hypoglycemia. In such patients, glycemic control should be strengthened, as it may be necessary to adjust the dose of insulin or oral hypoglycemic agent.

Hyperkalemia

Taking medications that act 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 underlying medical conditions, 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 over 70 years old);

- simultaneous use with one or more drugs acting on the RAAS and/or potassium-containing nutritional supplements. Drugs or therapeutic classes of drugs that may cause hyperkalemia include potassium-containing salt substitutes, potassium-sparing diuretics, ACE inhibitors, ARB II, NSAIDs including selective COX-2 inhibitors, heparin, immunosuppressants (cyclosporine or tacrolimus) and trimethoprim ;

- intercurrent diseases, especially dehydration, acute heart failure, metabolic acidosis, renal dysfunction, cytolysis syndrome (for example, acute limb ischemia, rhabdomyolysis, major trauma).

Patients at risk are advised to carefully monitor the potassium content in the blood plasma (see section “Interaction with other drugs”).

Ethnic differences

As noted for ACE inhibitors. Telmisartan and other II receptor antagonists appear to be less effective in lowering blood pressure in blacks than in other races, possibly due to a greater predisposition to decreased renin activity in these patient populations.

Other

As with the use of other antihypertensive drugs, a pronounced decrease in blood pressure in patients with ischemic cardiomyopathy or coronary artery disease can lead to the development of myocardial infarction or stroke.

Special information on excipients

For patients with fructose or lactose intolerance, lactase deficiency, or glucose-galactose malabsorption syndrome, Telmista® is contraindicated because it contains lactose and sorbitol (E420).

Hepatic impairment: Telmisartan is contraindicated in patients with cholestasis, biliary obstruction, or severe hepatic impairment (Child-Pugh class C) (see section 'Contraindications') since telmisartan is primarily excreted in the bile. It is assumed that in such patients the hepatic clearance of telmisartan is reduced. In patients with mild to moderate hepatic impairment (Child-Pugh classes A and B), Telmista should be used with caution (see section 'Caution').

Renovascular hypertension: When treated with drugs that act on the RAAS, the risk of severe hypotension and renal failure increases in patients with bilateral renal artery stenosis or arterial stenosis of a single functioning kidney.

Impaired renal function and kidney transplantation: When using Telmista in patients with impaired renal function, periodic monitoring of potassium levels and creatinine concentrations in the blood plasma is recommended. There is no clinical experience with telmisartan in patients who have recently undergone kidney transplantation.

Decreased blood volume: symptomatic arterial hypotension, especially after the first dose of TelmistaR, may occur in patients with reduced blood volume and/or sodium content in the blood plasma due to previous treatment with diuretics, restriction of salt intake, diarrhea or vomiting. Such conditions (hypovolemia and hyponatremia) must be eliminated before taking Telmista.

Dual blockade of the RAAS: simultaneous use of telmisartan with aliskiren is contraindicated in patients with diabetes mellitus or renal failure (GFR less than 60 ml/min/1.732 m2 body surface area).

The simultaneous use of telmisartan and ACE inhibitors is contraindicated in patients with diabetic nephropathy. As a result of inhibition of the RAAS, the following have been observed: arterial hypotension, syncope, hyperkalemia and impaired renal function (including acute renal failure) in predisposed patients, especially with the simultaneous use of several drugs that also act on this system. Therefore, double blockade of the RAAS (for example, while taking telmisartan with other RAAS antagonists) is not recommended.

In cases where vascular tone and renal function depend primarily on the activity of the RAAS (for example, in patients with CHF or kidney diseases, including renal artery stenosis or stenosis of the artery of a single kidney), the prescription of drugs that affect this system may be accompanied by the development of acute arterial hypertension. hypotension, hyperazotemia, oliguria, and in rare cases, acute renal failure.

Primary hyperaldosteronism: In patients with primary hyperaldosteronism, treatment with antihypertensive drugs that act by inhibiting the RAAS is usually ineffective. In this regard, the use of Telmista is not recommended.

Aortic and mitral valve stenosis, HOCM: As with other vasodilators, patients with aortic or mitral stenosis, as well as HOCM, should be especially careful when using Telmista.

Patients with diabetes mellitus receiving insulin or oral hypoglycemic agents.

During treatment with Telmista, these patients may develop hypoglycemia. In such patients, glycemic control should be strengthened, as it may be necessary to adjust the dose of insulin or hypoglycemic agent.

Hyperkalemia: Taking medications that act on the RAAS may 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 underlying medical conditions, 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 the development of hyperkalemia that should be considered are:

— diabetes mellitus, renal failure, age (patients over 70 years old);

- simultaneous use with one or more drugs acting on the RAAS and/or potassium-containing nutritional supplements. Drugs or therapeutic classes of drugs that may cause hyperkalemia include potassium-containing salt substitutes, potassium-sparing diuretics, ACE inhibitors, ARAs, NSAIDs including selective COX-2 inhibitors, heparin, immunosuppressants (cyclosporine or tacrolimus), and trimethoprim ;

- intercurrent diseases, especially dehydration, acute heart failure, metabolic acidosis, renal dysfunction, cytolysis syndrome (for example, acute limb ischemia, rhabdomyolysis, major trauma).

Patients at risk are advised to carefully monitor plasma potassium levels.

Special information on excipients.

For patients with rare hereditary fructose or lactose intolerance, lactase deficiency, or glucose-galactose malabsorption syndrome, Telmista is contraindicated because it contains lactose and sorbitol (E420).

Ethnic differences.

As noted for ACE inhibitors, telmisartan and other ARBs appear to be less effective in lowering blood pressure in blacks than in other races, possibly due to a greater predisposition to decreased renin activity in these patient populations.

Other.