Telzap, 80 mg, film-coated tablets, 90 pcs.
Liver dysfunction.
The use of Telzap® is contraindicated in patients with cholestasis, biliary obstruction, or severe liver dysfunction (Child-Pugh class C) (see “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 class A and B), Telzap should be used with caution (see Precautions
).
Renovascular hypertension.
When treating drugs that act on the RAAS, in patients with bilateral renal artery stenosis or stenosis of the artery of a single functioning kidney, the risk of severe arterial hypotension and renal failure increases.
Renal dysfunction and kidney transplantation.
When using Telzap® in patients with impaired renal function, periodic monitoring of potassium and creatinine levels in the blood plasma is recommended. There is no clinical experience with the use of Telzap® in patients who have recently undergone kidney transplantation.
Decrease in BCC.
Symptomatic arterial hypotension, especially after the first dose of Telzap®, may occur in patients with low 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 (fluid and/or sodium deficiency) must be eliminated before taking Telzap®.
Double blockade of the RAAS.
Concomitant use of telmisartan with aliskiren is contraindicated in patients with diabetes mellitus or renal failure (GFR less than 60 ml/min/1.73 m2) (see “Contraindications”).
The simultaneous use of telmisartan and ACE inhibitors is contraindicated in patients with diabetic nephropathy (see "Contraindications").
As a result of inhibition of the RAAS, the following were noted: arterial hypotension, fainting, hyperkalemia and impaired renal function (including acute renal failure) in patients predisposed to this, especially with the combined 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 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 Tezap® is not recommended.
Stenosis of the aortic and mitral valves, hypertrophic obstructive cardiomyopathy.
As with other vasodilators, patients with aortic or mitral stenosis, as well as hypertrophic obstructive cardiomyopathy, should be especially careful when using Telzap®.
Patients with diabetes mellitus receiving insulin or oral hypoglycemic agents.
During treatment with Telzap®, these patients may experience hypoglycemia. In such patients, glycemic control should be strengthened, because It may be necessary to adjust the dose of insulin or hypoglycemic agent.
Hyperkalemia.
Taking drugs that act on the RAAS can cause hyperkalemia. In elderly patients, patients with renal failure or diabetes mellitus, patients taking medications that also 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);
- combination with one or more drugs acting on the RAAS and/or potassium-containing nutritional supplements. Drugs or therapeutic classes of drugs that can cause hyperkalemia are salt substitutes containing potassium, potassium-sparing diuretics, ACE inhibitors, ARB II, NSAIDs, incl. selective COX-2 inhibitors, heparin, immunosuppressants (cyclosporine or tacrolimus) and trimethoprim;
- intercurrent conditions/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 (see “Interactions”).
Sorbitol.
This medicinal product contains sorbitol (E420). Patients with rare hereditary fructose intolerance should not take Telzap®.
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.
As with the use of other antihypertensive drugs, an excessive decrease in blood pressure in patients with ischemic cardiomyopathy or coronary artery disease can lead to the development of myocardial infarction or stroke.
Influence on the ability to drive vehicles and machinery.
No special clinical studies have been conducted to study the effect of the drug on the ability to drive a car or use machinery. When driving a car and working with mechanisms that require increased concentration, you should be careful, because Dizziness and drowsiness may rarely occur while taking Telzap®.
Telzap® Plus (Telsar® Plus)
The use of Telzap® Plus in patients with acute myocardial infarction is not recommended due to insufficient experience in clinical use.
The drug Telzap® Plus should not be used to relieve a hypertensive crisis.
Hydrochlorothiazide
Renal dysfunction
In patients with impaired renal function, hydrochlorothiazide may cause azotemia. In case of renal failure, accumulation of hydrochlorothiazide is possible.
In patients with reduced renal function, periodic monitoring of CK is necessary. If renal dysfunction progresses and/or oliguria (anuria) occurs, hydrochlorothiazide should be discontinued.
Liver dysfunction
When using thiazide diuretics in patients with impaired liver function, hepatic encephalopathy may develop. In patients with severe liver failure or hepatic encephalopathy, the use of thiazides is contraindicated. In patients with mild to moderate hepatic impairment and/or progressive liver disease, hydrochlorothiazide should be used with caution, since even slight changes in fluid electrolyte balance and ammonium accumulation in the blood serum can cause hepatic coma. If symptoms of encephalopathy occur, diuretics should be discontinued immediately.
Water-electrolyte balance and metabolic disorders
Thiazide diuretics (including hydrochlorothiazide) can cause a decrease in the volume of circulating fluid (hypovolemia) and disturbances in water and electrolyte balance (including hypokalemia, hyponatremia, hypochloremic alkalosis). Clinical symptoms of fluid and electrolyte imbalance include dry mouth, thirst, weakness, lethargy, fatigue, drowsiness, restlessness, muscle pain or cramps, muscle weakness, marked decrease in blood pressure, oliguria, tachycardia, arrhythmia and gastrointestinal disorders (such as nausea and vomiting). In patients receiving hydrochlorothiazide therapy (especially with long-term course treatment), clinical symptoms of water-electrolyte imbalance should be identified and the content of electrolytes in the blood plasma should be regularly monitored.
Sodium
All diuretics can cause hyponatremia, sometimes leading to severe complications. Hyponatremia and hypovolemia can lead to dehydration and orthostatic hypotension. A concomitant decrease in chlorine ions can lead to secondary compensatory metabolic alkalosis, but the frequency and severity of this effect are insignificant. It is recommended to determine the content of sodium ions in the blood plasma before starting treatment and regularly monitor this indicator while taking hydrochlorothiazide.
Potassium
When using thiazide and thiazide-like diuretics, there is a risk of a sharp decrease in the potassium content in the blood plasma and the development of hypokalemia (potassium concentration less than 3.4 mmol/l). Hypokalemia increases the risk of developing heart rhythm disturbances (including severe arrhythmias) and enhances the toxic effect of cardiac glycosides. In addition, hypokalemia (as well as bradycardia) is a condition that contributes to the development of polymorphic ventricular tachycardia of the “pirouette” type, which can be fatal.
Hypokalemia poses the greatest danger to the following groups of patients: elderly patients, patients simultaneously receiving therapy with antiarrhythmic and non-antiarrhythmic drugs that can cause torsades de pointes or prolong the duration of the QT interval on the ECG, patients with impaired liver function, coronary artery disease , chronic heart failure. In addition, patients with an increased QT interval are at increased risk. It does not matter whether this increase is caused by congenital causes or the effect of drugs.
In all the cases described above, it is necessary to avoid the risk of developing hypokalemia and regularly monitor the potassium content in the blood plasma. The first measurement of the content of potassium ions in the blood must be carried out within the first week from the start of treatment. If hypokalemia occurs, appropriate treatment should be prescribed. Hypokalemia can be corrected by using potassium-containing medications or eating foods rich in potassium (dried fruits, fruits, vegetables).
Calcium
Thiazide diuretics may reduce the excretion of calcium ions by the kidneys, leading to a slight and temporary increase in plasma calcium levels. In some patients, with long-term use of thiazide diuretics, pathological changes in the parathyroid glands were observed with hypercalcemia and hyperphosphatemia, but without the typical complications of hyperparathyroidism (nephrolithiasis, decreased bone mineral density, peptic ulcer). Severe hypercalcemia may be a manifestation of previously undiagnosed hyperparathyroidism.
Because of their effect on calcium metabolism, thiazides may interfere with laboratory parameters of parathyroid function. Thiazide diuretics (including hydrochlorothiazide) should be discontinued before testing parathyroid function.
Magnesium
Thiazides have been found to increase renal excretion of magnesium, which can lead to hypomagnesemia. The clinical significance of hypomagnesemia remains unclear.
Glucose
Treatment with thiazide diuretics may impair glucose tolerance. When using hydrochlorothiazide in patients with manifest or latent diabetes mellitus, it is necessary to regularly monitor the concentration of glucose in the blood. Dosage adjustment of hypoglycemic medications may be required.
Uric acid
In patients with gout, the frequency of attacks may increase or the course of gout may worsen. Careful monitoring of patients with gout and impaired uric acid metabolism (hyperuricemia) is necessary.
Lipids
When using hydrochlorothiazide, the concentration of cholesterol and triglycerides in the blood plasma may increase.
Acute myopia/secondary angle-closure glaucoma
Hydrochlorothiazide can cause an idiosyncratic reaction, leading to the development of acute myopia and an acute attack of secondary angle-closure glaucoma. Symptoms include: sudden loss of visual acuity or eye pain, usually occurring within hours to weeks of starting hydrochlorothiazide therapy. If left untreated, acute angle-closure glaucoma can lead to irreversible vision loss. If symptoms appear, you should stop taking hydrochlorothiazide as soon as possible. If intraocular pressure remains uncontrolled, emergency medical treatment or surgery may be required. Risk factors for the development of acute angle-closure glaucoma are: a history of an allergic reaction to sulfonamides or penicillin.
Immune system disorders
There are reports that thiazide diuretics (including hydrochlorothiazide) can cause exacerbation or progression of systemic lupus erythematosus, as well as lupus-like reactions.
In patients receiving thiazide diuretics, hypersensitivity reactions may occur even in the absence of a history of allergic reactions or bronchial asthma.
Photosensitivity
There is information about cases of the development of photosensitivity reactions when taking thiazide diuretics. If photosensitivity occurs while taking hydrochlorothiazide, treatment should be discontinued. If continued use of the diuretic is necessary, the skin should be protected from exposure to sunlight or artificial ultraviolet rays.
Non-melanoma skin cancer and lip cancer
Two pharmacoepidemiological studies using data from the Danish National Cancer Registry demonstrated an association between hydrochlorothiazide use and an increased risk of non-melanoma skin cancer (NMSC) basal cell carcinoma and squamous cell carcinoma. The risk of developing NMSC increased with increasing total (cumulative) dose of hydrochlorothiazide. A possible mechanism for the development of NMSC is the photosensitizing effect of hydrochlorothiazide. Another study observed a possible association between the risk of lip cancer and hydrochlorothiazide use. There was a clear relationship between cumulative dose and response for patients who received at least one dose, for patients who received the highest dose (≥25,000 mg), and for patients who received the highest cumulative dose (≥100,000 mg).
Patients taking hydrochlorothiazide as monotherapy or in combination with other drugs should be aware of the risk of developing NMSC. It is recommended that such patients undergo regular skin examination to identify any new suspicious lesions as well as changes in existing skin lesions.
Any suspicious skin changes should be reported to your doctor immediately. Suspicious areas of skin should be examined by a specialist. To clarify the diagnosis, histological examination of skin biopsies may be required.
To minimize the risk of developing NMSC, patients should be advised to follow preventive measures, such as limiting exposure to sunlight and UV rays, and using appropriate protective equipment.
Particular attention should be paid to patients who have known risk factors for skin cancer, including: skin phototypes I and II (pale and fair skin), a family history of skin cancer, a history of skin damage caused by sun or UV radiation, and radiation therapy, smoking and taking drugs with photosensitizing effects.
In patients with a history of NMSC, it is recommended to reconsider the use of hydrochlorothiazide.
Alcohol
During the treatment period, it is not recommended to drink alcoholic beverages, because ethanol enhances the antihypertensive effect of thiazide diuretics.
Athletes
Hydrochlorothiazide may give a positive result during doping control in athletes.
Other
In patients with severe atherosclerosis of the cerebral and coronary arteries, hydrochlorothiazide should be used with extreme caution.
Thiazide diuretics can reduce the amount of iodine bound to plasma proteins without causing signs of thyroid dysfunction.
Telmisartan
Liver dysfunction
The use of telmisartan is contraindicated in patients with cholestasis, biliary obstruction, or severe liver dysfunction (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 or moderate hepatic impairment (Child-Pugh class A and B), telmisartan should be used with caution (see section "With caution").
Renovascular hypertension
When treated with drugs acting on the RAAS, in patients with bilateral renal artery stenosis or arterial stenosis of a single functioning kidney, the risk of developing severe arterial hypotension and renal failure increases.
Renal dysfunction and kidney transplantation
When using the drug telmisartan in patients with impaired renal function, periodic monitoring of potassium and creatinine levels in the blood plasma is recommended. There is no experience with the clinical use of telmisartan in patients who have recently undergone kidney transplantation.
Decrease in circulating blood volume (CBV)
Symptomatic arterial hypotension, especially after the first dose of telmisartan, may occur in patients with low 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 (fluid and/or sodium deficiency) must be corrected before starting telmisartan.
Dual blockade of the renin-angiotensin-aldosterone system
Concomitant use of telmisartan with aliskiren or drugs containing aliskiren is contraindicated in patients with diabetes mellitus and/or moderate to severe renal failure (GFR less than 60 ml/min/1.73 m2 body surface area) (see section "Contraindications") and 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 were observed: arterial hypotension, fainting, hyperkalemia and impaired renal function (including acute renal failure) in patients predisposed to this, especially with the combined 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. If it is necessary to carry out double blockade of the RAAS, each case should be considered individually and carefully monitor renal function, water and electrolyte balance and blood pressure levels.
Other conditions associated with stimulation of the RAAS
U
patients whose vascular tone and renal function depend primarily on the activity of the RAAS (for example, patients with chronic heart failure or kidney disease, including renal artery stenosis, or stenosis of the artery of a solitary kidney), the use of drugs affecting 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 telmisartan is not recommended.
Stenosis of the aortic and mitral valves, hypertrophic obstructive cardiomyopathy
As with other vasodilators, patients with aortic or mitral stenosis, as well as hypertrophic obstructive cardiomyopathy, should be especially careful when using telmisartan.
Patients with diabetes mellitus receiving insulin or oral hypoglycemic agents
During treatment with telmisartan, hypoglycemia may occur in this group of 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 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);
- combination with one or more drugs acting on the RAAS and/or potassium-containing nutritional supplements. Drugs or therapeutic classes of drugs that can cause hyperkalemia include salt substitutes containing potassium, potassium-sparing diuretics, ACE inhibitors, angiotensin II receptor antagonists, 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”).
Sorbitol
This medicinal product contains sorbitol (E420). Patients with rare hereditary fructose intolerance should not take the drug.
Ethnic differences
As noted for ACE inhibitors. Telmisartan and other ARAs appear to be less effective in lowering blood pressure in black patients than in other races, possibly due to a greater predisposition to decreased renin activity in these patient populations.
Other
U
In patients with diabetes mellitus receiving treatment with insulin or oral hypoglycemic agents, hypoglycemia may develop when using telmisartan.
As with other antihypertensive drugs, an excessive decrease in blood pressure in patients with ischemic cardiomyopathy or coronary heart disease can lead to the development of myocardial infarction or stroke.
