Preductal® OD

Active substance, action, release form

"Hipotel" refers to sartans or angiotensin 2 receptor antagonists. The main active ingredient of the drug is telmisartan. Like other drugs in this group, it reduces blood pressure by selectively blocking AT2 receptors (type 2). After blocking the receptors, the lumen of the blood vessels expands, and the excretion of water and sodium in the urine increases. While taking Hypotel, side effects such as cough or angioedema do not develop, since telmisartan does not participate in the metabolism of bradykinin. Among the positive effects of sartans on the body, researchers highlight the ability to reduce the development and enlargement of the heart muscle. There is a protective effect on target organs: heart, eyes, kidneys.

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The hypotensive effect lasts for 24 hours. The maximum effect is achieved in the 6th week of continuous use of the drug. The drug "Hipotel" does not have the ability to accumulate in the body, and therefore requires constant use for a reliable and long-lasting effect. They produce 20, 40 and 80 mg of the active substance in one tablet.

Hipotel tablet 80 mg No. 28

HIPOTEL
Warehouse:

dyucha speech: telmisartan;

1 tablet with telmisartan 20 mg, 40 mg or 80 mg;

additional ingredients: sodium hydroxide, meglumine, mannitol (E 421), crospovidone, magnesium stearate.

Medicine form. Pills.

Pharmacotherapeutic group. Simple angiotensin II antagonist drugs.

ATS code C09C A07.

Clinical characteristics.

Showing.

Treatment of essential hypertension in adults.

Pregnancy of cardiac-vascular illnesses in patients with:

• manifest atherothrombotic cardiovascular disease (ischemic heart disease, stroke or history of peripheral artery disease) or
• type 2 diabetes due to documented damage to target organs.

Contraindicated.

• Hypersensitivity to the drug;
• another and third trimester of gestation;
• obstructive biliary disorders;
• severe impairment of liver function.

In cases of rare seizures, due to which there may be inconsistency with a similar drug, taking Hipotel is contraindicated.

Method of congestion and dosage.

Treatment of essential hypertension. The most effective dose is 40 mg per dose. For certain patients, a further dose of 20 mg may be sufficient. In cases of epilepsy, if the effect is not achieved, the dose of telmisartan can be increased to 80 mg 1 time per dose. Alternatively, telmisartan may be used in combination with thiazide diuretics, such as hydrochlorothiazide, which have been shown to further reduce arterial pressure when taken concomitantly with telmisartan. If a higher dosage is considered, it is necessary to take into account that the maximum antihypertensive effect in general is achieved after 4–8 days of treatment.

In the wake of heart-judgment illnesses. The recommended dose is 80 mg once per dose. The effectiveness of telmisartan in doses less than 80 mg in advanced cardiovascular diseases is unknown.

At the beginning of treatment with telmisartan for the prevention of cardiovascular disease, it is recommended to monitor arterial pressure and, if necessary, adjust the dose of drugs that reduce arterial pressure.

Hypotel can be taken with or without it.

Particular groups of patients.

Damage to the function of the nirok. For patients with lung deficiency and intermediate levels of severity, there is no need for adjusted doses. There is evidence for the treatment of patients with nitric deficiency or patients who are on hemodialysis or obstructions. For such patients, it is recommended to start treatment with a low dose of 20 mg.

Impaired liver function. For patients with mild or moderately impaired liver function, the dose does not need to exceed 40 mg 1 time per dose (section “Peculiarities of stagnation”).

Summer age patients. There is no need for adjusted doses for summer age patients.

Adverse reactions.

In the skin group, side effects are presented in the order of varying degrees of severity.

Infections and invasions: infections of the upper respiratory tract, including pharyngitis and sinusitis, infections of the respiratory tract, including cystitis, sepsis, etc. with a lethal legacy.

On the side of the blood and lymphatic system: anemia, thrombocytopenia, eosinophilia.

On the side of the immune system: hypersensitivity, anaphylactic reaction.

Metabolism and food disorders: hyperkalemia, hypoglycemia (in diabetic patients).

Mental disorders: depression, sleeplessness, restlessness.

On the side of the nervous system: syncope.

On the side of the organs of the eye: destruction of the eye.

On the side of the vestibular apparatus: vertigo.

Cardiac disorders: bradycardia, tachycardia.

Judicial disorders: arterial hypotension, orthostatic hypotension.

On the side of the respiratory system, the organs of the chest and the mediastinum: dyspnea, cough, interstitial illness.

Gut-intestinal disorders: abdominal pain, diarrhea, dyspepsia, flatulence, vomiting, discomfort in the gut, dry mouth.

Disorders of the hepatobiliary system: impaired liver function/liver disorders.

On the side of the skin and pelvis: severe sweating, itching, viscera, erythema, angioedema (including lethal lesions), drug-induced dermatitis, toxic dermatitis, eczema, urticaria.

On the side of the musculoskeletal system and related tissues: myalgia, back pain (such as sciatica), swelling of the muscles, arthralgia, pain in the ends, pain in the tendon (symptoms similar to tendinitis).

On the side of the genitourinary system: impaired function of the nerves, including gastrointestinal deficiency.

General disorders: pain in the chest, asthenia (weakness), flu-like symptoms.

Laboratory data: increased creatinine in the blood, increased sechoic acid in the blood, increased liver enzymes, increased level of creatine phosphokinase (CPK) in the blood, decreased hemoglobin.

Overdose.

Information has been shared regarding overdose in people.

Symptoms The most significant manifestations of overdose of telmisartan were arterial hypotension and tachycardia; Bradycardia, confusion, increased creatinine concentration in serum and acute nitric deficiency have also been reported.

Therapy. Telmisartan is not indicated for hemodialysis.

Patients must be kept under close control and receive symptomatic and supportive therapy. Therapy should be based on the time period after taking the drug and the severity of symptoms. Recommended steps include vomiting and/or washing the mucus. During overdose therapy, it is possible to stagnate the active substances of vugill. It is necessary to frequently check the level of electrolytes and creatinine in the serum. In case of severe arterial hypotension, the patient should be placed on his back and given additional help to increase the volume of salt in the body.

Suspension during pregnancy or breastfeeding.

The use of angiotensin II receptor antagonists is not recommended during the first trimester of pregnancy. The use of angiotensin II receptor antagonists is contraindicated during the second and third trimesters of pregnancy (section “Contraindications”).

There is no sufficient data on the administration of telmisartan to vaginal administration.

Since continued therapy with angiotensin II receptor antagonists is not strictly necessary, patients planning to become pregnant should switch to antihypertensive medications, which may be recommended by the professional. For the safety of drying during wet periods. If treatment with angiotensin II receptor antagonists is established, it is necessary to discontinue treatment and, if necessary, begin an alternative treatment. In the second and third trimesters of pregnancy, angiotensin II receptor antagonism appears to cause fetotoxicity (decreased breast function, oligohydramniosis, obstruction of the formation of cranial cysts) and neonatal toxicity (nirkova insufficiency). yes, hypotension, hyperkalemia). If the use of angiotensin II receptor antagonists begins in another trimester of pregnancy, it is recommended to carry out ultrasound stimulation of the functions of the skull and bones of the skull. Children whose mothers have taken angiotensin II receptor antagonists should be carefully monitored for the presence of arterial hypotension (section “Contraindications”).

Due to the lack of information regarding the use of telmisartan during breastfeeding, the drug is not recommended for use in women who are breastfeeding. Advantage is given to alternative care with a better safety profile, especially when breastfeeding a newborn or premature infant.

Children.

We would like to provide contraindications for children (up to 18 years of age) through the exchange of information to ensure the safety and effectiveness of the drug for this category of patients.

Features of stagnation.

Vasorenal hypertension. There is an increased risk of severe arterial hypotension and nitric deficiency, as patients with bilateral renal artery stenosis or stenosis of the arterial artery should be treated with drugs that are infused b on the renin-angiotensin-aldosterone system.

Nirka deficiency and nirka transplantation. If Hipotel is prescribed to patients with impaired thyroid function, periodic monitoring of potassium and creatinine levels in blood serum is recommended. There is no evidence of Hipotel use among patients with recent cervical transplantation.

Decrease in intravascular volume. Symptomatic hypotension, especially after the first dose of the drug, may occur in patients due to the decrease in intravascular volume and/or sodium levels that results from diuretic therapy, salts that go with the skin, diarrhea or vomiting. Before taking Hepotel, it is necessary to correct such conditions, especially a decrease in intravascular volume and/or sodium level.

Subsequent blockade of the renin-angiotensin-aldosterone system. As a result of galvanization of the renin-angiotensin-aldosterone system, more sensitive patients were wary of arterial hypotension, syncope, hyperkalemia and changes in the functions of the muscles (including nirkova). deficiency), especially if the combination therapy included drugs that affect this system . Therefore, continuous blockade of the renin-angiotensin-aldosterone system (for example, combining telmisartan with other blockers of the renin-angiotensin-aldosterone system) is not recommended. If one-hour stagnation is necessary, close monitoring of the function of the nirok is recommended.

Other situations that require stimulation of the renin-angiotensin-aldosterone system. In patients with cardiac tone and function, the activity of the renin-angiotensin-aldosterone system (for example, in patients with severe congestive heart failure or severe illness) rock, including stenosis of the artery, taking Hypotela with other medications that are infused on the renin-angiotensin-aldosterone system, can lead to acute arterial hypotension, hyperasotemia, oliguria, and sometimes to acute nitric deficiency.

Primary hyperaldosteronism. Patients with primary hyperaldosteronism generally do not respond to antihypertensive drugs that block the renin-angiotensin system. Therefore, telmisartan is not recommended for them.

Aortic and mitral valve stenosis, obstructive hypertrophic cardiomyopathy. As with other vasodilators, the drug is prescribed with special caution to patients diagnosed with aortic stenosis, mitral valve stenosis, or obstructive hypertrophic cardiomyopathy.

Hyperkalemia. During this period of ingestion of medications that affect the renin-angiotensin-aldosterone system, hyperkalemia may occur, especially if nicotine deficiency and/or heart failure is evident.

In patients with summer age, patients with nitric deficiency, diabetes, in patients who are simultaneously taking other medications that may cause an increase in potassium levels, and/or patients In cases of concomitant illnesses, hyperkalemia can be fatal.

Before taking any medications that suppress the renin-angiotensin system, it is necessary to pay attention to the joint cortex and rhizica.

The main factors that risk the development of hyperkalemia, which must be addressed:

• blood diabetes, nitric deficiency, age over 70 years;
• The therapy is combined with one or more other drugs that affect the renin-angiotensin system, and/or potassium supplements. Before drugs or therapeutic groups of drugs that can provoke hyperkalemia, there should be salt substitutes to replace potassium, potassium-sparing diuretics, angiotensin-converting enzyme inhibitors y, angiotensin II receptor antagonists, non-steroidal anti-inflammatory drugs (NSAIDs, including selective COX-2 inhibitors), heparin, immunosuppressants (cyclosporine or tacrolimus) and trimethoprim;
• concomitant illnesses, especially dehydration, cardiac decompensation, metabolic acidosis, impaired function of the liver, a sharp decline in the functioning of the muscles (for example, as a result of infectious illnesses), celiac disease isis (for example, as a result of acute ischemia of the ends, acute necrosis of skeletal muscles, extensive trauma).

Sick groups of rhizomes must undergo careful monitoring of serum potassium concentration.

Pechinkov's lack of availability. The drug cannot be used in patients with cholestasis, obstructive diseases of the biliary ducts, and severe liver failure (section “Contraindications”), so telmisartan should be removed primarily from the liver. In such patients, changes in hepatic clearance of telmisartan may be observed.

The drug should be used with caution in patients with liver failure from mild to moderate stage.

Diabetic patients who take insulin or antidiabetic medications. During treatment with telmisartan, such patients may develop hypokalemia. The need for appropriate monitoring of blood glucose levels in such patients is discussed. If indicated, the dosage of insulin or antidiabetic medications may need to be adjusted.

Patients suffering from cardiac diabetes with cardiovascular diseases (patients suffering from cardiac diabetes with concomitant diseases of the coronary arteries) are at risk of developing myocardial infarction with a fatal heir and cardiovascular mortality may be greater when treated with antihypertensive drugs such as angiotensin receptor antagonists II and ACE inhibitors. In patients with cardiovascular diabetes, concomitant diseases of the coronary arteries may be asymptomatic, and therefore they may go undiagnosed. Patients with chronic diabetes should be carefully tested, for example, with stress testing, to identify and treat concomitant disease of the coronary arteries before prescribing the drug.

Ethnic aspects. Like all other angiotensin II receptor antagonists, telmisartan is clearly less effective in reducing arterial pressure in patients of the black race than in representatives of other races. This may be due to the greater increase in low renin levels in patients of black race who suffer from arterial hypertension.

Inshi. As with any other antihypertensive drug, a decrease in arterial pressure in patients with ischemic cardiopathy or ischemic cardiovascular disease can lead to myocardial infarction arda or stroke.

This is due to the fluidity of the reaction when using vehicles or robots with other mechanisms.

Investigations of the infusion of telmisartan into the presence of keratin in a car and use with other mechanisms have not been carried out. However, it is necessary for mothers to be aware that during antihypertensive therapy they may develop confusion or hypersomnia.

Interactions with other medicinal drugs and other types of interactions.

Like other drugs that suppress the renin-angiotensin system, telmisartan can provoke hyperkalemia. The risk may increase with treatment in combination with other drugs that can also provoke hyperkalemia (salt substitutes, potassium substitutes, potassium-sparing diuretics, Angiotensin-converting enzyme inhibitors, angiotensin II receptor antagonists, non-steroidal anti-inflammatory drugs (including selective COX-2 inhibitors), heparin , immunosuppressants (cyclosporine or tacrolimus) and trimethoprim).

Hyperkalemia is due to underlying risk factors. The risk increases with the stagnation of more therapeutic combinations. The risk is particularly high when combined with potassium-sparing diuretics and in combination with salt substitutes to replace potassium. A combination with angiotensin-converting enzyme inhibitors or non-steroidal anti-inflammatory drugs is less risky for the clear treatment of side effects during stagnation.

Concomitant drying is not recommended.

Potassium-sparing diuretics or potassium supplements.

Angiotensin II receptor antagonists such as telmisartan reduce the loss of potassium caused by diuretics. Potassium-sparing diuretics, such as spironolactone, eplerenone, triamterene or amiloride, potassium supplements or salt substitutes that replace potassium, may cause a significant increase in potassium concentrations in serum. and blood. Since concomitant ingestion is indicated through documented hypokalemia, it is necessary to take the drugs with caution, often monitoring the level of potassium in the serum.

Lithium.

Due to the reverse increase in the concentration of lithium in the serum and increased toxicity under the hour of concomitant administration with angiotensin-converting enzyme inhibitors and angiotensin II receptor antagonists , including telmisartan. Since this combination is important, it is important to control the amount of liquid in the syrup during drying.

Concomitant drying requires caution.

Non-steroidal anti-inflammatory drugs.

Non-steroidal anti-inflammatory agents (including acetylsalicylic acid in anti-inflammatory treatment regimens, COX-2 inhibitors and non-selective non-steroidal anti-inflammatory agents) may reduce the antihypertensive effect of receptor antagonists angiotensin II.

In some patients with impaired function of the brain (for example, in patients with a cold-weathered body or in patients of summer age with impaired function of the brain), combinations of antagonists are used. Angiotensin II receptors and pathways that interfere with cyclooxygenase can lead to further impairment of thyroid function, including possible acute thyroid hormone deficiency , yak zvichichay є reverse. Therefore, this combination should be used with caution, especially for people of summer age. Patients should be ensured adequate hydration; In addition, after starting combination therapy, and periodically thereafter, it is necessary to check the function of the device.

Diuretics (thiazide or loop diuretics).

Frontal treatment with high doses of diuretics such as furosemide (loop diuretic) and hydrochlorothiazide (thiazide diuretic) may lead to volume depletion and risk of arterial hypotension, which will begin to treat the body. misartan.

The next step is to respect the current stagnation.

Other antihypertensive disorders.

The ability of telmisartan to reduce arterial pressure may be enhanced by the concomitant effects of other antihypertensive drugs.

On the basis of pharmacological authorities, baclofen and amifostine can be used, and these therapeutic agents can enhance the hypotensive effect of all antihypertensive agents, incl. telmisartan. In addition, orthostatic hypotension can be ameliorated by alcohol, barbiturates, drugs and antidepressants.

Corticosteroids (systemic stasis).

Reduced antihypertensive activity.

Pharmacological power.

Pharmacodynamics. Telmisartan is a specific and effective angiotensin II receptor antagonist (type AT1). Telmisartan, with a very high affinity, replaces angiotensin II at the sites of its binding to the AT1 subtype receptors, which are responsible for the activity of angiotensin II. Telmisartan does not show any partial agonistic response to the AT1 receptor. Telmisartan selectively binds to the AT1 receptor. We are waiting for the connection.

Telmisartan does not exhibit affinity with other receptors, including AT2 and other less affected AT receptors. The functional role of these receptors is unknown, as is the unknown effect of their possible “overstimulation” with angiotensin II, which is expected to occur with the infusion of telmisartan. Telmisartan reduces aldosterone levels in blood plasma. Telmisartan does not inhibit renin in human plasma and does not block ion channels. Telmisartan does not inhibit angiotensin-converting enzyme (kininase II), an enzyme that also destroys bradykinine. Therefore, the potency of bradykinin receptor-conducting side effects should not be observed.

In humans, telmisartan at a dose of 80 mg may significantly inhibit arterial pressure caused by angiotensin II. The blocking effect persists for 24 years and disappears until 48 years.

Treatment of arterial hypertension. After the first dose of telmisartan, antihypertensive activity is consistently observed over a period of 3 years. The maximum decrease in arterial pressure is detected after 4–8 days of treatment and is maintained with continued therapy.

The antihypertensive effect gradually wears off over a period of 24 years, including the remaining 4 years before the start of administration. This was confirmed by outpatient monitoring of arterial pressure. The ratio of the concentration of telmisartan before taking the initial dose to the peak concentration becomes 80% after taking 40 and 80 mg.

In patients with arterial hypertension, telmisartan reduces both systolic and diastolic pressure without affecting the pulse rate. With rapt treatment with telmisartan, the arterial pressure gradually returns over several days to the parameters that were before the treatment, without any risk of seizure syndrome.

Pharmacokinetics.

Soaked up. When soaking up telmisartan, the adsorbed quantities are separated. The average absolute bioavailability of telmisartan is close to 50%.

When Hypotel is taken within an hour of food, the decrease in the area under the plasma concentration-hour curve (AUC) for telmisartan varies from approximately 6% (40 mg) to 19% (160 mg). 3 years after administration, the blood plasma concentration remains the same, regardless of whether telmisartan is taken directly or afterwards.

Rozpodil. Telmisartan actively binds to plasma proteins (> 99.5%), mainly to albumin and alpha-1 acid glycoprotein. The volume of the compartment (Vss) becomes approximately 500 l.

Metabolism. Telmisartan is metabolized by conjugation with glucuronide. The pharmacological activity of the conjugate has not been established.

Vivedennya. Telmisartan is characterized by biexponential pharmacokinetics with a terminal half-life > 20 years. The maximum plasma concentration (Cmax) and the area under the plasma concentration-hour curve (AUC) increase disproportionately to the dose. There is no data on clinically significant accumulation of telmisartan when administered at recommended doses. Blood plasma concentrations were higher in women and lower in men, with no consistent effect on effectiveness.

After oral administration, telmisartan may be excreted in the feces mainly as it is unchanged. Cumulative excretion is <1% of the dose. The final plasma clearance (Clot) is high (approximately 1,000 ml/min), which is due to the hepatic blood flow (approximately 1,500 ml/min).

Particular categories of patients.

Summer age patients. The pharmacokinetics of telmisartan is reduced in young patients and in older patients.

Patients with impaired nirofunction. Patients with nitric deficiency undergoing dialysis have low plasma concentrations. Telmisartan has a high affinity for plasma proteins in patients with nicotine deficiency and is not eliminated by dialysis.

Patients with impaired liver function. Pharmacokinetic studies in patients with liver damage revealed an increase in absolute bioavailability to approximately 100%.

Pharmaceutical characteristics.

Main physical and chemical properties: white or even round biconvex tablets.

term of attribution. 2 rocks.

Save your mind.

Store at a temperature not exceeding 25 °C in the original packaging.

Keep out of the reach of children.

Package.

10 tablets per blister; 3 blisters in a cardboard package.

14 tablets per blister; 2 blisters per cardboard package.

Release category. For the recipe.

Virobnik. LLC "KUSUM FARM".

Miscenahodzhennya.

Ukraine, 40020, metro station Sumi, st. Skryabina, 54.

Indications for use

The effectiveness of the drug has been proven in the treatment of arterial hypertension.
The main indication for the use of the drug is the presence of arterial hypertension (essential or secondary) in adults. The next group of indications includes patients at risk of developing cardiovascular complications: heart attacks, strokes, vascular damage of the lower extremities. Patients with type 2 diabetes mellitus with damage to the kidneys or retinal vessels are also treated.

Instructions for use "Hipotel"

For the treatment of hypertension, a dose of 80 mg of telmisartan is used when the standard 40 mg is not effective and target blood pressure levels are not achieved (< 140/90 mmHg). To prevent cardiovascular complications, Hipotel is used at a dose of 80 mg per day. The tablets are taken once a day, regardless of meals. For the first month, it is recommended to take it on an empty stomach in the morning, without skipping it.

Features of use during pregnancy or breastfeeding

The use of the medication is contraindicated during pregnancy.
During pregnancy, it is absolutely contraindicated to prescribe sartans, as they have a toxic effect on the development of the fetus. Potential adverse effects in neonates include cranial hypoplasia, anuria, hypotonia, renal failure, and death. You should stop taking Hypotel if pregnancy is confirmed. If the angiotensin 2 receptor antagonist cannot be stopped, then a sonographic examination (ultrasound) should be performed, and the mother should be informed about the possible risks. There is no information on the use of telmisartan during breastfeeding, but alternative treatment that has proven safety is preferred.

How is it used in children?

The drug is contraindicated for persons under 18 years of age, since there is no evidence base for the effective use of Hypotel in children. There are no direct indications for the use of sartans in children; for similar pathologies, drugs that are harmless to the development of the child are used. In laboratory conditions, it has been proven that the maximum concentration is achieved in the same way as in adults - within 6–8 hours from the time of taking the drug.

Preductal® OD

Mechanism of action

Trimetazidine prevents a decrease in intracellular adenosine triphosphate (ATP) concentration by maintaining the energy metabolism of cells in a state of hypoxia. Thus, the drug ensures the normal functioning of membrane ion channels, transmembrane transport of potassium and sodium ions and the preservation of cellular homeostasis.

Trimetazidine inhibits the oxidation of fatty acids due to the selective inhibition of the enzyme 3-ketoacyl-CoA thiolase (3-CAT) of the mitochondrial long-chain isoform of fatty acids, which leads to increased oxidation of glucose and acceleration of glycolysis with oxidation of glucose, which determines the protection of the myocardium from ischemia. The switch of energy metabolism from fatty acid oxidation to glucose oxidation underlies the pharmacological properties of trimetazidine.

Pharmacodynamic properties:

— supports the energy metabolism of the heart and neurosensory tissues during ischemia;

— reduces the severity of intracellular acidosis and changes in the transmembrane ion flow that occur during ischemia;

- reduces the level of migration and infiltration of polynuclear neutrophils in ischemic and reperfused heart tissues;

- reduces the size of myocardial damage;

- does not have a direct effect on hemodynamic parameters.

In patients with angina, trimetazidine:

— increases coronary reserve, thereby slowing down the onset of ischemia caused by physical activity, starting from the 15th day of therapy;

- limits fluctuations in blood pressure caused by physical activity, without significant changes in heart rate;

- significantly reduces the frequency of angina attacks and the need for short-acting nitroglycerin;

— improves the contractile function of the left ventricle in patients with ischemic dysfunction.

The results of clinical studies have confirmed the effectiveness and safety of trimetazidine in patients with stable angina, both in monotherapy and as part of combination therapy when the effect of other antianginal drugs is insufficient.

In a study of 426 patients with stable angina, the addition of trimetazidine (60 mg/day) to metoprolol 100 mg/day (50 mg twice daily) for 12 weeks statistically significantly improved exercise test scores and clinical symptoms compared with placebo: total duration of exercise tests, total exercise time, time to 1 mm ST segment depression, time to angina attack, number of angina attacks per week, and short-acting nitrate intake per week, without hemodynamic changes.

In a study of 223 patients with stable angina, adding trimetazidine 35 mg twice daily to atenolol 50 mg once daily for 8 weeks increased the time to development of ischemic ST segment depression by 1 mm during exercise tests in a subgroup of patients compared with placebo. A significant difference was also shown for the time of development of angina attacks. There were no significant differences between groups for other secondary endpoints (total exercise test duration, total exercise time, and clinical endpoints).

In a study of 1962 patients with stable angina, trimetazidine (70 mg/day and 140 mg/day) was added to atenolol 50 mg/day compared with placebo. In the general population, including both asymptomatic and symptomatic patients with angina, trimetazidine did not demonstrate benefit on ergometric and clinical endpoints. However, in a retrospective analysis of a subgroup of patients with symptomatic angina, trimetazidine (140 mg) significantly improved total exercise test time and time to onset of angina.

Who is it contraindicated for?

Contraindications for the use of Hypotel include:

• hypersensitivity to telmisartan and other components;
• pregnancy;
• liver dysfunction;
• blockage of the bile ducts;
• narrowing of the renal arteries;
• taking ACE inhibitors (Lisinopril, Ramipril).

The medicine is not prescribed to patients with liver disease.
You should not combine the use of Hipotela tablets with lithium preparations, potassium-sparing diuretics (Veroshpiron, Spironolactone), immunosuppressants, heparin, or non-steroidal anti-inflammatory drugs. Such combinations lead to an increase in the amount of potassium in the body and leads to paralysis, heart rhythm disturbances, which can result in cardiac arrest.

Side effects

In addition to the expected effects of telmisartan, unwanted side effects may also occur that require medical attention. In 90% of cases, side effects disappear as the body gets used to and adapts to the medication. Some effects require emergency medical attention. The attending physician should provide information about possible effects and prevent or reduce their impact. If any of the conditions listed in the table below occur while taking the tablets, consult your doctor.

Overdose: what to do?

A large dose of the drug causes discomfort in the heart area.
During an overdose of the drug, a sharp decrease in blood pressure, increased heart rate, headache, and dizziness are observed. The level of creatinine in the blood serum increases, which indicates the development of acute renal failure. The condition directly depends on the time that has passed after taking the pills. In the hospital, the general condition of the patient is monitored. Monitor pulse, blood pressure, respiratory rate, as well as plasma electrolyte levels (sodium, potassium, calcium, chlorine), and creatinine concentrations. First aid consists of the following steps:

1. Flushing the stomach with plenty of water.
2. Use of sorbents - “Atoxil”, “White Coal”, “Enterosgel”.
3. Drink plenty of warm, slightly salted water.

Telpres Plus

Liver dysfunction

The use of Telpres Plus 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 liver dysfunction (class A and B according to the Child-Pugh classification), Telpres Plus should be used with caution (see section "With caution").

Renovascular hypertension

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

Renal dysfunction and kidney transplantation

When using the drug Telpres Plus 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 Telpres Plus in patients who have recently undergone kidney transplantation.

The use of thiazide diuretics in patients with impaired renal function may lead to azotemia. Periodic monitoring of renal function is recommended.

Decreased circulating blood volume

Symptomatic arterial hypotension, especially after the first dose of Telpres Plus, 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 starting Telpres Plus.

Dual blockade of the renin-angiotensin-aldosterone system

Concomitant use of telmisartan with drugs containing aliskiren is contraindicated in patients with diabetes mellitus and/or moderate or severe renal failure (GFR less than 60 ml/min/1.73 m2 body surface area) and is not recommended in other patients (see section "Contraindications" ), Concomitant use of telmisartan and ACE inhibitors is contraindicated in patients with diabetic nephropathy and is not recommended in other patients (see section "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 chronic heart failure or kidney disease, 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 hypotension, hyperazotemia, oliguria, and in rare cases, acute renal failure.

Primary aldosteronism

In patients with primary aldosteronism, treatment with antihypertensive drugs that act by inhibiting the RAAS is usually ineffective.

Aortic and mitral valve stenosis, hypertrophic obstructive cardiomyopathy

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

Choroidal effusion/acute myopia/acute angle-closure glaucoma

Thiazide and thiazide-like diuretics can cause an idiosyncratic reaction, leading to the development of choroidal effusion with visual field impairment, acute transient myopia and acute angle-closure glaucoma. Symptoms include acute onset of decreased visual acuity or eye pain and usually occur within hours to weeks of starting the drug. If left untreated, an acute attack of angle-closure glaucoma can lead to permanent vision loss. First of all, it is necessary to stop taking the drug as quickly as possible. If intraocular pressure remains uncontrolled, emergency medical treatment or surgery may be required. Risk factors for the development of an acute attack of angle-closure glaucoma are a history of allergic reactions to thiazide derivatives, sulfonamide and penicillins.

Effect on metabolism and function of endocrine glands

In patients with diabetes mellitus, changes in the dose of insulin or oral hypoglycemic agents may be required. During therapy with thiazide diuretics, latent diabetes mellitus may manifest.

In some cases, when using thiazide diuretics, hyperuricemia and exacerbation of gout may develop.

Water-electrolyte imbalance

When using the drug Telpres Plus, as in the case of diuretic therapy, periodic monitoring of the content of electrolytes in the blood serum is necessary.

Thiazide diuretics, including hydrochlorothiazide, can cause disturbances in water-electrolyte balance and acid-base status (hypokalemia, hyponatremia and hypochloremic alkalosis). Warning signs for these disorders are dryness of the oral mucosa, a feeling of thirst, general weakness, drowsiness, anxiety, myalgia or convulsive twitching of the calf muscles (cramps), muscle weakness, a marked decrease in blood pressure, oliguria, tachycardia and such gastrointestinal tract. intestinal disturbances such as nausea or vomiting.

When using thiazide diuretics, hypokalemia may develop, but concomitantly used telmisartan may increase the potassium level in the blood. The risk of hypokalemia increases most in patients with cirrhosis of the liver, with increased diuresis, while following a salt-free diet, as well as in case of simultaneous use with glucocorticosteroids, kalyditonin, ACTH (adrenocorticotropic hormone), glycyrrhizic acid (found in licorice root), telmisartan, which is part of Telpres Plus, on the contrary, can lead to hyperkalemia due to antagonism of angiotensin II receptors (AT subtype). Although clinically significant hyperkalemia has not been reported with Telpres Plus, it should be taken into account that risk factors for its development include renal and/or heart failure and diabetes mellitus.

There is no evidence that Telpres Plus can reduce or prevent diuretic-induced hyponatremia.

Hypochloremia is usually minor and does not require treatment.

Thiazide diuretics can reduce the excretion of calcium by the kidneys and cause (in the absence of obvious disturbances in calcium metabolism) a transient and slight increase in serum calcium. More severe hypercalcemia may be a sign of hidden hyperparathyroidism. Before assessing parathyroid function, thiazide diuretics should be discontinued.

Thiazide diuretics have been shown to increase renal excretion of magnesium, which may lead to hypomagnesemia.

In patients with coronary heart disease, the use of any antihypertensive drug, in case of excessive reduction in blood pressure, can lead to myocardial infarction or stroke.

Increased monitoring of patients with impaired uric acid metabolism is required; Thiazides can reduce the amount of iodine that binds to serum proteins without showing signs of thyroid dysfunction; There is information about cases of the development of photosensitivity reactions when taking thiazide diuretics. If a photosensitivity reaction occurs during treatment, it is recommended to suspend treatment. If it is decided that it is necessary to resume taking a diuretic, it is necessary to protect areas of the body that may be exposed to sunlight or ultraviolet A rays and avoid sun exposure; hydrochlorothiazide may increase the concentration of cholesterol and triglycerides in the blood; hydrochlorothiazide may give a positive result during doping control.

There are reports of the development of systemic lupus erythematosus with the use of thiazide diuretics.

Ethnic differences

ACE inhibitors, telmisartan, and other ARAPs 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.

Non-melanoma skin cancer

Two pharmacoepidemiological studies using data from the Danish National Cancer Registry demonstrated an association between hydrochlorothiazide use and an increased risk of nonmelanoma 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.

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.

In patients with a history of NMSC, it is recommended to reconsider the use of hydrochlorothiazide.

Other

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