Telsartan H Telmisartan and diuretics tablets 80mg/12.5mg №14

Telsartan H Telmisartan and diuretics tablets 80mg/12.5mg №14

Product Code: 11184
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Composition active ingredient: telmisartan, hydrochlorothiazide; 1 tablet contains telmisartan 40 mg or 80 mg and hydrochlorothiazide 12.5 mg Excipients: meglumin, sodium hydroxide, povidone, Polysorbate 80, manit (E 421) (Pearlitol SD 200), magnesium stearate, manit (E 421), lactose, iron oxide red (e 172). Dosage form Tablets. Basic physico-chemical properties: tablets 40 mg/12.5 mg-oblong two-layer tablets without a shell, with a layer from light pink to pink on the one hand and from white to almost white with possible inclusions of pink on the other hand, with prints "T" and " 1 "on both sides of the fault line; tablets 80 mg/12.5 mg-oblong two-layer tablets without a shell, with a layer from light pink to pink on the one hand and from white to almost white with possible inclusions of pink on the other hand, with prints "T" and " 2 "on both sides of the fault line. Pharmacological group Means acting on the renin-angiotensin system. A combination of drugs inhibitors of angiotensin II. Antagonists of angiotensin II and diuretics. ATC code C09D A07. Pharmacological properties Pharmacological. Alsartan - N is a combination of an antagonist of angiotensin II receptor telmisartan and thiazide diuretic hydrochlorothiazide. The combination of these ingredients has an additional antihypertensive effect, reducing blood pressure more than each component separately. Alsartan - N when used in therapeutic doses, once a day slowly and effectively lowers blood pressure. Telmisartan for oral administration is an effective and specific antagonist of the angiotensin II receptor (type AO 1 ). Telmisartan with very high affinity displaces angiotensin II to its binding on the receptor subtype AO 1 , which are responsible for known activity of angiotensin II. Telmisartan has no partial agonistic effects on AO 1 receptor and selectively binds AO 1 receptor. Binding is long-term. Telmisartan does not show kinship with other receptors, including AO 2 and other less described at receptors. The functional role of these receptors is not known, as well as the effect of possible excessive stimulation of angiotensin II, the level of which increases under the influence of telmizartan. Telmisartan reduces the level of aldosterone in blood plasma. Telmisartan does not inhibit renin in plasma of man, does not block ion channels. Telmisartan does not inhibit ACE (kininase II), also destroys bradykinin. So please don't expect a potentiation of the bradykinin mediated side effects. In humans, telmisartan at a dose of 80 mg almost completely suppresses the increase in blood pressure caused by angiotensin II. The blocking effect lasts for 24 hours and remains significant for up to 48 hours. After the first dose telmisartan antihypertensive activity gradually emerges during the 3:00. The maximum decrease in blood pressure manifests itself in 4-8 weeks from the start of treatment and remains with long-term therapy. Outpatient blood pressure measurements have shown that the antihypertensive effect is kept constant for 24 hours after dose administration, including the last 4:00 before the next reception. This is confirmed by measurements made at the point of maximum effect and immediately prior to application of the next dose (the ratio of the minimum to the maximum concentrations consistently above 80% after doses of 40 and 80 mg telmisartan in placebo-controlled clinical trials). In patients with hypertension telmisartan reduces both systolic and diastolic pressure without affecting the pulse rate. The antihypertensive efficacy of telmisartan is comparable to that of other classes of antihypertensive drugs (demonstrated in clinical studies, in which telmisartan was compared with amlodipine, atenolol, enalapril, hydrochlorothiazide and lisinopril). With the sudden cessation of treatment with telmisartan, blood pressure gradually returns to the parameters that preceded the treatment for several days without withdrawal syndrome. In clinical studies, cases of dry cough happens much less frequently in patients treated with telmisartan than in those who took ACE inhibitors. Telmisartan effect on mortality and cardiovascular disease is not known. Hydrochlorothiazide is a thiazide diuretic. The mechanism of action of antihypertensive effect of thiazide diuretics is still not fully known. Thiazides affect the renal tubular mechanism of electrolyte reabsorption, thereby directly increasing excretion of sodium and chloride in approximately equivalent amounts. Diuretic effect of hydrochlorothiazide reduces the volume of plasma, increases renin activity in plasma, increases the secretion of aldosterone with a consistent increase in potassium in urine and loss of bicarbonate and decrease in serum potassium levels. Possibly due to blockade of the renin-angiotensin-simultaneous use telmisartan promotes the reverse the potassium loss associated with these diuretics. When using hydrochlorothiazide, the onset of diuresis occurs after 2:00, the maximum effect is achieved after 4: 00, while the action lasts about 6-12 hours. Epidemiological studies have shown that long-term treatment with hydrochlorothiazide reduces the risk of cardiovascular morbidity and mortality. The effect of a fixed combination of telmisartan/hydrochlorothiazide on mortality and cardiovascular disease is currently unknown. Pharmacokinetics. The combined use of hydrochlorothiazide and telmisartan not affect the pharmacokinetics of each drug in healthy people. suctions Telmisartan After intake maximum concentration telmisartan achieved through 0.5-1.5 hours. Bioavailability of telmisartan 40 mg and 160 mg is 42% and 58% respectively. Food slightly reduces the effectiveness telmisartan, reducing the area under the curve "concentration-time" (AUC) telmisartan ranges from approximately 6% (40 mg) to 19% (160 mg dose). After 3:00 after application, the plasma concentration is the same and does not depend on how is telmisartan on an empty stomach or with food. I believe that a slight decrease in AUC does not cause a reduction in therapeutic effectiveness. Pharmacokinetics telmisartan intended for oral administration, is non-linear with increasing doses from 20 to 160 mg with the increase of concentration in plasma (C max and AUC), which is more than proportional. Telmisartan does not accumulate in plasma to a considerable extent in the case of re-appointments. hydrochlorothiazide After oral administration of the drug Alsartan - N max hydrochlorothiazide is reached in 1-3 hours. Based on cumulative renal excretion of hydrochlorothiazide, bioavailability was about 60%. distribution Telmisartan Telmisartan highly bound to plasma proteins (>99,5%), mainly albumin and alpha-1-acid glycoprotein. The volume of distribution telmisartan is approximately 500 liters, indicating additional tissue binding. hydrochlorothiazide Hydrochlorothiazide binds to plasma proteins by 68%, the visible volume of distribution is 0.83-1.14 l/kg. conclusion Telmisartan After oral 14 C-labeled telmisartan much of the dose (>97%) is excreted in the feces through biliary excretion. Only a small amount was found in the urine. Telmisartan metabolized by conjugation forming pharmacologically inactive acylglucuronide. The glucuronide of the parent compound is the only metabolite that has been identified in humans. After applying one dose of 14 C-labeled glucuronide telmisartan shows approximately 11% of the measured radioactivity in plasma. Isoforms of cytochrome P450 is not involved in the metabolism telmisartan. Telmisartan total clearance from plasma after oral administration is>1500 ml/min. the Overall half-life was>20 hours. hydrochlorothiazide Hydrochlorothiazide is not metabolised in man and is excreted almost entirely unchanged in the urine. Approximately 60% of the oral dose is excreted unchanged within 48 hours. Renal clearance is approximately 250 - 300 ml/min the Terminal half-life is 10-15 hours. Special status and category of patients Gender telmisartan Concentration in plasma in women, mostly in 2-3 times above, than at men. However, in clinical studies found no increase in the impact on blood pressure or the number of cases of orthostatic hypotension in women. There is no need to adjust the dose. In women, there is a tendency to a greater concentration of hydrochlorothiazide in blood plasma than in men, it has no clinical significance. Elderly patients the Pharmacokinetics telmisartan not differ from the elderly and people under the age of 65 years. Patients with impaired renal function Renal excretion does not have significant weight in clearance telmisartan. Based on some experience in patients with impaired renal function (creatinine clearance - 30-60 ml/min, with an average value - about 50 ml/min), there is no need to adjust the dose for patients with impaired renal function. Telmisartan is not displayed during hemodialysis. In patients with renal insufficiency, the rate of elimination of hydrochlorothiazide decreases. In typical studies, patients with average creatinine clearance of 90 ml/min increased the half-life of hydrochlorothiazide. In patients with nonfunctioning kidneys the half-life of 34 h. Patients with impaired liver function Pharmacokinetic studies in patients with impaired liver found increase in absolute bioavailability up to 100%. However, the elimination half-life in patients with impaired renal function do not change. Indications Arterial hypertension. As a combination with a fixed dose Telsartan-H is prescribed to patients, whose blood pressure is insufficiently controlled in the application separately telmisartan. Contraindications Hypersensitivity to any active substance or any of the auxiliary substances of the drug. Hypersensitivity to other substances that are sulfonamide derivatives (since hydrochlorothiazide is a sulfonamide derivative). The second and third trimesters of pregnancy. Cholestatic and biliary obstructive disorders. Hepatic insufficiency of severe degree. Severe renal impairment (creatinine clearance less than 30 ml/min). Refractory hypokalemia, hypercalcemia. Symptomatic hyperuricemia (gout). The simultaneous use of telmisartan with aliskiren is contraindicated in patients with diabetes diabetom or renal failure (GFR 2 ) (see "Method of application and dosage", "peculiarities of use", "Interaction with other medicinal products and other forms of interaction "). Interaction with other medicinal products and other forms of interaction The study of interaction was conducted only in adults. lithium With the simultaneous use of lithium with ACE inhibitors, a reversible increase in the concentration of lithium in serum and an increase in its toxicity was registered. On such rare occasions of interaction have also been reported with the use of antagonists of angiotensin II receptors (including telmisartan/hydrochlorothiazide). Simultaneous application of lithium and drug Alsartan - N is not recommended. If the efficacy of this combination is proven, careful monitoring of serum lithium levels is recommended. Medicinal products associated with potassium loss and hypokalaemia (e.g. other diuretics, deducing potassium, laxatives, corticosteroids, ACTH (ACTH), amphotericin, carbenoxolone, penicillin G sodium, salicylic acid and derivatives) When using these drugs, together with a combination of hydrochlorothiazide-telmisartan, it is recommended to monitor the level of potassium in the blood plasma. These drugs may increase the effect of hydrochlorothiazide on potassium levels in blood plasma. Drugs that may increase sodium levels and cause hyperkalemia (e.g. drugs that inhibit the renin-angiotensin system, potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium, cyclosporine or other medicinal products such as heparin sodium) When using these drugs, together with a combination of hydrochlorothiazide-telmisartan, it is recommended to monitor the level of potassium in the plasma. Based on the experience of other drugs that inhibit the renin-angiotensin system, the simultaneous use of these drugs can lead to an increase in the level of potassium in the blood serum and is therefore not recommended. Drugs that cause a violation of the level of potassium in serum It is recommended to monitor the level of potassium in the blood serum and ECG when using the drug Telsartan-H with drugs that cause a violation of the level of potassium in the blood serum (eg, digitalis glycosides, antiarrhythmic drugs), and drugs that stimulate paroxysmal tachycardia type torsades de pointes (including some antiarrhythmic drugs), hypokalemia, which is a provoking factor torsades de pointes: antiarrhythmic medicines of class Ia (e.g. quinidine, hydrogenizing, disopyramide) antiarrhythmic drugs class III (e.g. amiodarone, sotalol, dofetilide, ibutilide) some antipsychotics (e.g. thioridazine, chlorpromazine, levomepromazine, trifluoperazine, cyamemazine, sulpiride, sultopride, amisulpride, tiapride, pimozide, haloperidol, droperidol) other (e.g. bepridil, cisapride, diphemanil, erythromycin IV, halofantrine, mizolastine, pentamidine, sparfloxacin, terfenadine, vincamine has iv). the digitalis glycosides Hypokalemia or hypomagnesemia caused by thiazides, contribute to the emergence of cardiac arrhythmia caused by digitalis. digoxin While the use of telmisartan digoxin has noted an increase in the average values of the peak (49%) and minimum (20%) the concentration of digoxin in plasma. At the beginning of therapy, during dose adjustment and if telmisartan therapy is canceled, it is necessary to monitor the level of digoxin, in order to maintain the level within the therapeutic limits. Other antihypertensive drugs Telmisartan may increase hypotensive effect of other antihypertensive drugs. Antidiabetic drugs (oral drugs and insulin) It may be necessary to correct the dose of antidiabetic agents. metformin Metformin should be used with caution due to the risk of lactic acidosis caused by possible functional renal failure, while the use of hydrochlorothiazide. Colestyramine and cholesterol resins Absorption of hydrochlorothiazide is disturbed in the presence of anion exchange resins. Nonsteroidal anti-inflammatory drugs NSAIDs (in particular, acetylsalicylic acid in anti-inflammatory doses, COX-2 inhibitors, non-selective NSAIDs) can reduce the diuretic, natriuretic and antihypertensive effects of thiazide diuretics and the antihypertensive effects of angiotensin II receptor antagonists. In some patients with impaired renal function (in patients with dehydration or elderly patients with impaired renal function) the simultaneous use of angiotensin II receptor antagonists and agents that suppress COX, can cause impairment of kidney function, including acute renal failure, which is usually reversible. Therefore, the combination should be used with caution, especially in elderly patients. After starting therapy with a combination of drugs and periodically after patients need to provide adequate hydration and conduct a thorough control of kidney function. In one study, the simultaneous use of telmisartan and ramipril led to an increase of 2.5 times the area under the curve "concentration-time" (AUC 0-24 ) and maximum concentration in plasma (Cmax ) of ramipril and ramiprilat. The clinical significance of this observation remains unknown. Vasopressor amines (e.g. norepinephrine) The effect of vasopressor amines can be reduced. Nedepoliarizutmi the skeletal muscle relaxants (e.g. tubocurarine et al) Nedepoliarizutego action of skeletal muscle relaxants may be increased by hydrochlorothiazide. A medicine used to treat gout (e.g. probenecid, sulfinpirazon and allopurinol) It may be necessary to adjust the dose of drugs that promote the excretion of uric acid, because hydrochlorothiazide can increase the level of uric acid in the blood serum. It may be necessary to increase the dose of probenecide or sulfinpirazon. Simultaneous use of thiazide may increase the frequency of hypersensitivity reactions to allopurinol. calcium salt Thiazide diuretics can raise calcium levels in serum due to a decrease in excretion. If necessary, the appointment of calcium supplements should monitor the level of calcium in the blood serum and adjust the dose accordingly. Beta-blockers and diazoxide Hyperglycemic action of beta-blockers and diazoxide can be enhanced by thiazides. Anticholinergic medicines (e.g. atropine, biperiden) can increase the bioavailability of thiazide diuretics by decreasing gastrointestinal motility and the degree of emptying of the stomach. amantadine Thiazides increase the risk of side effects, amantadine. Cytotoxic drugs (e.g. cyclophosphamide, methotrexate) Thiazides may reduce renal excretion of cytotoxic drugs and potentiate their myelosuppressive effect. On the basis of pharmacological properties is expected to baclofen and amifostine may increase the hypotensive effect of all antihypertensive drugs, including telmisartan. In addition, orthostatic hypotension can be enhanced by the use of alcohol, barbiturates, drugs or antidepressants. salicylates With the use of high doses of salicylates hydrochlorothiazide may enhance their toxic effects on the Central nervous system. methyldopa Some cases of hemolytic anemia with the simultaneous use of hydrochlorothiazide and methyldopa were reported. cyclosporine With simultaneous use of cyclosporine may increase hyperuricemia and increase the risk of complications such as gout. The impact of medications on lab results Through the influence on calcium metabolism, thiazides can affect the results of the evaluation of the function of the parathyroid glands (see section "Features of application"). carbamazepine Given the risk of symptomatic hyponatremia, clinical and biological monitoring is needed. Iodine-containing contrast agents In the case of diuretics-induced dehydration, the risk of acute renal failure is increased, mainly with the use of high doses of iodine-containing contrast agents. Patients need rehydration before the introduction of iodine-containing drugs. Amphotericin B (parenteral administration), corticosteroids, ACTH and stimulant laxatives Hydrochlorothiazide increases electrolyte imbalance, mainly hypokalemia. Application features Impaired liver function Telsartan-N can not be prescribed to patients with cholestasis, obstructive diseases of the bile ducts and severe hepatic insufficiency, since telmisartan is excreted mainly with bile. These patients can be expected to reduce hepatic clearance telmisartan. In addition, Alsartan - N should be used with caution in patients with impaired hepatic function or progressive liver disease, since even minor changes in fluid and electrolyte balance may to cause hepatic coma. Clinical experience of the drug Telsartan-N patients with hepatic insufficiency no. renovascular hypertension There is an increased risk of severe hypotension and renal insufficiency when patients with bilateral renal artery stenosis or renal artery stenosis to a solitary kidney are taking medications that affect the renin-angiotensin-aldosterone system. Renal impairment and kidney transplantation Telsartan-H should not be used in patients with severe renal impairment (creatinine clearance less than 30 ml/min). There is no experience with Telsartan - N in patients who have recently had a kidney transplant. Since the experience of the drug Telsartan-N patients with impaired renal function of mild to moderate severity is small, it is recommended to conduct periodic monitoring of potassium, creatinine and uric acid levels in the blood serum. Patients with impaired renal function may experience nitrogen associated with thiazide diuretics. The decrease in BCC In patients with sodium deficiency and/or circulating blood volume in the body through powerful diuretic therapy, salt limitation in diet, diarrhea or vomiting, symptomatic hypotension may occur, especially after the first dose. Therefore, before the administration of the drug Telsartan-H should be carried out correction of the above-mentioned conditions. Dual blockade of the renin-angiotensin- As a result of inhibition of the renin-angiotensin-more sensitive patients experienced hypotension, syncope, hyperkalemia and changes in renal function (including acute renal failure), especially if combination therapy included drugs that affect this system. Therefore, a double blockade of renin-angiotensin - (for example, the addition of an ACE inhibitor to an angiotensin II receptor antagonist) is not recommended for patients who have already corrected blood pressure, and should be limited in some cases with careful monitoring of kidney function. Other conditions associated with stimulation of the renin-angiotensin- In patients, the vascular tone and renal function which depend mainly on the activity of the renin-angiotensin(e.g., patients with severe congestive heart failure or kidney disease, including renal artery stenosis), treatment with drugs that affect this system can result in acute hypotension, hyperasotemia, oliguria, and rarely with acute renal failure. Primary aldosteronism Patients with primary aldosteronism usually do not react to antihypertensive drugs, the action of which involves the suppression of renin-angiotensin system, so the use of the drug Telsartan - H is not recommended for such patients. Stenosis of the aorta and mitral valve, obstructive hypertrophic cardiomyopathy As with other vasodilators, special care is needed in the treatment of patients suffering from aortic stenosis and mitral valve or obstructive hypertrophic cardiomyopathy. Metabolic and endocrine effects Treatment with thiazides can disrupt glucose tolerance. For patients with diabetes mellitus may require dose adjustment of insulin or oral antidiabetic drugs. During thiazide therapy may manifest latent diabetes mellitus. Treatment with thiazide diuretics is associated with an increase of level of cholesterol and triglycerides. However, the dose of 12.5 mg contained in the drug Telsartan-H, has no such effect or is only minimal. Some patients receiving thiazide drugs may develop hyperuricemia or gout is obvious. electrolyte imbalance Any patient treated with diuretics, after a certain period of time should determine the level of serum electrolytes. Thiazides, including hydrochlorothiazide, can cause a liquid or electrolyte imbalance (in particular hypokalemia, hyponatremia and hypochloremic alkalosis). Signs of liquid and electrolyte imbalance is dry mouth, thirst, weakness, lethargy, drowsiness, restlessness, muscle pain or cramps, muscular fatigue, hypotension, oliguria, tachycardia and gastrointestinal disorders such as nausea and vomiting. hypokalemia Despite the fact that the result of the application of thiazide diuretics may develop hypokalemia, concomitant therapy with telmisartan may reduce gipokaliemia caused dioretikami. The risk of hypokalemia is higher in patients with liver cirrhosis, in patients with significant diuresis, in patients whose oral administration of electrolytes does not meet their needs, and in patients receiving therapy with corticosteroids or ACTH (ACTH). hyperkalemia On the contrary, through the antagonism of the angiotensin II receptor (at 1 ) caused by the telmisartan component of the drug Alsartan - N, you may experience hyperkalemia. Clinically significant hyperkalemia due to the administration of Telsartan - H has not been documented. The risk factors for the development of hyperkalemia include renal insufficiency and/or heart failure and diabetes. Potassium-sparing diuretics, potassium supplements or salt substitutes containing potassium should be administered with caution simultaneously with the combination of telmisartan/hydrochlorothiazide. Hyponatremia and hypochloremic alkalosis There is no evidence that Telsartan - H reduces or prevents hyponatremia caused by diuretics. Chlorine deficiency is generally weak and usually does not require treatment. hypercalcemia Thiazides can reduce the release of calcium in the urine and cause periodic and slight increase in serum calcium levels in the absence of calcium metabolism disorders. Significant hypercalcemia may be a sign of latent hyperparathyroidism. You should stop taking thiazides before carrying out tests of parathyroid. hypomagnesemia Thiazides cause increased release of magnesium in the urine, which can lead to hypomagnesemia. ethnic difference Like all other angiotensin II receptor antagonists, telmisartan is clearly less effective for lowering blood pressure in black patients than in other races. Perhaps this is due to the large distribution of States with low levels of renin in patients of black race, hypertension. other condition As the use of any other antihypertensive drugs, excessive reduction of blood pressure in patients with ischemic cardiopathy or ischemic cardiovascular disease can lead to myocardial infarction or stroke. General disorders Hypersensitivity reactions to hydrochlorothiazide are more likely in patients with a history of allergies or bronchial asthma. It is known that the use of thiazide diuretics, including hydrochlorothiazide, can lead to exacerbation of systemic lupus erythematosus. When using thiazide diuretics, there were cases of photosensitivity reactions. If photosensitization occurs during treatment, it is recommended to discontinue the use of the drug. If repeated use of diuretics is considered necessary, it is recommended to protect exposed areas from exposure to the sun or artificial ultraviolet radiation. Acute myopia and secondary glaucoma Hydrochlorothiazide, sulfonamide can cause hypersensitivity reactions and, as a consequence, acute transient myopia and acute closed-angle glaucoma. Symptoms include a sharp drop in visual acuity or eye pain and are usually observed from hours to weeks after the start of treatment. If left untreated, acute glaucoma can cause irreversible vision loss. Hydrochlorothiazide treatment should be discontinued as soon as possible. There may be a need for urgent medical or surgical treatment if intraocular pressure remains uncontrolled. Risk factors for acute closed-angle glaucoma include a history of Allergy to sulfonamide or penicillin. The drug can affect the results of laboratory tests: the drug can reduce the level of protein-bound iodine in blood plasma treatment should be discontinued before carrying out laboratory tests to assess the function of the parathyroid glands the drug is able to increase the concentration of free bilirubin in serum. Use during pregnancy or breast-feeding. Pregnancy. During pregnancy you can not start treatment with antagonists of angiotensin II receptors. If continuation of therapy with antagonists of angiotensin II receptors cannot be considered essential for the patient who is planning pregnancy, she should go to an alternative antihypertensive therapy that has an established safety profile for use during pregnancy. In case of pregnancy, treatment with angiotensin II receptor antagonists should be stopped immediately and alternative treatment should be started if necessary. Lactation. Thiazides cross the placental barrier and penetrate the umbilical cord blood. They can cause electrolyte disorders in the fetus and other reactions occurring in adults. When applying thiazide therapy reported cases of neonatal thrombocytopenia, embryonic or neonatal jaundice. Information on the use of Telsartan - H during breastfeeding is not available. Therefore, the use of the drug is not recommended during this period - preference is given to alternative treatment with a better studied safety profile. Thiazides are released into breast milk and can suppress lactation. The ability to influence the reaction rate when driving motor transport or operating other mechanisms. Study of the effect of telmisartan on the ability to drive and use machinery has not been. However, when driving a car and machinery it is necessary to take into account that in antihypertensive therapy, dizziness or drowsiness may occur. Method of application and doses adults Alsartan - N should take patients where blood pressure is insufficiently controlled in the application separately telmisartan. Against the transition to the reception combination with fixed dose should be individually determined dose of each of the components. According to clinical indications, direct replacement of monotherapy with fixed combination therapy is possible. Alsartan - N can be assigned to patients whose blood pressure is insufficiently controlled in the application separately telmisartan or hydrochlorothiazide, or patients who had previously achieved improve the condition when applied separately telmisartan and hydrochlorothiazide. Special populations of patients Patients with impaired renal function It is recommended to monitor kidney function. Patients with impaired liver function Patients with impaired hepatic function mild and moderate severity of the drug Alsartan - N appoint not more than 1 time per day. Telsartan-H is not prescribed to patients with severe hepatic impairment. It should be cautiously prescribed thiazides in patients with impaired liver function. Elderly people There is no need for dose adjustment for elderly patients. method of application Telsartan - N tablets are taken once a day on with liquid, regardless of meal. Safety measures before using the medicinal product Telsartan-H should be stored in a sealed blister pack, as the tablets are very hygroscopic. Remove tablets from the blister immediately before use. Children. Safety and efficacy of Telsartan - H for children and adolescents (under the age of 18) have not been established. Overdose Information about telmisartan overdose in humans is limited. The level of withdrawal of hydrochlorothiazide by hemodialysis is not established. Symptoms. In case of overdose telmisartan most pronounced symptoms were hypotension and tachycardia also reported bradycardia, dizziness, vomiting, increased serum creatinine and acute renal failure. With an overdose of hydrochlorothiazide is associated with a decrease in the concentration of electrolytes (hypokalemia, hypochloremia) and hypovolemia due to excessive diuresis. The most common symptoms of overdose are nausea and drowsiness. Hypokalemia can lead to muscle spasms and/or worsening cardiac arrhythmias with concomitant use of glycosides of the digitalis group or certain antiarrhythmic drugs. Treatment. Telmisartan is not removed by hemodialysis. Patients should be closely monitored and receive symptomatic and supportive therapy. Therapy depends on the time of taking the drug and the severity of symptoms. The recommended measures include inducing vomiting and/or gastric lavage. In the treatment of overdose can be used activated charcoal. It is necessary to control the level of the electrolyte

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