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Hydrochlorothiazide, Telmisartan

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Clinical Pharmacology

Pharmacotherapeutic group: Combined antihypertensive agent (angiotensin II receptor antagonist + diuretic agent)

ATH:

C.09.D.A.07 Telmisartan in combination with diuretics

Pharmacodynamics:

Telpres Plus is a combination of telmisartan (angiotensin II receptor antagonist) and hydrochlorothiazide, a thiazide diuretic. The simultaneous use of these components leads to a more pronounced antihypertensive effect than the use of each of them separately.

Taking the drug Telpres Plus once a day leads to a significant gradual decrease in blood pressure (BP).

Telmisartan

Telmisartan is a specific angiotensin II receptor antagonist (type AT1), effective when taken orally. It has high affinity for the AT 1 subtype of angiotensin II receptors, through which the action of angiotensin II is realized. Displaces angiotensin II from its association with the receptor, not having the action of an agonist on this receptor. Telmisartan binds only to the angiotensin II receptor subtype AT1. Communication is long lasting. It has no affinity for other receptors, including the AT2 receptor and other less studied angiotensin receptors. The functional significance of these receptors, as well as the effect of their possible over-stimulation with angiotensin II, the concentration of which increases with the administration of telmisartan, has not been studied. Reduces the concentration of aldosterone in the blood, does not inhibit renin in the blood plasma and does not block the ion channels. Telmisartan does not inhibit angiotensin-converting enzyme (kininase II) (an enzyme that also destroys bradykinin). Therefore, an increase in side effects caused by bradykinin is not expected.

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

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

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

Hydrochlorothiazide

Hydrochlorothiazide is a thiazide diuretic. Thiazide diuretics affect electrolyte reabsorption in the renal tubules, directly increasing the excretion of sodium and chloride (approximately in equivalent amounts). The diuretic effect of hydrochlorothiazide leads to a decrease in circulating blood volume (BCC), an increase in plasma renin activity, an increase in aldosterone secretion, with a subsequent increase in potassium and bicarbonate levels in urine and, as a result, a decrease in plasma potassium. When taken simultaneously with telmisartan, there is a tendency to stop the loss of potassium caused by these diuretics, presumably due to the blockade of the renin-angiotensin-aldosterone system (RAAS). After ingestion diuresis increases after 2 hours, and the maximum effect is observed after about 4 hours. The diuretic effect of the drug lasts for about 6-12 hours.

Prolonged use of hydrochlorothiazide reduces the risk of developing complications of cardiovascular diseases and mortality from them.

The maximum antihypertensive effect of Telpres Plus is usually achieved 4-8 weeks after the start of treatment.

Pharmacokinetics:

The combined use of telmisartan and hydrochlorothiazide does not affect the pharmacokinetics of each of the components of the drug.

Telmisartan:

Suction

When ingestion is rapidly absorbed from the gastrointestinal tract. Bioavailability is about 50%.When taken simultaneously with food, the decrease in AUC (the area under the concentration-time curve) ranges from 6% (at a dose of 40 mg) to 19% (at a dose of 160 mg). After 3 hours after ingestion, plasma concentration levels off regardless of food intake.

Distribution

Communication with plasma proteins - 99.5%, mainly with albumin and alpha-1 glycoprotein. The average value of the apparent volume of distribution at an equilibrium concentration is 500 l.

Metabolism

Metabolized by conjugation with glucuronic acid. Metabolites are pharmacologically inactive.

Removal

The half-life (T1 / 2) is more than 20 hours. Excreted through the intestine unchanged, the excretion of the kidneys - less than 2% of the dose. The overall plasma clearance is high (900 ml / min) compared with "hepatic blood flow" (about 1500 ml / min).

Pharmacokinetics in Special Patient Groups

Gender Differences

There is a difference in plasma concentrations in men and women. Cmax (maximum concentration) and AUC were approximately 3 and 2 times, respectively, higher in women compared to men without significant effect on efficacy. Dose adjustment is not required.

Elderly patients

The pharmacokinetics of telmisartan in elderly patients is not different from younger patients. Dose adjustment is not required.

Patients with impaired renal function

In patients with mild and moderate renal dysfunction, dose adjustment of telmisartan is not required.

Patients with severe renal insufficiency and patients on hemodialysis are recommended a lower initial dose of 20 mg per day. Telmisartan is not excreted by hemodialysis.

Patients with impaired liver function

Pharmacokinetic studies in patients with hepatic insufficiency showed an increase in the absolute bioavailability of telmisartan to almost 100%. When liver failure T1 / 2 does not change. In patients with mild and moderate liver dysfunction (class A and B on the Child-Pugh scale), the daily dose of the drug should not exceed 40 mg.

Hydrochlorothiazide:

After oral administration of the drug Telpres Plus, the maximum plasma concentrations of hydrochlorothiazide are reached within 1-3 hours. Absolute bioavailability based on total excretion by the kidneys is about 60%. Plasma protein binds 64% of hydrochlorothiazide, and the volume of distribution is 0.8 ± 0.3 l / kg. Hydrochlorothiazide is not metabolized in the body and excreted by the kidneys almost unchanged. About 60% of the dose taken orally is eliminated within 48 hours. Renal clearance of about 250-300 ml / min. T1L hydrochlorothiazide - 10 - 15 hours. There is a difference in plasma concentrations in men and women. In women, the concentration of telmisartan in the blood plasma is 2-3 times higher than in men, and women also have a tendency to increase in the blood plasma concentration of hydrochlorothiazide is clinically insignificant.

Patients with impaired renal function

In patients with impaired renal function, the rate of elimination of hydrochlorothiazide is reduced.

Studies conducted with the participation of patients with creatinine clearance (CC) of 90 ml / min showed that T1 / 2 hydrochlorothiazide increases. In patients with reduced T1 / 2 kidney function, about 34 hours.

Indications

Arterial hypertension (in case of failure of telmisartan or hydrochlorothiazide in monotherapy).

Composition

Each 25 mg + 80 mg tablet contains:

active ingredients: hydrochlorothiazide - 25.00 mg, telmisartan - 80.00 mg; excipients: mannitol - 327.70 mg, povidone-K25 - 21.60 mg, crospovidone - 20.0 mg, magnesium stearate - 9.00 mg, meglumine - 24.00 mg, sodium hydroxide - 6.70 mg, lactose monohydrate - 99.67 mg, microcrystalline cellulose - 64.00 mg, hypromellose - 6.00 mg, sodium carboxymethyl starch, type A - 4.00 mg, iron yellow oxide (E 172) - 0.33 mg.

Hydrochlorothiazide, Telmisartan is marketed under different brands and generic names, and comes in different dosage forms:

Brand nameManufacturerCountryDosage form
Telpres Plus pills
Telzap Plus pills
Telpres pills
Telsartan N pills

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Hydrochlorothiazide, Telmisartan

Dosage and Administration

Orally, regardless of meal times.

Telpres Plus should be taken 1 time per day.

- Telpres Plus 12.5 / 40 mg may be prescribed to patients in whom the use of telmisartan drugs at a dosage of 40 mg or hydrochlorothiazide does not lead to adequate control of blood pressure.

- Telpres Plus 12.5 / 80 mg may be prescribed to patients in whom the use of Telmisartan preparations at a dosage of 80 mg or Telpres Plus 12.5 / 40 mg does not lead to adequate blood pressure control.

- Telpres Plus 25/80 mg may be administered to patients in whom the use of telmisartan drugs at a dosage of 80 mg or Telpres Plus 12.5 / 80 mg does not lead to adequate blood pressure control, or to patients whose condition was previously stabilized by telmisartan or hydrochlorothiazide when administered separately. application.

In patients with severe arterial hypertension, the maximum daily dose of telmisartan is 160 mg in combination with hydrochlorothiazide at a daily dose of 12.5-25 mg.

Renal dysfunction

The limited experience of using Telpres Plus in patients with minor or moderately severe renal impairment does not require a change in the dose of the drug in these cases. In such patients, renal function should be monitored (with CC less than 30 ml / min, see section "Contraindications").

Liver function disorders

In patients with mild and moderate liver dysfunction (Child-Pugh class A and B), the daily dose of Telpres Plus should not exceed 12.5 / 40 mg per day (see the Pharmacokinetics section).

Elderly patients

Dosing regimen does not require changes.

Adverse reactions

1) Expected based on experience with Telmisartan

2) expected based on experience with hydrochlorothiazide

3) side effects that were not observed in clinical studies with simultaneous use of telmisartan and hydrochlorothiazide, but are expected during the use of the drug Telpres Plus

Respiratory disorders:

respiratory distress syndrome (including pneumonia and non-cardiogenic pulmonary edema) 3), shortness of breath 3).

Heart disorders:

arrhythmias, tachycardia, bradycardia.

Vascular disorders:

pronounced decrease in blood pressure (including orthostatic hypotension) 3).

Nervous system disorders:

syncope / syncope3), paresthesia3), sleep disorders3), insomnia3), dizziness3), increased excitability2), headache2).

Mental disorders:

anxiety3), depression3).

Disorders of the gastrointestinal tract:

Diarrhea3), dry oral mucosa3), flatulence3), abdominal pain3), constipation3), vomiting3), gastritis3), decreased appetite2), anorexia2), hyperglycemia2), hypercholesterolemia2), pancreatitis2), dyspepsia1) 2), ).

Disorders of the liver and biliary tract:

abnormal liver function3), jaundice (hepatocellular or cholestatic) 2).

Violations of the skin and subcutaneous tissues:

Eczema1), drug rash1), 2), toxic epidermal necrosis1), 2), erythema3), skin itch3), rash3), increased sweating3), photosensitization reaction2).

Disorders of the musculoskeletal and connective tissues:

backache3), muscle spasms3), myalgia3), arthralgia3), gastrocnemius muscle cramps3), arthrosis1), tendinitis-like symptoms1), chest pain3).

Violations of the blood and lymphatic system:

iron deficiency anemia1), aplastic anemia2), hemolytic anemia2), thrombocytopenia1), eosinophilia1), leukopenia2), neutropenia / agranulocytosis2), thrombocytopenia2).

Kidney and urinary tract disorders:

renal failure1), 2), including acute renal failure1), interstitial nephritis2), glycosuria2).

Violations by the organ of vision:

visual impairment3), transient blurred vision3), xantopsia2), acute angle-closure glaucoma2), acute myopia2).

Violations of the genital and breast organs:

Impotence3).

Infectious and parasitic diseases:

sepsis, including fatal cases1), upper respiratory tract infections (bronchitis, pharyngitis, sinusitis) 1), 3), urinary tract infections (including cystitis) 1), inflammation of the salivary glands 2).

Impact on the results of laboratory and instrumental studies:

increased concentration of creatinine in blood plasma3), increased activity of liver enzymes3), increased activity of creatine phosphokinase3), increased activity of concentration of blood uric acid3), hypertriglyceridemia 2), hypokalemia 2), 3), hypomagnesia2), hyperkalemia 1), hyponatremia 2), 3) hyperuricemia3), decreased BCC2), hypoglycemia (in patients with diabetes mellitus) 1), impaired glucose tolerance2), decreased hemoglobin in the blood1).

Immune system disorders:

angioedema (including fatal cases) 3), anaphylactic reactions1), 2), lupus-like reactions2), worsening or worsening symptoms of systemic lupus erythematosus3), necrotic vasculitis2), systemic vasculitis2), recurrent systemic lupus erythematosus2), vasculitis2)

General disorders and disorders at the site of administration:

influenza-like syndrome3), fever2), weakness 1), 2).

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

- Pregnancy;

- The period of breastfeeding;

- Obstructive diseases of the biliary tract;

- Severe abnormal liver functions (Child-Pugh class C);

- Severe renal dysfunction (CC less than 30 ml / min);

- Refractory hypokalemia, hypercalcemia;

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

- Simultaneous use of ACE inhibitors in patients with diabetic nephropathy;

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

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

Carefully:

- Bilateral stenosis of the renal arteries or stenosis of the artery of a single kidney (see section "Special instructions");

- Liver dysfunction (class A and B according to Child-Pugh classification) (see section "Special instructions");

- Reduction of BCC due to previous diuretic therapy, restriction of salt, diarrhea or vomiting;

- Hyperkalemia;

- Condition after kidney transplantation (no experience);

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

- Hypercalcemia;

- Hypercholesterolemia;

- Hypertriglyceridemia;

- Coronary heart disease;

- Progressive liver disease (risk of developing hepatic coma);

- Aortic and mitral valve stenosis;

- Idiopathic hypertrophic subaortic stenosis (hypertrophic obstructive cardiomyopathy);

- Diabetes;

- Primary hyper aldosteronism;

- Gout, hyperuricemia;

- Systemic lupus erythematosus;

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

- Use in patients of the Negroid race;

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

- Simultaneous use with ACE inhibitors or aliskiren;

- Simultaneous use with potassium preparations, potassium-sparing diuretics.

Drug interactions

Telmisartan

Telmisartan may increase the antihypertensive effect of other antihypertensive drugs. Other types of interactions of clinical significance have not been identified.

Combined use with digoxin, warfarin, hydrochlorothiazide, glibenclamide, ibuprofen, paracetamol, simvastatin and amlodipine does not lead to clinically significant interaction.

Double blockade of the renin-angiotensin-aldosterone system (RAAS)

Concomitant use of telmisartan with aliskiren is contraindicated in patients with diabetes or renal failure (GFR less than 60 ml / min / 1.73 m2 of body surface area) and is not recommended for other patients. Simultaneous use of telmisartan and ACE inhibitors is contraindicated in patients with diabetic nephropathy.

Data from clinical studies have shown that double blockade of the RAAS due to the combined use of ACE inhibitors, ARA II or aliskiren is associated with an increased incidence of adverse events, such as arterial hypotension, hyperkalemia and impaired renal function (including acute renal failure) compared to using only one drug acting on the RAAS.

The risk of developing hyperkalemia may increase when used in conjunction with other drugs that can cause hyperkalemia (potassium-containing dietary supplements and salt substitutes containing potassium and potassium-sparing diuretics (spironolactone, eplerenone, triamterene, or amiloride), nonsteroidal anti-inflammatory drugs (NPVV). 2 (COX)), heparin, immunosuppressants (cyclosporine, tacrolimus, trimethoprim)). If necessary, against the background of documented hypokalemia, the combined use of drugs should be carried out with caution and regularly monitor the content of potassium in the blood plasma.

Digoxin

When co-administration of telmisartan with digoxin, an increase in the mean Cmax of digoxin in the blood plasma by 49% and a minimum concentration by 20% was noted. At the beginning of treatment, when selecting a dose and stopping treatment with telmisartan, the concentration of digoxin in the blood plasma should be carefully controlled to maintain it within the therapeutic range.

Potassium-sparing diuretics or potassium-containing dietary supplements

Angiotensin II receptor antagonists, such as telmisartan, reduce the potassium loss caused by diuretics. Potassium-sparing diuretics, for example, spironolactone, eplerenone, triamterene or amiloride, potassium-containing dietary supplements or salt substitutes can lead to a significant increase in plasma potassium. If concomitant use is indicated, since there is documented hypokalemia, they should be used with caution and against the background of regular monitoring of potassium in the blood plasma.

Lithium preparations

When lithium preparations were taken together with ACE and APA II inhibitors, including telmisartan, there was a reversible increase in the concentration of lithium in the blood plasma and its toxic effect. If you need to use this combination of drugs is recommended to carefully monitor the concentration of lithium in the blood plasma.

Nonsteroidal anti-inflammatory drugs (NSAIDs)

NSAIDs (including acetylsalicylic acid in doses used for anti-inflammatory treatment, COX-2 inhibitors and non-selective NSAIDs) can weaken the antihypertensive effect of APA II. In some patients with impaired renal function (for example, patients with dehydration, elderly patients with impaired renal function), the combined use of APA II and cyclooxygenase-2 depressant drugs can lead to further deterioration of renal function, including the development of acute renal failure, which, as a rule is reversible. Therefore, the joint use of drugs should be carried out with caution, especially in elderly patients. Adequate fluid intake should be ensured, in addition, at the beginning of the joint use and periodically in the future, indicators of renal function should be monitored.

Diuretics (thiazide or loop diuretics)

Prior treatment with high doses of diuretics, such as furosemide (loop diuretic) and hydrochlorothiazide (thiazide diuretic), can lead to hypovolemia and risk of developing hypotension at the beginning of treatment with telmisartan.

Other antihypertensive drugs

The effect of telmisartan may be enhanced by the combined use of other antihypertensive drugs. Based on the pharmacological properties of baclofen and amifostine, it can be assumed that they will enhance the therapeutic effect of all antihypertensive drugs, including telmisartan. In addition, orthostatic hypotension may increase with alcohol, barbiturates, narcotic drugs, or antidepressants.

Corticosteroids (for systemic use)

Corticosteroids weaken the effect of telmisartan.

Hydrochlorothiazide

When applied simultaneously with:

- ethanol, barbiturates or narcotic analgesics: the risk of orthostatic hypotension;

- hypoglycemic agents for oral administration and insulin: may require correction of the dose of hypoglycemic agents for oral administration and insulin;

- Metformin: the risk of lactic acidosis;

- colestyramine and colestipol: in the presence of anionic exchange resins, the absorption of hydrochlorothiazide is disturbed;

- cardiac glycosides: the risk of hypokalemia or hypomagnesaemia caused by thiazide diuretics, the development of arrhythmias caused by taking cardiac glycosides;

- pressor amines (for example, norepinephrine): possible weakening of the effect of pressor amines;

- non-depolarizing muscle relaxants (for example, tubocurarine chloride): hydrochlorothiazide may enhance the effect of non-depolarizing muscle relaxants;

- anti-gouty agents: the concentration of uric acid in the blood serum may increase and, therefore, changes in the dose of uricosuric agents may be required. The use of thiazide diuretics increases the frequency of hypersensitivity reactions to allopurinol;

- calcium supplements and vitamin D: thiazide diuretics can increase the calcium content in blood serum due to a decrease in its excretion by the kidneys. If you want to use calcium supplements, you should regularly monitor the calcium content in the blood and, if necessary, change the dose of calcium supplements;

- beta-blockers and diazoxide: thiazide diuretics can increase hyperglycemia caused by beta-blockers and diazoxide;

- m-holinoblokatorami (for example, atropine, biperidine): decrease in motility of the gastrointestinal tract, increase in bioavailability of thiazide diuretics;

- amantadine: clearance of amantadine can be reduced by hydrochlorothiazide, which leads to an increase in the concentration of amantadine in the blood plasma and possible toxicity;

- cytotoxic agents (for example, cyclophosphamide, methotrexate): reduction of renal excretion of cytotoxic agents and enhancement of their myelosuppressive action;

- NSAIDs: combined use with thiazide diuretics can lead to a decrease in diuretic and antihypertensive effect;

- agents that lead to excretion of potassium and hypokalemia (for example, diuretics, potassium deducing; laxatives; glucocorticosteroids, calcitonin, ACTH (adrenocorticotropic hormone), glycyrrhizic acid (contained in licorice root), amphotericin B; carbenoxolone; benzylcycrolysic acid; ): increased hypokalemic effect. The hypokalemia caused by hydrochlorothiazide is compensated by the potassium-sparing effect of telmisartan;

- theophylline: increased risk of hypokalemia;

- amiodarone: simultaneous use with thiazide diuretics may lead to an increased risk of arrhythmias associated with hypokalemia;

- potassium-sparing diuretics, potassium preparations, other means capable of increasing the serum serum levels (for example, heparin) or the replacement of sodium in sodium chloride with potassium salts can lead to hyperkalemia.

It is recommended to periodically monitor the content of potassium in the blood plasma in cases where the drug Telpres Plus is prescribed together with drugs that can cause hypokalemia, as well as with drugs that can increase the content of potassium in the blood serum.

Special instructions

Liver function disorders

The use of the drug Telpres Plus is contraindicated in patients with cholestasis, obstruction of the biliary tract or severe liver dysfunction (Child-Pugh class C) (see section "Contraindications"), since telmisartan is mainly excreted in the bile. It is believed that these patients have reduced hepatic clearance of telmisartan. In patients with mild or moderate abnormal liver function (class A and B according to Child-Pugh classification), Telpres Plus should be used with caution (see section "With caution").

Renovascular hypertension

When treating 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.

Impaired renal function and kidney transplantation

When using the drug Telpres Plus in patients with impaired renal function, periodic monitoring of the content of potassium and creatinine in blood plasma is recommended. There is no experience with the clinical use of Telpres Plus in patients who have recently had a kidney transplant.

The use of thiazide diuretics in patients with impaired renal function can 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 BCC and / or sodium in the blood plasma on the background of previous treatment with diuretics, limitation of salt, diarrhea or vomiting. Such conditions (deficiency of liquid and / or sodium) should be eliminated before the start of Telpres Plus.

Double blockade of the renin-angiotensin-aldosterone system

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

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

As a result of inhibition of the RAAS, arterial hypotension, syncope, hyperkalemia and impaired renal function (including acute renal failure) in susceptible patients were noted, especially when several drugs were used together, also acting on this system. Therefore, a double blockade of RAAS (for example, against the background of receiving telmisartan with other RAAS antagonists) is not recommended.

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

Primary aldosteronism

In patients with primary aldosteronism, treatment with antihypertensive drugs, which are mediated by inhibition of the RAAS, is generally ineffective.

Aortic and mitral valve stenosis, hypertrophic obstructive cardiomyopathy

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

Acute myopia and secondary angle-closure glaucoma

Hydrochlorothiazide, a derivative of sulfonamide, can cause an idiosyncratic reaction in the form of acute transient myopia and acute angle-closure glaucoma. Symptoms of these disorders are an unexpected decrease in visual acuity or pain in the eyes, which in typical cases occur within a few hours to several weeks after the start of the drug. If not treated, acute angle-closure glaucoma can result in loss of vision. The main treatment is to discontinue hydrochlorothiazide as quickly as possible. It must be borne in mind that if intraocular pressure remains uncontrolled, emergency conservative or surgical treatment may be required. The risk factors for the development of acute angle-closure glaucoma include information on allergies to sulfonamides or penicillin in history.

Impact on the metabolism and function of the endocrine glands

Patients with diabetes may need to change the dose of insulin or hypoglycemic agents for oral administration. During treatment with thiazide diuretics, it can manifest latent flowing diabetes.

In some cases, the use of thiazide diuretics may cause hyperuricemia and exacerbation of the flow of gout.

Disorders of water and electrolyte balance

When using the drug Telpres Plus, as in the case of diuretic therapy, it is necessary to periodically control the content of electrolytes in the blood serum. Thiazide diuretics, including hydrochlorothiazide, can cause disturbances in the water electrolyte balance and acid-base state (hypokalemia, hyponatremia, and hypochloraemic alkalosis). Signs that are alarming for these disorders are dryness of the oral mucosa, thirst, general weakness, drowsiness, anxiety, myalgia or convulsive twitching of the gastrocnemius muscles (cramp), muscle weakness, marked reduction of blood pressure, oliguria, tachycardia and such gastrointestinal intestinal disturbances like nausea or vomiting.

When using thiazide diuretics, hypokalemia may develop, but at the same time using telmisartan may increase the content of potassium in the blood. The risk of hypokalemia is most increased in patients with cirrhosis of the liver, with increased diuresis, with a salt-free diet, as well as in the case of simultaneous use of glucocorticosteroids, calcitonin, ACTH (adrenocorticotropic hormone), glycyrrhizic acid (contained in licorice root), Telmisartan, enter, and glycyrrhizic acid (contained in licorice root), Telmisartan, enter, and lycerolizine acid (contained in licorice root), Telmisartan, enter, and lycerolysis. Telpres Plus, on the contrary, can lead to hyperkalemia due to angiotensin II receptor antagonism (AT1 subtype). Although the use of the drug Telpres Plus clinically significant hyperkalemia was not registered, it should be taken into account that the risk factors for its development include renal and / or heart failure and diabetes.

There is no evidence that Telpres Plus can reduce or prevent hyponatremia caused by diuretic therapy. 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 disorders of calcium metabolism) a transient and slight increase in the calcium content in the blood serum. More pronounced hypercalcemia can be a sign of latent hyperparathyroidism. Thiazide diuretics should be canceled before evaluating the function of the parathyroid glands.

Thiazide diuretics have been shown to increase the excretion of magnesium by the kidneys, which can lead to hypomagnesemia.

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

Requires enhanced monitoring of patients with impaired uric acid metabolism; thiazides can reduce the amount of iodine that binds to serum proteins, without showing signs of dysfunction of the thyroid gland; There is information about 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 to resume diuretic intake, it is necessary to protect areas of the body that may be exposed to the sun or ultraviolet rays of type A and avoid exposure to the sun; hydrochlorothiazide may increase the concentration of cholesterol and triglycerides in the blood; hydrochlorothiazide can give a positive result when carrying out 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 ARA II appear to be less effective at lowering blood pressure in patients of the Negroid race than in other races, possibly due to a greater predisposition to a decrease in renin activity in the population of these patients.

Other

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

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

There were no special clinical studies assessing the effect of Telpres Plus on the ability to drive vehicles and work with mechanisms requiring increased attention. However, when driving and taking on potentially hazardous activities, the possibility of developing vertigo and drowsiness should be taken into account, which requires caution.

Overdosage

Information regarding overdose is limited. Possible symptoms of overdose consist of symptoms from the individual components of the drug. Telmisartan - the most significant - a pronounced decrease in blood pressure and tachycardia, bradycardia, dizziness, increased serum creatinine levels and acute renal failure can also be observed.

Hydrochlorothiazide is a violation of the water-electrolyte balance of the blood (hypokalemia, hypochloremia), decreased BCC, which can lead to muscle spasms and / or increase cardiovascular disorders: arrhythmias caused by simultaneous use of cardiac glycosides or some antiarrhythmic drugs.

Treatment: symptomatic therapy, hemodialysis is ineffective. The degree of removal of hydrochlorothiazide during hemodialysis has not been established. Regular monitoring of electrolyte and serum creatinine levels is necessary. Hemodialysis is not effective.

  • Brand name: Telpres Plus
  • Active ingredient: Hydrochlorothiazide, Telmisartan
  • Manufacturer: Pharmproject

Studies and clinical trials of Hydrochlorothiazide, Telmisartan (Click to expand)

  1. Liquid chromatographic–tandem mass spectrometric method for the simultaneous quantitation of telmisartan and hydrochlorothiazide in human plasma
  2. Salt supplementation blunts the blood pressure response to telmisartan with or without hydrochlorothiazide in hypertensive patients with type 2 diabetes
  3. Efficacy and tolerability of a fixed-dose combination of telmisartan plus hydrochlorothiazide in patients uncontrolled with telmisartan monotherapy
  4. Telmisartan vs losartan plus hydrochlorothiazide in the treatment of mild-to-moderate essential hypertension—a randomised ABPM study
  5. Freehand three-dimensional echocardiographic evaluation of the effect of telmisartan compared with hydrochlorothiazide on left ventricular mass in hypertensive patients with mild-to-moderate hypertension: a multicentre study
  6. Effect of telmisartan/hydrochlorothiazide vs lisinopril/hydrochlorothiazide combination on ambulatory blood pressure and cognitive function in elderly hypertensive patients
  7. Combination treatment with telmisartan and hydrochlorothiazide in black patients with mild to moderate hypertension
  8. Telmisartan 80 mg/Hydrochlorothiazide 25 mg Provides Clinically Relevant Blood Pressure Reductions Across Baseline Blood Pressures
  9. Efficacy and Tolerability of Initial Therapy With Single-Pill Combination Telmisartan/Hydrochlorothiazide 80/25 mg in Patients With Grade 2 or 3 Hypertension: A Multinational, Randomized, Double-Blind, Active-Controlled Trial
  10. Application of first-derivative, ratio derivative spectrophotometry, TLC-densitometry and spectrofluorimetry for the simultaneous determination of telmisartan and hydrochlorothiazide in pharmaceutical dosage forms and plasma
  11. A 48-week study of amlodipine plus amiloride / hydrochlorothiazide vs. amlodipine plus telmisartan in the treatment of hypertension
  12. Effects of the Angiotensin II Receptor Blockers Telmisartan vs Valsartan in Combination With Hydrochlorothiazide 25 mg Once Daily for the Treatment of Hypertension
  13. Telmisartan or Valsartan Alone or in Combination with Hydrochlorothiazide: A Review
  14. Validated RP‐HPLC Method for Simultaneous Determination of Telmisartan and Hydrochlorothiazide in Pharmaceutical Formulation
  15. Effects of telmisartan hydrochlorothiazide combination versus nifedipine gits on blood pressure and sympathetic activity in hypertension
  16. A comparative analysis of the efficacy of olmesartan medoxomil (O)/hydrochlorothiazide (HCTZ), valsartan (V)/HCTZ, irbesartan (I)/HCTZ and telmisartan (T)/HCTZ combinations
  17. Effect of Telmisartan/Hydrochlorothiazide Combination Versus Nifedipine GITS on Ambulatory Blood Pressure and Sympathetic Activation
  18. Influence of telmisartan hydrochlorothiazide combination on cognitive function in elderly hypertensive patients
  19. Telmisartan + hydrochlorothiazide versus amlodipine + hydrochlorothiazide in older patients with predominantly systolic hypertension
  20. Telmisartan plus hydrochlorothiazide (80/25 mg) has a greater antihypertensive effect than valsartan plus hydrochlorothiazide (160/25 mg) in patients with stage 1 and 2 hypertension
  21. Simultaneous HPLC–UV analysis of telmisartan and hydrochlorothiazide in human plasma
  22. Design, statistical analysis and sample size calculation of dose response study of telmisartan and hydrochlorothiazide
  23. Comparison of fixed-dose combinations of telmisartan/hydrochlorothiazide 40/12.5 mg and 80/12.5 mg and a fixed-dose combination of losartan/hydrochlorothiazide 50/12.5 mg in mild to moderate essential hypertension: Pooled analysis of two multicenter, prospective, randomized, open-label, blinded-end point (PROBE) trials
  24. Effectiveness of hydrochlorothiazide in combination with telmisartan and olmesartan in adults with moderate hypertension not controlled with monotherapy: a prospective, randomized, open-label, blinded end point (PROBE), parallel-arm study

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