Telpres Plus (Telpres Plus)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceHydrochlorothiazide + TelmisartanHydrochlorothiazide + Telmisartan
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    • Dosage form: & nbsppills
    Composition:

    Each tablet of 12.5 mg + 40 mg contains:

    active ingredients: hydrochlorothiazide - 12.50 mg, telmisartan - 40.00 mg; Excipients: Mannitol - 163.85 mg, povidone-K25 - 10.80 mg, crospovidone - 10,0 mg, magnesium stearate - 4.50 mg, meglumine - 12.00 mg, sodium hydroxide - 3.35 mg, lactose monohydrate - 49.84 mg, microcrystalline cellulose - 32.00 mg, hypromellose - 3.00 mg, sodium carboxymethyl starch , type A - 2.00 mg, iron oxide yellow (E 172) - 0.17 mg.

    Each tablet of 12.5 mg + 80 mg contains:

    active ingredients: hydrochlorothiazide - 12.50 mg, telmisartan - 80.00 mg; Excipients: Mannitol - 327.70 mg, Povidone-K25 - 21.60 mg, Crospovidone - 40,0 mg, magnesium stearate - 8.50 mg, meglumine - 24.00 mg, sodium hydroxide - 6.70 mg, lactose monohydrate - 49.84 mg, microcrystalline cellulose - 32.00 mg, hypromellose - 3.00 mg, sodium carboxymethyl starch, type A - 2.00 mg, iron oxide red (E 172) - 0.17 mg.

    Each tablet of 25 mg + 80 mg 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 oxide yellow (E 172) - 0.33 mg.

    Description:

    Tablets 12.5 mg + 40 mg

    Round biconvex two-layer tablets, one layer of white, another layer of yellow.

    Tablets 12.5 mg + 80 mg

    Round biconvex two-layer tablets, one layer of white color, another layer of pink color with possible impregnations.

    Tablets 25 mg + 80 mg

    Round biconvex two-layer tablets, one layer of white, another layer of yellow.

    Pharmacotherapeutic group:A combined hypotensive drug (angiotensin II receptor antagonist + diuretic)
    ATX: & nbsp

    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 Telprus 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 at ingestion. Has a high affinity for the AT 1 subtype of angiotensin II receptors, through which the action of angiotensin is realized II. It displaces angiotensin II from the bond to the receptor, not having the action of an agonist for this receptor. Telmisartan binds only to the AT1 subtype of the angiotensin II receptor. Communication is of a lasting nature. Has no affinity for other receptors, including AT2 receptor and other, less studied receptors of angiotensin. Functional the significance of these receptors, as well as the effect of their possible excessive stimulation with angiotensin II, whose concentration increases with the appointment of telmisartan, have 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 the angiotensin-converting enzyme (kininase II) (an enzyme that also breaks down bradykinin).Therefore, the gain side effects of bradykinin, is not expected.

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

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

    In the case of a sharp cancellation of telmisartan, blood pressure gradually returns to the initial level without the development of the "withdrawal" syndrome.

    Hydrochlorothiazide

    Hydrochlorothiazide is a thiazide diuretic. Thiazide diuretics affect the reabsorption of electrolytes in the renal tubules, directly increasing the excretion of sodium and chlorides (approximately in equivalent amounts). The diuretic effect of hydrochlorothiazide leads to a decrease in the volume of circulating blood (BCC),an increase in renin activity in blood plasma, an increase in aldosterone secretion, followed by an increase in the content of potassium and hydrocarbonate in the urine and, consequently, a decrease in the potassium content in the blood plasma. With simultaneous administration 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 intake, diuresis is intensified after 2 hours, and the maximum effect is observed after about 4 hours. The diuretic effect of the drug persists for about 6-12 hours.

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

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

    Pharmacokinetics:

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

    Telmisartan:

    Suction

    When ingested quickly absorbed from the gastrointestinal tract. Bioavailability is about 50%.At reception simultaneously with food decrease 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 administration, the concentration in the blood plasma levels out regardless of the intake of food.

    Distribution

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

    Metabolism

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

    Excretion

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

    Pharmacokinetics the special patient groups

    Gender differences

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

    Elderly patients

    The pharmacokinetics of telmisartan in elderly patients does not differ from young patients.Dose correction is not required.

    Patients with impaired renal function

    In patients with mild to moderate renal dysfunction, dosage adjustment for telmisartan is not required.

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

    Patients with impaired hepatic function

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

    Hydrochlorothiazide:

    After ingestion of the preparation Telpres Plus, the maximum concentrations of hydrochlorothiazide in the plasma are reached within 1-3 hours. Absolute bioavailability, based on total excretion by the kidneys, is about 60%. It is bound by blood plasma proteins 64% hydrochlorothiazide, and the volume of distribution is 0.8 ± 0.3 l / kg. Hydrochlorothiazide It is not metabolized in the body and is excreted by the kidneys practically unchanged. About 60% of the dose taken internally is eliminated within 48 hours.Kidney clearance is 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 blood plasma is 2-3 times higher than in men, and the concentration of hydrochlorothiazide in the blood plasma is clinically insignificant in women.

    Patients with impaired renal function

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

    Studies conducted with the participation of patients with creatinine clearance (CK) of 90 ml / min, showed that T1/2 hydrochlorothiazide is increased. In patients with decreased renal function T1/2 about 34 hours.

    Indications:

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

    Contraindications:

    - Hypersensitivity to active ingredients or auxiliary components of the drug or other derivatives of sulfonamides;

    - Pregnancy;

    - The period of breastfeeding;

    - Obstructive diseases of the biliary tract;

    - Severe liver dysfunction (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 renal dysfunction (glomerular filtration rate less than 60 ml / min / 1.73 m2);

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

    - Deficiency of lactase, lactose intolerance, glucose-galactose malabsorption syndrome;

    - Age to 18 years (effectiveness and safety not established).

    Carefully:

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

    - Violations of liver function (class A and B according to the Child-Pugh classification) (see section "Special instructions");

    - Reduction of BCC due to previous therapy with diuretics, restriction of salt intake, diarrhea or vomiting;

    - Hyperkalemia;

    - Condition after kidney transplantation (no experience of application);

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

    - Hypercalcemia;

    - Hypercholesterolemia;

    - Hypertriglyceridemia;

    - Cardiac ischemia;

    - Progressive liver disease (risk of hepatic coma);

    - Stenosis of the aortic and mitral valve;

    - Idiopathic hypertrophic subaortal stenosis (hypertrophic obstructive cardiomyopathy);

    - Diabetes;

    - Primary hyperaldosteronism;

    - Gout, hyperuricemia;

    - Systemic lupus erythematosus;

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

    - The use of Negroid race in patients;

    - The experience of using in patients with renal impairment (QC 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.

    Pregnancy and lactation:

    Medicines that directly affect RAAS can cause serious damage and death of the developing fetus, so when planning or establishing the fact of pregnancy, the drug should be immediately withdrawn and, if necessary, an alternative antihypertensive therapy with an established safety profile for use during pregnancy is prescribed.The use of the drug during pregnancy is contraindicated.

    Telmisartan

    In pre-clinical studies of telmisartan, there was no teratogenic effect, but fetotoxicity was established. It is known that the effect of angiotensin II receptor antagonists during the second and third trimesters of pregnancy causes a person to have fetotoxicity (decreased kidney function, oligohydramnion, slowing ossification of the skull bones), and neonatal toxicity (kidney failure, arterial hypotension, hyperkalemia). Patients planning a pregnancy should be prescribed an alternative therapy with a proven safety profile in pregnant women. If treatment with antagonists of angiotensin II receptors occurred during the second trimester of pregnancy, it is recommended that ultrasound be checked for kidney function and skull bones in the fetus. Newborns whose mothers received angiotensin II receptor antagonists should be carefully monitored for arterial hypotension.

    Therapy with Telpres Plus is contraindicated in the period of breastfeeding.Studies of the impact on human fertility have not been conducted.

    Hydrochlorothiazide

    The experience with hydrochlorothiazide during pregnancy, especially during the first trimester, is limited.

    Hydrochlorothiazide penetrates the placental barrier. Given the pharmacological mechanism of action of hydrochlorothiazide, it is expected that its use during the second and third trimesters of pregnancy can disrupt fetoplacental perfusion and cause such changes in the embryo and fetus as jaundice, disturbances in water electrolyte balance and thrombocytopenia.

    Hydrochlorothiazide should not be used with edema of pregnant women, with hypertension of pregnant women or during preeclampsia, as there is a risk of a decrease in plasma volume and a decrease in placental perfusion, and there is no favorable effect in these clinical situations.

    Hydrochlorothiazide should not be used to treat essential hypertension in pregnant women, except in those rare situations when other types of treatment can not be used.

    Therapy with Telpres Plus is contraindicated in the period of breastfeeding.

    In animal studies, the effects of telmisartan and hydrochlorothiazide on fertility were not observed. Studies of the impact on human fertility have not been conducted.

    Dosing and Administration:

    Inside, regardless of meal time.

    The preparation Telpres Plus should be taken once a day.

    - Telpres Plus 12.5 / 40 mg can be given to patients who use telmisartan in a dosage of 40 mg or hydrochlorothiazide does not lead to adequate control of blood pressure.

    - Telpres Plus 12.5 / 80 mg can be given to patients who use telmisartan in a dosage of 80 mg or Telpres Plus 12,5 / 40 mg does not lead to adequate control of blood pressure.

    - Telpres Plus 25/80 mg can be given to patients who use telmisartan 80 mg or Telpres Plus 12,5 / 80 mg does not adequately control blood pressure, or patients whose condition has previously been stabilized by telmisartan or hydrochlorothiazide when administered separately .

    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 impairment

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

    Dysfunction of the liver

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

    Elderly patients

    Dosing regimen does not require any changes.

    Side effects:

    1) expected on the basis of experience with telmisartan

    2) Expected on the basis of the experience of using hydrochlorothiazide

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

    Disturbances from the respiratory system:

    Respiratory distress syndrome (including pneumonia and noncardiogenic pulmonary edema)3), dyspnea3).

    Heart Disease:

    arrhythmias3), tachycardia3), bradycardia1).

    Vascular disorders:

    a marked decrease in blood pressure (including orthostatic hypotension)3).

    Impaired nervous system:

    syncope / fainting3), paresthesia3), sleep disorders3), insomnia3), dizziness3), increased excitability2), headache2).

    Disorders from the psyche:

    anxiety3), depression3).

    Disorders from the gastrointestinal tract:

    Diarrhea3), dryness of the oral mucosa3), flatulence3), abdominal pain3), constipation3), vomiting3), gastritis3), decline appetite2), anorexia2), hyperglycemia2), hypercholesterolemia2), pancreatitis2), dyspepsia1),2),3).

    Disorders from the liver and bile ducts:

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

    Disturbances from the skin and subcutaneous tissues:

    Eczema1), drug rash1),2), toxic epidermal necrosis1),2), erythema3), cutaneous pruritus3), rash3), increased sweating3), the photosensitization reaction2).

    Disturbances from the musculoskeletal and connective tissue:

    backache3), muscle spasms3), myalgia3), arthralgia3), spasms of gastrocnemius muscles3), arthrosis1), tendonitis-like symptoms1), chest pain3).

    Violations from the blood and lymphatic system:

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

    Disorders from the kidneys and urinary tract:

    renal insufficiency1),2), including acute renal failure1), interstitial nephritis2), glucosuria2).

    Disorders from the side of the organ of vision:

    blurred vision3), transient blurred vision3), xanthopsy2), sharp closed-angle glaucoma2), acute myopia2).

    Violations of the genitals and breast:

    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 laboratory and instrumental research results:

    increase in the concentration of creatinine in the blood plasma3), increased activity of "hepatic" enzymes3), increased activity of creatine phosphokinase3), increased activity blood uric acid concentration3), hypertriglyceridemia2), hypokalemia2),3), hypomagnesemia2), hyperkalemia1), hyponatraemia2),3), hyperuricemia3), decrease in BCC2), hypoglycemia (in patients with diabetes mellitus)1), impaired glucose tolerance2), a decrease in hemoglobin in the blood1).

    Immune system disorders:

    angioedema (including fatal cases)3), anaphylactic reactions1),2), lupus-like reactions2), exacerbation or exacerbation of symptoms of systemic lupus erythematosus3), necrotizing vasculitis2), systemic vasculitis2), recurrence of systemic lupus erythematosus2), vasculitis2).

    General disorders and disorders at the site of administration:

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

    Overdose:

    Information on overdose is limited. Possible symptoms of an overdose consist of symptoms from the individual components of the drug. Telmisartan - the most significant - marked decrease in blood pressure and tachycardia, bradycardia, dizziness, increased serum creatinine concentration and acute renal failure may also occur.

    Hydrochlorothiazide - violations of water-electrolyte balance of blood (hypokalemia, hypochloraemia), decreased bcc, which can lead to muscle spasms and / or increase cardiovascular disorders: arrhythmias caused by simultaneous application of cardiac glycosides or some antiarrhythmic agents.

    Treatment: symptomatic therapy, hemodialysis is ineffective. The degree of removal of hydrochlorothiazide during hemodialysis is not established. Regular monitoring of the electrolytes and creatinine content in the blood serum is required. Hemodialysis is not effective.

    Interaction:

    Telmisartan

    Telmisartan may increase the antihypertensive effect of other antihypertensive agents. Other types of interactions that have clinical relevance 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)

    The concomitant use of telmisartan with aliskiren is contraindicated in patients with diabetes mellitus or renal insufficiency (GFR less than 60 mL / min / 1.73 m2 body surface area) and is not recommended for other patients. The simultaneous use of telmisartan and ACE inhibitors is contraindicated in patients with diabetic nephropathy.

    Clinical studies have shown that the double blockade of RAAS due to the combined use of ACE inhibitors, APA II or aliskiren is associated with an increased incidence of adverse events such as hypotension, hyperkalemia and renal dysfunction (including acute renal failure) compared with the use of only one drug , operating on the RAAS.

    The risk of hyperkalemia can increase when combined with other drugs capable of causing hyperkalemia (kalisodergaszczye supplements and salt substitutes containing potassium, potassium-sparing diuretics (spironolactone, eplerenone, triamterene or amiloride), non-steroidal anti-inflammatory drugs (NSAIDs, including selective inhibitors of cyclooxygenase-2 (COX)), heparin, immunosuppressants (ciclosporin, tacrolimus, trimethoprim)). If necessary, against the background of documented hypokalemia, joint use of drugs should be carried out with caution and regularly monitor the potassium content in the blood plasma.

    Digoxin

    With the joint administration of telmisartan with digoxin, an increase in the mean Cmof digoxin in the blood plasma by 49% and a minimum concentration of 20%. At the beginning of treatment, when choosing a dose and stopping telmisartan treatment, the concentration of digoxin in the blood plasma should be carefully monitored for its maintenance within the therapeutic range.

    Potassium-sparing diuretics or potassium-containing food additives

    Angiotensin II receptor antagonists, such as telmisartan, reduce the diuretic-induced loss of potassium. Potassium-sparing diuretics, for example, spironolactone, eplerenone, triamterene or amiloride, potassium-containing dietary supplements or salt substitutes can lead to a significant increase in potassium levels in the blood plasma. 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 co-administration of lithium preparations with ACE inhibitors and APA II, including telmisartan, there was a reversible increase in the concentration of lithium in the blood plasma and its toxic effect.If it is necessary to use this combination of drugs, it is recommended to carefully monitor the concentration of lithium in the blood plasma.

    Non-steroidal anti-inflammatory drugs (NSAIDs)

    NSAIDs (including acetylsalicylic acid in doses used for anti-inflammatory treatment, COX-2 inhibitors and nonselective NSAIDs) can reduce the antihypertensive effect of APA II. In some patients with impaired renal function (eg, patients with dehydration, elderly patients with impaired renal function), joint application of APA II and drugs depressing cyclooxygenase-2 can lead to further deterioration of renal function, including the development of acute renal failure, which is usually reversible. Therefore, joint use of drugs should be done with caution, especially elderly patients. Proper fluid intake should also be ensured, in addition, at the beginning of the joint application and periodically the kidney function should be monitored periodically thereafter.

    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 the risk of developing arterial hypotension at the beginning of telmisartan treatment.

    Other antihypertensive agents

    The effect of telmisartan may be enhanced by the joint 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 agents, including telmisartan. In addition, orthostatic hypotension may increase with the use of alcohol, barbiturates, drugs or antidepressants.

    Corticosteroids (for systemic use)

    Corticosteroids weaken the action of telmisartan.

    Hydrochlorothiazide

    When used simultaneously with:

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

    - hypoglycemic agents for oral administration and insulin: it may be necessary to correct the dose of hypoglycemic agents for ingestion and insulin;

    - Metformin: risk of lactic acidosis;

    - colstiramine and colestipolum: in the presence of anionic exchange resins, hydrochlorothiazide absorption is impaired;

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

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

    - Nondepolarizing muscle relaxants (for example, tubocurarine chloride): hydrochlorothiazide can enhance the effect of nondepolarizing muscle relaxants;

    - antidotal 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 development of hypersensitivity reactions to allopurinol;

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

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

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

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

    - with cytotoxic agents (eg, cyclophosphamide, methotrexate): decrease in renal excretion of cytotoxic agents and enhancement of their myelosuppressive action;

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

    - drugs that lead to the excretion of potassium and hypokalemia (for example, diuretics, potassium, laxatives, glucocorticosteroids, calcitonin, ACTH (adrenocorticotropic hormone), glycyrrhizic acid (found in licorice root), amphotericin B; carbenoxolone; benzylpenicillin; derivatives of acetylsalicylic acid): increased hypokalemic effect.Hypokalemia caused by hydrochlorothiazide is compensated by the potassium-sparing effect of telmisartan;

    - theophylline: increased risk of hypokalemia;

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

    - potassium-sparing diuretics, potassium preparations, other agents that can increase the content of serum in the blood serum (eg, heparin) or the replacement of sodium in table salt with potassium salts can lead to hyperkalemia.

    Periodic monitoring of the potassium content in the blood plasma is recommended in cases when the preparation Telprus Plus is prescribed together with drugs that can cause hypokalemia, as well as with drugs that can increase the potassium content in the blood serum.

    Special instructions:

    Dysfunction of the liver

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

    Renovascular hypertension

    When treating with drugs that act on RAAS, patients with bilateral artery stenosis or stenosis of the artery of a single functioning kidney are at increased risk for severe arterial hypotension and renal failure.

    Impaired renal function and kidney transplantation

    With the use of Telpres Plus in patients with impaired renal function, periodic monitoring of potassium and creatinine in the blood plasma is recommended. The experience of clinical use of the preparation Telpres Plus in patients who have recently undergone kidney transplantation is absent.

    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 administration of the Telpres Plus preparation, may occur in patients with reduced BCC and / or sodium in blood plasma on the background of previous treatment with diuretics, restriction of salt intake, diarrhea, or vomiting. Such conditions (deficiency of fluid and / or sodium) should be eliminated before the beginning of taking the drug Telprus Plus.

    Double blockade of the renin-angiotensin-aldosterone system

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

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

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

    In cases of vascular tone and kidney function, mainly from RAAS activity (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 that affect this system can accompanied by the development of acute arterial hypotension, hyperaemia, oliguria, and in rare cases acute renal failure.

    Primary aldosteronism

    In patients with primary aldosteronism, treatment with antihypertensive drugs, which are effected by inhibition of RAAS, is usually ineffective.

    Stenosis of the aortic and mitral valve, hypertrophic obstructive cardiomyopathy

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

    Acute myopia and secondary closed angle glaucoma

    Hydrochlorothiazide, being a sulfonamide derivative, can cause idiosyncratic reaction in the form of acute transient myopia and acute angle-closure glaucoma. Symptoms of these disorders are an unexpected reduction in visual acuity or eye pain, which typically occurs within a few hours to several weeks after starting the drug. If treatment is not performed, acute angle-closure glaucoma can lead to loss of vision. The main treatment consists in the fastest possible removal of hydrochlorothiazide. It should be borne in mind that if intraocular pressure remains uncontrolled, urgent surgical or surgical treatment may be required. The risk factors for the development of acute closed-angle glaucoma include information about allergies to sulfonamides or penicillin in the anamnesis.

    Effect on the metabolism and function of the endocrine glands

    Patients with diabetes may require a change in the dose of insulin or hypoglycemic agents for oral administration. During the treatment with thiazide diuretics, it can manifest latent diabetes mellitus.

    In some cases, with the use of thiazide diuretics, it is possible to develop hyperuricemia and exacerbation of gout.

    Violations of the water-electrolyte balance

    With the use of Telpres Plus, as in the case of diuretic therapy, periodic monitoring of the electrolyte content in the blood serum is necessary. Thiazide diuretics, including hydrochlorothiazide, can cause disturbances in the water electrolyte balance and acid-base state (hypokalemia, hyponatremia and hypochloraemic alkalosis). Symptoms that alarm these disorders include dryness of the oral mucosa, thirst, general weakness, drowsiness, anxiety, myalgia or spasmodic twitching of the calf muscles, muscle weakness, marked decrease in blood pressure, oliguria, tachycardia and such gastrointestinal symptoms, Intestinal disturbances like nausea or vomiting.

    With the use of thiazide diuretics hypokalemia may develop, but simultaneously it can be used telmisartan can increase the content of potassium in the blood. The risk of hypokalemia is greatest in patients with cirrhosis of the liver, with increased diuresis, while observing a salt-free diet,as well as in the case of simultaneous use of glucocorticosteroids, calcitonin, ACTH (adrenocorticotropic hormone), glycyrrhizic acid (found in licorice root), Telmisartan, which is part of the preparation Telpres Plus, on the contrary, can lead to hyperkalemia due to antagonism to the receptors of angiotensin II (subtype AT1). Although with the use of the drug Telpres Plus, clinically significant hyperkalemia has not been documented, it should be taken into account that renal and / or cardiac insufficiency and diabetes mellitus are at risk of developing it.

    Data that the preparation Telpres Plus can reduce or prevent hyponatremia, caused by the intake of diuretics, no. 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 violations of calcium metabolism) a transient and small increase in the serum calcium level. More pronounced hypercalcemia may be a sign of latent hyperparathyroidism. Before performing an evaluation of parathyroid function, thiazide diuretics should be discontinued.

    It is shown that thiazide diuretics increase the excretion of magnesium by the kidneys, which can lead to hypomagnesemia.

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

    Enhanced 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 development of the photosensitivity reaction with the use of thiazide diuretics. If the photosensitivity reaction occurs during treatment, it is recommended to suspend treatment. If it is decided that the diuretic should be resumed, it is necessary to protect areas of the body that can be exposed to sunlight or ultraviolet rays of type A and avoid sun exposure; hydrochlorothiazide can increase the concentration of cholesterol and triglycerides in the blood; hydrochlorothiazide can give a positive result in the conduct of 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 seem to be less effective in lowering arterial pressure in patients of the Negroid race than in representatives of other races, possibly due to a greater predisposition to a decrease in renin activity in the population of these patients.

    Other

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

    Effect on the ability to drive transp. cf. and fur:

    Special clinical studies to assess the effect of the preparation Telpres Plus on the ability to drive vehicles and work with mechanisms that require increased attention, was not conducted. However, when driving and dealing with potentially hazardous activities, one should take into account the possibility of developing dizziness and drowsiness, which requires caution.

    Form release / dosage:

    Tablets 12.5 mg + 40 mg, 12.5 mg + 80 mg, 25 mg + 80 mg.

    Packaging:

    For 14 tablets in Al / Al blister. For 2 or 7 blisters with instructions for use in a cardboard bundle.

    Storage conditions:

    At a temperature of no higher than 25 ° C, in the original packaging.

    Keep out of the reach of children!

    Shelf life:

    2 years.

    Do not use after the expiration date.

    Terms of leave from pharmacies:On prescription
    Registration number:LP-004330
    Date of registration:06.06.2017
    Expiration Date:06.06.2022
    The owner of the registration certificate:SiNViTi Pharma Co., Ltd.SiNViTi Pharma Co., Ltd. Cyprus
    Manufacturer: & nbsp
    Representation: & nbspXanter Pharma, LLCXanter Pharma, LLCRussia
    Information update date: & nbsp23.10.2017
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