Teveten Plus - instructions for use, dose, side effects, contraindications

Active substanceHydrochlorothiazide + EprosartanHydrochlorothiazide + Eprosartan

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Dosage form: & nbspFilm coated tablets.

Composition:

1 film coated tablet contains:

Active substances: Eprosartan mesylate - 735.8 mg, which corresponds to 600 mg of eprosartan, hydrochlorothiazide -12.5 mg.

Excipients: microcrystalline cellulose - 43.3 mg, lactose monohydrate 43.3 mg, corn pregelatinized corn starch 43.3 mg, crospovidone 38.5 mg, magnesium stearate 7.2 mg, purified water 50.9 mg.

Shell: Opadry II Butterscotch 85F27320 - 39 mg (polyvinyl alcohol - 15,60 mg, macrogol 3350 - 7,88 mg, talc - 5,77 mg, titanium dioxide (E171) - 9,41 mg, iron oxide yellow (E172) - 0,33 mg, iron oxide black (E172) - 0.004 mg).

Description:The tablets are covered with a film coating of yellow-brown color, oval in shape, biconvex with engraving "5147" on one side. On the break the tablets are white.

Pharmacotherapeutic group:antihypertensive drug combined (diuretic + angiotensin II receptor antagonist).

ATX: & nbsp

C.09.D.A.02 Eprosartan in combination with diuretics

Pharmacodynamics:

Eprosartan

The angiotensin II receptor antagonist (APA II), selectively acting on AT1 receptors located in the vessels, heart, kidneys and adrenal cortex, forms a strong bond with them, followed by a slow dissociation.

Prevents the development or weakening of the effects of angiotensin II, inhibits the activity of the renin-angiotensin-aldosterone system (RAAS). It has a vasodilating, anti-hypnotensive and mediated diuretic effect.

Reduces arterial vasoconstriction, general peripheral vascular resistance (OPSS), pressure in a small circle of circulation, reabsorption of fluid and sodium in the proximal segment of the renal tubules, and secretion of aldosterone. With prolonged use suppresses the proliferative effect of angiotensin II on smooth muscle cells of blood vessels and myocardium. Antihypertensive effect after taking a single dose inside develops within 24 hours, and a stable therapeutic effect develops with regular ingestion in 2-3 weeks without affecting the heart rate (HR).

Does not cause the development of orthostatic hypotension in response to taking the first dose of the drug.

Increases the renal blood flow and the rate of glomerular filtration, reduces the excretion of albumins (nephroprotective effect) while maintaining renal self-regulation, regardless of the degree of renal insufficiency.

Has no effect on lipid, carbohydrate and purine metabolism. At the termination of treatment does not cause the syndrome of "cancellation".

Less often than inhibitors of angiotensin-converting enzyme (ACE), causes the occurrence of effects associated with bradykinin activity (including dry persistent cough).

Two large randomized controlled trials of ONTARGET (a study continuing until the end result, to study the effects of Telmisartan alone and in conjunction with Ramipril) and VA NEPHRON-D (a study of diabetic nephropathy) were conducted in which the combined use of an ACE inhibitor with APA II was studied.

The ONTARGET study was conducted in patients with a history of cardiovascular or cerebrovascular disease, or type 2 diabetes mellitus with signs of damage to target organs. The VA NEPHRON-D study was performed in patients with type 2 diabetes and diabetic nephropathy. These studies showed no significant beneficial effects on renal and / or cardiovascular function and mortality, while at the same time there was an increased risk of hyperkalemia, acute renal damage, and / or hypotension compared with monotherapy.Taking into account similar pharmacodynamic characteristics, these results are also relevant for other ACE inhibitors and ARA II. ACE inhibitors and ARA II should not be used simultaneously in patients with diabetic nephropathy.

In addition, ALTITUDE (a study of the action of aliskiren in patients with type 2 diabetes, where changes in the function of the cardiovascular system and kidneys was taken) was performed, which tested the benefits of adding aliskiren to standard therapy (an ACE inhibitor or ARA II ) in patients with type 2 diabetes and chronic kidney disease, cardiovascular disease, or diseases of both types. The study was prematurely terminated because of the increased risk of adverse outcomes. The lethal outcome of cardiovascular diseases and stroke were much more frequent in the treatment group with the addition of aliskiren than in the placebo group, in addition, undesirable events and serious adverse events (hyperkalaemia, hypotension and renal dysfunction) were more common in the aliskiren group than in the group placebo.

Hydrochlorothiazide

Hydrochlorothiazide is a thiazide diuretic. Thiazides affect the mechanisms of reabsorption of electrolytes in the renal tubules, increasing the volume of release of liquid, sodium and chlorine.

Due to the diuretic effect of hydrochlorothiazide, the volume of blood plasma decreases, the renin activity in the blood plasma increases, the secretion of aldostrosin increases, which causes an increased excretion of potassium and hydrocarbonates by the kidneys and a decrease in the potassium content in the blood serum. The mechanism of antihypertensive action of hydrochlorothiazide is a combined diuretic and vasodilating effect.

Teventen® plus

In patients with elevated systolic blood pressure (BP) eprosartan provides a statistically significant reduction in blood pressure. Addition to a single daily dose (600 or 1200 mg) of eprosartan 12.5 mg of hydrochlorothiazide provides an additional statistically significant reduction in systolic blood pressure compared with the daily intake of only eprosartan. The combined administration of eprosartan with hydrochlorothiazide reduces the loss of potassium associated with the diuretic effect of hydrochlorothiazide.The diuretic effect of the drug Teveten® Plus develops within the first 2 hours, and reaches a maximum 4 hours after ingestion. Stable antihypertensive effect develops, usually after 2-3 weeks of treatment.

Pharmacokinetics:

Eprosartan

When administered, the absolute bioavailability is about 13%. The maximum concentration (C_ma_x) in the blood plasma is determined after 1 - 2 hours. Half-life (T_1/2) is usually 5-9 hours. The association with blood plasma proteins is high (98%) and remains constant after reaching a therapeutic concentration in the blood plasma. The degree of binding to blood plasma proteins does not depend on sex, age, liver function of patients and does not change with moderate or negligible renal failure, but can decrease with severe renal failure. Practically does not cumulate.

The volume of distribution is 13 liters, the total clearance is 130 ml / min. When ingestion is withdrawn mainly unchanged through the intestine (90%), kidney (7%). A small part (less than 2%) is excreted by the kidneys in the form of glucuronides.

In elderly patients, the values of C_m_Oh and the area under the curve "concentration-time" (AUC) increase by an average of 2 times, which, however, does not require dose adjustment.

With hepatic insufficiency, the AUC increase by an average of about 40%, which does not require dose adjustment.

In patients with moderate chronic renal failure (CRF) (SC from 30 to 59 ml / min) AUC and C_m_Oh by 30%, and with severe CRF (SC from 5 to 29 ml / min) - by 50% higher compared with healthy volunteers. The pharmacokinetics of eprosartan does not differ in male and female patients.

Hydrochlorothiazyd

Hydrochlorothiazide is not metabolized, quickly excreted by the kidneys. At least 61% of the ingested dose is excreted unchanged for 24 hours. It does not penetrate the blood-brain barrier, but penetrates the placental barrier and is excreted in breast milk.

Teveten® Plus

The simultaneous administration of eprosartan and hydrochlorothiazide does not have a clinically significant effect on the pharmacokinetics of both components. Eating does not affect the bioavailability of eprosartan and hydrochlorothiazide, but delays their absorption. Maximum plasma concentrations are reached 4 hours after taking eprosartan and 3 hours after ingestion of hydrochlorothiazide.

Indications:Arterial hypertension (in monotherapy or in combination with other antihypertensive drugs).

Contraindications:

- Established hypersensitivity to eprosartan, hydrochlorothiazide and other derivatives of sulfonamide and other components of the drug.

- Pregnancy and the period of breastfeeding.

- Severe renal failure (CC less than 30 ml / min).

- Severe hepatic failure (more than 9 on the Child-Pugh scale).

- Cholestasis and obstruction of the biliary tract.

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

- Hemodynamically significant bilateral stenosis of the renal arteries or severe arterial stenosis of a single functioning kidney.

- Refractory hypokalemia or hypercalcemia.

- Refractory hyponatremia.

- Symptomatic hyperuricemia or gout.

- Rare hereditary intolerance to galactose, lactase deficiency or glucose-galactose insufficiency insufficiency syndrome (the drug contains lactose).

- Simultaneous use with aliskiren and aliskirenoderzhaschimi drugs in patients with diabetes mellitus or moderate or severe renal dysfunction (glomerular filtration rate less than 60ml / min / 1.73 m²⁾

- Simultaneous use with ACE inhibitors in patients with diabetic nephropathy.

Carefully:Severe chronic heart failure (NYHA functional class IV), bilateral stenosis of the renal arteries, stenosis of the single kidney artery, decreased circulating blood volume (BCC), disturbance of the water-electrolyte balance of blood (due to taking large doses of diuretics, repeated vomiting, prolonged diarrhea, salt-free diet), mild or moderate hepatic insufficiency (less than 9 on Child-Pugh scale without history of cholestasis), diabetes mellitus, hypercholesterolemia, hypertriglyceridemia, stenosis ao or mitral valve, or hypertrophic obstructive cardiomyopathy, primary hyperaldosteronism, ischemic heart disease (limited experience), acute myopathy, secondary closed-angle glaucoma, systemic lupus erythematosus.

Pregnancy and lactation:

Pregnancy

The drug Teveten® plus is contraindicated for use during pregnancy. Eprosartan

The results of epidemiological studies,the risk of developing teratogenic effects with ACE inhibitors during the first trimester of pregnancy does not allow for unambiguous conclusions, but a slight increase in risk can not be excluded. While data from controlled epidemiological studies regarding the risk of using ARA II are not available, a similar risk may exist for this class of drugs. Except when continuation of ARA II therapy is considered necessary, patients planning a pregnancy should switch to taking approved hypotensive drugs that have established safety characteristics for use during pregnancy. Therapy of ARA II should be discontinued immediately after the diagnosis of pregnancy, and, if necessary, alternative therapy should be started.

It is known that the therapy of ARA II in the second and third trimesters of pregnancy is toxic to the fetus (impairment of kidney function, low blood pressure, ossification of the skull bones) and newborn (renal failure, arterial hypotension, hyperkalemia).

If ARA treatment II necessary in II trimester of pregnancy, it is recommended to perform ultrasound monitoring of kidney function and monitoring the condition of the skull in the fetus. Newborns whose mothers took ARA II, should be carefully observed for the detection of arterial hypotension.

Hydrochlorothiazide

The experience with hydrochlorothiazide during pregnancy, especially in the first trimester, is limited. Data obtained during animal studies is not enough. Hydrochlorothiazide penetrates the placental barrier. Based on the pharmacological mechanism of action of hydrochlorothiazide, the use of this drug in the second and third trimesters of pregnancy can lead to a violation of fetoplacental perfusion and the development of pathological effects in the newborn and fetus, such as jaundice, water-electrolyte disorders and thrombocytopenia. Do not use hydrochlorothiazide with gestational edema, hypertension in pregnant women or preeclampsia due to the risk of a decrease in the volume of plasma and the development of hypoperfusion of the placenta and the absence of any positive effects on the course of the disease. Hydrochlorothiazide It should not be used with essential hypertension in pregnant women, except in rare situations when there are no therapeutic alternatives.

Breastfeeding period

Eprosartan

Due to the lack of information regarding the use during the period of breastfeeding, the use of Teveten® Plus is not recommended, it is preferable to prescribe antihypertensive drugs with a well established safety profile, especially when feeding newborns or prematurely born children.

Hydrochlorothiazide

Hydrochlorothiazide is excreted in breast milk in small amounts. In high doses, thiazides increase diuresis, which can reduce the production of breast milk. The use of Teveten® Plus during breast-feeding is not recommended. If the drug is used during breastfeeding, its dose should be minimal.

Fertility

There are no clinical data on the effect on reproductive function. Pre-clinical studies of eprosartan did not confirm any effects on the fertility of males and females.There are no preclinical studies on the possible effects of hydrochlorothiazide on fertility.

Dosing and Administration:Inside, 1 tablet a day in the morning, regardless of food intake. The daily dose should not exceed 600 mg of eprosartan and 12.5 mg of hydrochlorothiazide. Correction of the dose of Teveten® plus in elderly patients, patients with mild and moderate impairment of liver function, as well as patients with impaired renal function (QC more than 30 ml / min) is not required.

Side effects:

Most often in patients treated with a combination hydrochlorothiazide + eprosartan, adverse drug reactions such as headache and nonspecific gastrointestinal disorders (GIT) occurred in approximately 11% and 8% of patients (compared with 14% and 8% of those receiving placebo), respectively.

Depending on the frequency of occurrence, the following groups of side effects are distinguished: very often (>1/10); often (>1/100, <1/10); infrequently (>1/1000, <1/100); rarely (>1/10 000, <1/1000); very rarely (<1/10 000); frequency is unknown (can not be calculated from available data). Undesirable drug reactions that occur during placebo-controlled clinical trials or described in the scientific literature are presented below.Adverse reactions in each occurrence frequency category are listed taking into account the data for eprosartan, combination hydrochlorothiazide + eprosartan, as well as hydrochlorothiazide, used in monotherapy.

From the side of the blood and lymphatic system:

Infrequently: leukopenia;

Rarely: hemolytic anemia *;

Frequency unknown: agranulocytosis, thrombocytopenia, aplastic anemia.

From the immune system:

Infrequently: hypersensitivity reactions;

Frequency unknown: anaphylactic reactions.

From the side of metabolism and nutrition:

Often: hyperglycemia;

Infrequently: hyperuricemia, exacerbation of gout, hyponatremia, hypokalemia, hypochloraemia, hypercholesterolemia;

Frequency unknown: hypercalcemia, hypomagnesemia,

hypertriglyceridemia, anorexia. Disorders of the psyche:

Infrequently: depression, anxiety, insomnia, nervousness, libido disorders;

Frequency unknown: anxiety.

From the nervous system:

Often: headache**;

Often: dizziness, paresthesia.

From the side of the organ of vision:

Frequency unknown: acute myopia, secondary closed angle glaucoma *.

From the side of the hearing organ and labyrinthine disorders:

Rarely: respiratory distress syndrome (including pneumonitis and noncardiogenic pulmonary edema).

From the digestive system:

Often: nonspecific abnormalities on the part of the digestive tract (nausea, vomiting, diarrhea);

Infrequently: constipation**;

Rarely: pancreatitis.

From the liver and bile ducts:

Frequency unknown: jaundice, including intrahepatic cholestatic jaundice.

From the skin and subcutaneous tissues:

Often: allergic skin reactions (skin rash, itching);

Infrequently: angioedema;

Frequency unknown: toxic epidermal necrolysis, reactions

photosensitivity, cutaneous lupus erythematosus.

From the side of the musculoskeletal and connective tissue:

Infrequently: muscle spasms**;

Frequency unknown: systemic lupus erythematosus.

From the side of the kidneys and urinary tract:

Frequency unknown: interstitial nephritis, kidney failure,

renal dysfunction in patients at risk (stenosis of the kidneys

arteries), glucosuria.

On the part of the genitals:

Infrequently: sexual dysfunction.

General disorders:

Often: asthenia;

Infrequently: hyperthermia.

* - frequency of occurrence, taking into account data from the scientific literature on hydrochlorothiazide,

** - frequency comparable to placebo.

Overdose:Data on overdose in humans are limited. In postmarketing studies, there were individual reports of doses of eprosartan up to 12,000 mg. Despite the fact that most patients did not have symptoms, it should be noted that one patient, after using eprosartan at a dose of 12,000 mg, caused a vascular collapse. The patient completely recovered. For combination hydrochlorothiazide + eprosartan the maximum dose taken was 3600 mg of eprosartan / 75 mg of hydrochlorothiazide. In this case, the reception was carried out for the purpose of suicide.

Overdose, most likely, will cause a pronounced decrease in blood pressure. Other symptoms may be associated with a decrease in BCC and loss of electrolytes (hypokalemia, hypochloraemia, hyponatremia), and are most likely to manifest as nausea and drowsiness.

Treatment should be symptomatic and supportive. Depending on the time of taking the drug inside, it is necessary to provoke vomiting, rinsing the stomach, and / or using activated charcoal.With a marked decrease in blood pressure, the patient must be laid on his back, raised his legs and carry out measures to restore the BCC. Eprosartan not removed by hemodialysis. The degree of excretion of hydrochlorothiazide by hemodialysis is not established.

Interaction:

Hydrochlorothiazide +Eprosartan

Lithium preparations

A reversible increase in lithium serum levels and an increase in toxicity was noted when lithium preparations were combined with ACE inhibitors and, in rare cases, with APA II. In addition, thiazides decrease the renal clearance of lithium and therefore may increase the risk of its toxic effects. In this regard, the joint use of the drug Teveten® plus with lithium preparations is not recommended. If this combination is necessary, regular monitoring of the lithium content in the blood serum is necessary.

Baclofen

Perhaps increased antihypertensive effect.

Non-steroidal anti-inflammatory drugs (NSAIDs)

As with the use of ACE inhibitors, the combined use of APA II and NSAIDs may increase the risk of impaired renal function,including the possibility of developing acute renal failure and an increase in serum potassium, especially in patients with already low renal function. Such combinations should be used with caution, especially in elderly patients. Patients should consume enough fluid and monitor kidney function after initiating concurrent therapy and periodically during treatment.

The combined use of losartan with indomethacin (NSAIDs) led to a decrease in the efficacy of APA II, The presence of a class of a specific effect can not be ruled out.

Amifostine

Perhaps increased antihypertensive effect.

Other antihypertensive drugs

The antihypertensive effect of Teveten® Plus can be enhanced by simultaneous use with other antihypertensive agents.

Ethanol, barbiturates, narcotics or antidepressants

Possible occurrence of orthostatic hypotension.

Eprosartan

Eprosartan does not inhibit isoenzymes CYP1 A, 2A6, 2C9 / 8, 2C19, 2D6, 2E and ZA of the cytochrome P450 system in vitro.

Drugs affecting the potassium content Based on the experience of using other drugs that affect RAAS, the combined use of potassium-sparing diuretics, potassium preparations, salt substitutes containing potassium, and other drugs that raise the potassium content in the blood serum (eg, heparin, ACE inhibitors) may lead to an increase the content of potassium in the blood serum. If medications that affect the potassium content are prescribed in combination with this drug, it is recommended to regularly monitor the potassium content in the serum.

Double blockade of RAAS

Clinical trial data showed that the dual blockade of RAAS by the combined use of ACE inhibitors, APA II or aliskiren is associated with an increased incidence of adverse events such as hypotension, hyperkalemia, and decreased kidney function (including acute renal failure) compared with the use of a separate agent acting on RAAS (see section "Special instructions", "Contraindications").

Hydrochlorothiazide

Drugs affecting the potassium content

The hypokalemic effect of hydrochlorothiazide can be enhanced bysimultaneous administration of other drugs leading to the excretion of potassium and hypokalemia (for example, other potassium-sparing diuretics, laxatives, corticosteroids, glycyrrhizic acid (contained in the licorice root), adrenocorticotropic hormone, amphotericin B (for intravenous administration), carbenoxolone, penicillin G (sodium salt) or derivatives of salicylic acid). In this regard, the use of this combination is not recommended.

Salts of calcium and vitamin D

Thiazide diuretics can increase the serum calcium content due to a decrease in its excretion. If it is necessary to use calcium preparations or drugs that affect the calcium content in the blood serum (for example, vitamin D), it is necessary to control the calcium content in the blood serum and adjust its dose accordingly.

Resins colestramine and Colestypol

The absorption of hydrochlorothiazide decreases with the simultaneous use of anion-exchange resins, for example, colestyramine or colestipol. The separate administration of hydrochlorothiazide and resin can minimize their drug interaction, i.e. accept hydrochlorothiazide recommended at least 4 hours before or after 4-6 hours after taking the resin.

Cardiac glycosides

Hypokalemia or hypomagnesemia caused by thiazide diuretics, contributes to the development of arrhythmia.

Drugs that depend on changes in potassium content

It is recommended to periodically check the potassium content in the blood serum and the ECG in case of simultaneous application of the drug to medicinal products, the effectiveness of which changes under the influence of deviations in potassium content in the blood serum (for example, cardiac glycosides and antiarrhythmic drugs), and with the following drugs (including antiarrhythmics ), causing a polymorphic ventricular tachycardia such as "pirouette" (ventricular tachycardia); with hypokalemia is a risk factor predisposing to the development of polymorphic ventricular tachycardia like "pirouette" (ventricular tachycardia): Antiarrhythmic drugs IA class (for example, quinidine, hydroquinidine, disopyramide).

Antiarrhythmic drugs of the third class (for example, amiodarone, dofetilide, ibutilide) and sotalol.

Some antipsychotics (for example, thioridazine, chlorpromazine, levomepromazine, trifluoperazine, cyamemazine, sulpiride, sultopride, amisulpride, tiapride, pimozide, haloperidol, droperidol).

Other drugs (eg, bepridil, cisapride, difemanyl, erythromycin in / in, halofantrine, misolastine, pentamidine, terfenadine, wincamine in / in).

Nondepolarizing muscle relaxants (eg, tubocurarine)

Hydrochlorothiazide can enhance the effect of nondepolarizing muscle relaxants. Anticholinergic drugs (eg, atropine, biperidene) Increased bioavailability of thiazide diuretics by reducing gastrointestinal motility and gastric emptying rate.

Preparations for the treatment of diabetes mellitus (hypoglycemic drugs for oral administration and insulin)

The use of thiazide can influence glucose tolerance, which can require correction of the dose of hypoglycemic agents.

Metformin

Metformin should be used with caution in connection with the risk of developing lactic acidosis due to possible functional renal failure caused by hydrochlorothiazide.

Beta-blockers and diazoxide

Thiazides can enhance the hyperglycemic effect of beta-adrenoblockers and diazoxide.

Pressor amines (e.g., norepinephrine) Possible reduction of the effect of pressor amines.

Anti-gouty drugs (probenecid, sulfinpyrazone and allopurinol)

Correction of doses of antidotal drugs is necessary, since hydrochlorothiazide can increase the concentration of uric acid in the serum. An increase in the dose of probenecid or sulfinpyrazone may be required. Joint use with thiazide diuretics can increase the frequency of development of hypersensitivity reactions to allopurinol.

Amantadine

Thiazides may increase the risk of developing unwanted reactions caused by amantadine.

Cytostatic preparations (for example, cyclophosphamide, methotrexate)

Thiazides can reduce the excretion of cytostatic drugs by the kidneys and enhance their myelosuppressive effect.

Tetracyclines

With the combined use of tetracyclines and thiazides, the risk of increasing urinary levels in the urine caused by tetracycline increases. This interaction, in all probability, does not apply to doxycycline.

Drugs that reduce the sodium content in blood serum

When combined with antidepressants, antipsychotics and antiepileptic drugs, the hyponatremic effect of hydrochlorothiazide can be enhanced. For prolonged use of these drugs, caution is recommended.

Special instructions:

Patients with a risk of impaired renal function

In some patients, the renal function of which depends on the activity of RAAS (for example, patients with severe chronic heart failure IV functional class by classification NYIIA), During treatment with ACE inhibitors, oliguria and / or progressive azotemia may develop and, in rare cases, acute renal failure. These phenomena are most likely in patients taking diuretics simultaneously. Due to the lack of experience with the use of ARA II in patients with severe chronic heart failure IV functional class by classification NYHA, It is impossible to exclude the violation of renal function against the background of the use of the drug Teveten® plus due to the suppression of the activity of RAAS. In connection with the presence of an increased risk of severe arterial hypotension and renal failure in these patients, kidney function should be carefully monitored.

Renal dysfunction and kidney transplantation

Before prescribing Teveten® plus patients with renal insufficiency and periodically during the treatment should monitor the kidneys, the content of potassium and uric acid in the blood serum. If there is a worsening of renal function during this period, the advisability of continuing Teveten® Plus should be reconsidered. In patients with impaired renal function, hydrochlorothiazide-associated azotemia can be observed.

The experience of using the drug in patients who have undergone kidney transplantation is absent.

Dysfunction of the liver

Eprosartan should be used with caution to treat patients with mild and moderate hepatic insufficiency because of the limited clinical experience of the drug in these patients. In connection with the possibility of developing intrahepatic cholestasis, hydrochlorothiazide should be used with caution to treat mild and moderate hepatic insufficiency.

Changes in the water-electrolyte balance can cause hepatic coma. Metabolic and endocrine disorders

Hydrochlorothiazide can reduce glucose tolerance, which may require correction of the dose of hypoglycemic drugs and insulin. Latent-flowing diabetes mellitus can manifest during the treatment with Teveten® Plus. At a dose of 12.5 mg of hydrochlorothiazide contained in Teveten® plus, only mild metabolic and endocrine adverse effects have been observed so far (increased serum cholesterol and triglyceride levels). Violations of the water-electrolyte balance

The use of hydrochlorothiazide can lead to a violation of the water-electrolyte balance of the blood (hypokalemia, hyponatremia, hypercalcemia, hypomagnesemia and hypochloraemic alkalosis). All patients undergoing treatment with diuretics, including hydrochlorothiazide, it is necessary to periodically monitor the content of electrolytes in the blood serum. Potassium-sparing diuretics, potassium or salt substitutes containing potassium should be used with Teveten® plus with caution.

Symptomatic arterial hypotension

With pronounced hyponatremia or decreased bcc (for example, during treatment with large doses of diuretics, repeated vomiting, prolonged diarrhea, a salt-free and low-salted diet), taking Teveten® Plus can cause a sharp drop in blood pressure. Correction of hyponatremia and / or BCC is necessary and, if possible, the elimination of diuretics before treatment with Teveten® Plus.

Acute myopia and secondary closed angle glaucoma

Hydrochlorothiazide, being a sulfonamide, can cause an idiosyncratic reaction, manifested in acute transient myopia and an attack of acute closed-angle glaucoma. Symptoms that include a sharp decrease in visual acuity or pain in the eye usually develop within a few hours to several weeks after starting the drug. Absence of treatment in acute closed-angle glaucoma can lead to irreversible loss of vision. Primary treatment consists in the fastest possible removal of hydrochlorothiazide. You may need urgent medical or surgical treatment if the intraocular pressure remains uncontrolled.Risk factors for the development of an acute acute angle-closure glaucoma include the presence of allergic reactions to sulfanilamide or penicillin in the anamnesis.

Primary hyperaldosteronism

In patients with primary hyperaldosteronism, the use of antihypertensive agents that inhibit RAAS is usually ineffective. Concerning

application of Teveten® plus this group of patients is not recommended.

Stenosis of the aortic and mitral valve, hypertrophic obstructive cardiomyopathy

As with the use of other vasodilators, caution is required when administering the drug to patients with stenosis of the aortic or mitral valve or with hypertrophic obstructive cardiomyopathy.

Other Cautions and Precautions

Hypersensitivity reactions to hydrochlorothiazide are most likely for patients with an allergy in the anamnesis, including hypersensitivity to sulfanylamide derivatives.

There are reports of the development of exacerbations or activation of systemic lupus erythematosus on the background of taking thiazide diuretics.

Hydrochlorothiazide can give a positive result in the test for doping control.

Double blockade of RAAS

There is evidence that the combined use of ACE inhibitors, ARA II or aliskiren increases the risk of hypotension, hyperkalemia and decreased renal function (including acute renal failure) compared with the separate use of funds acting on RAAS. In this regard, the double blockade of RAAS by the combined use of ACE inhibitors, APA II or aliskiren is not recommended.

If a double blockade is necessary, then it should be performed strictly under the supervision of a specialist and with constant monitoring of kidney function, electrolyte content and blood pressure. ACE inhibitors and ARA II should not be used simultaneously in patients with diabetic nephropathy.

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

Studies on the effect on the ability to drive vehicles and work with other mechanisms have not been carried out, however, based on the pharmacodynamic properties of Teveten® plus, the effect is unlikely.

During the treatment with Teveten® Plus, care must be taken when driving vehicles and engaging in potentially hazardous activities requiring increased attention and speed of psychomotor reactions,in connection with the possibility of dizziness and weakness.

Form release / dosage:Film-coated tablets, 12.5 mg + 600 mg.

Packaging:For 14 tablets in PVC / Aklar / Al blisters.

For 1, 2 or 4 PVC / Aklar / Al blisters along with instructions for use in a cardboard box.

Storage conditions:In a dry place at a temperature of no higher than 25 ° C. Keep out of the reach of children!

Shelf life:

3 years.

Do not use after the expiry date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:LS-000319

Date of registration:21.02.2011

The owner of the registration certificate:Abbott Laboratories, GmbHAbbott Laboratories, GmbH Germany

Manufacturer: & nbsp

ABBOTT HEALTHCARE, SAS Netherlands

Representation: & nbspABBOTT LABORATORIES LLC ABBOTT LABORATORIES LLC Russia

Information update date: & nbsp29.12.2015

Illustrated instructions

Instructions

Teveten® Plus (Teveten® Plus)