Bloktran GT - instructions for use, dose, side effects, contraindications

Excipients: Microcrystalline cellulose - 40.1 mg, potato starch 23.4 mg, sodium carboxymethyl starch (starch sodium glycolate) 7.0 mg, lactose monohydrate (milk sugar) 3.5 mg, povidone (low molecular weight polyvinylpyrrolidone, povidone K 17 ) - 1.4 mg, silicon dioxide colloid (aerosil) - 1.4 mg, magnesium stearate - 0.7 mg.

Sheath:

Opadrai II Pink 57U36011 [hypromellose (HPMC 2910) -2,0150 mg, polydextrose 1.6600 mg, titanium dioxide (E171) 1.6887 mg, talc 0.4550 mg, maltodextrin or dextrin 0.3250 mg, medium chain triglycerides 0.2600 mg, carmine red dye (Carmine E120) - 0.0663 mg] - 6.5 mg.

Description:The tablets covered with a film cover from light pink to dark pink or dark pink with a violet shade of color, round, biconcave form. On the cut is white or almost white.

Pharmacotherapeutic group:Hypotensive combined agent (angiotensin II receptor antagonist [ARA II] + diuretic)

ATX: & nbsp

C.09.D.A.01 Losartan in combination with diuretics

Pharmacodynamics:

The components of the drug Bloktran ® HT have an additive antihypertensive effect, reducing blood pressure (BP) more than each of the components individually.Due to the diuretic effect hydrochlorothiazide increases the activity of renin of blood plasma (ARP), stimulates the secretion of aldosterone, increases the concentration of angiotensin II and reduces the potassium content in the blood serum. The administration of losartan blocks all the physiological effects of angiotensin II and, due to suppression of aldosterone effects, can help reduce the loss of potassium associated with taking a diuretic.

Hydrochlorothiazide causes a slight increase in the concentration of uric acid in the blood plasma, losartan has a moderate and transient uricosuric effect. The combination of losartan and hydrochlorothiazide helps reduce the severity of hyperuricemia caused by a diuretic.

Losartan

Angiotensin II is a potent vasoconstrictor, the main active hormone of the renin-angiotensin-aldosterone system, as well as the crucial pathophysiological link in the development of arterial hypertension. Losartan - an antagonist of angiotensin II receptors (type AT |). Angiotensin II selectively binds to AT1 receptors found in many tissues (in the smooth muscle tissues of the vessels, in the adrenal, kidney and heart) and performs several important biological functions, including vasoconstriction and aldosterone release.Angiotensin II also stimulates proliferation of smooth muscle cells. Losartan and its pharmacologically active metabolite (E 3174) both in vitro and in vivo block all the physiological effects of angiotensin II, regardless of the source or route of synthesis.

Losartan does not bind or block receptors of other hormones and ion channels, which play an important role in regulating the function of the cardiovascular system. Besides, losartan does not inhibit angiotensin-converting enzyme (ACE), responsible for the destruction of bradykinin. Therefore, side effects, mediated by bradykinin (eg, angioedema) are rare. When using losartan, the absence of negative feedback influence on renin secretion leads to an increase in ARP. Increased ARP leads to an increase in angiotensin II in blood plasma. However, antihypertensive activity and a decrease in plasma aldosterone concentration are preserved, which indicates an effective blockade of angiotensin II receptors. Losartan and its active metabolite have a greater affinity for the angiotensin I receptors than for angiotensin II receptors.The active metabolite is 10-40 times more active than losartan. After a single oral intake, the antihypertensive effect reaches a maximum after 6 hours, then gradually decreases within 24 hours. The maximum antihypertensive effect develops in 3-6 weeks after the start of the drug. Antihypertensive effect increases with increasing dose of losartan.

Losartan does not affect vegetative reflexes and does not have a lasting effect on the concentration of noradrenaline in the blood plasma.

In patients with hypertension and left ventricular hypertrophy losartan, including in combination with hydrochlorothiazide, reduces the risk of cardiovascular morbidity and mortality.

Hydrochlorothiazide

The mechanism of antihypertensive action of thiazide diuretics is unknown. Thiazide diuretics usually do not affect normal BP. Hydrochlorothiazide is a diuretic and antihypertensive agent. It affects the reabsorption of electrolytes in the distal tubules of the kidneys. Hydrochlorothiazide approximately the same degree increases the excretion of sodium and chlorine ions.Sodium urine may be accompanied by a small loss of potassium ions, bicarbonates and a delay in calcium ions in the body. When administered, the diuretic effect begins after 2 hours, reaches a maximum on average after 4 hours and lasts from 6 to 12 hours.

Pharmacokinetics:

The pharmacokinetics of losartan and hydrochlorothiazide with simultaneous administration does not differ from that in their separate application.

Suction

Losartan

Ingestion losartan is well absorbed from the gastrointestinal tract and is metabolized by "primary passage" through the liver, resulting in the formation of an active carboxylated metabolite and inactive metabolites, involving isoenzyme CYP2C9. Systemic bioavailability of losartan is approximately 33%. The maximum concentration (C_m_Oh) of losartan and its active metabolite are achieved after 1 hour and 3-4 hours, respectively. When losartan was taken during a normal meal, there was no clinically significant effect on the profile of losartan concentration in the blood plasma.

Hydrochlorothiazide

Ingestion hydrochlorothiazide quickly absorbed from the gastrointestinal tract. The time to reach the maximum concentration is 1.5-3 hours.

Distribution

Losartan

Lozartan and its active metabolite bind to plasma proteins (mainly albumin) by more than 99%. The volume of distribution of losartan is 34 liters. Studies in rats have shown that losartan practically does not penetrate the blood-brain barrier.

Hydrochlorothiazide

Hydrochlorothiazide binds to blood plasma proteins by 40-60%, penetrates the placental barrier, does not penetrate the blood-brain barrier, is secreted with breast milk.

Metabolism

Losartan

Approximately 14% of the dose of losartan, administered intravenously or by mouth, is converted to its active metabolite. After oral administration or intravenous administration of losartan, labeled ¹⁴C, the radioactivity of the circulating blood plasma is primarily associated with the presence in it of losartan and its active metabolite. In addition to the active metabolite, also biologically inactive metabolites are formed, including two metabolites, which are formed as a result of hydroxylation of the butyl side chain, and one secondary - N-2-tetrazole-glucuronide.

Excretion

Losartan

The plasma clearance of losartan and its active metabolite is about 600 ml / min and 50 ml / min, respectively. The renal clearance of losartan and its active metabolite is approximately 74 ml / min and 26 ml / min, respectively. When taking losartan, about 4% of the dose is excreted by the kidneys unchanged and about 6% of the dose is excreted as an active metabolite. Losartan and its active metabolite is characterized by linear pharmacokinetics when administered to losartan potassium in doses up to 200 mg. After oral administration, the plasma concentrations of losartan and its active metabolite decrease polyexponentially with a finite half-life (T _1/2) approximately 2 and 6-9 hours, respectively. With a single dose of 100 mg losartan, nor does its active metabolite significantly accumulate in the blood plasma. The excretion of losartan and its metabolites occurs through the intestine and kidneys. After ingestion of losartan, labeled ¹⁴C, about 35% of the radioactive label is found in urine and 58% in feces. After intravenous administration of losartan, labeled ¹⁴C, approximately 43% of the radioactive label is detected in the urine and 50% in the feces.

Hydrochlorothiazide

Hydrochlorothiazide is not metabolized and is rapidly excreted by the kidneys.The half-life period varies from 5.6 to 14.8 hours. At least 61% of the ingested dose is excreted unchanged for 24 hours.

Pharmacokinetics in special groups of patients.

In patients with alcoholic liver cirrhosis of mild and moderate severity, the concentration of losartan was 5 times, and the active metabolite was 1.7 times higher than in healthy male volunteers.

When the creatinine clearance (CK) is above 10 ml / min, the concentration of losartan in the blood plasma does not differ from that with normal kidney function.

In patients on hemodialysis, the area under the concentration-time curve (AUC) approximately 2 times higher than in patients with normal renal function.

Neither losartan, nor its active metabolite is removed from the body by hemodialysis.

The concentrations of losartan and its active metabolite in blood plasma in elderly patients with arterial hypertension do not differ significantly from the values of these parameters in young patients of men with hypertension.

Values of plasma concentrations of losartan in women with arterial hypertension are 2 times higher than the corresponding values in men with arterial hypertension. The concentrations of the active metabolite in men and women do not differ.This pharmacokinetic difference is not clinically relevant.

Indications:

- Arterial hypertension (patients who are shown combined therapy);

- reducing the risk of developing cardiovascular disease and mortality in patients with hypertension and left ventricular hypertrophy.

Contraindications:

- severe arterial hypotension;

- anuria;

-hyperkalemia;

- dehydration;

- refractory hypokalemia;

- hard-to-control diabetes mellitus;

- Addison's disease;

- severe renal dysfunction (creatinine clearance less than 30 ml / min);

- primary hyperaldosteronism;

- simultaneous use with potassium preparations, potassium-sparing diuretics;

- severe violations of the liver (more than 9 points on the scale Child-Pugh), cholestasis;

- pregnancy and the period of breastfeeding;

- age to 18 years (efficacy and safety of use not established);

- hypersensitivity to the drug components, other sulfonamide derivatives;

- lactose intolerance, lactase deficiency, glucose-galactose malabsorption syndrome.

Carefully:

In patients with a violation of the water-electrolyte balance of blood, for example, against diarrhea or vomiting (hyponatremia, hypochloraemic alkalosis, hypomagnesia, hypokalemia).

In patients with renal insufficiency (creatinine clearance more than 30 ml / min), with bilateral stenosis of the renal arteries or with stenosis of the artery of a single kidney; with a violation of liver function (less than 9 on the Child-Pugh scale); with diabetes mellitus, with hypercalcemia, hyperuricemia and / or gout, with a weighed allergic

anamnesis (in some patients, angioedema developed earlier with the administration of other drugs, including ACE inhibitors) and bronchial asthma, as well as systemic connective tissue diseases (including systemic lupus erythematosus); hypovolemia (including against a background of high doses of diuretics); with simultaneous appointment from

non-steroidal anti-inflammatory drugs (NSAIDs), including cyclooxygenase 2 inhibitors (COX-2), with cardiac glycosides; in patients with ischemic heart disease and elderly patients; in patients with acute attack of angle-closure glaucoma.

Pregnancy and lactation:

Use of the drug Bloktran® HT is contraindicated in pregnancy!

The use of drugs that directly affect the renin-angiotensin-aldosterone system during the second and third trimesters of pregnancy,can cause a fetal developmental defect or even cause its death. When pregnancy occurs, you must immediately stop taking the drug. Hydrochlorothiazide penetrates the placental barrier and is found in the umbilical cord blood. The use of diuretics in pregnant women is not recommended, as this increases the risk of developing fetal adverse events such as fetal and neonatal jaundice, and the mother's thrombocytopenia and possibly other adverse reactions. Especially not recommended the use of hydrochlorothiazide in the first trimester of pregnancy. There is no evidence that losartan excreted in breast milk, hydrochlorothiazide in breast milk excreted. The drug Blocktrans® GT is contraindicated for use throughout the whole period of breastfeeding because of the potential risk to the newborn. If it is necessary to use the drug Blocktrans® GT in the lactation period, breastfeeding should be discontinued.

Dosing and Administration:

The drug Blocktrans® GT is taken inside, regardless of the meal, the frequency of reception - 1 time per day.

Arterial hypertension

The initial and maintenance dose is 1 tablet 1 time per day. In some cases, to achieve a greater effect, the dose is increased to 2 tablets once a day. The maximum daily dose is 2 tablets of the drug Blocktrans® GT. It is not necessary to adjust the dose to elderly patients and patients with moderate renal failure (CK 30-50 ml / min).

Decrease risk of development of cardiovascular diseases and mortality in patients with hypertension and left ventricular hypertrophy.

The standard initial dose of losartan is 50 mg once a day. Patients who failed to achieve the target blood pressure when taking Losartan 50 mg / day, the choice of therapy by combithe nation of losartan with low doses of hydrochlorothiazide (12.5 mg), and, if necessaryneed to increase the dose of the lozartana up to 100 mg in combination with hydrochlorothiazide in a dose of 12.5 mg / day, in the long-termshem - increase to 2 tablets of the drugthat of Blocktran® GT (total 100 mg of losartan and 25 mg hydrochlorothiazide per day alonefold).

Side effects:

The frequency of side effects is classified according to the recommendations of the World Health Organization: very often - not less than 10%; often - not less than 1%, but less than 10%; infrequently - not less than 0,1%,but less than 1%; rarely - not less than 0.01%, but less than 0.1%; very rarely - 0.01%, including single messages.

In clinical studies with losartan / hydrochlorothiazide, no adverse events specific to this combination drug have been observed. Undesirable effects were limited to those reported earlier with losartan and hydrochlorothiazide alone.

The following adverse events were observed with the use of losartan and hydrochlorothiazide in monotherapy.

Losartan

From the side of the blood and lymphatic system: infrequently - anemia, purpura Shenlaine-Henoch, ecchymosis, hemolytic anemia.

Allergic reactions: rarely - anaphylactic reactions, angioedema, hives.

From the side of metabolism and nutrition: infrequently - anorexia, exacerbation of gout. From the side of the central nervous systemwe: often - headache, dizzinessinsomnia; infrequently - anxiety, paresthesia, peripheral neuropathy, Tremor, migraine, fainting, anxiety, anxietyacute disorders, panic disordersconstructions, confusion, depressionssoy, sleepiness, sleep disorder, worseningmemory.

From the side of the organ of vision: infrequent - a breach of vision, a feeling of dryness and burning in eyes, conjunctivitis, decreased visual acuity.

From the side of the hearing organ: infrequently - vertigo, noise in the ears.

On the part of the respiratory system, often - nasal congestion, cough, upper respiratory tract infections (fever, sore throat, sinusopathy, sinusitis, pharyngitis); infrequently - pharyngitis, laryngitis, dyspnea, bronchitis, rhinitis, nosebleeds, discomfort in the pharyngeal region.

On the part of the organs of the gastrointestinal tract: often - nausea, diarrhea, dyspeptic phenomena, abdominal pain; infrequently - dryness of the oral mucosa, toothache, vomiting, flatulence, gastritis, constipation.

From the side of the musculoskeletal system: often - cramps, myalgia, back pain, in the legs; infrequently - arthralgia, pain in the hands, in the shoulder, knee, arthritis, fibromyalgia, muscle weakness, swelling of the joints, musculoskeletal pain.

From the side of the cardiovascular system: infrequently - arterial hypotension, orthostatic hypotension (dose-dependent), palpitations, tachy- or bradycardia, arrhythmias, angina pectoris, chest pain, AV blockade II degree, cerebrovascular events, myocardial infarction, vasculitis.

From the genitourinary system: infrequently - nocturia, frequent urination, urinary tract infections, weakening of libido, impotence.

From the skin: infrequently - dry skin, erythema, "tide" of blood to the skin of the face, photosensitivity, itching, skin rash, increased sweating, alopecia, dermatitis.

Other: often - asthenia, increased fatigue; infrequently - swelling of the face, fever. Laboratory indicators: often - hyperkalemia, decrease in hematocrit and hemoglobin; infrequently - increased concentrations of urea and creatinine; very rarely - increased activity of "liver" transaminases.

Hydrochlorothiazide

On the part of the blood and lymphatic system: infrequently - agranulocytosis, aplastic anemia, hemolytic anemia, leukopenia, purpura, thrombocytopenia.

Allergic reactions: rarely anaphylactic reactions.

From the side of metabolism and nutrition: infrequently - anorexia, hyperglycemia, hyperuricemia, hypokalemia, hyponatremia.

From the nervous system: often - a headache, infrequently - dizziness, insomnia.

From the side of the organ of vision: infrequently - transient visual impairment, xanthopsia.

From the side of the cardiovascular system: infrequently - necrotizing vasculitis.

On the part of the respiratory system: infrequently -respiratory distress syndrome, pneumoniamonitor and pulmonary edema.

From the digestive system: infrequently - sialodenitis, irritation of the mucous membrane of the gastrointestinal tract, nausea, vomiting, diarrhea, constipation, jaundice (intrahepatic cholestasis), pancreatitis.

From the skin and subcutaneous tissue: infrequently - photosensitization, urticaria, toxic epidermal necrolysis.

From the side of the musculoskeletal system: infrequently - muscle cramps.

From the urinary system: infrequently - glucosuria, interstitial

nephritis, impaired renal function, renal failure.

Common violations: infrequently, fever.

In the post-marketing application of losartan / hydrochlorothiazide, the following adverse events were observed:

From the digestive system: rarely - hepatitis.

Laboratory indicators: rarely - hyperkalemia, increased activity of "liver" transaminases.

Overdose:

Data on the specific treatment of an overdose of a combination of losartan / hydrochlorothiazide

are limited.In case of an overdose, the drug Bloktran® HT should be discontinued, the patient must carefully monitor the performance of vital organs, symptomatic therapy - induction of vomiting if the drug is taken recently, as well as eliminating dehydration, electrolyte disorders, hepatic coma, and lowering blood pressure by standard methods.

Losartan

Symptoms: marked decrease in blood pressure, tachycardia, bradycardia may occur due to parasympathetic (vagal) stimulation.

Treatment: in the case of a marked decrease in blood pressure, maintenance therapy is indicated. Losartan and its active metabolite are not excreted by hemodialysis.

Hydrochlorothiazide

Symptoms: deficiency of electrolytes (hypokalemia, hypochloraemia, hyponatremia); dehydration (due to excessive diuresis). With the simultaneous administration of cardiac glycosides, hypokalemia can aggravate the course of arrhythmias.

Treatment: if the drug is taken recently - gastric lavage, reception of activated charcoal; if necessary, correct the water-electrolyte disturbances. It is not established to what extent hydrochlorothiazide can be removed from the body by hemodialysis.

Interaction:

Can be prescribed with other antihypertensive drugs.

Losartan

There was no clinically significant pharmacokinetic interaction of the drug with such drugs as hydrochlorothiazide, digoxin, warfarin, cimetidine, phenobarbital, ketoconazole and erythromycin. Rifampicin reduces the concentration of the active metabolite. The clinical significance of this interaction is not established. As with the use of other agents that block the formation of angiotensin II and its effects, the concomitant use of potassium-sparing diuretics (spironolactone, triamterene, amiloride, eplerenone), potassium-containing additives and salts containing potassium, can lead to an increase in the potassium content in the blood serum. As with other agents that affect the excretion of sodium, treatment with losartan may be accompanied by a decrease in excretion and an increase in serum lithium concentration; therefore, when treating with lithium preparations simultaneously, its serum concentration should be monitored.

Nonsteroidal anti-inflammatory drugs (NSAIDs), including selective inhibitors of COX-2 may reduce the effects of diuretics and other hypotensive drugs. Therefore, the antihypertensive effect of angiotensin II receptor antagonists may be attenuated while the use of NSAIDs, including selective COX-2 inhibitors.

In some patients with impaired renal function, who were treated with NSAIDs, including selective inhibitors of COX-2, co-administration of angiotensin II receptor antagonists can cause a further deterioration of renal function, including acute renal failure. Usually, this effect is reversible. Dual blockade of the RAAS - the combined use of an angiotensin II receptor blocker with an ACE inhibitor - leads to a significant increase in adverse effects, such as hypotension, syncope, hyperkalemia, renal failure, acute renal failure. The highest risk is in patients with established diagnosis of atherosclerosis, heart failure, diabetes mellitus (with any complication). The question of the application of the double blockade of RAAS (for example,by simultaneous administration of an ACE inhibitor and an angiotensin II receptor antagonist) should be addressed in each case individually with careful monitoring of renal function.

Fluconazole, isoenzyme inhibitor CYP2C9, reduces plasma concentrations of the active metabolite and increases the concentration of losartan, however, the pharmacodynamic significance of this phenomenon has not been established. It is shown that in individuals who do not metabolize losartan in the active metabolite, there is a very rare and specific defect of the isoenzyme CYP2C9.

Hydrochlorothiazide

When used simultaneously with barbiturates, narcotic analgesics, ethanol, orthostatic hypotension may develop. When used simultaneously with hypoglycemic drugs (for ingestion and insulin), a dose adjustment of hypoglycemic drugs may be required. In view of the risk of developing lactic acidosis due to possible renal dysfunction with hydrochlorothiazide metformin should be used with caution.

With simultaneous use with other antihypertensive agents, an additive effect is observed.

It should avoid simultaneous application with lithium salts (renal clearance of lithium decreases, its toxicity increases).

When used simultaneously with corticosteroids, adrenocorticotropic hormone, glycyrrhizic acid (found in the licorice root), amphotericin B, a significant decrease in the content of electrolytes, especially potassium, occurs.

With simultaneous use with nondepolarizing muscle relaxants (tubocurarine), it is possible to intensify their action.

NSAIDs, including selective inhibitors of COX-2, can reduce the diuretic, natriuretic and antihypertensive effects of hydrochlorothiazide. A single dose of colestyramine or colestipol can reduce the absorption of hydrochlorothiazide in the gastrointestinal tract by 85% and 43%, respectively. With the simultaneous use of the drug with pressor amines (norepinephrine, epinephrine), a slight decrease in the effect of pressor amines is possible. Drugs used to treat gout (probenecid, sulfinpyrazone and allopurinol) - a dose adjustment (an increase in the dose of probenecid and sulfinpyrazone) may be required, since hydrochlorothiazide can increase the concentration of uric acid in the serum. The combined use of thiazide diuretics can increase the incidence of hypersensitivity reactions to allopurinol. Anticholinergics (for example, atropine, biperidene) - increased bioavailability of thiazide diuretics due to decreased motility of the gastrointestinal tract and the rate of gastric emptying.

Thiazide diuretics can reduce renal excretion of cytotoxic drugs (for example, cyclophosphamide, methotrexate) and enhance their myelosuppressive effect.

Thiazide diuretics can increase the toxic effects of salicylates on the central nervous system when used in high doses.

Individual cases of development of hemolytic anemia have been reported with simultaneous use of hydrochlorothiazide and methyldopa.

Concomitant treatment with cyclosporine may increase the risk of hyperuricemia and gout.

Hypokalemia or hypomagnesemia caused by the use of thiazide diuretics can promote the development of arrhythmias with simultaneous use with cardiac glycosides.

Simultaneous use of thiazide diuretics with antiarrhythmic drugs (quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide), some antipsychotic drugs (neuroleptics) (thioridazine, chlorpromazine, levomepromazine, trifluoperazine, cyamemazine, sulpiride, sultopride, amisulpride, tiapride, pimozide, haloperidol, droperidol) and other drugs (bepridil, cisapride, difemanyl, erythromycin, halofantrine, misolastine, pentamidine, terfenadine, wincamine) may be accompanied by the development of hypokalemia, which, in turn, can cause the development of piruet-type arrhythmias.

Thiazide diuretics can lead to hypercalcemia as a result of a decrease in its excretion, so it is necessary to monitor the calcium content in the serum. In connection with the effect of thiazide diuretics on calcium metabolism, their administration may distort the results of the study of the function of parathyroid glands.

With simultaneous use with carbamazepine, there is a risk of symptomatic hyponatraemia.

With the development of dehydration against the background of the use of diuretics, there is a possibility of acuterenal failure, especially with simultaneous use with iodine preparations.

Special instructions:

Losartan

Due to the inhibition of the renin-angiotensin-aldosterone system, some susceptible patients experienced changes in kidney function, including renal failure; These changes were reversible and disappeared after discontinuation of therapy.

Perhaps the manifestation of such a symptom of hypersensitivity as angioedema, so patients with angioedema need a careful history.

Blocktrans® HT, like some drugs that affect the renin-angiotensin-aldosterone system, can increase the concentration of blood urea and serum creatinine in patients with bilateral renal artery stenosis or stenosis of the artery of a single kidney. These changes in kidney function were reversible and disappeared after therapy was discontinued.

It is not recommended to administer the drug with a symptomatic increase in the concentration of uric acid and with gout.

Pharmacological data indicate that,that the concentration of losartan in the blood plasma in patients with cirrhosis of the liver is significantly increased, so patients with a history of liver disease should use the drug in a lower dose. During treatment with the drug Blocktrans® GT, as with any antihypertensive therapy, there may be a marked decrease in blood pressure. Patients should be examined for clinical signs of decreased circulating blood volume (BCC) and water-electrolyte balance disorders, including hyponatremia, hypochloraemic alkalosis, hypomagnesemia, or hypokalemia that may result from episodes of diarrhea or vomiting as a result of diuretic therapy, with restriction consumption of table salt. Such patients need control of the content of plasma electrolytes.

Simultaneous use with potassium preparations, potassium-sparing diuretics is not recommended (see the section "Interaction with other medicinal products").

In patients with primary hyperaldosteronism, the use of antihypertensive drugs that affect the renin-angiotensin-aldosterone system, including Bloktran® GT, is ineffective.

A sharp decrease in blood pressure during therapy with the drug Blocktrans® GT, as well as other antihypertensive drugs, in patients with ischemic cardiovascular and cerebrovascular diseases can lead to the development of acute myocardial infarction or stroke.

In patients with heart failure, both with a deficiency of kidney function and without it, the use of Bloktran® GT as well as other agents affecting RAAS increases the risk of a sharp decline in blood pressure and the development of acute renal failure.

Care should be taken with the use of the drug Blocktrans® GT in patients with aortic stenosis, mitral stenosis and hypertrophic cardiomyopathy. It should be borne in mind that angiotensin II receptor antagonists, including losartan are less effective for the treatment of hypertension when used in patients of the Negroid race than in other patients.

Hydrochlorothiazide

As in the case of taking any antihypertensive drugs, some patients may experience symptomatic hypertension. In some patients hydrochlorothiazide can increase water-electrolyte imbalance (decrease in bcc, hyponatremia, hypochloraemic alkalosis, hypomagnesemia, hypokalemia), impair glucose tolerance, reduce calcium ion excretion in the urine, cause a transient slight increase in the concentration of calcium ions in plasma, increase the concentration of cholesterol and triglycerides, provoke the occurrence of hyperuricemia and / or gout (because losartan reduces the concentration of uric acid, the severity of hyperuricemia caused by a diuretic is reduced).

Hydrochlorothiazide in connection with the impact on calcium metabolism can change the results of parathyroid function analysis. Before the study of parathyroid function, a thiazide diuretic should be discontinued.

There are reports of the development of exacerbation or progression of systemic lupus erythematosus on the background of thiazide diuretics.

Thiazide diuretics should be used with caution in patients with impaired liver function or progressive liver disease, this can lead to the development of intrahepatic stool, which, in combination with a violation of the water-electrolyte balance, can lead to the development of a "hepatic" coma.

Hydrochlorothiazide is a sulfonamide that can cause an idiosyncratic reaction leading to the development of acute transient myopia and acute closed-angle glaucoma. Symptoms include: sudden reduction in visual acuity or pain in the eyes, which appear, usually within a few hours or weeks from the initiation of hydrochlorothiazide therapy. In the absence of treatment, an acute attack of angle-closure glaucoma can lead to a permanent loss of vision.

Treatment: it is necessary to stop taking hydrochlorothiazide as soon as possible. If intraocular pressure remains uncontrolled, immediate medical treatment or surgery may be required. Risk factors for the development of acute closed-angle glaucoma are: an allergic reaction to sulfonamide or benzylpenicillin in the anamnesis.

Effect on the ability to drive transp. cf. and fur:Some of the side effects of the drug, such as dizziness, weakness, drowsiness and impaired vision, can adversely affect the ability to drive vehicles and perform potentially dangerous activities requiring increased concentration and speed of psychomotor reactions.At the beginning of therapy with the drug it is recommended to refrain from driving vehicles and performing work that requires an increased concentration of attention and speed of psychomotor reactions (due to the possible development of dizziness and drowsiness), then you should be careful.

Form release / dosage:

The tablets covered with a film cover, 12,5 mg + 50 mg.

Packaging:

10 tablets in a contour mesh box made of polyvinylchloride film and aluminum foil printed lacquered.

1, 2, 3, 5 or 6 contour cell packs, together with instructions for medical use, are placed in a pack of cardboard.

Storage conditions:At a temperature of no higher than 25 ° C. Keep out of the reach of children.

Shelf life:2 years. The drug should not be used after the expiry date indicated on the package.

Terms of leave from pharmacies:On prescription

Registration number:LP-002099

Date of registration:13.06.2013 / 11.12.2013

Expiration Date:13.06.2018

The owner of the registration certificate:PHARMSTANDART-FORESTRY, OJSC PHARMSTANDART-FORESTRY, OJSC Russia

Manufacturer: & nbsp

PHARMSTANDART-FORESTRY, OJSC Russia

Information update date: & nbsp18.02.2017

Illustrated instructions

Instructions

Blocktran® GT (Bloctran GT)