Blocktran GT tablets coated. 12.5 mg + 50 mg 30 pcs. (Hydrohlorotyazyd, Losartan)

Release form

Film-coated tablets.

Packing

30 pcs.

Pharmacological action

Components of Blocktran GT have an additive antihypertensive effect, lowering blood pressure (BP) to a greater extent than each of the individual components. Due to the diuretic effect, hydrochlorothiazide increases the activity of plasma renin (ARP), stimulates the secretion of aldosterone, increases the concentration of aigiotensin II and reduces the potassium content in the blood serum. Receiving losartan blocks all physiological effects of aigiotensin II and, due to the suppression of the effects of aldosterone, can help reduce the loss of potassium associated with taking a diuretic.

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

losartan.

Angiotensin II is a powerful vasoconstrictor, the main active hormone of the renin-angiotensin-aldosterone system, and also a crucial pathophysiological link in the development of arterial hypertension. Losartan is an antagonist of aigiotensin II receptors (type AT1). Angiotensin II selectively binds to AT1 receptors found in many tissues (in smooth muscle tissues of blood vessels, adrenal glands, kidneys and heart) and performs several important biological functions, including vasoconstriction and the release of aldosterone. Angiotensin II also stimulates the proliferation of smooth muscle cells. Losartan and its pharmacologically active metabolite (E3174) as in vitro, and in vivo block all physiological effects of aigiotensin II, regardless of the source or route of synthesis.

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

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

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

hydrochlorothiazide.

The mechanism of the antihypertensive effect of thiazide diuretics is unknown. Thiazide diuretics usually do not affect normal blood pressure. Hydrochlorothiazide is a diuretic and antihypertensive. It acts on the reabsorption of electrolytes in the distal tubules of the kidneys. Hydrochlorothiazide approximately equally increases the excretion of sodium and chlorine ions. Natriuresis may be accompanied by a slight loss of potassium ions, bicarbonates and a delay of 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.

Indications

- arterial hypertension (for patients which combined therapy is shaken)

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



Contraindications - severe hypotension

- anuria

- hyperkalemia

- dehydration

- refractory hypokalemia

- unmanageable diabetes

- Addison's disease

- severe renal impairment (creatinine clearance less than 30 mL / min)

- primary hyperaldosteronism

- simultaneous use with potassium preparations,

potassium-sparing diuretics - severe liver dysfunction (more than 9 points on the Child-Pugh scale),

cholestasis - pregnancy and the period of breast cancer rmlivaniya

- up to age 18 years (effectiveness and safety have not been established)

- hypersensitivity to the drug Bloktran GT, other derivatives sulfonamides

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

Precautions: violation of the water-electrolyte balance of the blood, for example, against the background of diarrhea or vomiting (hyponatremia, hypochloremic alkalosis, hypomagnesemia, hypokalemia). In patients with renal failure (creatinine clearance greater than 30 ml / min), with bilateral renal artery stenosis or with artery stenosis of a single kidney with impaired liver function (less than 9 Child-Pugh score) with diabetes, with hypercalcemia, hyperuricemia and / or gout, with a burdened allergic history (in some patients, angioedema developed earlier with other drugs, including ACE inhibitors) and bronchial asthma, and in case of systemic diseases of the connective tissue (including systemic lupus erythematosus) with hypovolemia (including poyey high doses of diuretics): as well as with the simultaneous administration of non-steroidal anti-inflammatory drugs (NSAIDs), including type 2 cyclooxygenase inhibitors (COX) -2), with cardiac glycosides in patients with coronary heart disease and elderly patients in patients with an acute attack of angle-closure glaucoma.

Use during pregnancy and lactation

The use of the drug Blocktran GT is contraindicated in pregnancy.

The use of drugs that have a direct effect on the renin-angiotensin-aldosterope system during the second and third trimesters of pregnancy can cause a fetal development defect or even cause death. If pregnancy occurs, you must immediately stop taking the drug. Hydrochlorothiazide crosses the placental barrier and is found in cord blood. The use of diuretics in pregnant women is not recommended, as this increases the risk of developing adverse effects in the fetus such as the development of fetal and neonatal jaundice, and in the mother thrombocytopenia and possibly other adverse reactions. The use of hydrochlorothiazide in the first trimester of pregnancy is especially not recommended.

There is no evidence that losartan is excreted in breast milk, hydrochlorothiazide is excreted in breast milk. The drug Blocktran GT is contraindicated for use during the entire period of breastfeeding due to the potential risk to the newborn. If necessary, use the drug Blocktran GT during lactation, breastfeeding should be discontinued.

Special instructions

losartan.

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

The manifestation of such a symptom of hypersensitivity as angioedema is possible, so patients with a history of angioedema require careful monitoring.

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

The use of the drug is not recommended for symptomatic increase in uric acid concentration and for gout.

Pharmacological data indicate that the concentration of losartan in the blood plasma in patients with cirrhosis is significantly increased, therefore, patients with a history of liver disease should use a lower dose. During treatment with Blocktran GT, as with any antihypertensive therapy, a marked decrease in blood pressure is possible. Patients should be examined in order to identify clinical signs of a decrease in circulating blood volume (BCC) and water-electrolyte imbalance, including hyponatremia, hypochloremic alkalosis, hypomagnesemia or hypokalemia, which may occur as a result of episodes of diarrhea or vomiting as a result of diuretic therapy, while limiting salt consumption. In such patients, control of the plasma electrolyte content is necessary.

Concomitant use with potassium preparations, potassium-sparing diuretics is not recommended (see section "Interaction with other medicinal products"). In patients with primary hyperaldosteronism, the use of antihypertensive drugs that affect the renin-angiotensin-aldosterone system, including Blocktran GT, is ineffective.

A sharp decrease in blood pressure during therapy with Blocktran 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 and without renal failure, the use of Blocktran GT, as well as other drugs that affect RAAS, increases the risk of a sharp decrease in blood pressure and the development of acute renal failure.

Caution should be exercised when using Blocktran GT in patients with aortic stenosis, mitral stenosis, and hypertrophic cardiopathy. It should be borne in mind that angiogensin II receptor antagonists, including losartan, are less effective for the treatment of arterial hypertension when used in patients of the nephoid race than in other patients.

hydrochlorothiazide.

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

Hydrochlorothiazide due to its effect on calcium metabolism may alter the results of parathyroid function analysis. Before examining the function of the parathyroid glands, a thiazide diuretic must be withdrawn.

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

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

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

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

Influence on the ability to drive vehicles and work with mechanisms

Some side effects of the drug, such as dizziness, weakness, drowsiness, and blurred vision, can adversely affect the ability to drive a vehicle and perform potentially dangerous activities that require increased concentration and speed psychomotor reactions. At the beginning of drug therapy (the duration of this period is determined individually), it is recommended to refrain from driving vehicles and performing work requiring an increased concentration of attention and speed of psychomotor reactions (due to the possible development of dizziness and drowsiness), and caution should be exercised in the future.

Composition

1 tab: - potassium losartan 50 mg

- hydrochlorothiazide 12.5 mg

Excipients: microcrystalline cellulose - 40.1 mg, potato starch - 23.4 mg, sodium carboxymethyl starch (sodium starch glycolate) - 7 mg, lactose monohydrate (3.5 mg milk powder) low molecular weight polyvinylpyrrolidone medical) - 1.4 mg, colloidal silicon dioxide (aerosil) - 1.4 mg, magnesium stearate - 0.7 mg.

Shell composition: opadra II pink 57U36011 (hypromellose (HPMC 2910) - 2.0150 mg, polydextrose - 1.69 mg, titanium dioxide (E171) - 1.6887 mg, talc - 0.455 mg, maltodextrin or dextrin - 0.325 mg, medium chain triglycerides, 0.26 mg dye carmine red (carmine E120) - 0.0663 mg) - 6.5 mg.

Dosage and administration of

The drug Blocktran GT is taken orally, regardless of the niche intake, the frequency of administration is 1 time per day.

Arterial Hypertension: The initial and maintenance dose is 1 tablet 1 time per day. In 13 separate cases, to achieve a greater effect, the dose is increased to 2 tablets 1 time per day. The maximum daily dose is 2 tablets of the drug Blocktran GG.

Dosage adjustment is not required for elderly patients and patients with moderate renal failure (CC 30-50 ml / min).

Reducing the risk of developing cardiovascular disease and mortality in patients with arterial hypertension and left ventricular hypertrophy: The standard initial dose of losartan is 50 mg once a day. Patients who have not been able to achieve the target blood pressure while taking losartan 50 mg / day require treatment by combining losartan with low doses of hydrochlorothiazide (12.5 mg), and, if necessary, you need to increase the dose of losartan to 100 mg in combination with hydrochlorothiazide at a dose of 12.5 mg / day, in the future - increase to 2 tablets of Blocktran GT (only 100 mg of losartan and 25 mg of hydrochlorothiazide per day once).

Side effects

The frequency of side effects is classified in accordance with the recommendations of the World Health Organization: very often - at least 10% often - at least 1%, but less than 10% infrequently - at least 0.1%, but less than 1% rarely - at least 0.01%, at least 0.1% very rarely - 0.01%, including single messages.

In clinical trials with losartan / hydrochlorothiazide, no adverse events specific to this combination drug were observed. Adverse events were limited to those previously reported with losartan and hydrochlorothiazide alone.

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

Losartan: On the part of the blood and lymphatic system: infrequently - anemia, Shenlein-Genoch purpura, ecchymosis, hemolytic anemia.

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

From the side of metabolism and nutrition: infrequently - anorexia, exacerbation of the course of gout.

From the central nervous system: often - headache, dizziness, insomnia infrequently - restlessness, paresthesia, peripheral neuropathy, tremor, migraine, fainting, anxiety, anxiety disorders, panic disorders, confusion, depression, drowsiness, sleep disturbance, memory impairment.

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

On the part of the organ of hearing: infrequently - vertigo, tinnitus.

From the respiratory system: often - nasal congestion, cough, upper respiratory tract infections (fever, sore throat, sinusopathy, sinusitis, pharyngitis) infrequently - pharyngitis, laryngitis, dyspnea, bronchitis, rhinitis, nosebleeds, pharyngeal discomfort area.

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

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

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

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

From the skin: infrequently - dry skin, erythema, “rush” 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, a decrease in hematocrit and hemoglobin infrequently - an increase in the concentration of urea and creatinine is very rare - an increase in the 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 - headache, infrequently - dizziness, insomnia.

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

From the cardiovascular system: infrequently - necrotizing vasculitis.

On the part of the respiratory system: infrequently - respiratory distress syndrome, pneumonitis 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 - photosensitivity, urticaria, toxic epidermal necrolysis.

From the musculoskeletal system: infrequently - muscle cramps.

From the urinary system: infrequently - glucosuria, interstitial nephritis, impaired renal function, renal failure.

General Disorders: infrequently - fever.

Following post-marketing use 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

There is limited data on the specific treatment of overdose with the losartan / hydrochloroshazide combination. In the event of an overdose, the administration of Blotran GT should be discontinued, the patient should be carefully monitored for vital organ function indicators, symptomatic therapy - induction of vomiting if the drug was recently taken, and elimination of dehydration, electrolyte disorders, hepatic coma, and BP reduction.

Losartan.

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

Treatment: Supportive therapy is indicated in the case of marked BP. Losartan and its active metabolite are not eliminated by hemodialysis.

Hydrochlorothiazide.

Symptoms: electrolyte deficiency (hypokalemia, hypochloremia, hyponatremia) dehydration (due to excessive diuresis). With concomitant administration of cardiac glycosides, hypokalemia may aggravate the course of arrhythmias.

Treatment: if the drug is taken recently - gastric lavage, activated carbon intake: if necessary, correct the water-electrolyte disorders. It has not been established to what extent hydrochlorothiazide can be removed from the body by hemodialysis.

Deystvuyuschee substances

Hydrochlorothiazide, Losartan

Cond Ovia pharmacy vacation

Prescription

Form of Treatment

tablets

Pharmstandard-Leksredstva, Russia



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