Vasotens H (Vasotens H)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceLosartan + HydrochlorothiazideLosartan + Hydrochlorothiazide
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  • Vasotens H
    pills inwards 
    SiNViTi Pharma Co., Ltd.     Cyprus
  • Losartan-N Richter
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    GEDEON RICHTER, OJSC     Hungary
  • Losartan-N Richter
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    GEDEON RICHTER, OJSC     Hungary
    • Dosage form: & nbsptfilm-covered laths
    Composition:

    1 tablet, film-coated, 50 mg + 12.5 mg contains:

    active substances: losartan potassium 50 mg and hydrochlorothiazide 12.5 mg;

    Excipients: mannitol-82.5 mg, microcrystalline cellulose 40.0 mg, croscarmellose sodium 8.0 mg, povidone 4.0 mg, magnesium stearate 3.0 mg, opadine white 4.0 mg (hypromellose 3cR 1.4 mg, hydroxypropylcellulose 1.2 mg, titanium dioxide 0.8 mg, macrogol 0.4 mg, hypromellose 5 OxR 0.2 mg).

    1 tablet, film-coated, 100 mg + 25 mg contains:

    active substances: losartan potassium 100 mg and hydrochlorothiazide 25 mg;

    Excipients: mannitol 165.0 mg, microcrystalline cellulose 80.0 mg, croscarmellose sodium 16.0 mg, povidone 8.0 mg, magnesium stearate 6.0 mg, opadine white 6.0 mg (hypromellose 3cP 2.8 mg, hydroxypropylcellulose 2.4 mg, titanium dioxide 1.6 mg, macrogol 0.8 mg, hypromellose 50 cP 0.4 mg).

    Description:

    Tablets 50 mg + 12.5 mg

    Round, biconvex tablets, white, film-coated, with risk from both sides of the tablet and lateral risks, with the designation "LH" on the one hand of the risks and "1" on the other side of the risks.

    Tablets 100 mg + 25 mg

    Round, biconvex tablets, white, film-coated, with risk from both sides of the tablet and lateral risks, with the designation "LH "on the one hand of the risks and" 2 "on the other side of the risks.

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

    C.09.D.A   Angiotensin II antagonists in combination with diuretics

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

    Pharmacodynamics:

    The combined drug has an antihypertensive effect. Contains losartan potassium - an antagonist of angiotensin II receptors (subtype AT1) and hydrochlorothiazide - Diuretic.

    Losartan is a specific antagonist of angiotensin II receptors (subtype AT1). Does not inhibit kinase II - an enzyme that destroys bradykinin. Reduces the overall peripheral resistance (OPSS), the concentration in the blood of adrenaline and aldosterone, blood pressure (BP), pressure in the small circle of the circulation; reduces afterload, has a diuretic effect. It prevents the development of myocardial hypertrophy, increases tolerance to physical activity in patients with chronic heart failure.

    Hydrochlorothiazide - Thiazide diuretic. Reduces the reabsorption of sodium ions, increases the release of urine ions of potassium, bicarbonate and phosphate. Reduces blood pressure by reducing the volume of circulating blood (BCC), changes in the reactivity of the vascular wall, reducing the pressor effect of vasoconstrictors and increasing the depressor effect on the ganglion.

    Pharmacokinetics:

    Losartan is rapidly absorbed from the gastrointestinal tract. Bioavailability is about 33%. Has the effect of "first passage" through the liver, is metabolized by carboxylation to form an active metabolite. Connection with blood plasma proteins - 99%. The time to reach the maximum concentration in the blood plasma of losartan is 1 hour, the active metabolite 3-4 hours after ingestion. The half-life is 1.5-2 hours, and its main metabolite is 3-4 hours, respectively. About 35% of the dose is excreted in the urine, about 60% - through the intestine.

    Hydrochlorothiazide quickly absorbed from the gastrointestinal tract. The half-life is 5.8-14.8 hours. It is not metabolized by the liver. About 61% is excreted by the kidneys unchanged.

    Indications:

    - Arterial hypertension (in patients for whom combination therapy is optimal);

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

    Contraindications:

    - Hypersensitivity to the components of the drug, increased sensitivity to other sulfonamide derivatives;

    - anuria;

    - severe arterial hypotension;

    - severe liver dysfunction;

    - severe renal dysfunction (creatinine clearance <30 mL / min.)

    - hypovolemia (including against a background of high doses of diuretics)

    - pregnancy and lactation;

    - age to 18 years (efficacy and safety not established).

    Carefully:Ppatients with bilateral stenosis of the renal arteries or stenosis of the artery of a single kidney, with disturbances in the water-electrolyte balance of blood (dehydration, hyponatremia, hypochloraemic alkalosis, hypomagnesemia, hypokalemia).

    With caution, the drug is prescribed in patients with diabetes mellitus, hypercalcemia, hyperuricemia and / or gout, as well as patients with a history of allergic anamnesis and bronchial asthma, as well as systemic connective tissue diseases (including systemic lupus erythematosus),while concomitant administration with non-steroidal anti-inflammatory drugs (NSAIDs), including cyclooxygenase-II (COX-2 inhibitors).

    Pregnancy and lactation:

    The use of the drug Vazotens H is contraindicated in pregnancy. It is known that drugs acting directly on the renin-angiotensin-aldosterone system, when applied in the second and third trimesters of pregnancy, can cause a developmental defect or even the death of a developing fetus. Therefore, when diagnosing pregnancy, taking Vazotens N should be stopped immediately.

    Hydrochlorothiazide penetrates the placental barrier and is detected in the blood of the umbilical cord. Routine use of diuretics in pregnant women increases the risk of developing adverse events such as embryonic jaundice, neonatal jaundice, and abnormal electrolyte balance and thrombocytopenia that may occur in the mother.

    There is no evidence that losartan excreted in breast milk. However, it is known that thiazides excreted in breast milk.

    In the event that a decision is made to use Vasotens H, it is necessary to stop breastfeeding.

    Dosing and Administration:

    Inside, regardless of meals, with a glass of water (200-250 ml).

    Arterial hypertension

    Vazotens H can be used with other antihypertensive drugs.

    Vasotensis N is prescribed for patients who failed to achieve target BP levels when taking losartan or hydrochlorothiazide with monotherapy. It is recommended that the dose of active components (losartan and hydrochlorothiazide) be initially titrated. Then you can go to receive a fixed combination of Vasotens N.

    Usually, the initial and maintenance doses of the drug are 1 tablet (50 mg of losartan + 12.5 mg of hydrochlorothiazide) per day.

    For those patients who do not achieve target BP levels at this dose, the dose can be increased to 2 tablets (50 mg / 12.5 mg) or 1 tablet (100 mg / 25 mg) once a day. The maximum dose is 2 tablets (50 mg / 12.5 mg) or 1 tablet (100 mg / 25 mg) once a day.

    In general, the maximum antihypertensive effect is achieved within 3-4 weeks after the start of treatment.

    In patients with a reduced volume of circulating blood (for example, when taking large doses of diuretics), the recommended initial dose of losartan is 25 mg once a day.In this regard, therapy with Vazotens H should be started after the elimination of diuretics and correction of hypovolemia.

    In elderly patients and patients with moderate renal failure, including those on dialysis, no correction of the initial dose is required.

    Reducing the risk of developing cardiovascular disease 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 per day require a combination of losartan with low doses of hydrochlorothiazide (12.5 mg) and, if necessary, a dose of losartan to 100 mg in combination with hydrochlorothiazide at a dose of 12.5 mg per day, further increase to 2 tablets of the preparation Vasotens H 50 / 12.5 mg or 1 tablet of the preparation Vasotens H 100/25 mg (total 100 mg of losartan and 25 mg of hydrochlorothiazide in day once).

    There is no need for a special selection of an initial dose for elderly patients.

    Side effects:

    Adverse reactions are limited to those previously observed with the use of losartan potassium and / or hydrochlorothiazide.

    The most common side effects in the treatment of essential hypertension include dizziness

    Allergic reactions: anaphylactoid reactions, angioedema, including laryngeal and / or tongue edema, resulting in airway obstruction, and / or edema of the face, lips, pharynx and / or tongue occasionally seen with losartan. Some of these patients had angioedema earlier with other drugs, including ACE inhibitors. Very rarely, when taking losartan, there were manifestations of vasculitis, including Shenlain-Henoch disease.

    From the side of the cardiovascular system: a decrease in blood pressure.

    From the side of the digestive tract: when receiving losartan, rare (<1%) cases of hepatitis, diarrhea were registered.

    On the part of the respiratory system: when taking losartan - cough.

    From the skin: hives.

    Laboratory indicators: rarely (<1%) hyperkalemia (serum potassium more than 5.5 mmol / l), increased activity of "liver" enzymes.

    Overdose:

    Symptoms:

    Losartan - marked decrease in blood pressure, tachycardia, bradycardia (as a result of vagal stimulation).

    Hydrochlorothiazide - loss of electrolytes (hypokalemia, hyperchloremia, hyponatremia), as well as dehydration, resulting from excessive diuresis.

    Treatment: symptomatic and supportive therapy. If the drug is taken recently, the stomach should be washed; if necessary, correct the water-electrolyte disturbances.

    Lozartan and its active metabolites are not removed by hemodialysis.

    Interaction:

    Losartan can be used with other antihypertensive drugs.

    There was no clinically significant interaction with hydrochlorothiazide, digoxin, warfarin, cimetidine, phenobarbital, ketoconazole and erythromycin.

    Rifampicin and fluconazole reduce the concentration of the active metabolite in the blood plasma. The clinical significance of these interactions is unknown.

    In patients with reduced BCC (previous treatment with large doses of diuretics), there may be a marked decrease in blood pressure.

    Strengthens (mutually) the effect other antihypertensive drugs (diuretics, beta-blockers, sympatholytics).

    As with the use of other agents that block the formation of angiotensin II and its operation, joint application potassium-sparing diuretics (spironolactone, triamterene, amiloride), preparations of potassium and salts containing potassium, can lead to an increase in the potassium content in the serum.

    Non-steroidal anti-inflammatory drugs (NSAIDs), including selective inhibitors of cyclooxygenase-2 (COX-2), can reduce the effect of diuretics and other antihypertensive agents.

    In some patients with impaired renal function (including elderly patients with reduced BCC, including due to previous treatment with diuretics) who have been treated with NSAIDs, including selective COX-2 inhibitors, simultaneous administration of angiotensin II receptor antagonists can cause further impairment of kidney function up to development of acute renal failure. Usually, this effect is reversible.

    With the combined use of angiotensin II receptor antagonists and lithium it is possible to increase the concentration of lithium in blood plasma. Considering this, it is necessary to weigh the benefits and risks of joint use of losartan with lithium salts. In case of necessity of joint application of preparations, it is necessary to regularly monitor the concentration of lithium in blood plasma.

    Hydrochlorothiazide

    When combined with thiazide diuretics, the following drugs can interact:

    Barbiturates, narcotic drugs, ethanol may potentiate the risk of developing orthostatic hypotension.

    Hypoglycemic agents (oral and insulin) - a dose adjustment of hypoglycemic agents may be required.

    Other antihypertensives - additive effect is possible.

    Kolestyramine and colestipol reduce the absorption of hydrochlorothiazide.

    Corticosteroids, adrenocorticotropic hormone - a marked decrease in the electrolyte content, in particular, the risk of hypokalemia.

    Pressor amines (e.g., epinephrine and norepinephrine) - possibly reducing the severity of the response to the introduction of pressor amines, not interfering with their use.

    Muscle relaxants of nondepolarizing action type (eg, tubocurarine) - it is possible to strengthen the action muscle relaxants.

    Lithium preparations - Diuretics reduce renal clearance of lithium and increase the risk of its toxic effect, so the simultaneous use of these groups of drugs is not recommended.

    NSAIDs, including selective inhibitors of COX-2 - some patients receiving NSAIDs, including COX-2 inhibitors, can reduce the diuretic, natriuretic and antihypertensive effects of diuretics.

    Influence on the results of laboratory studies

    In connection with the effect of thiazide diuretics on calcium metabolism, their reception may distort the results of the study of parathyroid function.

    Special instructions:

    Losartan

    It is necessary to correct the reduced BCC before losartan is administered or to begin treatment with a lower dose.

    Drugs that affect the renin-angiotensin-aldosterone system can increase the concentration of urea in the blood and serum creatinine in patients with bilateral stenosis of the renal arteries or stenosis of the artery of a single kidney.

    During the period of treatment, the potassium content in the blood should be regularly monitored, especially in elderly patients, with renal dysfunction.

    Hydrochlorothiazide

    As in the case of taking any antihypertensive drugs, in some patients there may be a marked symptomatic decrease in blood pressure. Patients are required to monitor for the timely detection of clinical signs of disturbance of the water-electrolyte balance, for example, dehydration,hyponatremia, hypochloraemic alkalosis, hypomagnesemia or hypokalemia, which can develop against intercurrent diarrhea or vomiting. Such patients need control of the serum electrolyte level.

    Thiazide therapy can lead to impaired glucose tolerance. In some cases, a dose adjustment of hypoglycemic agents (including insulin) may be required.

    Thiazides can reduce the excretion of calcium in the urine and cause an episodic and insignificant increase in the serum calcium level. Expressed hypercalcemia may indicate latent hyperparathyroidism.

    Due to the influence of thiazides on calcium metabolism, their administration can distort the results of the investigation of parathyroid gland function, therefore, before the investigation of parathyroid gland functions, the thiazide diuretic should be discarded.

    Elevated blood cholesterol and triglycerides may also be associated with thiazide diuretics.

    In some patients, the use of thiazide diuretics can lead to hyperuricemia and / or gout development. Because the losartan reduces the level of uric acid, its combination with hydrochlorothiazide reduces the severity of hyperuricemia caused by a diuretic.

    In patients receiving thiazides, hypersensitivity reactions can occur even if there is no indication of a history of allergy or bronchial asthma.

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

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

    There were no special clinical studies to assess the effect of the drug on the ability to drive vehicles and work with mechanisms. It should take into account the possibility of developing drowsiness and dizziness, so you need to be careful when doing work that requires increased concentration, especially at the beginning of treatment or with an increase in the dose of the drug.

    Form release / dosage:

    Tablets, film-coated, 50 mg + 12.5 mg, 100 mg + 25 mg.

    Packaging:

    For 7, 10 or 14 tablets in a blister of PVC / PVDC / aluminum foil; 2, 4 blisters (7 tablets each), or 1, 3, 9, 10 blisters (10 tablets each), or 1, 2 blisters (14 tablets) together with instructions for use in a cardboard box.

    Storage conditions:

    At a temperature of no higher than 30 ° C.

    Keep out of the reach of children.
    Shelf life:

    3 years.

    Do not use after expiry date.

    Terms of leave from pharmacies:On prescription
    Registration number:LSR-005199/08
    Date of registration:03.07.2008 / 10.12.2015
    Expiration Date:Unlimited
    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: & nbsp11.01.2017
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