Active substanceHydrochlorothiazide + LosartanHydrochlorothiazide + Losartan
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  • Dosage form: & nbspfilm-coated tablets
    Composition:

    1 tablet, film-coated, contains:

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

    Excipients: lactose 111.55 mg, microcrystalline cellulose 37.2 mg, pregelatinized starch 35 mg, magnesium stearate 3.75 mg;

    sheath: opadray green [giprolosa, hypromellose, titanium dioxide, dye quinoline yellow] 7.8 mg.

    Description:Oblong biconvex tablets, covered with a yellow or yellow coating with a greenish tinge.
    Pharmacotherapeutic group:Hypotensive combined agent (angiotensin II receptor blocker + diuretic)
    ATX: & nbsp

    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 ATI) and hydrochlorothiazide diuretic.

    Losartan is a specific antagonist of angiotensin II receptors (ATI subtype). Do not suppress the kinase II 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, a decrease in the pressor effect of vasoconstrictors and an increase in the denser effect on the ganglion.

    Pharmacokinetics:

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

    Hydrochlorothiazide is rapidly 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).
    Contraindications:

    - Pincreased sensitivity to the components of the drug;

    - anuria;

    - severe arterial hypotension;

    - expressed violations of the liver and kidneys (creatinine clearance <30 ml / s);

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

    - pregnancy and lactation;

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

    Carefully:

    - Patients with bilateral renal stenosis or stenosis of the artery of a single kidney.

    - patients with diabetes mellitus, hypercalcemia, hyperuricemia and / or gout.

    - patients with a history of allergic anamnesis and bronchial asthma.

    - with systemic diseases of connective tissue (including systemic lupus erythematosus).

    Dosing and Administration:

    Inside, regardless of food intake.

    The usual initial and maintenance dose of the drug is 1 tablet per day. For those patients who do not manage to achieve adequate control of blood pressure at this dosage, the dose can be increased to 2 tablets once a day. The maximum dose is 2 tablets once a day.In general, the maximum antihypertensive effect is achieved within 3 weeks after the start of treatment. 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 potassium losartan and / or hydrochlorohiazide.

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

    Allergic reactions: angioedema, including swelling of the larynx and / or tongue, resulting in airway obstruction, and / or edema of the face, lips. pharynx and / or tongue, occasionally noted when taking 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 Shenlen-Henoch disease.

    From the cardiovascular system: lowering of blood pressure.

    From 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

    5.5 mmol / l), increased activity of "liver" transaminases.

    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 strengthens the effect of other antihypertensive drugs. There was no clinically significant interaction with hydrochlorothiazide, digoxin. indirect anticoagulants, cimetidine, phenobarbital, ketokenazole. erythromycin. Like other drugs that block angiotensin II or its effect, the simultaneous administration of potassium-sparing diuretics (eg, spironolactone, triamterene, amiloride), potassium or salt substitutes containing potassium, can lead to hyperkalemia.

    Hydrochlorothiazide

    The following medicines can interact with thiazide diuretics with the simultaneous appointment:

    Barbiturates, narcotic drugs, ethanol - Potentiation of orthostatic hypotension may occur.

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

    Other antihypertensives - additive effect is possible.

    Kolestyramine reduces the absorption of hydrochlorothiazide.

    Corticosteroids, ACTH increased loss of electrolytes, especially potassium.

    Pressor amines - a slight decrease in the effect of pressor amines, which does not prevent their use, is possible.

    Nondepolarizing muscle relaxants (eg, tubocurarine) it is possible to increase the effect of muscle relaxants.

    Lithium preparations - diuretics reduce renal clearance of GH and increase the risk of lithium intoxication, so simultaneous use is not recommended.

    Non-steroidal anti-inflammatory drugs (NSAIDs) - in some patients, the use of NSAIDs may reduce the diuretic, sodium, and hypotensive effects of diuretics.

    Impact on laboratory results

    Due to the effect on calcium excretion, thiazides can influence the results of parathyroid gland function analysis.

    Special instructions:

    Cardomin plus - sanovel can be prescribed together with other antihypertensive drugs. There is no need for a special selection of an initial dose for elderly patients. The drug can increase the concentration of urea and creatinine in the blood plasma in patients with bilateral stenosis of the renal arteries or stenosis of the renal artery of a single kidney.

    Hydrochlorothiazide can increase arterial hypotension and disturbances of water-electrolyte balance (decrease in the volume of circulating blood, hyponatremia, hypochloraemic alkalosis, hypomagnesemia, hypokalemia), impair glucose tolerance, reduce calcium excretion in the urine and cause a slight slight increase in calcium concentration in the blood plasma, increase concentration cholesterol and triglycerides, to provoke the emergence of hyperuricemia and / or gout. The intake of drugs directly acting on the renin-angiotensin system during the second and third trimesters of pregnancy can lead to fetal death. When pregnancy occurs, the drug is canceled.

    Pregnant women use of diuretics is usually not recommended due to the risk of jaundice in the fetus and newborn, thrombocytopenia of the mother. Diuretic therapy does not prevent the development of pregnancy toxicity.

    Effect on the ability to drive transp. cf. and fur:There is no information on the effect on the ability to drive and other mechanisms.
    Form release / dosage:
    Tablets, film-coated 12.5 mg + 50 mg.
    Packaging:

    For 14 tablets in a blister of PVC-aluminum foil.

    For 2 or 6 blisters in a cardboard pack together with instructions for use.

    Storage conditions:At a temperature of no higher than 30 ° C. Keep out of the reach of children.
    Shelf life:2 years. Do not use after the date shown on the package.
    Terms of leave from pharmacies:On prescription
    Registration number:LSR-008491/08
    Date of registration:24.10.2008 / 01.08.2017
    Expiration Date:Unlimited
    The owner of the registration certificate:AKRIKHIN HFK, JSC AKRIKHIN HFK, JSC Russia
    Manufacturer: & nbsp
    Representation: & nbspAKRIKHIN OJSC AKRIKHIN OJSC Russia
    Information update date: & nbsp12.12.2017
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