Lozap Plus pills 50mg+12.5mg, 60pcs

Composition

1 film-coated tablet contains active ingredients:  

Losartan potassium 50 mg and hydrochlorothiazide 12.5 mg

Auxiliary substances

Mannitol,

microcrystalline cellulose,

croscarmellose sodium,

povidone,

magnesium stearate,

hypromellose 2910/5,

macrogol 6000,

talc,

simethicone emulsion,

Opaspray yellow M-1-22801 (Opaspray yellow M-1-22801) (which includes: purified water, titanium dioxide, denatured ethanol (methylated alcohol BP) (99% ethanol: 1% methanol), hypromellose, Quinolin Yellow dye (E 104), Pounceau 4R dye (E 124)).

DESCRIPTION

Oblong tablets of light yellow color, film-coated, with a risk dividing in half on both sides.

Pharmacological action

PHARMACOTHERAPEUTIC GROUPPOTENSIVE COMBINATION AGENT (angiotensin II receptor blocker + diuretic)ATX code: C 09DA 01 PHARMACOLOGICAL propertiespharmacodynamiccombinated drug, has a hypotensive effect. Contains losartan potassium, an angiotensin II receptor antagonist (AT subtype 1) and hydrochlorothiazide, a diuretic. Losartan is a specific angiotensin II receptor antagonist (AT subtype 1). It does not inhibit kinase II, an enzyme that destroys bradykinin. Reduces total peripheral vascular resistance (OPSS), blood concentrations of epinephrine and aldosterone, blood pressure( BP), pressure in the small circle of blood circulation; reduces afterload, has a diuretic effect. Prevents the development of myocardial hypertrophy, increases exercise tolerance in patients with chronic heart failure. Hydrochlorothiazide is a thiazide diuretic. Reduces Na+ reabsorption, increases urinary excretion of K+, bicarbonate, and phosphates. Lowers blood pressure by reducing the volume of circulating blood (BCC), changing the reactivity of the vascular wall, reducing the pressor effect of vasoconstrictors and increasing the depressive effect on the ganglia. Pharmacokineticalosartan is rapidly absorbed from the gastrointestinal tract. Bioavailability is about 33%. It has a “first pass” effect through the liver, is metabolized by carboxylation to form an active metabolite. Binding to plasma proteins is 99%. The time to reach the maximum concentration of losartan is 1 hour, the active metabolite 3-4 hours, after oral use. The elimination 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 intestines. Hydrochlorothiazide is rapidly absorbed from the gastrointestinal tract. The elimination half-life is 5.8 – 14.8 hours. It is not metabolized by the liver. About 61% is excreted unchanged by the kidneys.

Indications

-Arterial hypertension (in patients for whom combination therapy is optimal);-Reduction of the risk of cardiovascular diseases and mortality in patients with arterial hypertension and left ventricular hypertrophy.

Contraindications

-hypersensitivity to the components of the drug; – anuria; – severe hypotension; – severe liver and kidney function disorders (creatinine clearance ? 30 ml / s); – hypovolemia (including against the background of high doses of diuretics); – pregnancy and lactation; – age up to 18 years (efficacy and safety have not been established). Use caution in patients with bilateral renal stenosis or stenosis of the artery of a single kidney. With caution, the drug is prescribed in patients with diabetes mellitus, hypercalcemia, hyperuricemia and/or gout, as well as in patients with a burdened allergic history and bronchial asthma, as well as in patients with systemic connective tissue diseases (including systemic lupus erythematosus).

Side effects

Adverse reactions are limited to those previously observed with losartan potassium and / or hydrochlorothiazide. The most common side effects in the treatment of essential hypertension include dizziness. Allergic reactions: angioedema, including laryngeal and/or tongue edema, resulting in airway obstruction, and/or swelling of the face, lips, pharynx, and/or tongue, occasionally reported with losartan. Some of these patients have previously experienced angioedema with other medications, including ACE inhibitors. Extremely rare cases of vasculitis, including Schonlein-Heinoch disease, have been reported with losartan. From the cardiovascular system: reduction of blood pressure. From the digestive tract: when taking losartan, rare cases were recorded (From the respiratory system: when taking losartan – cough. Skin disorders: urticaria. Laboratory parameters: rare (

Interaction

Losartan enhances the effect of other antihypertensive agents. There were no clinically significant interactions with hydrochlorothiazide, digoxin, indirect anticoagulants, cimetidine, phenobarbital, ketokenazole, or erythromycin. As with other drugs that block angiotensin II or its effects, concomitant use of potassium-sparing diuretics (for example, spironolactone, triamterene, amiloride), potassium preparations, or salt substitutes containing potassium may lead to hyperkalemia. Hydrochlorothiazidethe following medications may interact with thiazide diuretics when administered concomitantly:  Barbiturates, narcotic analgesics, ethanol – the potential for orthostatic hypotension may occur. Hypoglycemic agents (oral agents and insulin)-dose adjustment of hypoglycemic agents may be required. Other antihypertensive agents – an additive effect is possible. Colistyramine reduces the absorption of hydrochlorothiazide. Corticosteroids, ACTH-increased loss of electrolytes, especially potassium. Pressor amines – it is possible to slightly reduce the effect of pressor amines, which does not prevent their use. Non-depolarizing muscle relaxants (for example, tubocurarine) – may increase the effect of muscle relaxants. Lithium diuretics reduce the renal clearance of Li+ and increase the risk of lithium intoxication, so concomitant use is not recommended. Nonsteroidal anti-inflammatory drugs (NSAIDs) – in some patients, NSAID use may reduce the diuretic, natriuretic, and hypotensive effects of diuretics. Effects on laboratory test results Due to their effect on calcium excretion, thiazides may affect the results of parathyroid gland function analysis.

How to take, course of use and dosage

Inside, regardless of the meal. Arterial hypertension The usual initial and maintenance dose of LOZAP PLUS is 1 tablet per day. For those patients who do not manage to achieve adequate blood pressure control at this dosage, the dose of LOZAP PLUS can be increased to 2 tablets once a day. The maximum dose is 2 tablets once a day. In general, the maximum hypotensive effect is achieved within 3 weeks after the start of treatment. There is no need for special selection of the initial dose for elderly patients. Reduced risk of cardiovascular disease and mortality in patients with arterial hypertension and left ventricular hypertrophy The standard initial dose of LOZAP (losartan) is 50 mg once a day. Patients who failed to achieve the target blood pressure levels while taking LOZAP (losartan) 50 mg / day should be selected for therapy by combining losartan with low doses of hydrochlorothiazide (12.5 mg) – LOZAP PLUS, and, if necessary, the dose should be increased to 2 tablets of LOZAP PLUS (a total of 100 mg of losartan and 25 mg of hydrochlorothiazide per day once).

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 flushed; if necessary, correction of water-electrolyte disorders is carried out. Losartan and its active metabolites are not removed by hemodialysis.

Special instructions

LOZAP PLUS can be prescribed together with other antihypertensive agents. There is no need for a special selection of the initial dose for elderly patients. The drug may increase the concentration of urea and creatinine in blood plasma in patients with bilateral renal artery stenosis or stenosis of the renal artery of a single kidney. Hydrochlorothiazide can increase arterial hypotension and water-electrolyte balance disorders (decrease in the volume of circulating blood, hyponatremia, hypochloremic alkalosis, hypomagnesemia, hypokalemia), disrupt glucose tolerance, reduce the excretion of Ca2+ in the urine and cause a transient slight increase in the concentration of Ca2+ in blood plasma, increase the concentration of cholesterol and triglycerides, provoke the occurrence of hyperuricemia and/or gout. Taking medications that directly affect the renin-angiotensin system during the second and third trimesters of pregnancy can lead to fetal death. If pregnancy occurs, discontinuation of the drug is indicated. The use of diuretics is usually not recommended for pregnant women due to the risk of jaundice in the fetus and newborn, and maternal thrombocytopenia. Diuretic therapy does not prevent the development of pregnancy toxicosis. There is no information about the impact on the ability to drive a car and other mechanisms.

Form of production

Film-coated tablets 50 mg / 12.5 mg. 14 tablets each in an Al/PVC foil container. 2 blisters together with the instructions for use are placed in a cardboard box. 10 tablets in a blister of Al/PVC foil,1,3 or 9 blisters (10,30 or 90 tablets) together with the instructions for use are placed in a cardboard box.

Storage conditions

List B. Keep dry and out of reach of children at temperatures up to 30 C.

Shelf

life is 3 years. Do not use after the expiration date indicated on the package.

Active ingredient

Hydrochlorothiazide, Losartan

Conditions of release from pharmacies

By prescription

Dosage form

Tablets

Purpose

For adults as directed by your doctor

Indications

Hypertension, Prevention of heart attacks and strokes