Lozap Plus pills 50mg+12.5mg, 90pcs

Composition

Active ingredients:

losartan potassium 50 mg;

hydrochlorothiazide 12.5 mg;

Auxiliary substances:

MCC;

mannitol;

croscarmellose sodium;

povidone 30;

magnesium stearate;

hypromellose;

macrogol; talc;

dimethicone emulsion;

Opaspray Yellow M-1-22801 dye (which includes: purified water, titanium dioxide, BP methyl alcohol, hypromellose, Quinolin Yellow (E104), Ponceau 4R (E124))

Pharmacological action

Lozap plus – antihypertensive, diuretic.

Pharmacodynamics

Combined drug, has a hypotensive effect. Contains losartan potassium, an angiotensin II receptor antagonist (AT subtype 1) “and a hydrochlorothiazide diuretic. “

Losartan is a specific angiotensin II receptor antagonist (AT subtype 1).

It does not inhibit kinase II, an enzyme that destroys bradykinin. Reduces OPSS, the concentration of epinephrine and aldosterone in the blood, blood pressure, 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 it Blood pressure by reducing BCC, changing the reactivity of the vascular wall, reducing the pressor effect of vasoconstrictors.

Pharmacokinetics

Losartan 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 Cmaxlosartan is 1 hour, the active metabolite is 3-4 hours after oral use. T1/2 — 1,5–2 and its main metabolite — 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. T1/2 — 5,8–14,8 h. 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).

Use during pregnancy and lactation

Taking drugs 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 thrombocytopenia in the mother. Diuretic therapy does not prevent the development of pregnancy toxicosis.

Contraindications

• hypersensitivity to the components of the drug;
• anuria;
• severe hypotension;
• severe liver and kidney function disorders (creatinine
• clearance hypovolemia (including against the background of high doses of diuretics);
• pregnancy;
• lactation;
• age up to 18 years (efficacy and safety have not been established).

With caution:

• 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 burdened allergic history and bronchial asthma, as well as with systemic connective tissue diseases (including systemic lupus erythematosus).

Side effects

Allergic reactions:  angioedema, including laryngeal and/or tongue edema leading to airway obstruction, and/or swelling of the face, lips, pharynx, and/or tongue that has occasionally occurred with losartan.

Some of the patients with the above-mentioned allergic reactions have previously experienced angioedema when using other drugs, including ACE inhibitors. Extremely rare cases of vasculitis, including Schonlein-Henoch disease, have been reported with losartan.

From the cardiovascular system:  reduction of blood pressure.

From the digestive tract:  when taking losartan, rare cases have been reported (

Respiratory system disorders:  when taking losartan — cough.

From the side of the skin:  urticaria.

Laboratory parameters:  rarely (5.5 mmol / l), increased activity of hepatic transaminases.

Interaction

Losartan enhances the effect of other antihypertensive agents. There was no clinically significant interaction with digoxin, indirect anticoagulants, cimetidine, phenobarbital, ketoconazole, and erythromycin.

As with other drugs that block angiotensin II or its effects, concomitant use of potassium-sparing diuretics (such as spironolactone, triamterene, amiloride), potassium preparations, or salt substitutes containing potassium may lead to hyperkalemia.

Hydrochlorothiazide. The following drugs may interact with thiazide diuretics when administered concomitantly: :

barbiturates, narcotic painkillers, ethanol – potentiation of orthostatic hypotension may occur;

hypoglycemic agents (oral agents and insulin) — it may be necessary to adjust the dose of hypoglycemic agents;

other antihypertensive agents-an additive effect is possible;

colestyramine-a decrease in the absorption of hydrochlorothiazide;

corticosteroids, ACTH-increased loss of electrolytes, especially potassium;

non-depolarizing muscle relaxants (for example, tubocurarine) — it is possible to increase the effect

of muscle relaxants; lithium diuretics reduce the renal clearance of Li+ and increase the risk of lithium intoxication, so simultaneous use is not recommended;

NSAIDs — in some patients, the use of NSAIDs may reduce the diuretic, natriuretic and hypotensive effects of diuretics.

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

How to take, course of use and dosage

Inside, regardless of the meal.

The usual starting and maintenance dose is 1 tablet per day. For those patients who do not achieve adequate blood pressure at this dosage, the dose of the drug 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 special selection of the initial dose in elderly patients.

Overdose

Symptoms:  losartan — a 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 care. If the drug is taken recently, the stomach should be washed; 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 administered together with other antihypertensive agents.

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 may increase disturbances in the water-electrolyte balance (decrease in BCC, 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.

Composition

Tablet Form of production

Storage conditions

In a dry place, at a temperature not exceeding 30 °C.

Shelf life

3 years

Active ingredient

Hydrochlorothiazide, Losartan

Conditions of release from pharmacies

By prescription

Dosage form

Tablets

Description

For adults as directed by your doctor

Indications

Hypertension, Prevention of heart attacks and strokes