Lozap Plus, 50 mg+12, 5 mg 30 pcs

Lozap plus is a hypotensive, diuretic.

Pharmacokinetics

Lozartan is rapidly absorbed from the gastrointestinal tract. Bioavailability is about 33%. It has a “first pass” effect through the liver and is metabolized by carboxylation to form the active metabolite.

Binding to plasma proteins is 99%. Time to reach Cmaxlozartan – 1 hour, active metabolite – 3-4 hours after oral administration. T1/2 is 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. T1/2 is 5.8-14.8 hours.

It is not metabolized by the liver. About 61% is excreted unchanged by the kidneys. Pharmacodynamics Combined drug, has hypotensive effect.

Contains potassium losartan – angiotensin II receptor antagonist (AT1 subtype) – and hydrochlorothiazide – diuretic. Losartan is a specific angiotensin II receptor antagonist (AT1 subtype).

It does not inhibit kinase II, an enzyme that degrades bradykinin. Reduces RPS, blood concentrations of adrenaline and aldosterone, BP, pressure in the small circulatory circle; reduces post-load, has a diuretic effect.

Inhibits the development of myocardial hypertrophy, increases exercise tolerance in patients with chronic heart failure. Hydrochlorothiazide is a thiazide diuretic. It reduces Na+ reabsorption, increases urinary excretion of K+, hydrogen carbonate and phosphate. Lowers BP by reducing the blood circulation, changing the reactivity of the vascular wall, reducing the pressor effect of vasoconstrictors.

Indications

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

Composition

Active substances:

losartan potassium 50 mg;

hydrochlorothiazide 12.5 mg;

Associates:

MCC;

mannitol;

croscarmellose sodium;

povidone 30;

magnesium stearate;

p> hypromellose;

macrogol;

talc;

dimethicone emulsion;

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

How to take, the dosage

Ingestion, regardless of meals.

The usual starting and maintenance dose is 1 tablet daily. For those patients in whom adequate BP cannot be achieved at this dosage, the dose of the drug may be increased to 2 tablets once daily.

The maximum dose is 2 tablets once daily. 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 starting dose in elderly patients.

Interaction

Lozartan enhances the effect of other hypotensive agents. No clinically significant interaction with digoxin, indirect anticoagulants, cimetidine, phenobarbital, ketoconazole, erythromycin has been noted.

As with other drugs that block angiotensin II or its effects, simultaneous administration of potassium-saving diuretics (e.g., spironolactone, triamterene, amiloride), potassium preparations or substitute salts containing potassium may lead to hyperkalemia.

Hydrochlorothiazide. May interact with thiazide diuretics when the following drugs are prescribed concomitantly:

Barbiturates, narcotic analgesics, ethanol – potentiation of orthostatic hypotension may occur;

Hypoglycemic agents (oral agents and insulin) – correction of the dose of hypoglycemic agents may be required;

Other hypotensive agents – possible additive effect;

Colestyramine – decreased absorption of hydrochlorothiazide;

Corticosteroids, ACTH – increased loss of electrolytes, especially potassium;

depolarizing myorelaxants (e.g., tubocurarin) – possible increase in myorelaxant action;

Lithium preparations – Diuretics decrease renal clearance of Li+ and increase the risk of lithium intoxication, so concomitant use is not recommended;

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

Thiazides may affect the results of parathyroid function tests due to their effect on calcium excretion.

Special Instructions

Lozap plus may be administered together with other hypotensive agents.

The drug may increase plasma urea and creatinine concentrations in patients with bilateral renal artery stenosis or renal artery stenosis of the single kidney.

. Hydrochlorothiazide may exacerbate water-electrolyte balance disorders (decreased RBC, hyponatremia, hypochloremic alkalosis, hypomagnesemia, hypokalemia), impair glucose tolerance, decrease the urinary excretion of Ca2+ and cause transient slight increase in plasma Ca2+ concentration, increase the concentration of cholesterol and triglycerides, provoke the occurrence of hyperuricemia and/or gout.

Contraindications

Developed arterial hypotension; hypersensitivity to the components of the drug; anuria; severe hepatic and renal dysfunction (Cl creatinine hypovolemia (including against high doses of diuretics); pregnancy and lactation; age under 18 years (effectiveness and safety are not established).

With caution: patients with diabetes, hypercalcemia, hyperuricaemia and/or gout; patients with bilateral renal stenosis / stenosis of the artery of the only kidney; patients with aggravated allergic anamnesis and bronchial asthma, as well as in systemic connective tissue diseases (including systemic lupus erythematosus).including systemic lupus erythematosus).

Side effects

Skin disorders: urticaria.

Cardiovascular system: decreased BP.

Gastrointestinal disorders: rare cases have been reported while taking losartan.

Respiratory system: when taking losartan – cough.

Allergic reactions: angioedema, including swelling of the larynx and/or tongue, leading to airway obstruction, and/or swelling of the face, lips, pharynx and/or tongue occasionally noted while taking losartan.

Some of the patients with the above allergic reactions have previously had angioedema when using other drugs, including ACE inhibitors.

In extremely rare cases of vasculitis, including Schoenlein-Henoch disease, have been reported while taking losartan.

Laboratory findings: rare (5.5 mmol/L), increased hepatic transaminase activity.

Overdose

Symptoms: losartan – tachycardia, marked BP decrease, bradycardia (as a result of vagus stimulation); hydrochlorothiazide – electrolyte loss (hyperchloremia, hypokalemia, hyponatremia), and dehydration resulting from excessive diuresis.

Treatment: symptomatic and supportive therapy.

If the drug has been taken recently, the stomach should be flushed; if necessary, correction of water-electrolyte disturbances should be performed. Lozartan and its active metabolites are not excreted by hemodialysis.

Pregnancy use

The administration of drugs acting directly on the renin-angiotensin system during the second and third trimesters of pregnancy may lead to fetal death. If pregnancy occurs, withdrawal of the drug is indicated.

The use of diuretics in pregnant women is generally not recommended due to the risk of jaundice in the fetus and newborn, thrombocytopenia in the mother. Diuretic therapy does not prevent the development of toxemia of pregnancy.