Expiration date: 10/2025

Composition:

Active ingredients: losartan potassium, hydrochlorothiazide 

Indications for use:

Arterial hypertension (in patients, which shows the combined therapy),

Reducing the risk of cardiovascular morbidity and mortality in patients with hypertension and left ventricular hypertrophy.

Contraindications:

Hypersensitivity to losartan, a derivative of sulfonamide and other auxiliary substances,

Anuria, severe renal failure (creatinine clearance (CC) less than 30 ml/min),

Severe hepatic impairment, cholestasis and obstructive disease of the biliary tract,

The age of 18 years (efficacy and safety not established),

Hypokalemia or hypercalcemia that is resistant to therapy

Refractory hyponatremia,

Symptomatic hyperuricemia / gout,

Pregnancy, breastfeeding,

Lactase deficiency, lactose intolerance, syndrome of glucose-galactose malabsorption, because the preparation includes lactose.

With caution: severe hyponatremia and/or state, accompanied by a decrease in BCC (including diet with restriction of salt, diarrhea, vomiting, therapy with high doses of diuretics), violations of water-electrolyte balance of the blood, diabetes mellitus, renal insufficiency (QC 30-50 ml/min), violations of liver function mild and moderate severity without signs of cholestasis, a history of congestive heart failure (CHF) of III-IV functional class NYHA classification, and other conditions associated with activation of the RAAS, bilateral renal artery stenosis or stenosis of artery only kidneys, condition after kidney transplantation, primary aldosteronism, ischemic heart disease and cerebrovascular disease, because excessive reduction in blood pressure may lead to myocardial infarction and stroke, stenosis of aortic and/or mitral valve, hypertrophic obstructive cardiomyopathy (HACMP), burdened allergological anamnesis (presence of the patient angionevroticheskogo edema in anamnesis in the use of drugs, including angiotensin converting enzyme inhibitors (ACE)) and bronchial asthma, systemic lupus erythematosus, acute myopia and secondary acute angle-closure glaucoma.

Pharmacodynamics:

Combined preparation, components of which have an additive hypotensive effect and cause a more pronounced decrease in blood pressure (BP) in comparison with their separate application. Due to the diuretic action of hydrochlorothiazide increases plasma renin activity blood aldosterone secretion, decreases serum potassium and increases the level of angiotensin II. Losartan blocks the physiological effects of angiotensin II and through inhibition of the secretion of aldosterone can reverse the loss of potassium ions, caused by the diuretic. Losartan has a uricosuric effect. Hydrochlorothiazide causes a moderate increase in the concentration of uric acid, while at the same time use of losartan hydrochlorothiazide decreases hyperuricemia caused by diuretic. Hypotensive effect of the combination gidrokhlorisiazit / losartan lasts for 24 h. Despite a significant decrease in blood pressure, the combination of hydrochlorothiazide / losartan has no clinically significant effect on heart rate (HR).

Pharmacokinetics:

The pharmacokinetics of losartan and gidrohlorotiazida while receiving no different from that in their separate appointment.

Losartan. Well absorbed from the gastrointestinal tract. Undergoes significant metabolism when "first pass" through the liver. Bioavailability is approximately 33%. Tmax — 1 h after ingestion, but its active metabolite— 3-4 h.

More than 99% of losartan is associated with blood plasma proteins, mainly to albumin. The volume of distribution of losartan is 34 L. Very poorly crosses the GEB.

T1/2 of losartan and the active metabolite is 2 h and 6-9 h respectively. It is excreted mainly in the bile — 58%, renal — 35%.

Hydrochlorothiazide. After oral absorption of hydrochlorothiazide is 60-80%. Cmax of hydrochlorothiazide in the blood is achieved through 1-5 hours after ingestion. Linking blood plasma proteins of hydrochlorothiazide is 64%.

Hydrochlorothiazide is not metabolized and is rapidly excreted through the kidneys. T1/2 is 5-15 hours

The method of preparation or use:

Inside, regardless of meals.

The combination of hydrochlorothiazide/losartan is indicated for patients who have when applied separately, or losartan hydrochlorothiazide does not adequately control blood pressure.

Hypertension. The initial and maintenance dose — 1 tab. 1 time per day. The maximum antihypertensive effect is achieved within 3 weeks of treatment. To achieve a more pronounced effect can increase the dose to 2 table. 1 time per day. The maximum daily dose — 2 tab. drug.

Reducing the risk of cardiovascular morbidity and mortality in patients with hypertension and left ventricular hypertrophy. The standard starting dose of losartan is 50 mg 1 time a day.

Patients who have failed to achieve target BP levels in patients receiving losartan 50 mg/day, requires selection of the therapy by combination of losartan with low dose of hydrochlorothiazide (12.5 mg), if necessary, increase dosage of losartan to 100 mg in combination with hydrochlorothiazide dose 12.5 mg/day and further to 2 table (total of 100 mg of losartan and 25 mg hydrochlorothiazide 1 time per day).

Storage conditions:

Keep out of the reach of children, dry, protected from light place, at temperature not above 25 °C.