Lorista

1 tablet contains:

 losartan potassium 

hydrochlorothiazide 

Excipients:

pregelatinized starch,

microcrystalline cellulose,

lactose monohydrate,

magnesium stearate,

hypromellose,

macrogol 4000,

dye quinoline yellow (E104),

titanium dioxide (E171),

talc.

Lorista ND - a combined preparation; has a hypotensive effect. Losartan is a selective antagonist of angiotensin II receptors (type AT1) for oral administration, non-protein nature. In vivo and in vitro, losartan and its biologically active carboxylic metabolite (EXP-3174) block all physiologically significant effects of angiotensin II on AT1 receptors, regardless of the pathway of its synthesis: it leads to an increase in the activity of blood plasma renin, reduces the concentration of aldosterone in the blood plasma, etc. Losartan indirectly induces the activation of AT2 receptors by increasing the level of angiotensin II. Losartan does not inhibit the activity of kininase II, an enzyme that is involved in the metabolism of bradykinin.

Reduces total peripheral vascular resistance (OPSS), 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 (CHF). Taking losartan once a day leads to a statistically significant decrease in systolic and diastolic blood pressure (BP).

Losartan evenly controls blood pressure throughout the day, while the antihypertensive effect corresponds to the natural circadian rhythm. The decrease in blood pressure (BP) at the end of the dose of the drug was approximately 70-80% of the effect at the peak of the drug, 5-6 hours after administration.

Withdrawal syndrome is not observed; also losartan does not have a clinically significant effect on the heart rate (HR). Losartan is effective in men and women, as well as in the elderly (&> 65 years) and younger patients (& <65 years). Hydrochlorothiazide. Thiazide diuretic, the diuretic effect of which is associated with impaired reabsorption of sodium, chlorine, potassium, magnesium, water ions in the distal nephron; delays the excretion of calcium ions, uric acid. It has antihypertensive properties; the hypotensive effect develops due to the expansion of arterioles. Virtually no effect on normal blood pressure (BP).

The diuretic effect occurs in 1-2 hours, reaches a maximum in 4 hours and lasts 6-12 hours. The antihypertensive effect occurs after 3-4 days, but it may take 3-4 weeks to achieve the optimal therapeutic effect.

• Arterial hypertension;
• chronic heart failure.

There are no data on the use of losartan during pregnancy.

Renal perfusion of the fetus, which depends on the development of the renin-angiotensin system, begins to function in the third trimester of pregnancy.

The risk to the fetus increases when losartan is taken in the second and third trimesters.

When pregnancy is established, Lorista ND therapy should be discontinued immediately.

If it is necessary to prescribe the drug during lactation, it is necessary to stop breastfeeding.

Hypersensitivity to losartan, to drugs that are derivatives of sulfonamides and other components of the drug, anuria, severe renal dysfunction (creatinine clearance (CC) less than 30 ml / min.), Hyperkalemia, dehydration (including when taking high doses of diuretics) , severe liver dysfunction, refractory hypokalemia, pregnancy, lactation period, arterial hypotension, age up to 18 years (efficacy and safety have not been established), lactase deficiency, galactosemia or glucose / galactose malabsorption syndrome.

On the part of the blood and lymphatic system: infrequently - anemia, Schönlein-Henoch disease.

From the immune system: rarely - anaphylactic reactions, angioedema (including edema of the larynx and tongue, causing airway obstruction and / or edema of the face, lips, pharynx).

From the side of the central nervous system and peripheral nervous system: often - headache, systemic and non-systemic dizziness, insomnia, fatigue; infrequently - migraine.

From the side of the cardiovascular system: often - orthostatic hypotension (dose-dependent), palpitations, tachycardia; rarely - vasculitis.

From the respiratory system: often - cough, upper respiratory tract infections, pharyngitis, swelling of the nasal mucosa.

From the gastrointestinal tract: often - diarrhea, dyspepsia, nausea, vomiting, abdominal pain.

From the hepatobiliary system: rarely - hepatitis, liver dysfunction.

On the part of the skin and subcutaneous fat: infrequently - urticaria, itching.

From the musculoskeletal system and connective tissue: often - myalgia, back pain; infrequently - arthralgia.
Others: often - asthenia, weakness, peripheral edema, chest pain.

Laboratory indicators: often - hyperkalemia, increased concentration of hemoglobin and hematocrit (clinically not significant); sometimes - a moderate increase in serum urea and creatinine levels; very rarely - an increase in the activity of liver enzymes and bilirubin.

Losartan In clinical studies of pharmacokinetic interactions, no clinically significant interactions of the drug with hydrochlorothiazide, digoxin, warfarin, cimetidine, phenobarbital, ketoconazole and erythromycin were detected. Rifampicin and fluconazole reduce the level of the active metabolite (this interaction has not been clinically studied).

The combination of losartan with potassium-sparing diuretics (spironolactone, triamterene, amiloride), potassium-sparing supplements, or potassium salts can lead to hyperkalemia. NSAIDs, including selective inhibitors of cyclooxygenase-2, can reduce the effect of diuretics and other antihypertensive drugs, including losartan. In patients with impaired renal function treated with NSAIDs (including cyclooxygenase-2 inhibitors), therapy with angiotensin II receptor antagonists may lead to further deterioration of renal function, including acute renal failure, which is usually reversible. The antihypertensive effect of losartan, like other antihypertensive drugs, can be reduced when taking indomethacin.

Hydrochlorothiazide With thiazide diuretics, drugs such as ethanol, barbiturates, and narcotics may potentiate the risk of orthostatic hypotension.

Hypoglycemic agents (oral and insulin) - dose adjustment of hypoglycemic agents may be required. Other antihypertensive drugs - additive effect. Colestyramine and colestipol - in the presence of anionic exchange resins, the absorption of hydrochlorothiazide is impaired. Corticosteroids, ACTH (adrenocorticotropic hormone) - a marked decrease in electrolyte levels, in particular hypokalemia.

Pressor amines (for example, epinephrine, norepinephrine) - a decrease in the severity of the response to the intake of pressor amines. Muscle relaxants of a non-depolarizing type of action (for example, tubocurarine) - an increase in the effect of muscle relaxants. Lithium - diuretics reduce the renal clearance of lithium and increase the risk of developing toxic effects of lithium; simultaneous use is not recommended. NSAIDs (including cyclooxygenase-2 inhibitors) - can reduce the diuretic, natriuretic and hypotensive effect of diuretics. Due to the effect on calcium metabolism, their intake may distort the results of the study of the function of the parathyroid glands.

Inside, regardless of food intake. Lorista ND can be combined with other antihypertensive drugs. Arterial hypertension The initial and maintenance dose is 1 tablet of Lorista ND (100/25 mg) once a day. As a rule, the drug is prescribed in the absence of an adequate therapeutic effect of Lorista N (50 / 12.5 mg).

The maximum antihypertensive effect is achieved within three weeks of therapy. The maximum daily dose is 1 tablet of Lorista ND. In patients with a reduced circulating blood volume (for example, while taking large doses of diuretics), the recommended starting dose of losartan in patients with hypovolemia is 25 mg once a day. In this regard, therapy with Lorista ND should be started after discontinuation of diuretics and correction of hypovolemia.

In elderly patients and patients with moderate renal insufficiency (creatinine clearance 30-50 ml / min), including those on dialysis, no adjustment of the initial dose is required. Reducing the risk of cardiovascular morbidity and mortality in patients with arterial hypertension and left ventricular hypertrophy

The standard starting dose of losartan is 50 mg once a day. Patients who failed to achieve target blood pressure levels while taking losartan 50 mg / day need to select therapy by combining losartan with low doses of hydrochlorothiazide (12.5 mg), and, if necessary, increase the dose of losartan to 100 mg per day. in combination with hydrochlorothiazide at a dose of 12.5 mg / day, then increase to 1 tablet of Lorista ND 100/25 mg in total (100 mg of losartan and 25 mg of hydrochlorothiazide per day, once).

Losartan 
Symptoms: marked decrease in blood pressure, tachycardia; bradycardia due to parasympathetic (vagal) stimulation. 
Treatment: forced diuresis, symptomatic therapy, hemodialysis is ineffective.

Hydrochlorothiazide 
Symptoms: The most common symptoms are due to electrolyte deficiency (hypokalemia, hypochloremia, hyponatremia) and dehydration due to excessive diuresis. With the simultaneous administration of cardiac glycosides, hypokalemia can aggravate the course of arrhythmias. 
Treatment: symptomatic.

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

Hydrochlorothiazide can increase arterial hypotension and disturbances in water and electrolyte balance (decrease in circulating blood volume, hyponatremia, hypochloremic alkalosis, hypomagnesemia, hypokalemia), impair glucose tolerance, reduce urinary calcium excretion and cause a transient, slight increase in the concentration of calcium in the blood plasma the concentration of cholesterol and triglycerides, provoke the occurrence of hyperuricemia and / or gout.

Taking drugs that directly act on the renin-angiotensin system during the II and III trimesters of pregnancy can lead to fetal death.

When pregnancy occurs, drug withdrawal is indicated. The use of diuretics is usually not recommended for pregnant women due to the risk of jaundice in the fetus and newborn, thrombocytopenia in the mother. Diuretic therapy does not prevent the development of pregnancy toxicosis.

Lorista N film-coated tablets.