Lorista N - Instructions For Use, 50 Mg + 12.5 Mg, Price, Reviews, Analogues

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Lorista N

Latin name: Lorista H

ATX code: C09DA01

Active ingredient: losartan + hydrochlorothiazide (losartan + hydrochlorothiazide)

Manufacturer: KRKA (Slovenia), KRKA-RUS (Russia)

Description and photo update: 2018-25-10

Prices in pharmacies: from 259 rubles.

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Lorista N is a combined antihypertensive drug.

Release form and composition

Lorista N is produced in the form of film-coated tablets: oval, slightly biconvex, on one side of the risk, color from yellowish-green to yellow, a white core stands out at the break (7 pcs. In blisters, in a cardboard box 2, 4, 8, 12 or 14 blisters; 10 pcs. In blisters, in a carton of 3, 6 or 9 blisters; 14 pcs. In blisters, in a carton of 1, 2, 4, 6 or 7 blisters) …

1 tablet contains:

• active ingredients: losartan (in the form of potassium losartan) - 50 mg; hydrochlorothiazide - 12.5 mg;
• auxiliary components: microcrystalline cellulose, pregelatinized starch, magnesium stearate, lactose monohydrate;
• film shell: macrogol 4000, hypromellose, titanium dioxide (E171), quinoline yellow dye (E104), talc.

Pharmacological properties

Pharmacodynamics

Lorista N is a combined antihypertensive drug, the effectiveness of which is due to the properties of its active ingredients.

Losartan is a selective antagonist of angiotensin II receptors (AT ₁ -subtype) of non-protein nature. The substance, together with its biologically active carboxyl metabolite EXP-3174, according to in vivo and in vitro studies, blocks all physiologically significant effects of angiotensin II on AT ₁ receptors, regardless of the method of its synthesis, thereby increasing the activity of blood plasma renin and decreasing plasma concentration of aldosterone. Due to an increase in the level of angiotensin II, AT ₂ receptors are indirectly activated. The activity of the enzyme involved in the metabolism of bradykinin - kininase II, it does not inhibit.

Losartan reduces OPSS (total peripheral vascular resistance), lowering pressure in the pulmonary circulation and afterload, and also has a diuretic effect. By preventing myocardial hypertrophy, losartan increases the susceptibility to physical activity in CHF (chronic heart failure).

As a result of taking losartan 1 time per day, systolic and diastolic blood pressure (blood pressure) significantly decreases. During the day, losartan normalizes blood pressure, while the antihypertensive effect is consistent with the natural circadian rhythm. At the end of the action of a single dose of the drug, the decrease in blood pressure was ~ 70–80% of its maximum effect, which occurs 5–6 hours after administration. Losartan does not cause withdrawal symptoms after discontinuation of therapy and does not have a clinically significant effect on heart rate (heart rate). The effectiveness of the substance does not depend on gender (it is the same in men and women), as well as on the age of the patients.

Hydrochlorothiazide is a thiazide diuretic, the diuretic effect of which is based on impaired reabsorption in the distal nephron of chlorine, sodium, magnesium, potassium, and water ions. It delays the elimination of calcium and uric acid ions. Has a hypotensive effect, which develops due to vasodilation of arterioles. Hydrochlorothiazide has practically no effect on normal blood pressure. Its diuretic effect occurs 1–2 hours after administration, reaches a maximum after 4 hours and lasts 6–12 hours. The antihypertensive effect of hydrochlorothiazide develops by 3–4 days, but to obtain the optimal therapeutic effect, long-term therapy may be required, from 3 to 4 weeks …

Pharmacokinetics

The pharmacokinetics of losartan and hydrochlorothiazide when taken in combination does not differ from that when taken separately.

Pharmacokinetic characteristics of losartan:

• absorption: absorbed from the gastrointestinal tract (gastrointestinal tract) well; serum concentrations of the substance do not clinically significantly depend on the diet and quality of food. The bioavailability index is ~ 33%. C _max (maximum concentration) in blood plasma is determined 1 hour after oral administration, and C _{max of} its biologically active carboxylic metabolite EXP -3174 is reached after 3-4 hours;
• distribution: losartan and EXP-3174 are 99% or more bound to blood plasma proteins, mostly albumin. V _d (volume of distribution) is 34 liters. Permeability through the BBB (blood-brain barrier) is extremely low;
• metabolism: undergoes significant first-pass metabolism, the so-called. the effect of the first passage through the liver, with the formation of the active metabolite EXP-3174 (14%) and a number of inactive metabolites;
• elimination: plasma clearance of losartan and its active metabolite EXP-3174 is ~ 600 ml / min (10 ml / s) and 50 ml / min (0.83 ml / s), respectively; renal clearance indices are ~ 74 ml / min (1.23 ml / s) and 26 ml / min (0.43 ml / s), respectively. T _1/2 (half-life) of losartan - 2 hours, metabolite EXP-3174 - 6-9 hours. About 58% of the drug is excreted in the bile, up to 35% - by the kidneys.

Pharmacokinetic characteristics of hydrochlorothiazide:

• absorption and distribution: absorption after oral administration ranges from 60 to 80%. C _max in blood plasma is reached after 1–5 hours. Up to 64% of the substance binds to plasma proteins;
• metabolism and excretion: not metabolized, excreted by the kidneys quickly; T _1/2 is from 5 to 15 hours.

Indications for use

According to the instructions, Lorista N is recommended to be used for the treatment of arterial hypertension in patients for whom combination therapy is indicated.

The drug is also prescribed to reduce the risk of cardiovascular disease and mortality in patients with arterial hypertension and left ventricular hypertrophy.

Contraindications

Absolute:

• severe renal failure with creatinine clearance (CC) <30 ml / min;
• anuria;
• dehydration (including during high-dose diuretic therapy);
• hyperkalemia;
• severe liver failure;
• arterial hypotension;
• refractory hypokalemia;
• lactase deficiency, glucose-galactose malabsorption syndrome, galactosemia;
• the period of pregnancy and lactation (breastfeeding);
• children and adolescents under 18 years of age;
• hypersensitivity to sulfonamide derivatives, losartan and / or any other ingredients of the drug.

Relative contraindications for taking Lorista N, in which the drug should be taken with caution, are: disturbances in the water-electrolyte balance of the blood (hypochloremic alkalosis, hyponatremia, hypokalemia, hypomagnesemia), bilateral renal artery stenosis or stenosis of an artery of a single kidney, diabetes mellitus, hypercalcemia, hyperuricemia and / or gout, aggravated allergic history [angioneurotic edema in some patients developed earlier when taking other drugs, including ACE inhibitors (angiotensin converting enzyme)], bronchial asthma, systemic blood diseases (including systemic lupus erythematosus), concomitant use with NSAIDs (nonsteroidal anti-inflammatory drugs), including with inhibitors of COX (cyclooxygenase) -2.

Instructions for use of Lorista N: method and dosage

Lorista N is intended for oral administration. The timing of taking pills does not depend on the diet. The drug can be combined with other antihypertensive drugs.

For the treatment of arterial hypertension, it is recommended to take Lorista N in the initial and maintenance dose - 1 tablet (50 + 12.5 mg) once a day. The maximum antihypertensive effect occurs by the end of the third week of treatment. In order to achieve a more pronounced therapeutic effect, you can increase the dose of the drug to the maximum allowable - 2 tablets per day for 1 dose.

In the case of a reduced BCC (circulating blood volume), for example, while taking high doses of diuretics, patients with hypovolemia are advised to start treatment with a dose of losartan - 25 mg once a day. In this regard, the reception of Lorista N should be started after stopping diuretic treatment and correcting hypovolemia.

Elderly patients, patients with an average degree of renal insufficiency (with CC 30-50 ml / min), including those on dialysis, do not need to adjust the initial dose.

With arterial hypertension and left ventricular hypertrophy, in order to reduce the risk of cardiovascular pathologies and mortality, losartan is prescribed at an initial dose of 50 mg once a day. If the target blood pressure cannot be achieved while taking losartan in a daily dose of 50 mg, it is necessary to select the dose by combining it with low doses of hydrochlorothiazide (12.5 mg per day). If necessary, the daily dose of losartan should be increased to 100 mg in combination with hydrochlorothiazide at a dose of 12.5 mg, and then the daily dose of Lorista N should be increased to 2 tablets.

Side effects

• central nervous system: often - headaches, dizziness (systemic and non-systemic), fatigue, insomnia; sometimes migraine;
• digestive system: often - nausea / vomiting, diarrhea, dyspepsia, abdominal pain; rarely - liver dysfunction, hepatitis; extremely rarely - an increase in the activity of hepatic transaminases and bilirubin;
• cardiovascular system: often - tachycardia, palpitations, dose-dependent orthostatic hypotension; rarely - vasculitis;
• respiratory system: often - upper respiratory tract infections, cough, pharyngitis, swelling of the nasal mucosa;
• hematopoietic system: infrequently - hemorrhagic vasculitis (Shenlein's purpura - Henoch), anemia;
• musculoskeletal system: often - back pain, myalgia; sometimes - arthralgia;
• hypersensitivity reactions: sometimes - pruritus, urticaria; rarely - anaphylaxis, angioedema (including swelling of the tongue and larynx, causing airway obstruction, and / or swelling of the lips, face, pharynx);
• laboratory data: often - a clinically insignificant increase in the concentration of hematocrit and hemoglobin, hyperkalemia; sometimes - a moderate increase in serum creatinine and urea;
• other reactions: often - weakness, asthenia, chest pain, peripheral edema.

Overdose

Symptoms of an overdose of losartan are tachycardia, a marked decrease in blood pressure and bradycardia caused by vagal (parasympathetic) stimulation.

For treatment, it is recommended to carry out forced diuresis and, if indicated, symptomatic therapy. Hemodialysis is ineffective.

The most common symptoms of hydrochlorothiazide overdose (as a consequence of electrolyte deficiency) are hypokalemia, hypochloremia, hyponatremia, as a result of excessive diuresis - dehydration. With the combined use of cardiac glycosides, hypokalemia can aggravate the course of arrhythmias.

For treatment, it is recommended to carry out a set of therapeutic measures aimed at eliminating symptoms.

special instructions

Lorista N can be taken concomitantly with other antihypertensive drugs.

Due to the use of Lorista N, it is possible to increase the plasma concentration of urea and creatinine in bilateral renal artery stenosis or renal artery stenosis of a single kidney.

Under the influence of hydrochlorothiazide, it is possible to increase arterial hypotension and a violation of the water-electrolyte balance, manifested by a decrease in BCC, hyponatremia, hypochloremic alkalosis, hypomagnesemia, hypokalemia, impaired glucose tolerance, a decrease in the elimination of calcium in the urine and a transient, slight increase in blood plasma concentration cholesterol and TG (thyroglobulin), provoking the appearance of hyperuricemia and / or gout.

Due to the content of lactose in Lorista H tablets, they are not prescribed to patients with lactase deficiency, glucose-galactose malabsorption syndrome, galactosemia.

Influence on the ability to drive vehicles and complex mechanisms

At the beginning of taking Lorista N, some patients may experience side effects such as arterial hypotension and dizziness, which indirectly affect their psychophysical state. These situations require increased attention when performing potentially dangerous types of work, including when driving vehicles. It is necessary to conduct an objective assessment of the body's response to the treatment.

Application during pregnancy and lactation

There are insufficient data from studies of the use of losartan during pregnancy. It is known that the function of renal perfusion of the fetus, which depends on the development of the renin-angiotensin system, is activated in the third trimester of pregnancy, therefore the risk for fetal development when taking losartan increases in the II-III trimesters, since substances acting directly on the renin-angiotensin system taken during this period can lead to fetal death.

Taking diuretics during pregnancy is not recommended due to the risk of jaundice in the fetus / newborn and thrombocytopenia in the mother. Taking diuretics does not help against the development of toxicosis during pregnancy.

If pregnancy is confirmed, Lorista N should be discontinued immediately.

If, according to indications, the drug must be used during lactation, it is necessary to decide on the termination of breastfeeding.

Pediatric use

There is insufficient data on the safety and efficacy of Lorista N in pediatrics, and therefore the drug is contraindicated for the treatment of children and adolescents under the age of 18.

With impaired renal function

Lorista N 50 mg + 12.5 mg is contraindicated for use in severely impaired renal function, as well as in patients on hemodialysis.

For violations of liver function

Lorista N is contraindicated for use in severe liver damage.

Use in the elderly

Elderly patients do not need to adjust the initial dose.

Drug interactions

Losartan

• hydrochlorothiazide, digoxin, warfarin, cimetidine, phenobarbital, ketoconazole, erythromycin: no clinically significant pharmacokinetic interaction with losartan has been identified according to studies;
• rifampicin, fluconazole: reduce the level of the active metabolite of losartan (the clinical significance of this interaction has not been studied);
• potassium-sparing diuretics (triamterene, spironolactone, amiloride), potassium-containing supplements or potassium salts: hyperkalemia may develop;
• NSAIDs (including selective COX-2 inhibitors): can reduce the effectiveness of diuretics, as well as other antihypertensive drugs, including losartan. With impaired renal function in patients who received NSAIDs (including COX-2 inhibitors) in combination with angiotensin II receptor antagonists, further deterioration of renal function may develop, up to acute renal failure (usually reversible);
• indomethacin: may reduce the antihypertensive effect of losartan, like other antihypertensive drugs.

Hydrochlorothiazide

• thiazide diuretics, barbiturates, ethanol, narcotic substances: may increase the likelihood of developing orthostatic hypotension;
• oral hypoglycemic drugs and insulin: dose adjustment may be necessary;
• other antihypertensive drugs: exhibit additive synergy;
• cholestyramine, colestipol: inhibit the absorption of hydrochlorothiazide;
• glucocorticosteroids, adrenocorticotropic hormone: have a pronounced decrease in electrolyte levels, in particular, cause hypokalemia;
• epinephrine, norepinephrine, other pressor amines: hydrochlorothiazide reduces their effectiveness;
• non-depolarizing muscle relaxants, such as tubocurarine: hydrochlorothiazide enhances their effectiveness;
• lithium: diuretics reduce its renal clearance and increase the likelihood of developing toxic effects (simultaneous use is not recommended);
• NSAIDs (including selective COX-2 inhibitors): inhibition of the diuretic, natriuretic and hypotensive effects of diuretics is possible.

Due to the effect of thiazide diuretics on calcium metabolism, their intake can distort the results of studies of the function of the parathyroid glands.

Analogs

Lorista N analogs are: Hydrochlorothiazide + Losartan TAD, Blocktran GT, GIZAAR Forte, Gizaar, Lozarel Plus, Lozap plus, Losartan-N Canon, Losartan N, Losartan / Hydrochlorothiazide-Teva, Lorista ND, Simartan-N,

Terms and conditions of storage

Store at temperatures up to 30 ° C. Keep out of the reach of children.

The shelf life is 3 years.

Terms of dispensing from pharmacies

Dispensed by prescription.

Reviews about Lorista N

According to reviews, Lorista N is an effective combined agent for normalizing blood pressure and reducing puffiness. Patients emphasize the mild action of the drug, its quick therapeutic effect, the possibility of simultaneous use with other drugs, ease of use, and long shelf life.

As disadvantages, some indicate the need for long-term daily use of Lorista N in the morning.

Price for Lorista N in pharmacies

Approximate price for Lorista N 50 mg + 12.5 mg for 30 pcs. in the package - 240 rubles, for 60 pcs. in the package - 430 rubles, for 90 pcs. in the package - 512 rubles.

Lorista N: prices in online pharmacies

Drug name Price Pharmacy

Lorista N 12.5 mg + 50 mg film-coated tablets 30 pcs. 259 r Buy

Lorista N tablets p.o. 50mg + 12.5mg 30 pcs. 306 r Buy

Lorista N 100 12.5 mg + 100 mg film-coated tablets 30 pcs. 349 r Buy

Lorista N 100 tablets p.o. 100mg + 12.5mg 30 pcs. 373 r Buy

Lorista N 12.5 mg + 50 mg film-coated tablets 60 pcs. 453 r Buy

Lorista N tablets p.o. 50mg + 12.5mg 60 pcs. 504 RUB Buy

Lorista N 12.5 mg + 50 mg film-coated tablets 90 pcs. 582 r Buy

Lorista N tablets p.o. 50mg + 12.5mg 90 pcs. RUB 609 Buy

Lorista N 100 tablets p.o. 100mg + 12.5mg 90 pcs. 749 RUB Buy

Lorista N 100 12.5 mg + 100 mg film-coated tablets 90 pcs. 749 RUB Buy

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Anna Kozlova Medical journalist About the author

Education: Rostov State Medical University, specialty "General Medicine".

Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!