Lorista, 100 mg, film-coated tablets, 30 pcs.
More than 20,000 patients took part in studies on the effectiveness and safety of Lorista.
The results of the studies demonstrated the following data:
— in the “Take Off” study, Lorista® (losartan from KRKA) significantly reduced uric acid levels by 32.6% in patients with arterial hypertension (AH) and concomitant hyperuricemia and/or gout. 100% of patients participating in the study achieved the target blood pressure level. Therapy with Lorista has a pronounced positive effect on the elasticity of the vascular wall in patients with hypertension1;
— in the open-label multicenter clinical trial LAURA2 (Lorista® and uric acid), the relationship between treatment with Lorista and its fixed combination with hydrochlorothiazide (Lorista® H and Lorista® HD) and hyperuricemia was studied. Based on the results of the study in patients with hypertension and hyperuricemia, Lorista®, Lorista® H and Lorista® ND, due to their apparent ability to lower uric acid levels, can be used as the preferred therapy;
— the EFFECT3 study proved the effectiveness and safety of losartan (Lorista®) in patients with mild and moderate hypertension. In addition, it is important to emphasize the safety of using Lorista (adverse effects in less than 1% of patients), which makes the drug an indispensable assistant in the fight against hypertension;
— as a result of the international study Gemera4, the effectiveness and safety of the use of Lorista® and a fixed combination with hydrochlorothiazide (Lorista® N) in patients with stage 1–2 hypertension was confirmed. 100% of patients achieved CAP.
The results of clinical studies conducted with the drug KRKA Lorista (losartan) and its fixed combinations with hydrochlorothiazide further indicate that the drug contributes not only to the effective and well-tolerated treatment of hypertension, but also to the reduction of cardiovascular risk.
Literature
1. Nedogoda S.V., Ledyaeva A.A., Chumachok E.V., Tsoma V.V., Salasyuk A.S. Possibilities of losartan in angioprotection against hyperuricemia in patients with arterial hypertension. Systemic hypertension. - 2012. - No. 4. - P.50–54.
2. Svishchenko E.P., Bezrodnaya L.V., Gorbas I.M. Clinical and uricosuric efficacy of losartan in patients with arterial hypertension. Results of the open multicenter clinical trial LAURA. Arterial hypertension.- 2012.- 5 (25).- P.25–32.
3. Drapkina O.M., Kozlova E.V. The place of angiotensin receptor antagonists in the treatment of cardiovascular diseases. Study EFFECT: use of Lorista in patients with mild and moderate arterial hypertension in real clinical practice. Problems of women's health.- 2009.- 4(4).- P.17–26.
4. Chazova I.E., Martynyuk T.V. Federal State Budgetary Institution Russian Cardiology Research and Production Complex of the Ministry of Health of the Russian Federation, Moscow. First results of the international clinical trial GEMERA: two therapeutic regimens for the effective treatment of patients with stage 1–2 arterial hypertension.
Lorista® h 100 (Lorista® h 100)
Losartan
Renal dysfunction
With the use of losartan, reversible impairment of renal function is possible, including renal failure, which disappears after discontinuation of losartan. Drugs that affect the RAAS may lead to increased plasma urea and creatinine concentrations in patients with bilateral renal artery stenosis or arterial stenosis of a solitary kidney. These changes in renal function may be reversible and disappear after discontinuation of therapy. In patients with impaired renal function who have been treated with NSAIDs (including COX-2 inhibitors), therapy with angiotensin II receptor antagonists may lead to further worsening of impaired renal function, including acute renal failure, which is usually reversible, and may also increase plasma potassium concentrations in patients with pre-existing renal impairment. This combination is recommended to be used with caution, especially in elderly patients. Patients should receive sufficient fluids and have their renal function monitored before and after starting treatment with Lorista® N 100.
Hydrochlorothiazide
Arterial hypotension and water-electrolyte imbalance
As with any antihypertensive drug, patients may experience symptomatic hypotension. Patients should be monitored for clinical signs of fluid and electrolyte disturbances, such as dehydration, hyponatremia, hypochloremic alkalosis, hypomagnesemia or hypokalemia, which may develop with concomitant diarrhea or vomiting. In such patients, it is necessary to monitor the content of electrolytes in the blood plasma.
Metabolic and endocrine effects
Thiazide diuretic therapy may impair glucose tolerance. In some cases, dose adjustments of oral hypoglycemic agents and/or insulin may be required.
Thiazides may reduce renal excretion of calcium and cause a short-term and slight increase in plasma calcium concentrations. Severe hypercalcemia may indicate latent hyperparathyroidism.
Due to the effect of thiazides on calcium metabolism, their use may distort the results of testing the function of the parathyroid glands, therefore, before testing the function of the parathyroid glands, the thiazide diuretic should be discontinued.
Increased blood cholesterol and triglyceride concentrations may also be associated with thiazide diuretic therapy.
In some patients, the use of thiazide diuretics may lead to hyperuricemia and/or the development of gout. Since losartan reduces uric acid concentrations, its combination with hydrochlorothiazide reduces the severity of diuretic-induced hyperuricemia.
Acute attack of angle-closure glaucoma
Hydrochlorothiazide is a sulfonamide that can cause an idiosyncratic reaction leading to an acute attack of angle-closure glaucoma.
Symptoms: sudden decrease in visual acuity or eye pain, which usually appears within a few hours or weeks of starting hydrochlorothiazide therapy. If left untreated, an acute attack of angle-closure glaucoma can lead to permanent vision loss.
Treatment: Stop taking hydrochlorothiazide immediately. If intraocular pressure remains uncontrolled, emergency medication or surgery may be required.
Risk factors for developing an acute attack of angle-closure glaucoma are a history of an allergic reaction to sulfonamide or benzylpenicillin.
Other effects
In patients receiving thiazide diuretics, hypersensitivity reactions can be observed even in the absence of a history of indications of allergic reactions or bronchial asthma. There are reports of exacerbation or progression of systemic lupus erythematosus during the use of thiazide diuretics.
Excipients
It should be taken into account that the excipients of the drug Lorista® N 100 include lactose monohydrate, therefore the drug is contraindicated in patients with lactase deficiency, lactose intolerance, and glucose-galactose malabsorption syndrome.
Impact on the ability to drive vehicles and operate machinery
For patients
Care must be taken when driving vehicles and working with other technical devices that require increased concentration and speed of psychomotor reactions.
Dosages and methods of therapy from the instructions for Lorista
Oral medication can be combined with other drugs responsible for lowering blood pressure. Taking the product is not associated with food.
The instructions indicate the following methods of treatment with Lorista N:
- Arterial hypertension - 1 tablet for three days. During this period, the maximum effect in reducing blood pressure is achieved. To obtain greater results, use 2 units of medication daily - this is the highest permitted dose of the medication.
- Reduced blood volume - allows the use of 25 mg of losartan per day. If the deviation occurs due to large dosages of diuretics, then the diuretics are discontinued before therapy.
- Initial doses do not imply a change in the standard regimen for the treatment of patients with moderate renal failure, over 65 years of age, on dialysis.
A daily dose of 50 mg of the drug is recommended to reduce the likelihood of developing cardiovascular pathologies and the risk of death in patients with a hypertrophied left ventricle of the heart and arterial hypertension.
In the absence of the expected effect, 12.5 mg of Hydrochlorothiazide is added to 50 mg of Lorista N. If necessary, the amount of the main medication is increased to 100 mg, and the volume of the second drug remains in its original position. The maximum permissible dosage is 2 tablets.
Lorista ND is prescribed in the absence of the expected results from Lorista N. Daily doses are similar for both forms of the drug.
Accidentally exceeding the recommended amount of medication provokes a slow or rapid heartbeat and a drop in blood pressure. In case of overdose, symptomatic therapy is carried out with forced diuresis, without hemodialysis.
An excess of hydrochlorothiazide also leads to the appearance of side symptoms with a sharp decrease in the volume of sodium, potassium, and chlorine in the bloodstream. Treatment of the condition consists of suppressing the emerging clinical manifestations of intoxication.
Lorista N (tab.p.pl/vol. 100 mg + 12.5 mg No. 90)
A country
Slovenia
The country of production may vary depending on the batch of goods. Please check with the operator for detailed information when confirming your order.
Compound
1 tablet contains: losartan potassium 100 mg, hydrochlorothiazide 12.5 mg.
Excipients: pregelatinized starch - 59.2 mg, microcrystalline cellulose - 137.1 mg, lactose monohydrate - 88.4 mg, magnesium stearate - 2.8 mg. Film shell composition: hypromellose - 8 mg, macrogol 4000 - 0.8 mg, titanium dioxide (E171) - 2.4 mg, talc - 0.8 mg. White film-coated tablets, oval, biconvex. On a cross section there is a white rough mass with a white film shell.
pharmachologic effect
Combined drug; has a hypotensive effect. Contains losartan, an angiotensin II receptor antagonist (type AT1), and hydrochlorothiazide, a thiazide diuretic.
Indications for use
- arterial hypertension; - to reduce the risk of cardiovascular morbidity and mortality in patients with arterial hypertension and left ventricular hypertrophy.
Side effects
Decreased blood pressure, dizziness, allergic reactions: angioedema (swelling of the face, lips and/or tongue), hyperkalemia, increased activity of liver transaminases.
Contraindications
- hypersensitivity;
- anuria; — hypovolemia (including against the background of high doses of diuretics); - liver and/or kidney failure; - pregnancy; - lactation period. Use during pregnancy and lactation Contraindications: pregnancy, lactation. Taking medications that directly affect the RAAS in the II-III trimesters of pregnancy can lead to fetal death. If pregnancy occurs, discontinuation is indicated (thiazides penetrate the BBB). For relatively healthy pregnant women, the use of diuretics is usually not recommended due to the risk of fetal and neonatal jaundice and maternal thrombocytopenia. Diuretic therapy does not prevent the development of pregnancy toxicosis.
Use in elderly patients There is no need for special selection of the initial dose for elderly patients.
Mode of application
The method of administration and dosage regimen of a particular drug depend on its release form and other factors. The optimal dosage regimen is determined by the doctor. The compliance of the dosage form of a particular drug with the indications for use and dosage regimen should be strictly observed. Orally, 1 tablet/day, regardless of meals. The maximum dose is 2 tablets. 1 time/day The maximum hypotensive effect develops within 3 weeks after the start of treatment.
special instructions
There is no need for special selection of the initial dose for elderly patients. Possible co-administration with other antihypertensive drugs. May increase plasma urea and creatinine concentrations in patients with bilateral renal artery stenosis or renal artery stenosis of a solitary kidney. Hydrochlorothiazide can increase hypotension and water-electrolyte imbalance (decrease in blood volume, hyponatremia, hypochloremic alkalosis, hypomagnesemia, hypokalemia), impair glucose tolerance, reduce urinary calcium excretion and cause a transient slight increase in plasma calcium concentration, increase cholesterol and TG concentrations, provoke the occurrence of hyperuricemia and/or gout. Taking medications that directly affect the RAAS in the II-III trimesters of pregnancy can lead to fetal death. If pregnancy occurs, discontinuation is indicated (thiazides penetrate the BBB). For relatively healthy pregnant women, the use of diuretics is usually not recommended due to the risk of fetal and neonatal jaundice and maternal thrombocytopenia. Diuretic therapy does not prevent the development of pregnancy toxicosis.
Overdose
Symptoms of Losartan - decreased blood pressure, tachycardia, bradycardia (as a result of vagal stimulation). Hydrochlorothiazide - loss of electrolytes (hypokalemia, hypochloremia, hyponatremia); dehydration (excessive diuresis). Treatment: - symptomatic and supportive therapy. If the drug has been taken recently, the stomach should be rinsed; — if necessary, correct water and electrolyte imbalances. Losartan and its active metabolites are not removed by hemodialysis.
Interaction with other drugs
When taking hydrochlorothiazide simultaneously with ethanol, barbiturates, and opioid analgesics, the risk of developing orthostatic hypotension increases; with oral hypoglycemic drugs and insulin, dosage adjustment of hypoglycemic drugs may be required; an additive effect is possible with other antihypertensive drugs; with cholestyramine and colestipol - impaired absorption of hydrochlorothiazide. A single dose of cholestyramine or colestipol can reduce the absorption of hydrochlorothiazide in the gastrointestinal tract by 85 and 43%, respectively. With the simultaneous use of hydrochlorothiazide with GCS, ACTH, increased loss of electrolytes and worsening hypokalemia are possible; with pressor amines (norepinephrine, epinephrine), a slight decrease in the effect of pressor amines is possible, which does not interfere with their use; with non-depolarizing muscle relaxants (tubocurarine) - enhancing their effect; with NSAIDs - a decrease in diuretic, natriuretic, and hypotensive effects is possible. Do not use simultaneously with lithium preparations, because diuretics reduce the renal clearance of lithium and increase the risk of intoxication.
Dispensing conditions in pharmacies
On prescription
Indications and contraindications for therapy with Lorista
Both forms of medication are prescribed to patients:
- to reduce the likelihood of developing cardiovascular pathologies;
- to prevent death in patients with high blood pressure and hypertrophic changes in the left ventricle;
- as a component of combination treatment of hypertension.
The instructions indicate the following contraindications to Lorista:
- in the absence of urine entering the bladder;
- insufficient amount of lactase, increased or decreased amounts of potassium;
- hepatic, renal dysfunction, disorders of the conversion of galactose into glucose;
- dehydration, low blood pressure;
- intolerance to the component composition;
- pregnancy, breastfeeding, under age.
Particular care during therapy with Lorista is required for patients:
- with diabetes mellitus, bilateral narrowing of arterial vessels in the kidneys;
- water-electrolyte imbalance - with insufficient amounts of magnesium, potassium, sodium;
- systemic blood pathologies, allergic reactions;
- a large amount of calcium, uric acid in the blood;
- bronchial asthma, gout.
Lorista is not used in conjunction with NSAIDs; in some cases it causes the development of adverse reactions. During drug therapy, the following may occur:
- attack of dizziness, sleep disturbance with insomnia, cephalgia;
- accelerated heart rate, decreased blood pressure (dose-dependent), vasculitis;
- swelling of the nasal passages, pharyngitis, infection of the upper respiratory tract;
- cough, pain in the abdominal area, nausea with vomiting, dyspeptic disorders;
- hepatitis, increased activity of liver enzymes, liver dysfunction;
- muscle and joint pain, anemic conditions, capillary toxicosis;
- swelling in the peripheral areas, chest pain, asthenic syndrome, general weakness;
- nettle fever, anaphylaxis, obsessive itching, Quincke's edema.
Treatment may change the levels of urea, creatinine, potassium, hemoglobin, and hematocrit.
