Description
Release form
Film-coated tablets.
Packing
60 pcs.
Contraindications
Hypersensitivity to losartan, to sulfonamide derivatives and other components of the drug, anuria, severe renal impairment (creatinine clearance (CC) less than 30 ml / min.), hyperkalemia, dehydration (including during administration high doses of diuretics) severe liver dysfunction, refractory hypokalemia, pregnancy, lactation, arterial hypotension, under 18 years of age (efficacy and safety have not been established), lactase deficiency, galactosemia, or glucose / galactose malabsorption syndrome.
Use during pregnancy and lactation
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 with losartan in the second and third trimesters. When pregnancy is established, Lorista ND therapy should be stopped immediately. If necessary, the appointment of the drug during lactation, it is necessary to stop breastfeeding.
Special instructions
May be prescribed with other antihypertensives. There is no need for 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 single kidney. Hydrochlorothiazide can enhance arterial hypotension and disturbances in the water-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 plasma calcium concentration the concentration of cholesterol and triglycerides, provoke the occurrence of hyperuricemia and / or gout. Taking medications directly acting on the renin-angiotensin system during the second and third trimesters of pregnancy can lead to fetal death. If 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, and maternal thrombocytopenia. Diuretic therapy does not prevent the development of toxicosis of pregnancy.
Composition
1 tablet contains: losartan potassium 100 mg, hydrochlorothiazide 25 mg excipients: pregelatinized starch, microcrystalline cellulose, lactose monohydrate, magnesium stearate, hypromellose, macrogoline 4 (yellow) 4 colorant1, yellow colorant 4, yellow color 1, yellow color 1 , talc.
Dosage and administration
Inside, regardless of food intake. Lorista ND can be combined with other antihypertensive agents. Arterial hypertension The initial and maintenance dose is 1 tablet Lorista ND (100/25 mg) once a day. As a rule, the drug is prescribed in the absence of an adequate therapeutic effect 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 the drug Lorista ND. In patients with a reduced volume of circulating blood (for example, while taking large doses of diuretics), the recommended initial dose of losartan in patients with hypovolemia is 25 mg once a day. In this regard, therapy with Lorista ND must be started after the diuretics are canceled and hypovolemia is corrected. In elderly patients and patients with moderate renal failure (creatinine clearance of 30-50 ml / min), including those on dialysis, an initial dose adjustment is not required. Reducing the risk of cardiovascular morbidity and mortality in patients with arterial hypertension and left ventricular hypertrophy The standard initial dose of losartan is 50 mg once a day. Patients who have not been able to achieve target blood pressure levels while taking losartan 50 mg / day require treatment by combining losartan with low doses of hydrochlorothiazide (12.5 mg), and if necessary, increase the dose of losartan to 100 mg in combination with hydrochlorothiazide at a dose of 12.5 mg / day, in the future – increase to 1 tablet Lorista ND 100/25 mg total (100 mg of losartan and 25 mg of hydrochlorothiazide per day once).
Side effects of
From the blood and lymphatic system: infrequently – anemia, Shenlein-Genoch disease.
On the part of the immune system: rarely – anaphylactic reactions, angioedema (including swelling of the larynx and tongue, causing obstruction of the airways and / or swelling 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 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, impaired liver function.
From the skin and subcutaneous fat: infrequently – urticaria, pruritus.
From the side of the musculoskeletal system and connective tissue: often – myalgia, back pain infrequently – arthralgia.
Other: often – asthenia, weakness, peripheral edema, chest pain.
Laboratory indicators: often – hyperkalemia, an increase in the concentration of hemoglobin and hematocrit (not clinically significant) sometimes – a moderate increase in the level of urea and creatinine in the blood serum is very rare – an increase in the activity of liver and bilirubin enzymes.
Overdose
Losartan
Symptoms: severe BP, tachycardia bradycardia caused by parasympathetic (vaginal) 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 concomitant administration of cardiac glycosides, hypokalemia may aggravate the course of arrhythmias.
Treatment: symptomatic.
Storage conditions
Store in a dry place, at a temperature not exceeding 30 ° C.
Shelf life
3 years.
Deystvuyushtee substance
Gidrohlorotiazid, Losartan
Prescription conditions
pharmacy Prescription
Dosage PMA
Possible product names
LORISTA ND 0.1 + 0.025 N60 TABLE P / O
LORISTA ND 100mg + 25mg p / o captive. Tab. X60 / until 11.10g /
Lorista ND 25mg + 100mg Tab. p / pl / rev X60
Lorista ND tab p / o 100 + 25mg x 60
LORISTA ND TAB. P.P.O. 100MG + 25MG No. 60
KRKA d.d. Novo mesto AO, Slovenia
