Instructions for use of LORISTA® ND (LORISTA® HD)
Losartan
Caution is required when using the drug in patients with a history of angioedema of any origin.
In patients with hypovolemia and/or hyponatremia (due to intensive diuretic therapy, low sodium diet, diarrhea or vomiting), hypotension may occur, especially after the first dose. These conditions require correction before starting treatment with the drug.
Electrolyte imbalances are common in patients with renal failure, especially those with diabetes mellitus. Thus, during treatment, the concentration of potassium in the blood plasma and CC should be monitored (in particular, in patients with CC 30-50 ml/min).
Lorista® ND should be administered with caution to patients with a history of mild to moderate liver dysfunction. Since there is no data on the therapeutic use of losartan in patients with severe liver failure, Lorista® ND is contraindicated in this category of patients.
As a result of suppression of the RAAS, renal dysfunction, including renal failure, was observed (in particular, in patients with dependence of renal function on the RAAS - patients with severe heart failure or chronic renal failure).
As is the case with other drugs acting on the RAAS, increased concentrations of urea and creatinine were observed in patients with bilateral renal artery stenosis or arterial stenosis of a solitary kidney. These changes are reversible upon cessation of therapy.
Losartan should be used with caution in patients with bilateral renal artery stenosis or stenosis of the artery of a solitary kidney.
There are no data on the use of the drug in patients who have undergone kidney transplantation.
Patients with primary hyperaldosteronism generally do not respond to antihypertensive drugs that suppress the RAAS. Therefore, the use of the losartan/hydrochlorothiazide combination is not recommended.
As with other antihypertensive drugs, a significant decrease in blood pressure in patients with coronary artery disease and cerebrovascular disease can lead to myocardial infarction or stroke.
Patients with heart failure (with or without renal failure) are at increased risk of developing severe hypotension and renal failure (often acute).
As with the use of other vasodilators, extreme caution should be taken when prescribing the drug to patients with aortic stenosis, mitral valve stenosis and obstructive hypertrophic cardiomyopathy.
It has been shown that ACE inhibitors, losartan and other angiotensin II receptor antagonists have a significantly less hypotensive effect when used in blacks. Perhaps this circumstance is explained by the fact that this category of patients often has low levels of renin in the blood.
Dual blockade of the RAAS is associated with an increased risk of hypotension, hyperkalemia and renal dysfunction (including acute renal failure) compared with monotherapy. Dual blockade of the RAAS using an ACE inhibitor, angiotensin II receptor antagonist, or aliskiren cannot be recommended in any patient, especially in patients with diabetic nephropathy. In some cases, when the combined use of an ACE inhibitor and an angiotensin II receptor antagonist is absolutely indicated, careful supervision by a specialist and mandatory monitoring of renal function, water-electrolyte balance, and blood pressure are necessary. This applies to the use of candesartan or valsartan as adjunctive therapy to ACE inhibitors in patients with chronic heart failure. Carrying out double blockade of the RAAS under the careful supervision of a specialist and mandatory monitoring of renal function, water-electrolyte balance and blood pressure is possible in patients with chronic heart failure with intolerance to aldosterone antagonists (spironolactone), who have persistence of symptoms of chronic heart failure, despite other adequate therapy.
Hydrochlorothiazide
As with other antihypertensive therapy, symptomatic hypotension may occur in some patients. Therefore, the patient should be constantly monitored for clinical signs of fluid and electrolyte imbalance (hypovolemia, hyponatremia, hypochloremic alkalosis, hypomagnesemia or hypokalemia), for example, after diarrhea or vomiting. In such patients, plasma electrolytes should be regularly monitored. Patients with edema in hot weather may experience dilutional hyponatremia.
Therapy with thiazide diuretics can lead to impaired glucose tolerance. Dosage adjustment of antidiabetic agents may be necessary, incl. insulin. When using thiazide diuretics, latent diabetes mellitus can manifest itself.
Thiazide diuretics can reduce the excretion of calcium in the urine and thereby lead to a short-term slight increase in its concentration in the blood plasma. Severe hypercalcemia may indicate hidden hyperparathyroidism. Before testing the function of the parathyroid glands, thiazide diuretics should be discontinued.
Increases in cholesterol and triglycerides in the blood may be associated with the use of thiazide diuretics.
In some patients, therapy with thiazide diuretics may provoke hyperuricemia and/or an attack of gout. Since losartan reduces the concentration of uric acid, its combination with hydrochlorothiazide reduces the likelihood of hyperuricemia associated with the use of diuretics.
In patients with liver failure or progressive liver disease, thiazide diuretics should be used with caution, because they can cause intrahepatic cholestasis, and minor changes in water and electrolyte balance can trigger the development of hepatic coma. Lorista® ND is contraindicated in patients with severe liver failure.
Patients taking thiazide diuretics may experience hypersensitivity reactions, regardless of a history of allergies or bronchial asthma.
There are reports of exacerbation or recurrence of systemic lupus erythematosus with the use of thiazide diuretics.
Lorista® ND
Lorista® ND contains lactose and is therefore contraindicated in patients with rare hereditary diseases such as galactose intolerance, lapp lactase deficiency or glucose-galactose malabsorption.
Impact on the ability to drive vehicles and operate machinery
When carrying out antihypertensive therapy, dizziness and drowsiness sometimes occur, especially at the beginning of treatment or when increasing the dose, so care should be taken when carrying out activities that require increased attention and speed of psychomotor reactions (driving vehicles, working with complex mechanisms).
Lorista ND (tab.p.pl/vol. 25mg+100mg No. 30)
A country
Russia
The country of production may vary depending on the batch of goods. Please check with the operator for detailed information when confirming your order.
Active substance
Losartan + Hydrochlorothiazide
Compound
1 tablet contains: losartan potassium 100 mg, hydrochlorothiazide 25 mg.
Excipients: pregelatinized starch - 69.84 mg, microcrystalline cellulose - 175.4 mg, lactose monohydrate - 126.26 mg, magnesium stearate - 3.5 mg. Film-coated tablets from yellow to yellow with a greenish tint, oval, slightly biconvex.
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.
Mode of application
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.
Interaction
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.
Side effect
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.
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 disturbances. Losartan and its active metabolites are not removed by hemodialysis.
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.
Dispensing conditions in pharmacies
On prescription
