Losartan, 12.5 mg, film-coated tablets, 30 pcs.
Hypersensitivity reactions
In patients with a history of angioedema (swelling of the face, lips, pharynx/larynx and/or tongue), monitoring of the use of the drug is necessary (see "Side effects"
).
Embryotoxicity
The use of drugs that affect the RAAS during the second and third trimester of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and mortality. The development of oligohydramnios may be associated with fetal lung hypoplasia and skeletal deformities. Possible adverse events in neonates include calvarial hypoplasia, anuria, hypotension, renal failure and death.
When diagnosing pregnancy, the drug LOSARTAN should be taken immediately.
Arterial hypotension and fluid disturbances
-
electrolyte balance or decreased circulating blood volume
In patients with reduced circulating blood volume (CBV) (for example, receiving treatment with large doses of diuretics), symptomatic arterial hypotension may occur. Correction of such conditions must be carried out before prescribing the drug LOSARTAN or starting treatment with a lower dose of the drug LOSARTAN (see " Method of administration and dosage"
»)
Fluid and electrolyte imbalance is common in patients with impaired renal function with or without diabetes mellitus, so careful monitoring of these patients is necessary. In clinical studies in patients with type 2 diabetes mellitus with proteinuria, the incidence of hyperkalemia was greater in the LOSARTAN group than in the placebo group. Several patients discontinued therapy due to hyperkalemia (see “ Side Effects”)
»).
During treatment with LOSARTAN, it is not recommended to take potassium-sparing diuretics, potassium supplements or potassium-containing salt substitutes.
Aortic or mitral stenosis, hypertrophic obstructive cardiomyopathy
Like all drugs that have a vasodilating effect, ARA II should be prescribed with caution to patients with aortic or mitral stenosis or hypertrophic obstructive cardiomyopathy.
Coronary heart disease and cerebrovascular diseases
Like all drugs that have a vasodilating effect, ARA II should be prescribed with caution to patients with coronary heart disease or cerebrovascular diseases, since an excessive decrease in blood pressure in this group of patients can lead to the development of myocardial infarction or stroke.
Chronic heart failure
As with the use of other drugs that act on the RAAS, patients with CHF and with or without impaired renal function are at risk of developing severe hypotension or acute renal impairment.
Since there is insufficient experience with the use of the drug LOSARTAN in patients with heart failure and concomitant severe renal impairment, in patients with severe heart failure (NYHA functional class IV), as well as in patients with heart failure and symptomatic life-threatening arrhythmias, the drug LOSARTAN should be prescribed with caution to patients in these groups.
Primary hyperaldosteronism
Since patients with primary hyperaldosteronism, as a rule, do not respond positively to therapy with antihypertensive drugs that act by inhibiting the RAAS, the use of LOSARTAN is not recommended in this group of patients.
Liver dysfunction
Data from pharmacokinetic studies indicate that the concentration of losartan in the blood plasma in patients with cirrhosis of the liver is significantly increased, therefore patients with a history of impaired liver function should be prescribed the drug LOSARTAN at a lower dose. There is no experience with the use of the drug LOSARTAN in patients with severe liver dysfunction, so the drug should not be used in this group of patients (see “ Pharmacological properties. Pharmacokinetics
";
" Contraindications
";
" Method of administration and dosage
").
Renal dysfunction
Due to inhibition of the RAAS, changes in renal function, including the development of renal failure, have been observed in some susceptible patients. These changes in renal function may return to normal after treatment is stopped.
Some drugs that affect the RAAS may increase blood urea and serum creatinine concentrations in patients with bilateral renal artery stenosis or renal artery stenosis of a solitary kidney. Similar effects have been reported when taking the drug LOSARTAN. Such renal dysfunction may be reversible after discontinuation of therapy. LOSARTAN should be used with caution in patients with bilateral renal artery stenosis or renal artery stenosis of a solitary kidney.
Special patient groups
Race
Analysis of data from the entire population of patients included in the LIFE study to study the effect of losartan on reducing the incidence of the main composite criterion of the study in patients with hypertension and left ventricular hypertrophy (n = 9193) showed that the ability of losartan compared with atenolol to reduce the risk of stroke and myocardial infarction, as well as reduce cardiovascular mortality in patients with hypertension and left ventricular hypertrophy (by 13.0%. p = 0.021) does not apply to patients of the Negroid race, although both treatment regimens effectively reduced blood pressure in these patients. In this study, the drug LOSARTAN, compared with atenolol, reduced cardiovascular morbidity and mortality in patients with hypertension and left ventricular hypertrophy of all races except blacks (n = 8660, p = 0.003). However, in this study, black patients receiving atenolol had a lower risk of the study's primary composite endpoint (i.e., lower combined incidence of cardiovascular death, stroke, and myocardial infarction) compared with race-matched patients receiving losartan (p= 0.03).
Children and teenagers
The effectiveness and safety of the drug LOSARTAN in children and adolescents under 18 years of age have not been established.
If oliguria or arterial hypotension develops in newborns whose mothers took LOSARTAN during pregnancy, symptomatic therapy aimed at maintaining blood pressure and renal perfusion is necessary. Blood transfusions or dialysis may be required to prevent hypotension and/or maintain renal function.
Elderly patients
Clinical studies have not revealed any particularities regarding the safety and effectiveness of losartan in elderly patients (over 65 years of age).
Double renin blockade
-
angiotensin
-
aldosterone system (RAAS)
Concomitant use of angiotensin II receptor antagonists with drugs containing aliskiren is contraindicated in patients with diabetes mellitus and/or moderate or severe renal failure (GFR less than 60 ml/min/1.73 m2 body surface area) and is not recommended in other patients.
Concomitant use of angiotensin II receptor antagonists with ACE inhibitors is contraindicated in patients with diabetic nephropathy and is not recommended in other patients.
Impact on the ability to drive vehicles and operate machinery
No studies have been conducted to evaluate the effect on the ability to drive or operate machines, but caution should be exercised when using antihypertensive therapy and driving or operating machines, as dizziness and drowsiness may develop, especially at the beginning of therapy or when the dose is increased.
Losartan
Hypersensitivity reactions
In patients with a history of angioedema (swelling of the face, lips, pharynx/larynx and/or tongue), monitoring of the use of the drug is necessary.
Embryotoxicity
The use of drugs that affect the RAAS during the second and third trimester of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and mortality. The development of oligohydramnios may be associated with fetal lung hypoplasia and skeletal deformation. Possible adverse events in neonates include calvarial hypoplasia, anuria, hypotension, renal failure and death. If pregnancy is established, losartan should be discontinued immediately (see Use during pregnancy and breastfeeding).
Arterial hypotension and water-electrolyte imbalance or decreased circulating blood volume (CBV)
In patients with reduced blood volume (for example, those receiving treatment with large doses of diuretics), symptomatic arterial hypotension may occur. Correction of such conditions must be carried out before prescribing losartan or starting treatment with a lower dose of the drug (see Dosage and Administration). Fluid and electrolyte imbalance is common in patients with impaired renal function with or without diabetes mellitus, so careful monitoring of these patients is necessary.
During treatment with losartan, it is not recommended to take potassium-sparing diuretics, potassium supplements, or potassium-containing salt substitutes without prior consultation with your doctor.
Aortic or mitral stenosis, hypertrophic obstructive cardiomyopathy
Like all drugs that have a vasodilating effect, ARA II should be prescribed with caution to patients with aortic or mitral stenosis or hypertrophic obstructive cardiomyopathy.
Coronary heart disease and cerebrovascular diseases
Like all drugs that have a vasodilating effect, ARA II should be prescribed with caution to patients with coronary heart disease or cerebrovascular diseases, since an excessive decrease in blood pressure in this group of patients can lead to the development of myocardial infarction or stroke.
Chronic heart failure
As with the use of other drugs that act on the RAAS, in patients with CHF and with or without impaired renal function, there is a risk of developing severe arterial hypotension or acute renal dysfunction. Since there is insufficient experience with the use of losartan in patients with heart failure and concomitant severe renal impairment, in patients with severe heart failure (NYHA functional class IV), as well as in patients with heart failure and symptomatic life-threatening arrhythmias, losartan should be prescribed with caution in patients of these groups.
Primary hyperaldosteronism
Since patients with primary hyperaldosteronism generally do not respond well to therapy with antihypertensive drugs that act by inhibiting the RAAS, the use of losartan is not recommended in this group of patients.
Liver dysfunction
Data from pharmacokinetic studies indicate that plasma concentrations of losartan in patients with liver cirrhosis are significantly increased, so patients with a history of impaired liver function should be prescribed the drug at a lower dose. There is no experience with the use of losartan in patients with severe liver dysfunction, so the drug should not be used in this group of patients).
Renal dysfunction
Due to inhibition of the RAAS, changes in renal function, including the development of renal failure, have been observed in some susceptible patients. These changes in renal function may return to normal after treatment is stopped.
Some drugs that affect the RAAS may increase blood urea and serum creatinine concentrations in patients with bilateral renal artery stenosis or renal artery stenosis of a solitary kidney. Similar effects have been reported with losartan.
Such renal dysfunction may be reversible after discontinuation of therapy.
Dual blockade of the renin-angiotensin-aldosterone system (RAAS)
The simultaneous use of angiotensin II receptor antagonists with drugs containing aliskiren is contraindicated in patients with diabetes mellitus and/or with moderate or severe renal impairment (GFR less than 60 ml/min/1.73 m2 body surface area) and is not recommended in other patients.
Concomitant use of angiotensin II receptor antagonists with ACE inhibitors is contraindicated in patients with diabetic nephropathy and is not recommended in other patients.
Special patient groups
Race
The ability of losartan, compared with atenolol, to reduce the risk of stroke and myocardial infarction, as well as reduce cardiovascular mortality in patients with hypertension and left ventricular hypertrophy, does not apply to black patients, although both treatment regimens effectively reduced blood pressure in these patients.
Children and teenagers
The effectiveness and safety of losartan in children and adolescents under 18 years of age have not been established.
If oliguria or arterial hypotension develops in newborns whose mothers took losartan during pregnancy, symptomatic therapy aimed at maintaining blood pressure and renal perfusion is necessary. Blood transfusions or dialysis may be required to prevent hypotension and/or maintain renal function.
Elderly patients
Clinical studies have not revealed any particularities regarding the safety and effectiveness of losartan in elderly patients (over 65 years of age).
Lactose
The drug contains lactose monohydrate. It must be taken into account that the use of the drug is contraindicated in patients with rare congenital galactose intolerance, lactase deficiency or glucose-galactose malabsorption.
Features of the action of the drug at the first dose
Patients with reduced blood volume (for example, when taking high doses of diuretics, limiting salt intake, diarrhea or vomiting) may develop symptomatic hypotension, especially after taking the first dose and after increasing the dose of the drug.
Features of the action of the drug upon its withdrawal
You should not stop taking the drug without consulting a doctor, as symptoms may return.
Features of the actions of a doctor (paramedic) or patient when one or more doses of a drug are missed
If you miss a dose of the drug, you must take the next dose at your usual time. Do not take a double dose to make up for a missed dose.
