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.
Instructions for use LOSARTAN
Hypersensitivity
Patients with a history of angioedema (swelling of the face, lips, larynx and/or tongue) should be closely monitored.
Arterial hypotension and water-electrolyte balance
In patients with reduced blood volume and/or sodium content, symptomatic hypotension may develop as a result of enhanced diuretic therapy, salt restriction, diarrhea and vomiting. These conditions should be corrected before starting the use of losartan or the initial dose of the drug should be reduced.
Double blockade of the RAAS
Dual blockade of the RAAS is accompanied by an increased risk of arterial hypotension, hyperkalemia and renal dysfunction (including acute renal failure) compared with monotherapy.
Dual blockade of the RAAS using an ACE inhibitor, an angiotensin II receptor antagonist and aliskiren cannot be recommended for any patient, especially 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 prescription of candensartan 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 .
Electrolyte imbalance
It should be taken into account that electrolyte imbalances are common in patients with impaired renal function (with or without diabetes mellitus). According to data from a clinical study involving patients with type 2 diabetes mellitus and nephropathy, the incidence of hyperkalemia in the group receiving losartan was higher compared to the group receiving placebo. Therefore, potassium levels in the blood plasma and creatinine clearance should be carefully monitored, especially in patients with heart failure and creatinine clearance 30-50 ml/min.
It is not recommended to take losartan with potassium-sparing diuretics, potassium supplements, or potassium-containing salt substitutes.
Liver dysfunction
According to pharmacokinetic data, a significant increase in plasma concentrations of losartan was detected in patients with liver cirrhosis; therefore, patients with impaired liver function should be prescribed the drug in lower doses. Losartan should not be used in patients with severe liver dysfunction.
Renal dysfunction
Due to inhibition of the RAAS, renal dysfunction, including renal failure, has been reported with the drug (particularly in patients whose renal function is dependent on the activity of the RAAS, such as patients with severe heart failure or patients with existing renal impairment). As with the use of other drugs that affect the RAAS, increased serum urea and creatinine concentrations have been reported in patients with bilateral renal artery stenosis or arterial stenosis of a solitary kidney; these changes in renal function may be reversible after discontinuation of therapy. Losartan should be used with caution in the treatment of patients with bilateral renal artery stenosis or arterial stenosis of a solitary kidney.
When treating with losartan, renal function should be regularly monitored, because its violation is possible. This is especially true when losartan is used against the background of other pathological conditions (fever, dehydration) that may affect kidney function.
The simultaneous use of losartan and ACE inhibitors worsens renal function, so this combination is not recommended.
Kidney transplant
There is no experience using the drug to treat patients who have recently undergone kidney transplantation.
Primary hyperaldosteronism
In patients with primary hyperaldosteronism, antihypertensive drugs that act by inhibiting the RAAS are generally ineffective. Therefore, the use of losartan is not recommended.
IHD and cerebrovascular diseases
As with the use of other antihypertensive drugs, an excessive decrease in blood pressure in patients with coronary artery disease and cerebrovascular diseases can lead to the development of myocardial infarction or stroke.
Heart failure
As with other drugs that affect the RAAS, patients with heart failure with or without renal impairment are at risk of developing severe hypotension and (often acute) renal impairment.
There is insufficient therapeutic experience with losartan in patients with heart failure and concomitant severe renal impairment, in patients with severe heart failure (NYHA class IV), and in patients with heart failure and symptomatic, life-threatening cardiac arrhythmia. Therefore, losartan should be used with caution in this group of patients. Losartan should be used with caution in combination with beta-blockers.
Stenosis of the aortic and mitral valves, obstructive hypertrophic cardiomyopathy
As with the use of other vasodilators, the drug should be prescribed with extreme caution to patients with aortic or mitral valve stenosis or obstructive hypertrophic cardiomyopathy.
Lactose intolerance
The drug contains lactose. The drug should not be prescribed to patients with such rare hereditary pathologies as galactose intolerance, lapp lactase deficiency or glucose-galactose malabsorption.
Use in pediatrics
Losartan is contraindicated in children and adolescents under 18 years of age.
, since there is insufficient data regarding the use of the drug in this group of patients.
Ethnic differences
It has been established that ACE inhibitors, losartan and other angiotensin antagonists are significantly less effective in reducing blood pressure in patients of the Negroid race than in representatives of other races; This may be due to the fact that among black patients suffering from arterial hypertension, individuals with low renin activity predominate.
Impact on the ability to drive vehicles and operate machinery
Studies of the effect of the drug on the ability to drive a car and operate machinery have not been conducted. However, when driving or operating machinery, it is necessary to take into account that when using antihypertensive drugs, sudden onset of dizziness or drowsiness is possible, especially at the beginning of treatment or when the dose is increased.
