Lozap, 50 mg, film-coated tablets, 30 pcs.
Hypersensitivity.
Patients with a history of angioedema (swelling of the face, lips, pharynx and/or tongue) should be closely monitored.
Arterial hypotension and water-electrolyte imbalance.
Symptomatic hypotension, especially after the first dose or after dose increases, may occur in patients with hypovolemia and/or hyponatremia as a result of high-dose diuretics, a low-salt diet, diarrhea, or vomiting.
It is necessary to either correct these conditions before prescribing Lozap®, or use initial doses of the drug.
Water and electrolyte disturbances.
Water and electrolyte disturbances are typical for patients with impaired renal function in combination with or without diabetes mellitus and require correction. In a clinical study conducted in type 2 diabetic patients with nephropathy, the incidence of hyperkalemia in the losartan group was higher than in the placebo group. This indicates the need for constant monitoring of potassium levels in the blood plasma and creatinine Cl levels - patients with heart failure and creatinine Cl levels from 30 to 50 ml/min require especially strict monitoring.
Prescribing potassium-sparing diuretics, potassium supplements and potassium-containing salt substitutes simultaneously with Lozap® is not recommended.
Liver dysfunction.
Taking into account pharmacokinetic data indicating a significant increase in plasma concentrations of losartan in patients with cirrhosis, patients with a history of impaired liver function (more than 9 points on the Child-Pugh scale) are recommended to prescribe the drug in lower doses. There is no experience with the use of the drug in patients with severe liver failure. Taking this into account, Lozap® is contraindicated in patients with severe liver failure.
Double blockade of the RAAS.
There is evidence that the simultaneous use of ACE inhibitors, ARB II or aliskiren increases the risk of arterial hypotension, hyperkalemia and renal dysfunction (including acute renal failure).
The use of Lozap® in combination with aliskiren is contraindicated in patients with diabetes mellitus and/or moderate or severe renal failure (GFR <60 ml/min/1.73 m2) and is not recommended in other patients (see “Contraindications”).
The use of Lozap® in combination with an ACE inhibitor is contraindicated in patients with diabetic nephropathy and is not recommended for other patients (see “Contraindications”).
IHD and cerebrovascular diseases.
As with the use of any antihypertensive drugs, too sharp a decrease in blood pressure in patients with coronary artery disease and cerebrovascular diseases can lead to myocardial infarction or ischemic stroke.
Heart failure.
In patients with heart failure with or without renal impairment, as with other drugs acting on the RAAS, there is a risk of developing severe hypotension and acute renal failure.
experience with the use of losartan in the treatment of patients with heart failure and concomitant severe renal failure in patients with severe CHF (functional class IV according to the NYHA
), as well as in patients with heart failure and life-threatening arrhythmias. With this in mind, caution should be exercised when prescribing losartan to these categories of patients.
Combined use with ACE inhibitors for CHF.
When using Lozap® in combination with ACE inhibitors, the risk of side effects may increase, especially renal dysfunction and hyperkalemia (see “Side Effects”). In these cases, careful observation and monitoring of laboratory parameters is necessary.
Hemodialysis.
During hemodialysis, the sensitivity of blood pressure to the action of AT1 receptor antagonists increases as a result of a decrease in blood volume and activation of the RAAS. It is necessary to adjust the dose of Lozap® under careful monitoring of blood pressure in patients on hemodialysis.
Kidney transplantation.
There are no data on the use of Lozap® in patients who have recently undergone a kidney transplant.
General anesthesia.
Patients receiving ARA II during general anesthesia and surgical procedures may develop arterial hypotension as a result of blockade of the RAAS. Very rarely, cases of severe arterial hypotension may occur, requiring IV fluids and/or vasopressors.
Aortic and mitral valve stenosis, hypertrophic obstructive cardiomyopathy.
When using the drug Lozap®, as well as other vasodilators, caution should be exercised in patients with hypertrophic obstructive cardiomyopathy or hemodynamically significant stenosis of the aortic or mitral valve.
Primary hyperaldosteronism.
Patients with primary hyperaldosteronism are usually resistant to treatment with antihypertensive drugs that affect the RAAS. In this regard, Lozap® is not recommended for use in such patients.
Elderly patients.
As a rule, patients over 75 years of age are recommended to start treatment with Lozap® with a dose of 25 mg/day.
Other special instructions and precautions.
As clinical experience with the use of ACE inhibitors, losartan and other AT1 receptor antagonists shows, these drugs are less effective in reducing blood pressure in patients of the Negroid race than in representatives of other races, possibly due to low renin activity in patients of this race.
Impact on the ability to drive vehicles and machinery.
Not studied. When driving vehicles and engaging in potentially hazardous activities that require increased concentration and speed of psychomotor reactions, it should be taken into account that when using the drug, dizziness, drowsiness and fainting may occur.
Lozap, tablets covered. captivity. about. 100 mg, 30 pcs.
Hypersensitivity
Patients with a history of angioedema (swelling of the face, lips, pharynx and/or tongue) should be closely monitored.
Arterial hypotension and water-electrolyte imbalance
Symptomatic hypotension, especially after the first dose or after dose increases, may occur in patients with hypovolemia and/or hyponatremia as a result of high-dose diuretics, a salt-restricted diet, diarrhea or vomiting. It is necessary to either correct these conditions before prescribing the drug LOZAP®, or use or prescribe lower doses of the drug.
Fluid and electrolyte disturbances
Water and electrolyte disturbances are typical for patients with impaired renal function in combination with or without diabetes mellitus and require correction. In a clinical study conducted in patients with type 2 diabetes mellitus with nephropathy, the incidence of hyperkalemia in the losartan group was higher than in the placebo group. This indicates the need for regular monitoring of potassium levels in the blood plasma and creatinine clearance (CC) indicators - patients with heart failure and creatinine clearance from 30 to 50 ml/min require especially strict monitoring. Prescribing potassium-sparing diuretics, potassium preparations and potassium-containing salt substitutes simultaneously with LOZAP® is not recommended.
Liver dysfunction
Taking into account pharmacokinetic data indicating a significant increase in plasma concentrations of losargan in patients with cirrhosis, patients with a history of impaired liver function (more than 9 points on the Child-Pugh scale) are recommended to prescribe the drug in lower doses. There is no experience with the use of the drug in patients with severe liver failure. Taking this into account, LOZAP® is contraindicated in patients with severe liver failure.
Dual blockade of the renin-angiotensin-aldosterone system
There is evidence that the simultaneous use of ACE inhibitors. APAII or aliskiren increases the risk of arterial hypotension, hyperkalemia and renal dysfunction (including acute renal failure).
The use of LOZAP® together with alnekiren is contraindicated in patients with diabetes mellitus or impaired renal function (GFR less than 60 ml/min/1.73 m2 body surface area) and is not recommended for other patients.
The use of LOZAP® in combination with an ACE inhibitor is contraindicated in patients with diabetic nephropathy and is not recommended for other patients.
Coronary heart disease (CHD) and cerebrovascular diseases
As with any antihypertensive drugs, too sharp a decrease in blood pressure in patients with coronary artery disease and cerebrovascular diseases can lead to myocardial infarction or ischemic stroke.
Heart failure
In patients with heart failure with or without renal impairment, as with other drugs acting on the RAAS, there is a risk of severe hypotension and acute renal failure.
There is virtually no experience with the use of losartan in the treatment of patients with heart failure and concomitant severe renal failure, in patients with severe chronic heart failure (NYHA functional class IV), as well as in patients with heart failure and life-threatening arrhythmias. Taking this into account, caution should be exercised when prescribing the drug LOZAP® to these categories of patients.
Combined use with ACE inhibitors in chronic heart failure (CHF)
When using the drug LOZAP® in combination with ACE inhibitors, the risk of side effects may increase, especially renal dysfunction and hyperkalemia. In these cases, careful observation and monitoring of laboratory parameters is necessary.
Hemodialysis
During hemodialysis, the sensitivity of blood pressure to the action of AT1 receptor antagonists increases as a result of a decrease in blood volume and activation of the RAAS. It is necessary to adjust the dose of LOZAP® under close monitoring of blood pressure in patients on hemodialysis. Kidney transplantation There are no data on the use of LOZAP® in patients who have recently undergone kidney transplantation.
General anesthesia
In patients receiving angiotensin II antagonists, arterial hypotension may develop during general anesthesia and surgical procedures as a result of blockade of the renin-angiotensin-aldosterone system. Very rarely, cases of severe arterial hypotension may occur, requiring replenishment of blood volume and/or vasopressor drugs.
Aortic and mitral titanium stenosis, hypertrophic obstructive cardiomyopathy
When using the drug LOZAP®, as well as other vasodilators, caution should be exercised in patients with hypertrophic obstructive cardiomyopathy or hemodynamically significant stenosis of the aortic or mitral valve.
Primary hyperaldosteronism
Patients with primary hyperaldosteronism are usually resistant to treatment with antihypertensive drugs that affect the RAAS. In this regard, the drug LOZAP® is not recommended for such patients.
Patients over 75 years of age
As a rule, patients over 75 years of age are recommended to start treatment with LOZAP® with a dose of 25 mg per day.
Other special instructions and precautions
As clinical experience with the use of ACE inhibitors, losartan and other AT1 receptor antagonists shows, these drugs are less effective in reducing blood pressure in patients of the Black race than in representatives of other races, possibly due to low renin activity in patients of this race.
Impact on the ability to drive vehicles and operate machinery
The effect of LOZAP® on the ability to drive vehicles or operate machinery has not been studied.
When driving vehicles and engaging in potentially hazardous activities that require increased concentration and speed of psychomotor reactions, you should be careful, because When using the drug, dizziness, drowsiness and fainting may occur.
