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Instructions for use of LORISTA® H

Losartan

Caution is required when using the drug in patients with a history of angioedema (swelling of the face, lips, pharynx and/or tongue).

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® N should be administered with caution to patients with a history of mild to moderate liver dysfunction. Since there are no data on the therapeutic use of losartan in patients with severe liver failure, Lorista® N 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, an 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® N 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® N

Lorista® N 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 N, 12.5 mg+50 mg, film-coated tablets, 60 pcs.

Losartan

Angioedema.

Patients with a history of angioedema (of the face, lips, pharynx and/or larynx) should be closely monitored.

Arterial hypotension and hypovolemia (dehydration).

In patients with hypovolemia (dehydration) and/or reduced sodium content in the blood plasma during diuretic therapy, restriction of salt intake, diarrhea or vomiting, symptomatic arterial hypotension may develop, especially after taking the first dose of Lorista® N. Before using the drug, it should be restored BCC and/or sodium content in blood plasma.

Water and electrolyte imbalances.

Fluid and electrolyte imbalances are common in patients with impaired renal function, especially in the setting of diabetes mellitus. In this regard, it is necessary to carefully monitor the potassium content in the blood plasma and creatinine clearance, especially in patients with heart failure and creatinine Cl 30-50 ml/min.

Concomitant use with potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium, or other drugs that can increase the level of potassium in the blood plasma (for example, heparin) is not recommended.

Liver dysfunction.

The concentration of losartan in the blood plasma increases significantly in patients with liver cirrhosis, so Lorista® N should be used with caution in patients with mild or moderate liver dysfunction.

Renal dysfunction.

Impaired renal function, including renal failure, may occur due to inhibition of the RAAS (especially in patients whose renal function is dependent on the RAAS, such as those with severe heart failure or a history of renal dysfunction).

Renal artery stenosis.

In patients with bilateral renal artery stenosis, as well as stenosis of the artery of the only functioning kidney, drugs affecting the RAAS, incl. and ARA II, can reversibly increase the concentrations of urea and creatinine in the blood plasma.

Losartan should be used with caution in patients with bilateral renal artery stenosis or arterial stenosis of a solitary kidney.

Kidney transplantation.

There is no experience with the use of Lorista® N in patients who have recently undergone kidney transplantation.

Primary hyperaldosteronism.

Patients with primary hyperaldosteronism are resistant to antihypertensive drugs that affect the RAAS, therefore, in such patients, the use of Lorista® N is not recommended.

IHD and cerebrovascular diseases.

As with the treatment of any antihypertensive drugs, an excessive decrease in blood pressure in patients with coronary artery disease or cerebrovascular diseases can lead to the development of myocardial infarction or stroke.

Heart failure.

In patients whose renal function depends on the state of the RAAS (for example, with CHF III–IV functional class according to the NYHA classification, accompanied or not accompanied by impaired renal function), therapy with drugs affecting the RAAS may be accompanied by severe arterial hypotension, oliguria and/or progressive azotemia, and in rare cases, acute renal failure. It is impossible to exclude the development of these disorders due to suppression of RAAS activity while taking ARA II.

Stenosis of the aortic and/or mitral valve, HOCM.

Lorista® N, like other vasodilators, should be used with caution in patients with hemodynamically significant stenosis of the aortic and/or mitral valve, or HOCM.

Ethnic characteristics.

Losartan (like other drugs that affect the RAAS) has a less pronounced hypotensive effect in patients of the Black race compared to representatives of other races, possibly due to the higher incidence of hyporeninemia in these patients with arterial hypertension.

Hydrochlorothiazide

Arterial hypotension and disturbances of water and electrolyte metabolism.

It is necessary to monitor blood pressure, clinical signs of impaired water and electrolyte metabolism, incl. dehydration, hyponatremia, hypochloremic alkalosis, hypomagnesemia or hypokalemia, which may develop against the background of diarrhea or vomiting.

Serum electrolyte levels should be monitored periodically.

Metabolic and endocrine effects.

Caution is necessary in all patients receiving treatment with oral hypoglycemic agents or insulin, because hydrochlorothiazide may weaken their effect. During therapy with thiazide diuretics, latent diabetes mellitus can manifest itself.

Thiazide diuretics, including hydrochlorothiazide, can cause fluid and electrolyte imbalance (hypercalcemia, hypokalemia, hyponatremia, hypomagnesemia and hypokalemic alkalosis).

Thiazide diuretics may reduce renal excretion of calcium and cause a temporary and slight increase in plasma calcium.

Severe hypercalcemia may be a sign of hidden hyperparathyroidism. Before testing the function of the parathyroid glands, thiazide diuretics must be discontinued.

During treatment with thiazide diuretics, it is possible to increase the concentration of cholesterol and triglycerides in the blood serum.

Therapy with thiazide diuretics may worsen hyperuricemia and/or aggravate gout in some patients.

Losartan reduces the concentration of uric acid in the blood plasma, so its use in combination with hydrochlorothiazide neutralizes the hyperuricemia caused by the thiazide diuretic.

Liver dysfunction.

Thiazide diuretics should be used with caution in patients with impaired liver function or progressive liver disease, as they can cause intrahepatic cholestasis, and even minimal disturbances in water and electrolyte balance can contribute to the development of hepatic coma.

The drug Lorista® N is contraindicated in patients with severe liver dysfunction, because there is no experience in using the drug in this category of patients.

Acute myopia and secondary acute angle-closure glaucoma.

Hydrochlorothiazide is a sulfonamide that can cause an idiosyncratic reaction leading to transient acute myopia and acute angle-closure glaucoma. Symptoms include: sudden decrease in visual acuity or eye pain, usually occurring within hours to weeks of starting hydrochlorothiazide therapy. If left untreated, acute angle-closure glaucoma can lead to permanent vision loss.

Treatment:

Stop taking hydrochlorothiazide as soon as possible. If IOP remains uncontrolled, emergency medical treatment or surgery may be required. Risk factors for the development of acute angle-closure glaucoma are: a history of an allergic reaction to sulfonamide or benzylpenicillin.

Are common

In patients taking thiazide diuretics, hypersensitivity reactions may develop with or without a history of an allergic reaction or bronchial asthma, but are more likely if there is a history of such.

There are reports of exacerbation of systemic lupus erythematosus with the use of thiazide diuretics.

Special information on excipients

The drug Lorista® N contains lactose, therefore the drug is contraindicated in patients with lactase deficiency, lactose intolerance, and glucose-galactose malabsorption syndrome.

Impact on the ability to perform potentially hazardous activities that require special attention and quick reactions (for example, driving vehicles, working with moving mechanisms).

At the beginning of therapy, Lorista® N may cause a decrease in blood pressure, dizziness or drowsiness, thus indirectly affecting the psycho-emotional state. For safety reasons, patients should first assess their response to treatment before engaging in activities requiring increased alertness.