Instructions for use of LORISTA® ND (LORISTA® HD)

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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).

Dosages and methods of therapy from the instructions for Lorista

Oral medication can be combined with other drugs responsible for lowering blood pressure. Taking the product is not associated with food.

The instructions indicate the following methods of treatment with Lorista N:

  1. Arterial hypertension - 1 tablet for three days. During this period, the maximum effect in reducing blood pressure is achieved. To obtain greater results, use 2 units of medication daily - this is the highest permitted dose of the medication.
  2. Reduced blood volume - allows the use of 25 mg of losartan per day. If the deviation occurs due to large dosages of diuretics, then the diuretics are discontinued before therapy.
  3. Initial doses do not imply a change in the standard regimen for the treatment of patients with moderate renal failure, over 65 years of age, on dialysis.

A daily dose of 50 mg of the drug is recommended to reduce the likelihood of developing cardiovascular pathologies and the risk of death in patients with a hypertrophied left ventricle of the heart and arterial hypertension.

In the absence of the expected effect, 12.5 mg of Hydrochlorothiazide is added to 50 mg of Lorista N. If necessary, the amount of the main medication is increased to 100 mg, and the volume of the second drug remains in its original position. The maximum permissible dosage is 2 tablets.

Lorista ND is prescribed in the absence of the expected results from Lorista N. Daily doses are similar for both forms of the drug.

Accidentally exceeding the recommended amount of medication provokes a slow or rapid heartbeat and a drop in blood pressure. In case of overdose, symptomatic therapy is carried out with forced diuresis, without hemodialysis.

An excess of hydrochlorothiazide also leads to the appearance of side symptoms with a sharp decrease in the volume of sodium, potassium, and chlorine in the bloodstream. Treatment of the condition consists of suppressing the emerging clinical manifestations of intoxication.

Indications and contraindications for therapy with Lorista

Both forms of medication are prescribed to patients:

  • to reduce the likelihood of developing cardiovascular pathologies;
  • to prevent death in patients with high blood pressure and hypertrophic changes in the left ventricle;
  • as a component of combination treatment of hypertension.

The instructions indicate the following contraindications to Lorista:

  • in the absence of urine entering the bladder;
  • insufficient amount of lactase, increased or decreased amounts of potassium;
  • hepatic, renal dysfunction, disorders of the conversion of galactose into glucose;
  • dehydration, low blood pressure;
  • intolerance to the component composition;
  • pregnancy, breastfeeding, under age.

Particular care during therapy with Lorista is required for patients:

  • with diabetes mellitus, bilateral narrowing of arterial vessels in the kidneys;
  • water-electrolyte imbalance - with insufficient amounts of magnesium, potassium, sodium;
  • systemic blood pathologies, allergic reactions;
  • a large amount of calcium, uric acid in the blood;
  • bronchial asthma, gout.

Lorista is not used in conjunction with NSAIDs; in some cases it causes the development of adverse reactions. During drug therapy, the following may occur:

  • attack of dizziness, sleep disturbance with insomnia, cephalgia;
  • accelerated heart rate, decreased blood pressure (dose-dependent), vasculitis;
  • swelling of the nasal passages, pharyngitis, infection of the upper respiratory tract;
  • cough, pain in the abdominal area, nausea with vomiting, dyspeptic disorders;
  • hepatitis, increased activity of liver enzymes, liver dysfunction;
  • muscle and joint pain, anemic conditions, capillary toxicosis;
  • swelling in the peripheral areas, chest pain, asthenic syndrome, general weakness;
  • nettle fever, anaphylaxis, obsessive itching, Quincke's edema.

Treatment may change the levels of urea, creatinine, potassium, hemoglobin, and hematocrit.

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