Lorista H 50mg/12.5mg 90 tablets — Made in Slovenia — Free Delivery

(Lorista H)
Lorista H 50mg/12.5mg 90 tablets — Made in Slovenia — Free Delivery
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Description Lorista H 50mg/12.5mg 90 tablets — Made in Slovenia — Free Delivery

Indications

Treatment of hypertension when losartan monotherapy or hydrochlorothiazide monotherapy is insufficient.
Lorista H 100. Reducing the risk of cardiovascular disease and death in patients with hypertension, left ventricular hypertrophy.

Application

Lorista may be used with other antihypertensive agents. tablets should be swallowed with a glass of water. the use of the preparation does not depend on food intake.
AG
With insufficient effectiveness of monotherapy with the components of the preparation, you can use the combined preparation directly. The usual initial and maintenance dose for most patients is 1 tablet of Lorista H (50/12.5 mg) 1 time per day. For patients in whom the use of 1 tablet of Lorista H does not give sufficient effect, the dose can be increased to 2 tablets of Lorista H 1 time per day (in the morning), 1 tablet of Lorista H 100 or up to 1 tablet of Lorista HD (100/25 mg) 1 time per day. day (morning).
The maximum hypotensive effect is achieved within 3-4 weeks of treatment. The maximum recommended dose is 2 Lorista H tablets or 1 Lorista HD tablet once daily.
Lorista H 100 is intended for those patients who receive a titrated dose of losartan 100 mg and who require additional blood pressure monitoring.
Reducing the risk of cardiovascular disease and death in hypertensive patients with left ventricular hypertrophy. The usual starting dose is 50 mg losartan once daily. Patients who fail to achieve target blood pressure levels when taking losartan 50 mg / day, should select therapy using a combination of losartan with low doses of hydrochlorothiazide (12.5 mg) and, if necessary, then increase the dose to 100 mg losartan / 12 5 mg hydrochlorothiazide once a day. If necessary, the dose should be increased to 100 mg of losartan and 25 mg of hydrochlorothiazide 1 time per day.
Lorista H, Lorista H 100 and Lorista HD are appropriate alternative medicines for patients who would otherwise need to take losartan plus hydrochlorothiazide in combination.
Use in patients with renal insufficiency and in patients who are on hemodialysis. Patients with moderate renal insufficiency (creatinine clearance 30-50 ml / min) do not need to adjust the initial dose.
Losartan and hydrochlorothiazide tablets are not recommended for use in patients on hemodialysis. Losartan/hydrochlorothiazide tablets are contraindicated in patients with severe renal insufficiency (creatinine clearance 30 ml/min).
Use in patients with a decrease in intravascular volume of circulating fluid. Correction of fluid and/or sodium deficits should be carried out before starting the use of losartan/hydrochlorothiazide tablets.
Use in patients with hepatic impairment. Losartan/hydrochlorothiazide is contraindicated in patients with severe hepatic impairment.
Use in elderly patients. Elderly patients do not usually require dose adjustment.

Contraindications

  • Hypersensitivity to losartan, substances that are derivatives of sulfonamides (such as hydrochlorothiazide), or any excipients;
  • pregnant women or women planning to become pregnant (see Use during pregnancy and lactation);
  • severe renal failure (namely, creatinine clearance of 30 ml / min);
  • anuria;
  • severe liver failure, cholestasis, obstructive diseases of the biliary tract;
  • therapeutically resistant hypokalemia or hypercalcemia;
  • persistent hyponatremia;
  • symptomatic hyperuricemia/gout;
  • simultaneous use of aliskiren in patients with diabetes mellitus or impaired renal function (GFR 60 ml / min / 1.73 m2) (see SPECIAL INSTRUCTIONS and INTERACTIONS).

Side effects

Adverse reactions that may occur during treatment with losartan are classified into groups according to the frequency of occurrence: very often (1/10); often (1/100, 1/10); infrequently (1/1000, 1/100); rarely (1/10,000, 1/1000); very rarely (1/10,000); unknown (cannot be estimated from available data).
In studies with hypertension, dizziness was the only side effect associated with the active substance, and was observed in more than 1% of patients (significantly more than in the placebo group).
From the hepatobiliary system: rarely - hepatitis.
Changes in laboratory parameters: rarely - hyperkalemia, increased levels of ALT.
Additional side effects that have been observed with the use of one of the individual components of the preparation and which may be potential side effects of the preparation when using losartan potassium / hydrochlorothiazide are as follows:
Losartan
On the part of the blood and lymphatic system: infrequently - anemia, Shenlein-Genoch purpura, ecchymosis, hemolysis.
From the immune system: rarely - anaphylactic reactions, angioedema, urticaria.
From the side of metabolism and nutrition: infrequently - anorexia, gout.
Mental disorders: often - insomnia; infrequently - anxiety, anxiety, confusion, depression, nightmares, sleep disturbances, drowsiness, memory impairment.
From the nervous system: often - headache, dizziness; infrequently - nervousness, paresthesia, peripheral neuropathy, tremor, migraine, fainting.
On the part of the organ of vision: infrequently - blurred vision, burning sensation / itching in the eye, conjunctivitis, visual impairment.
On the part of the organ of hearing and the vestibular apparatus: infrequently - dizziness and tinnitus.
From the side of the cardiovascular system: infrequently - arterial hypotension, orthostatic hypotension, chest pain, angina pectoris, block II degree, cerebrovascular disorders, myocardial infarction, palpitations, arrhythmias (atrial fibrillation, sinus bradycardia, tachycardia, ventricular tachycardia, ventricular fibrillation of the heart ).
From the vascular system: infrequently - vasculitis.
From the respiratory system and mediastinal organs: often - cough, inflammation of the upper respiratory tract, nasal congestion, sinusitis, changes in the sinuses; infrequently - a feeling of pharyngeal discomfort, pharyngitis, laryngitis, shortness of breath, bronchitis, epistaxis, rhinitis, impaired airway patency.
From the digestive tract: often - abdominal pain, nausea, diarrhea, dyspepsia; infrequently - constipation, toothache, dry mouth, flatulence, gastritis, vomiting.
From the hepatobiliary system: unknown - functional disorders of the liver.
From the skin and subcutaneous tissues: sometimes - alopecia, dermatitis, dry skin, erythema, redness, photosensitivity, itching, rash, urticaria, increased sweating.
From the musculoskeletal system and connective tissues: often - muscle cramps, back pain, pain in the legs, myalgia; infrequently - pain in the hands, swelling of the joints, pain in the knees, bone and muscle pain, pain in the shoulders, feeling of stiffness in the joints, arthralgia, arthritis, coxalgia, fibromyalgia, muscle weakness, pain in the hip joint; very rarely - rhabdomyolysis.
From the side of the kidneys and urinary tract: infrequently - nocturia, intense urination, urinary tract infections.
On the part of the reproductive system and mammary glands: infrequently - decreased libido, impotence.
Systemic disorders and complications at the injection site: often - increased fatigue, chest pain; infrequently - swelling of the face, fever
Changes in laboratory parameters: often - hyperkalemia, a slight decrease in hematocrit and hemoglobin; infrequently - a slight decrease in the concentration of residual nitrogen and creatinine; very rarely - an increase in liver enzymes and bilirubin levels.
Hydrochlorothiazide
On the part of the blood and lymphatic system: infrequently - agranulocytosis, aplastic anemia, hemolytic anemia, leukopenia, purpura, thrombocytopenia.
From the immune system: rarely - anaphylactic reactions.
From the side of metabolism and nutrition: infrequently - anorexia, hyperglycemia, hyperuricemia, hypokalemia, hyponatremia.
Mental disorders: infrequently - insomnia, mood changes.
From the nervous system: often - headache.
On the part of the organ of vision: infrequently - temporary blurred vision, xanthopsia.
From the vascular system: infrequently - necrotizing angiitis (vasculitis and cutaneous vasculitis).
From the respiratory system and mediastinal organs: infrequently - respiratory distress, including pneumonitis and pulmonary edema.
From the digestive tract: infrequently - inflammation of the salivary glands, intestinal spasms, stomach irritation, nausea, vomiting, diarrhea, constipation.
From the hepatobiliary system: infrequently - jaundice (intrahepatic cholestatic), pancreatitis.
From the skin and subcutaneous tissues: often - photosensitivity, urticaria, toxic epidermal necrolysis; infrequently - Stevens-Johnson syndrome, skin reactions resembling the skin form of systemic lupus erythematosus, reactivation of the skin form of lupus erythematosus.
From the musculoskeletal system and connective tissues: infrequently - muscle cramps.
From the side of the kidneys and urinary tract: infrequently - glucosuria, interstitial nephritis, kidney dysfunction, renal failure.
Systemic disorders and complications at the injection site: rarely - fever, dizziness.

special instructions

Losartan. increased sensitivity. angioedema may occur. close monitoring of patients with a history of angioedema (of the face, lips, larynx and/or tongue) should be established.
Arterial hypotension and disturbances in water and electrolyte balance. In patients with a deficiency in the volume of circulating fluid and / or sodium in the body due to the intensive use of diuretics, restriction of salt intake, diarrhea or vomiting, symptomatic arterial hypotension may occur, especially after taking the 1st dose and after increasing the dose. Such conditions require their correction before using the preparation or reducing the initial dose.
Violations of water and electrolyte balance. In patients with renal insufficiency, both diabetic and non-diabetic, electrolyte disturbances often occur that require correction. During clinical studies conducted among patients with type II diabetes mellitus and nephropathy, the incidence of hyperkalemia was higher in the losartan group compared to the placebo group. Therefore, it is necessary to regularly monitor the concentration of potassium in the blood plasma and creatinine clearance. Particularly careful monitoring requires patients with heart failure and creatinine clearance from 30 to 50 ml / min. Potassium-sparing diuretics, potassium supplements, and potassium salt substitutes are not recommended concomitantly with losartan.
Impaired liver function. Based on pharmacokinetic data that indicate a significant increase in the concentration of losartan in blood plasma in patients with liver cirrhosis, patients with a history of hepatic dysfunction should reduce the dose of the preparation. There is no experience with the therapeutic use of losartan in patients with severe hepatic impairment. Therefore, losartan should not be taken in patients with severe hepatic impairment.
Impaired kidney function. As a consequence of inhibition of the renin-angiotensin system, changes in kidney function, including renal failure, have been observed (particularly in patients in whom kidney function depends on the functioning of the renin-angiotensin-aldosterone system, such as severe heart failure or the presence of underlying renal dysfunction) . As with the use of other preparationsthat affect the renin-anotensin-aldosterone system, in patients with bilateral renal artery stenosis or renal artery stenosis of a single kidney, an increase in the level of urea and creatinine in the blood serum is observed. Losartan should be used with caution in patients with bilateral renal artery stenosis or renal artery stenosis in a solitary kidney.
Kidney transplant. There is no experience of using the preparation in patients who have recently undergone kidney transplantation.
Primary hyperaldosteronism. Patients with primary aldosteronism generally do not respond to treatment with antihypertensive preparations whose mechanism of action is to suppress the renin-angiotensin system. Therefore, they are not recommended to use losartan tablets.
ischemic heart disease and cerebrovascular disease. As with any antihypertensive preparation, a rapid decrease in blood pressure in patients with coronary artery disease and cerebrovascular disease can cause myocardial infarction or stroke.
Heart failure. In patients with heart failure, with or without impaired renal function, when using losartan, as well as any other preparations acting on the renin-angiotensin system, there is a risk of severe arterial hypotension and renal failure (very often acute). In patients with heart failure and concomitant severe renal failure, severe renal failure (NYHA class IV), as well as heart failure and cardiac arrhythmias, which are accompanied by clinical manifestations and pose a threat to life, there is no sufficient experience with losartan. Therefore, in these categories of patients, losartan should be used with caution. The combination of losartan with β-blockers should also be used with caution.
Stenosis of the aortic and mitral valve, obstructive hypertrophic cardiomyopathy. As with other vasodilators, special caution should be exercised in patients with aortic or mitral valve stenosis or obstructive hypertrophic cardiomyopathy.
Pregnancy. Angiotensin II receptor antagonists should not be started during pregnancy. If continued angiotensin II receptor antagonist therapy is not considered important, patients planning pregnancy should be switched to an alternative antihypertensive treatment that has an approved safety profile for use during pregnancy. If pregnancy is established, treatment with losartan should be stopped immediately and, if possible, alternative therapy should be started.
Other Warnings and Cautions. Like ACE inhibitors, losartan and other angiotensin antagonists are less effective in lowering blood pressure in blacks than in other races, probably due to the greater number of individuals with low renin levels in this population of patients with hypertension.
Double blockade of the renin-angiotensin-aldosterone (RAAS). With the simultaneous use of aliskiren and angiotensin II receptor antagonists or ACE inhibitors, the risk of arterial hypotension, hyperkalemia and changes in renal function, including acute renal failure, increases. Due to the dual blockade of the RAAS, the simultaneous use of aliskiren and angiotensin II receptor antagonists or ACE inhibitors is not recommended (see Interactions). In case of extreme need for a double blockade of the RAAS, renal function, blood electrolyte levels and blood pressure should be carefully monitored. Angiotensin II receptor antagonists and ACE inhibitors should not be used concomitantly in patients with diabetes mellitus.
Hydrochlorothiazide. Arterial hypotension and disturbance of water and electrolyte balance. As with other antihypertensive agents, some patients may develop symptomatic hypotension. Patients should be evaluated for clinical signs of fluid and electrolyte imbalance, such as fluid deprivation, hyponatremia, hypochloremic alkalosis, hypomagnesemia, or hypokalemia, which may result from intercurrent diarrhea or vomiting. In such patients, periodic determination of serum electrolytes should be carried out at appropriate intervals. Dilutional hyponatremia may occur in patients with edema in hot weather.
Metabolic and endocrine effects. Thiazides are able to change glucose tolerance. Doses of antidiabetic preparations, including insulin, may need to be adjusted. During thiazide therapy, latent diabetes mellitus may occur.
Thiazides may reduce urinary calcium excretion. Thiazides can also cause a slight and transient increase in serum calcium levels. Severe hypercalcemia may be a sign of latent hyperparathyroidism. Thiazides should be discontinued prior to testing parathyroid function.
An increase in the level of cholesterol and TG can also be associated with therapy with thiazide diuretics.
Thiazide therapy may lead to hyperuricemia and/or gout in some patients. Due to the fact that losartan reduces the content of uric acid in the urine, losartan in combination with hydrochlorothiazide reduces diuretic-induced hyperuricemia.
Liver failure. Thiazides should be used with caution in patients with hepatic impairment or progressive liver disease, as it can cause intrahepatic cholestasis, and minor changes in fluid and electrolyte balance can cause hepatic coma. The preparation is contraindicated in patients with severe hepatic impairment.
Other states. In patients receiving thiazides, allergic reactions may occur regardless of a history of allergic conditions or asthma. Relapses or worsening of systemic lupus erythematosus have been reported in patients treated with thiazides.
Special information on certain excipients. The preparation contains lactose. Patients with rare hereditary problems of galactose intolerance, the lactase deficiency or malabsorption of glucose-galactose should not take this medicine.

Use during pregnancy or lactation

Pregnancy. The preparation is contraindicated in pregnant women or women planning pregnancy.
If the patient becomes pregnant, the course of therapy with the preparation should be interrupted and start taking other preparations.
It is known that the therapeutic dose of the combination of losartan / hydrochlorothiazide in the II and III trimester of pregnancy caused fetotoxicity (decrease in kidney function, oliohydramnios (oligohydramnios), delayed ossification of the cranial bones in the fetus) and toxic manifestations in the newborn (renal failure, arterial hypotension, hypokalemia).
If the use of angiotensin II inhibitors occurred in the second trimester of pregnancy, it is recommended to conduct an ultrasound of the function of the kidneys and skull.
Infants whose mothers have taken angiotensin II inhibitors should be carefully monitored for arterial hypotension, oliguria and hyperkalemia (see CONTRAINDICATIONS, SPECIAL INSTRUCTIONS).
Hydrochlorothiazide. There is limited experience with the use of hydrochlorothiazide during pregnancy, especially in the first trimester. Animal studies are limited.
Hydrochlorothiazide crosses the placental barrier. Based on the pharmacological mechanism of action of hydrochlorothiazide, its use in the II and III trimester can damage the blood supply between the placenta and the fetus and cause jaundice, electrolyte imbalance and thrombocytopenia in the fetus and newborn.
Hydrochlorothiazide should not be used to treat gestational edema, as well as gestational hypertension or preeclampsia due to the risk of a decrease in blood plasma volume and the occurrence of uteroplacental hypoperfusion, without a beneficial effect on the course of the disease.
Hydrochlorothiazide should not be used to treat hypertension in pregnant women unless alternative treatment cannot be used.
Lactation. It is not recommended to use the preparation due to the lack of sufficient data on the use during lactation. The patient should be switched to an alternative antihypertensive treatment that has an approved safety profile for use during breastfeeding, especially in neonates or premature infants.
Children. There is no experience of using the preparation in children, so losartan / hydrochlorothiazide should not be used in this category of patients.
The ability to influence the reaction rate when driving vehicles or other mechanisms
Given the possibility of developing such adverse reactions as dizziness and arterial hypotension, the preparation should be used with caution when driving vehicles or other mechanisms.

Interactions

Losartan. there have been reports that rifampicin and fluconazole reduce the level of the active metabolite. the clinical consequences of these interactions were not evaluated.
As with other preparations that block angiotensin II receptors or their effects, concomitant use of potassium-sparing diuretics (eg spironolactone, triamterene, amiloride), potassium supplements, or salt substitutes containing potassium may lead to an increase in serum potassium levels. Simultaneous use is not recommended.
As with other preparations that affect sodium excretion, lithium excretion may be reduced. Therefore, serum lithium levels should be carefully monitored if lithium salts are used in conjunction with angiotensin II receptor antagonists.
NSAIDs (acetylsalicylic acid in anti-inflammatory dosing regimen, selective COX-2 inhibitors) and non-selective NSAIDs can reduce the antihypertensive effect of angiotensin II receptor antagonists. The concomitant use of angiotensin II receptor antagonists or diuretics and NSAIDs may lead to deterioration of renal function, including possible acute renal failure, and an increase in plasma potassium levels, especially in patients with impaired renal function. This combination should be taken with caution, especially in the elderly. Patients require adequate hydration and close monitoring of renal function at the start of concomitant therapy and periodically thereafter.
In some patients with impaired renal function, concomitant use of angiotensin II receptor antagonists and preparations that inhibit COX-2 may lead to further deterioration of renal function. These effects are usually reversible.
Other preparations that can cause arterial hypotension as a primary disease or side effect are tricyclic antidepressants, antipsychotics, baclofen, amifostine. The simultaneous use of these preparations may increase the risk of arterial hypotension.
Studies have shown that as a result of dual blockade of the RAAS with the simultaneous use of ACE inhibitors, angiotensin II receptor antagonists or aliskiren, the risk of adverse reactions, such as arterial hypotension, hyperkalemia and changes in renal function, including AKI, is increased compared with the use of a single agent of the RAAS (see. CONTRAINDICATIONS, SPECIAL INSTRUCTIONS).
Hydrochlorothiazide. With simultaneous use, these preparations can interact with thiazide diuretics.
Alcohol, barbiturates, preparations or antidepressants. Orthostatic hypotension may worsen.
Antidiabetic agents (oral preparations and insulin). The use of thiazides may affect glucose tolerance. It may be necessary to change the dose of antidiabetic agents. Metformin should be used with caution, as there is a risk of lactic acidosis caused by possible renal failure associated with the use of hydrochlorothiazide.
Other antihypertensive preparations. additive effect.
Colestyramine and colestipol, resins. In the presence of anion exchange resins, the absorption of hydrochlorothiazide is impaired. A single dose of resins, cholestyramine and colestipol binds hydrochlorothiazide and, accordingly, reduces its absorption in the gastrointestinal tract by 85% or 43%.
Corticosteroids, ACTH. The loss of electrolytes increases, especially the risk of developing hypokalemia.
Pressor amines (e.g. epinephrine). Possible decreased response to pressor amines. The degree of this decrease is insignificant, therefore, the use of these funds is not excluded.
Non-depolarizing musculoskeletal relaxants (eg tubocurarine). Possible increased response to muscle relaxants.
lithium preparations. Diuretics reduce renal clearance and increase the risk of lithium intoxication; simultaneous use is not recommended.
Preparations used to treat gout (probenecid, sulfinpyrazone and allopurinol). It may be necessary to change the dose of preparations that remove uric acid, because hydrochlorothiazide can increase the concentration of uric acid in the blood plasma. An increase in the dose of probenecid or sulfinpyrazone may be required. The simultaneous use of thiazides may increase the likelihood of allergic reactions to allopurinol.
Anticholinergic preparations (eg atropine, biperiden). An increase in the bioavailability of thiazide diuretics is associated with a decrease in the motor activity of the gastrointestinal tract and the rate of gastric emptying.
Cytotoxic agents (cyclophosphamide, methotrexate). Thiazides can reduce the renal excretion of cytotoxic agents and enhance myelosuppressive effect.
Salicylates. When using high doses of salicylates, hydrochlorothiazide can increase the toxic effect of salicylates on the central nervous system.
Methyldopa. In some cases, with the simultaneous use of hydrochlorothiazide and methyldopa, hemolytic anemia was noted.
Cyclosporine. With the simultaneous use of cyclosporine, the risk of hyperuricemia and complications such as gout increases.
cardiac glycosides. Thiazide-induced hypokalemia or hypomagnesemia contribute to the formation of arrhythmias caused by cardiac glycosides.
Preparations whose effect varies depending on the level of potassium in the blood. It is necessary to periodically monitor the concentration of potassium in the blood plasma and conduct ECG monitoring when using losartan / hydrochlorothiazide with preparations whose effect depends on the level of potassium in the blood plasma (cardiac glycosides and antiarrhythmic preparations), as well as with preparations that cause torsades de pointes (ventricular tachycardia), including some antiarrhythmic preparations, since hypokalemia contributes to the formation of ventricular tachycardia:
class Ia antiarrhythmic preparations (eg quinidine, hydroquinidine, disopyramide);
class III antiarrhythmic preparations (eg amiodarone, sotalol, dofetilide, ibutilide);
certain antipsychotics (thioridazine, chlorpromazine, levomepromazine, trifluoperazine, cyamemazine, sulpiride, sultopride, amisulpride, tiapride, pimozide, haloperidol, droperidol);
other preparations (eg bepridil, cisapride, diphemanil, intravenously administered erythromycin, halofantrine, mizolastine, pentamidine, terfenadine, intravenously administered vincamine).
Salts of calcium. Thiazide diuretics may increase serum calcium due to decreased excretion. If it is necessary to use preparations that replenish calcium, you should regularly monitor the level of calcium in the blood serum and, in accordance with the result, determine the dose of these preparations.
Impact on laboratory parameters. Due to the effect on calcium metabolism, thiazides may interfere with the results of parathyroid function tests.
Carbamazepine. Risk of developing symptomatic hyponatremia. Clinical observation of the patient and laboratory blood control are necessary.
Contrast media containing iodine. Dehydration caused by diuretics may increase the risk of AKI, especially when high doses of iodine-containing preparations are administered. Before the introduction of iodine, it is necessary to restore the iodine balance.
Amphotericin B (parenteral), corticosteroids, ACGH and laxatives. Hydrochlorothiazide can contribute to the violation of water and electrolyte balance, causing mainly hypokalemia.

Overdose

There are no specific data on the treatment of preparation overdose. overdose therapy is symptomatic and supportive. the course of therapy with the preparation  should be interrupted and the patient's condition should be carefully monitored. if the preparation has been recently taken, induce vomiting and take measures to eliminate dehydration, electrolyte disturbances, hepatic coma and hypotension.
Losartan. Data on preparation overdose in humans are limited. The most likely manifestations of an overdose are arterial hypotension, tachycardia; bradycardia may be due to parasympathetic (vagal) stimulation. In the case of symptomatic arterial hypotension, maintenance therapy is indicated.
Losartan and its active metabolite are not removed by hemodialysis.
Hydrochlorothiazide. Frequent symptoms of overdose are due to electrolyte deficiency (hypokalemia, hypochloremia, hyponatremia) and dehydration due to excessive urination. With the simultaneous administration of cardiac glycosides, hypokalemia can cause an increase in arrhythmias.
Hydrochlorothiazide is removed by hemodialysis, but the extent of removal has not been established.

Storage conditions

In original packaging at a temperature not exceeding 30 °C

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