Lorista 50mg 90 tablets — Made in Slovenia — Free Delivery

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

Indications

Treatment of essential hypertension in adults, as well as in children over the age of 6 years.
Treatment of kidney disease in adult hypertensive patients with type II diabetes mellitus with proteinuria ≥0.5 g/day as part of antihypertensive therapy.
Treatment of chronic heart failure (in patients 60 years of age and older), when the use of ACE inhibitors is considered impossible due to incompatibility, especially with cough, which is contraindicated. Patients with heart failure who have stabilized on an ACE inhibitor should not be treated with losartan. The patient should have a left ventricular ejection fraction of ≤40%, be clinically stable, and follow an established chronic heart failure treatment regimen.
Reducing the risk of stroke in adult patients with hypertension and left ventricular hypertrophy, as documented by ECG.

Application

Losartan tablets should be taken with a glass of water. the use of the preparation does not depend on food intake.
AG. Usually the initial and maintenance dose for most patients is 50 mg 1 time per day (1 tablet of Lorista 50 mg). The maximum antihypertensive effect is achieved at 3-6 weeks after the start of treatment. For some patients, it may be beneficial to increase the dose of the preparation to 100 mg 1 time per day (in the morning).
Lorista can be used in combination with other antihypertensive preparations, especially diuretics (eg hydrochlorothiazide).
Patients with hypertension and type II diabetes mellitus with proteinuria ≥0.5 g/day. The usual starting dose is 50 mg (1 lorista tablet) once daily. The dose can be increased to 100 mg 1 time per day, depending on what the blood pressure indicators are 1 month after the start of treatment. Lorista can be used with other antihypertensive preparations (eg, diuretics, calcium channel blockers, α- or β-receptor blockers, and centrally acting preparations), as well as insulin and other commonly used hypoglycemic preparations (eg, sulfonylurea, glitazones, and glucosidase inhibitors).
Heart failure. The usual initial dose of Lorista in patients with chronic heart failure is 12.5 mg once daily. As a rule, the dose is titrated at weekly intervals (namely: 12.5; 25; 50 mg / day) to the usual maintenance dose of 50 mg (1 tablet of Lorista) 1 time per day, depending on individual tolerance.
Reducing the risk of stroke in patients with hypertension and left ventricular hypertrophy, as documented by ECG. The usual starting dose is 50 mg of losartan (1 lorista 50 mg tablet) once daily. Depending on changes in blood pressure levels, low-dose hydrochlorothiazide should be added to treatment and / or the dose of Lorista should be increased to 100 mg 1 time per day.
Separate groups of patients
Use in patients with reduced BCC. Patients with reduced BCC (for example, due to treatment with high doses of diuretics) should start therapy with a dose of 25 mg 1 time per day.
Use in patients with impaired renal function and patients undergoing hemodialysis sessions. When prescribing Lorista to patients with impaired renal function and patients undergoing hemodialysis sessions, an initial dose adjustment is not necessary.
Use in patients with impaired liver function. For patients with a history of hepatic impairment, consideration should be given to prescribing the preparation at a lower dose. There is no experience in the treatment of patients with severe hepatic impairment, therefore losartan is contraindicated in this group of patients.
Application in children. Data on the efficacy and safety of the use of losartan in children aged 6–18 years for the treatment of hypertension are limited. There is also little data on pharmacokinetics in children with hypertension from 1 month of age.
For children who can swallow tablets and whose body weight is 20 kg and 50 kg, the recommended dose is 25 mg 1 time per day. In exceptional cases, the dose can be increased to a maximum of 50 mg 1 time per day. The dose should be adjusted depending on the effect on blood pressure.
In patients weighing 50 kg, the usual single dose is 50 mg 1 time per day. In exceptional cases, the dose can be increased to a maximum of 100 mg 1 time per day. Doses greater than 1.4 mg/kg (or 100 mg) per day have not been studied in children. Losartan is not recommended for use in children under 6 years of age, since there are insufficient data on the use of the preparation in this group of patients.
The preparation  is not recommended for use in children with a glomerular filtration rate of 30 ml / min / 1.73 m2, since there are no relevant data on the use. Losartan is also not recommended for use in children with hepatic impairment.
Use in elderly patients. As a rule, there is no need to adjust the initial dose for elderly patients, although the possibility of prescribing the preparation  at an initial dose of 25 mg to patients over 75 years of age should be considered.

Contraindications

Hypersensitivity to losartan or any other component of the preparation.
Pregnant women or women planning to become pregnant (see Use during pregnancy and lactation). Severe liver dysfunction. Simultaneous use with aliskiren in patients with diabetes mellitus or impaired renal function (glomerular filtration rate (GFR) 60 ml / min / 1.73 m2) (see SPECIAL INSTRUCTIONS).

Side effects

An adverse reaction frequently reported in clinical studies was dizziness.
The frequency of adverse reactions listed below: 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 determined from the available data).
AG
From the nervous system: often - dizziness, vertigo; infrequently - drowsiness, headache, insomnia, muscle cramps.
From the side of the heart: infrequently - palpitation, angina pectoris, tachycardia.
From the vascular system: infrequently - symptomatic arterial hypotension (especially in patients with intravascular dehydration, for example, with severe heart failure or when treated with diuretics in high doses), dose-dependent orthostatic effect.
From the digestive tract: infrequently - abdominal pain, dyspepsia, persistent constipation.
From the respiratory system: infrequently - cough, runny nose, sinusitis, pharyngitis, upper respiratory tract infection.
General condition and disorders associated with the way the preparation is used: infrequently - asthenia, weakness, swelling, rash.
Laboratory indicators
In controlled clinical trials, clinically significant changes in standard laboratory parameters have rarely been associated with the use of losartan tablets. AlAT levels rarely increased and usually returned to normal after discontinuation of the preparation. Hyperkalemia (serum potassium level 5.5 mmol/l) was observed in 1.5% of patients with hypertension.
Patients with left ventricular hypertrophy
From the nervous system: often - dizziness.
On the part of the organ of hearing and balance: often - vertigo.
General condition and disorders associated with the way the preparation is used: often - asthenia / weakness.
Chronic heart failure
From the nervous system: infrequently - dizziness, headache; rarely - paresthesia.
From the side of the heart: rarely - syncope, atrial fibrillation, stroke.
From the vascular system: infrequently - arterial hypotension, including orthostatic hypotension.
Respiratory, thoracic and mediastinal disorders: infrequently - dyspnea.
From the digestive tract: infrequently - diarrhea, nausea, vomiting.
From the skin and subcutaneous tissues: infrequently - urticaria, itching, rash.
General condition and disorders associated with the way the preparation is used: infrequently - asthenia / weakness.
Laboratory indicators: infrequently - an increase in the level of urea, creatinine in the blood serum and potassium in the blood serum.
Hypertension and type II diabetes mellitus with kidney disease
From the nervous system: often - dizziness.
From the vascular system: often - arterial hypotension.
General condition and disorders associated with the way the preparation is used: often - asthenia / weakness.
Laboratory indicators: often - hypoglycemia, hyperkalemia.
The following adverse reactions occurred more frequently in patients treated with losartan than in patients in the placebo group:
  • on the part of the blood and lymphatic system: unknown - anemia.
From the side of the heart: unknown - syncope, palpitation.
From the vascular system: unknown - orthostatic arterial hypotension.
From the digestive tract: unknown - diarrhea.
From the musculoskeletal system and connective tissue: unknown - back pain.
From the side of the kidneys and urinary tract: unknown - urinary tract infections.
General condition and disorders associated with the way the preparation is used: unknown - flu-like symptoms.
Laboratory indicators: patients with type II diabetes mellitus and nephropathy treated with losartan tablets developed hyperkalemia of 5.5 mEq / l compared with patients in the placebo group.
Post-marketing surveillance
During post-marketing surveillance, the following side effects have been reported:
on the part of the blood and lymphatic system: unknown - anemia, thrombocytopenia.
On the part of the organ of hearing and the labyrinth: unknown - ringing in the ears.
From the immune system: rarely - hypersensitivity reactions (anaphylactic reactions, angioedema, including swelling of the larynx and glottis, which leads to airway obstruction and / or swelling of the face, lips, pharynx and / or tongue; some patients had a history of angioedema edema, which is associated with the use of other preparations, including ACE inhibitors; vasculitis, including Shenlein-Genoch purpura.
From the nervous system: unknown - migraine, dysgeusia.
Respiratory, thoracic and mediastinal disorders: unknown - cough.
From the digestive tract: unknown - diarrhea, pancreatitis, vomiting.
From the hepatobiliary system: rarely - hepatitis; unknown - impaired liver function.
From the skin and subcutaneous tissue: unknown - urticaria, itching, rash, photosensitivity, erythroderma.
From the musculoskeletal system and connective tissue: unknown - myalgia, arthralgia, rhabdomyolysis.
From the reproductive system and mammary glands: unknown - erectile dysfunction / impotence.
From the side of the kidneys and urinary tract: as a consequence of inhibition of the renin-angiotensin-aldosterone system, changes in renal function have been reported, including renal failure in patients at risk; such changes may be reversible upon discontinuation of treatment.
Mental disorders: unknown - depression.
Laboratory indicators: unknown - hyponatremia.
Children. The profile of adverse reactions in children is similar to that in adult patients. Data on adverse reactions in children are limited.

special instructions

Angioedema. angioedema may occur. Patients with a history of angioedema (swelling of the face, lips, throat and/or tongue) should be frequently monitored.
Arterial hypotension and water-electrolyte imbalance. Symptomatic arterial hypotension, especially after the first dose of the preparation or after increasing the dose, may occur in patients with reduced BCC or sodium deficiency caused by the use of strong diuretics, dietary restriction of salt intake, diarrhea or vomiting. Such conditions require correction before starting treatment with Lorista or reducing the initial dose of the preparation. The same recommendations apply to children over 6 years of age.
electrolyte imbalance. Electrolyte imbalance is often noted in patients with impaired renal function (with or without diabetes mellitus), which should be taken into account. In a clinical study involving patients with type II diabetes mellitus and nephropathy, the incidence of hyperkalemia was higher in the treatment with losartan compared with the placebo group. Therefore, the concentration of potassium in the blood plasma and creatinine clearance should be regularly monitored, especially in patients with heart failure and creatinine clearance of 30-50 ml / min.
The simultaneous use of losartan and potassium-sparing diuretics, supplements containing potassium, salt substitutes containing potassium is not recommended.
Impaired liver function. Based on pharmacokinetic data indicating a significant increase in the concentration of losartan in the blood plasma of patients with liver cirrhosis, dose reduction should be considered for patients with a history of liver dysfunction. There is no experience with the therapeutic use of losartan in patients with severe hepatic impairment, so losartan should not be taken in such patients.
Losartan is not recommended for use in children with hepatic impairment.
Impaired kidney function. Changes in renal function, including renal insufficiency, have been reported and have been associated with suppression of the renin-angiotensin system (especially in patients with renal function dependent on the renin-angiotensin-aldosterone system, i.e. patients with severe heart failure or with pre-existing impaired renal function) .
Preparations that affect the renin-angiotensin-aldosterone system can cause an increase in the level of urea and serum creatinine in patients with bilateral renal artery stenosis or stenosis of the artery of a single kidney. These changes in renal function may be reversible upon discontinuation of therapy. Losartan should be used with caution in patients with bilateral renal artery stenosis or arterial stenosis of a single kidney.
Use in children with impaired renal function. Losartan is not recommended for use in children with a glomerular filtration rate of 30 ml / min / 1.73 m2, since there are no relevant data on the use.
During the period of losartan use, kidney function should be monitored regularly, as it may worsen. This is especially true in situations where losartan is used in the presence of other pathological conditions (fever, dehydration) that can affect kidney function.
The simultaneous use of losartan and ACE inhibitors worsens kidney function, so this combination is not recommended.
Kidney transplant. There is no experience regarding the safety of the preparation in patients who have recently undergone kidney transplantation.
Primary hyperaldosteronism. In patients with primary hyperaldosteronism, as a rule, there is no effect when using antihypertensive preparations that act by inhibiting the renin-angiotensin system. Therefore, Lorista is not recommended for this group of patients.
Coronary artery disease and cerebrovascular disease. As with other antihypertensive preparations, excessive reduction in blood pressure in patients with ischemic coronary artery disease and cerebrovascular disease can lead to the development of myocardial infarction or stroke.
Heart failure. As with other preparations that affect the renin-angiotensin-aldosterone system, patients with heart failure with or without impaired renal function are at risk of developing severe arterial hypotension and (often acute) impaired renal function. There is insufficient therapeutic experience with the use of losartan in patients with heart failure and concomitant severe renal impairment, severe heart failure (class IV according to the NYHA classification), as well as heart failure and symptomatic, life-threatening arrhythmias. Therefore, losartan should be used with caution in this group of patients. The combination of losartan with β-adrenergic blockers should be used with caution at the same time.
Stenosis of the aortic and mitral valves, obstructive hypertrophic cardiomyopathy. As with the use of other vasodilators, the preparation is prescribed with extreme caution to patients with aortic or mitral valve stenosis or obstructive hypertrophic cardiomyopathy.
Pregnancy. The use of angiotensin II receptor antagonists (ARA II) should not be initiated during pregnancy. Unless continued therapy with ARA II is considered necessary, patients planning pregnancy should be given alternative antihypertensive therapy with an established safety profile for use during pregnancy. If pregnancy is diagnosed, treatment with ARA II should be stopped immediately and, if necessary, alternative treatment should be initiated.
Other Warnings and Cautions. As found with ACE inhibitors, losartan and other angiotensin antagonists are less effective in lowering blood pressure in black patients than in other patients, possibly due to low renin activity in this group of patients with hypertension.
Special information on certain excipients. Lorista contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or malabsorption of glucose-galactose should not use this preparation.
Double blockade of the renin-angiotensin-aldosterone system (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.
Use during pregnancy or lactation
Pregnancy. The preparation is contraindicated in pregnant women or women planning pregnancy. If pregnancy is confirmed during treatment, its use must be immediately discontinued and replaced with another preparation approved for use in pregnant women. Epidemiological data regarding the risk of teratogenic effects due to the use of ACE inhibitors during the first trimester of pregnancy are not convincing, but a small increase in risk cannot be ruled out. Since there are no controlled epidemiological data regarding the risk of using ARA II, similar risks may exist for this class of preparations. Unless continued therapy with ARA II is considered necessary, patients who are planning a pregnancy should be given alternative antihypertensive therapy with an established safety profile for use during pregnancy. If pregnancy is diagnosed, treatment with ARA II should be stopped immediately and, if necessary, alternative treatment should be initiated.
It is known that the use of ARA II during the II and III trimester of pregnancy causes the appearance of fetotoxic phenomena (decrease in kidney function, oligohydramnios, delayed ossification of the skull bones) and manifestations of neonatal toxicity (renal failure, arterial hypotension, hyperkalemia).
If ARA II was used during the second trimester of pregnancy, an ultrasound scan is recommended to check kidney function and the condition of the bones of the skull.
The condition of newborns whose mothers used ARA II should be checked frequently for the development of arterial hypotension.
breastfeeding period. Since there is no information regarding the use of losartan during lactation, it is not recommended to prescribe the preparation during this period. Alternative treatment with preparations with a better known safety profile regarding use during lactation is desirable, especially in neonates or premature infants.
Children. Losartan is not recommended for use in children under 6 years of age, as data are limited in this group of patients.
The ability to influence the reaction rate when driving vehicles or other mechanisms
Studies have not been conducted on the effect of the preparation on the ability to drive vehicles and other mechanisms. However, one should be aware of the possibility of developing adverse reactions such as dizziness and drowsiness, especially at the beginning of treatment and with an increase in the dose of the preparation.

Interactions

Other antihypertensive preparations may enhance the hypotensive effect of losartan. other preparations that can cause hypotension include tricyclic antidepressants, antipsychotics, baclofen, amifostine. the main or side effect of the simultaneous use of these preparations with antihypertensive preparations may be an increased risk of arterial hypotension.
Losartan is metabolized predominantly with the participation of the cytochrome P450 (CYP) 2C9 system with the formation of an active carboxylic acid metabolite. In clinical studies, fluconazole (an inhibitor of CYP 2C9) was found to reduce the exposure of the active metabolite by approximately 50%. It has been established that the simultaneous use of losartan and rifampicin (an inducer of metabolic enzymes) leads to a 40% decrease in the concentration of the active metabolite in the blood plasma.
The clinical significance of this effect is unknown. There is no difference in exposure when losartan is co-administered with fluvastatin (a weak inhibitor of CYP 2C9).
As with other preparations that block angiotensin II or its effects, concomitant use of preparations that retain potassium in the body (for example, potassium-sparing diuretics: spironolactone, triamterene, amiloride) or increase potassium levels (for example, heparin), or supplements containing potassium, or salt substitutes with potassium, can lead to an increase in the level of potassium in the blood serum. The simultaneous use of such agents is not recommended.
A reversible increase in the concentration of lithium in the blood serum and the occurrence of toxic manifestations have been reported with the simultaneous use of lithium with ACE inhibitors. Also, such manifestations have been very rarely reported with the use of ARA II. Simultaneous treatment with lithium and losartan should be carried out with caution. If the use of such a combination is considered necessary, it is recommended to check the level of lithium in the blood serum during the combined treatment.
With the simultaneous use of ARA II and NSAIDs (for example, selective COX-2 inhibitors, acetylsalicylic acid in doses that have an anti-inflammatory effect, non-selective NSAIDs), the antihypertensive effect may be weakened. The simultaneous use of angiotensin II antagonists or diuretics with NSAIDs may lead to an increased risk of renal dysfunction, including the possible development of acute renal failure, as well as an increase in serum potassium levels, especially in patients with existing renal dysfunction. This combination should be used with caution, especially in elderly patients. Patients should be adequately dehydrated and consideration should be given to monitoring renal function after initiation of concomitant preparation use and periodically during treatment.
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 kidney function, including AKI, is increased compared with the use of a single RAAS agent (see CONTRAINDICATIONS , SPECIAL INSTRUCTIONS).

Overdose

Symptoms. There are limited data on overdose with losartan. depending on the degree of intoxication, symptoms such as arterial hypotension, tachycardia, and bradycardia may appear.
Treatment. Therapeutic measures depend on the length of time elapsed after taking the preparation, the nature and severity of the symptoms. The priority measure should be the stabilization of the function of the cardiovascular system. After oral overdose, the use of activated charcoal at the appropriate dose is indicated. The recommended measures are stimulation of vomiting and gastric lavage. Later, you should often monitor the main vital signs of the body and correct them if necessary. Losartan and active metabolites are not removed by hemodialysis.

Storage conditions

At temperatures up to 30 °C.

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