Losartan-LF tablets p/o 50mg №10×6

Name:
Losartan-lf
Description:
Round tablets, film-coated, white, biconvex shape. Main active ingredient Losartan Release form Film-coated tablets Dosage 50 mg arterial hypertension and left ventricular hypertrophy; chronic renal failure in adult patients with arterial hypertension and type 2 diabetes mellitus with concomitant proteinuria ≥ 0.5 g / day as an antihypertensive agent as part of complex therapy; chronic heart failure in adult patients, when therapy with ACE inhibitors is unacceptable due to intolerance to these drugs, especially due to the occurrence of cough, or the presence of contraindications. It is not recommended to transfer patients with chronic heart failure and stable indicators while taking ACE inhibitors to losartan therapy. If you have any doubts or questions, please consult your doctor. Dosage and administration The drug Losartan-LF is taken orally with a glass of water. Food intake does not affect the bioavailability of the drug. Film-coated tablets are indivisible and cannot be used to obtain a lower dosage. If it is necessary to use losartan in doses less than 50 mg, it is recommended to consider the use of medicinal products containing losartan in the appropriate dosage. Arterial hypertension The usual initial and maintenance dose for most patients is 50 mg once a day. The maximum antihypertensive effect is achieved 3-6 weeks after the start of treatment. In some patients, a better effect can be achieved by increasing the dose of the drug to 100 mg per day (in the morning). Losartan can be used in combination with other antihypertensive drugs, especially diuretics (eg hydrochlorothiazide). Reducing the risk of stroke in adult patients with arterial hypertension and left ventricular hypertrophy. The usual starting dose is 50 mg losartan once daily. Depending on blood pressure readings, treatment may be supplemented with a low dose of hydrochlorothiazide and/or the dose of losartan may be increased to 100 mg once daily. Chronic renal failure in adult patients with arterial hypertension and type 2 diabetes mellitus with concomitant proteinuria ≥ 0.5 g / day The usual initial dose is 50 mg once a day. The dose may be increased to 100 mg once a day, depending on the blood pressure readings one month after the start of treatment. Losartan can be used with other antihypertensive drugs (eg, diuretics, calcium channel blockers, alpha or beta receptor blockers, centrally acting drugs), as well as with insulin and other commonly used hypoglycemic drugs (eg, sulfonylurea, glitazones, and inhibitors glucosidase). Chronic heart failure The usual starting dose is 12.5 mg once daily. Typically, the dose is titrated at weekly intervals (i.e., 12.5 mg/day, 25 mg/day, 50 mg/day, 100 mg/day) up to the maximum dose of 150 mg/day for the disease, depending on individual tolerance. Special patient groups Use in patients with reduced circulating blood volume For the treatment of patients with reduced circulating blood volume (for example, as a result of treatment with high doses of diuretics), the use of the drug at an initial dose of 25 mg once a day should be considered. Use in patients with impaired renal function and in patients undergoing hemodialysis There is no need to adjust the initial dose for patients with impaired renal function, as well as for patients on hemodialysis. Use in patients with impaired liver function For patients with a history of impaired liver function, the drug should be prescribed 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. Use in elderly patients Dose adjustment for elderly patients is usually not required, however, for patients over 65 years of age, if necessary, consider starting therapy with losartan at a dose of 25 mg. Use in children There are few data on the efficacy and safety of the use of losartan in children and adolescents aged 6-18 years for the treatment of arterial hypertension. There is also little data on pharmacokinetics in children with arterial hypertension over the age of one month. For patients who can swallow tablets and weighing > 20 but < 50 kg, the recommended dose is 25 mg once daily. In exceptional cases, the dose may be increased to a maximum of 50 mg once a day. The dose of the drug should be adjusted according to the patient's blood pressure readings. In patients weighing more than 50 kg, the usual dose is 50 mg once daily. In exceptional cases, the dose can be increased to a maximum of 100 mg once a day. Doses greater than 1.4 mg/kg (or greater than 100 mg) per day have not been studied in children. If you have any doubts or questions, please consult your doctor. Use during pregnancy and lactation Pregnancy Drugs acting directly on the renin-angiotensin system may cause pathology or death of the fetus. If pregnancy is diagnosed, losartan should be discontinued immediately. The use of losartan is not recommended during the first trimester of pregnancy and is contraindicated during the second and third trimesters of pregnancy. Epidemiological data on the risk of teratogenicity after the use of ACE inhibitors during the first trimester of pregnancy are not convincing, however, a small increase in risk cannot be ruled out. Since there are no controlled epidemiological data regarding the risk of using angiotensin II receptor antagonists (ARA II), similar risks may exist for this class of drugs. 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 losartan should be stopped immediately and, if necessary, alternative treatment should be initiated. The use of ARA II during the second and third trimesters of pregnancy induces fetotoxicity (impaired renal function, oligohydramnios, delayed ossification of the skull bones) and neonatal toxicity (renal failure, hypotension, hyperkalemia). If losartan has been used since the second trimester of pregnancy, an ultrasound examination is recommended to check kidney function and the condition of the fetal skull bones. For newborns whose mothers took losartan during pregnancy, medical supervision should be established in order to timely detect and correct arterial hypotension. Lactation There is no data on the excretion of losartan into breast milk. In this regard, it is not recommended to use the drug Losartan-LF during breastfeeding. Alternative treatment with medicinal products with a better established safety profile during breastfeeding is preferred, especially in neonatal and premature infants. Precautions Use in children Losartan is not recommended for children under 6 years of age due to the lack of sufficient data on the use of the drug in this group of patients. The drug is not recommended for children with a glomerular filtration rate of less than 30 ml / min / 1.73 m2, since there are no data on the use of the drug in this group of patients. The drug Losartan-LF is not recommended for use in children with impaired liver function. Hypersensitivity Angioedema. Patients with a history of angioedema (swelling of the face, lips, throat and/or tongue) should be monitored frequently. Arterial hypotension and water-electrolyte imbalance Symptomatic arterial hypotension, especially after the use of the first dose of the drug or after increasing the dose, may occur in patients with reduced intravascular volume and / or sodium deficiency caused by the use of strong diuretics, dietary salt restriction, diarrhea or vomiting . Before starting treatment with losartan, such conditions should be corrected or the drug should be used at a lower initial dose. The same recommendations apply to children aged 6 to 18. Electrolyte imbalance Electrolyte imbalance is often observed 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 2 diabetes mellitus and nephropathy, the incidence of hyperkalemia in the losartan group was higher than in the placebo group. Plasma potassium concentrations and creatinine clearance should be checked frequently, especially in patients with heart failure and creatinine clearance of 30–50 ml/min. The simultaneous use of losartan and potassium-sparing diuretics, potassium supplements and salt substitutes containing potassium is not recommended. Liver dysfunction Taking into account pharmacokinetic data indicating a significant increase in plasma concentrations of losartan in patients with liver cirrhosis, consideration should be given to reducing the dose of the drug for patients with a history of liver dysfunction. Losartan should not be used in patients with severe hepatic impairment due to lack of experience with the use. Losartan is not recommended for use in children with hepatic impairment. Renal impairment Changes in renal function, including renal failure, associated with inhibition of the renin-angiotensin system have been reported (especially in patients with renal function dependent on the renin-angiotensin-aldosterone system, i.e. patients with severely impaired cardiac function or with pre-existing impaired function kidneys). As with the use of other drugs that affect the renin-angiotensin-aldosterone system, an increase in blood urea and serum creatinine levels has been reported in patients with bilateral renal artery stenosis or with stenosis of the artery to 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 stenosis of the artery to a single kidney. Use in children with impaired renal function The drug is not recommended for use in children with a glomerular filtration rate below 30 ml / min / 1.73 m2, due to the lack of data on the safety of use. While taking losartan, kidney function should be checked 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 renal function. The simultaneous use of losartan and ACE inhibitors worsens kidney function, so this combination is not recommended. Kidney transplantation There is no experience with the drug in patients who have recently undergone kidney transplantation. Primary hyperaldosteronism In patients with primary hyperaldosteronism, antihypertensive drugs that act by inhibiting the renin-angiotensin system are usually ineffective. Therefore, the use of losartan is not recommended. Coronary artery and cerebrovascular disease As with other antihypertensive drugs, excessive lowering of blood pressure in patients with ischemic cardiovascular disease and cerebrovascular disease may lead to the development of myocardial infarction or stroke. Heart failure As with other medicinal products that affect the renin-angiotensin system, there is a risk of severe hypotension and (often acute) renal impairment in patients with heart failure with or without impaired renal function. There is insufficient therapeutic experience with the use of losartan in patients with heart failure and concomitant severe renal impairment, in patients with severe heart failure (NYHA class IV), as well as in patients with heart failure and symptomatic, life-threatening cardiac arrhythmias. Therefore, losartan should be used with caution in this group of patients. Caution should be exercised when losartan and beta-blockers are co-administered. Stenosis of the aortic and mitral valves, obstructive hypertrophic cardiomyopathy As with the use of other vasodilators, the drug is prescribed with particular caution to patients with stenosis of the aortic and mitral valves or obstructive hypertrophic cardiomyopathy. Excipients The composition of the drug includes lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency and glucose-galactose malabsorption should not use Losartan-LF. Pregnancy Losartan should not be used during pregnancy. If continued treatment with losartan is not considered essential, patients who are planning a pregnancy should be given an alternative antihypertensive agent with an established safety profile for use during pregnancy. If pregnancy is confirmed, treatment with losartan should be stopped immediately and, if necessary, alternative treatment should be initiated. Other Precautions and Warnings ACE inhibitors, losartan, and other angiotensin antagonists are less effective in black patients, possibly due to the higher incidence of low renin activity in black patients with hypertension. Double blockade of the renin-angiotensin-aldosterone system (RAAS). There is evidence of an increased risk of hypotension, hyperkalemia, and deterioration of renal function (including acute renal failure), so dual blockade of the RAAS through the simultaneous use of ACE inhibitors, angiotensin II receptor blockers, or aliskiren is not recommended. If double blockade is considered absolutely necessary, such therapy should only be carried out under specialist supervision with frequent monitoring of renal function, electrolyte levels, and blood pressure. ACE inhibitors and angiotensin II receptor blockers should not be co-administered in patients with diabetic nephropathy. Influence on the ability to drive vehicles or potentially dangerous mechanisms No studies have been conducted on the effect of losartan on the ability to drive vehicles and mechanisms. However, when driving vehicles and other mechanisms, 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 drug. Interaction with other drugsAlways tell your doctor what medicines you are taking or have recently taken, even if they are over-the-counter medicines. Other antihypertensive drugs may increase the hypotensive effect of losartan. Simultaneous use with other drugs that can induce the occurrence of arterial hypotension as an adverse reaction (tricyclic antidepressants, antipsychotics, baclofen and amifostine) may increase the risk of hypotension. Losartan is metabolized mainly with the participation of the cytochrome P450 (CYP) 2C9 system to the active carboxylic acid metabolite. In a clinical study, fluconazole (a CYP2C9 inhibitor) was found to reduce the exposure of the active metabolite by approximately 50%. It has been established that simultaneous treatment with 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 CYP2C9). As with other drugs that block angiotensin II or its effects, concomitant use of drugs that retain potassium in the body (eg, potassium-sparing diuretics: spironolactone, triamterene, amiloride) or may increase potassium levels (eg, heparin) as well as those containing potassium in the form of supplements or salt substitutes, can lead to an increase in the content of potassium in the blood serum. The simultaneous use of such agents is not recommended. A reversible increase in serum lithium concentrations, as well as its toxicity, has been reported with the simultaneous use of lithium with ACE inhibitors. Also very rarely reported cases with the use of ARAII. 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 levels of lithium in the blood serum during simultaneous use. With the simultaneous use of ARAII and non-steroidal anti-inflammatory drugs (for example, selective inhibitors of cyclooxygenase-2 (COX-2), 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 worsening renal function, including the possible development of acute renal failure, as well as an increase in serum potassium levels, especially in patients with existing impaired renal function. This combination should be used with caution, especially in elderly patients. Patients should be adequately hydrated and consideration should be given to monitoring renal function after initiation of concomitant therapy, and periodically thereafter. Double blockade of the renin-angiotensin-aldosterone system. Data from clinical studies have shown that dual blockade of the renin-angiotensin-aldosterone system (RAAS) due to the concomitant use of ACE inhibitors, angiotensin II receptor blockers or aliskiren is associated with an increased incidence of hypotension, hyperkalemia and deterioration of kidney function (including acute renal failure), in compared with monotherapy with a drug that acts on the RAAS. Contraindications Hypersensitivity to the active substance and any auxiliary component that is part of the drug. 2nd and 3rd trimester of pregnancy. Severe liver dysfunction (no experience of use). The combined use of the drug Losartan-LF with drugs containing aliskiren is contraindicated in patients with diabetes mellitus or impaired renal function (GFR less than 60 ml / min / 1.73 m2). Composition Each tablet contains: active substance: losartan potassium - 50 mg or 100 mg; excipients: magnesium stearate, sodium stearyl fumarate, corn starch, lactose monohydrate, anhydrous colloidal silicon dioxide, microcrystalline cellulose; shell composition: Opadry II white (polyvinyl alcohol, titanium dioxide (E 171), polyethylene glycol, talc). OverdoseSymptoms There are few data on cases of drug overdose. The most likely manifestations of an overdose may be arterial hypotension and tachycardia. Bradycardia may occur due to parasympathetic (vagal) stimulation. Treatment If arterial hypotension occurs, supportive treatment should be carried out. Treatment depends on the length of time after taking the drug, as well as the nature and severity of the symptoms. The priority measure should be the stabilization of the cardiovascular system. After oral administration of the drug, the use of activated charcoal in the appropriate dose is indicated. Later, vital signs should be monitored frequently and adjusted if necessary. Losartan and the active metabolite are not excreted from the body during hemodialysis. Side effects In general, losartan is well tolerated by patients. Adverse events are mild and do not require discontinuation of the drug. The frequency of adverse reactions is defined as follows: very often (> 1/10), often (> 1/100 – < 1/10), infrequently (> 1/1.000 – < 1 /100), rare (> 1/10.000 – < 1/1.000), very rare (< 1/10.000), unknown (cannot be determined from the available data). In patients with arterial hypertension Nervous system disorders: often - dizziness; infrequently - drowsiness, headache, sleep disturbance. Hearing disorders: often - vertigo. Cardiac disorders: infrequently - palpitations, angina pectoris. Vascular disorders: infrequently - (orthostatic) hypotension, including dose-dependent orthostatic effects (especially in patients with reduced circulating blood volume, such as patients with severe heart failure or when treated with diuretics in high doses). Gastrointestinal disorders: infrequently - abdominal pain, persistent constipation. Skin and subcutaneous tissue disorders: infrequently - rash. General condition and disorders associated with the way the drug is used: infrequently - asthenia, fatigue, edema. Impact on laboratory parameters: often - hyperkalemia; rarely - an increase in the activity of alanine aminotransferase (ALT), usually reversible after discontinuation of the drug. In patients with hypertension and left ventricular hypertrophy of the heart Nervous system disorders: often - dizziness. Hearing and labyrinth disorders: often - vertigo. General condition and disorders associated with the way the drug is used: often - asthenia, fatigue. Arterial hypertension and type 2 diabetes mellitus, in combination with kidney disease. Nervous system disorders: often - dizziness. Vascular disorders: often - (orthostatic) hypotension, including dose-dependent orthostatic effects (especially in patients with reduced circulating blood volume, such as patients with severe heart failure or when treated with diuretics in high doses). General condition and disorders associated with the way the drug is used: often - asthenia, fatigue. Impact on laboratory parameters; often - hypoglycemia, hyperkalemia. Chronic heart failure Nervous system disorders; infrequently - dizziness, headache; rarely - fainting, atrial fibrillation, stroke. Respiratory system disorders: infrequently - shortness of breath. Gastrointestinal disorders: infrequently - diarrhea, nausea, vomiting. Skin and subcutaneous tissue disorders: infrequently - urticaria, itching, rash. General condition and disorders associated with the way the drug is used: infrequently - weakness, fatigue. Post-registration experience Adults Blood and lymphatic system disorders: frequency unknown - anemia, thrombocytopenia. Hearing and labyrinth disorders: frequency unknown - ringing in the ears. Immune system disorders: rarely - hypersensitivity reactions (anaphylactic reactions, angioedema, including swelling of the larynx and glottis, leading to airway obstruction, and / or swelling of the face, lips, pharynx and / or tongue); some of these patients had a history of angioedema, which is associated with the use of other drugs, including ACE inhibitors; vasculitis, including Henoch-Schonlein purpura. Nervous system disorders: frequency unknown - migraine, dysgeusia. Respiratory, thoracic and mediastinal disorders: frequency unknown - cough. Gastrointestinal disorders: frequency unknown - diarrhea. General condition and disorders associated with the way the drug is used: frequency unknown - malaise. On the part of the hepatobiliary tract: rarely - hepatitis, the frequency is unknown - impaired liver function, pancreatitis. Skin and subcutaneous tissue disorders: frequency unknown - urticaria, pruritus, rash, photosensitivity. Musculoskeletal and connective tissue disorders: frequency unknown - myalgia, arthralgia, rhabdomyolysis. Disorders of the reproductive system and mammary glands: the frequency is unknown - erectile dysfunction / impotence. Psychiatric disorders: frequency unknown - depression. Impact on laboratory parameters; frequency unknown - hyponatremia. Renal and urinary disorders: due to inhibition of the renin-angiotensin-aldosterone system, changes in renal function, including renal failure, have been reported in patients at risk; such changes in renal function may be reversible upon discontinuation of therapy. The following adverse reactions occurred more frequently in patients receiving losartan than in patients receiving placebo: frequency unknown - back pain, urinary tract infections, flu-like symptoms. Children The profile of adverse reactions in children is similar to that in adult patients. Data on adverse reactions in children are limited. In the event of adverse reactions, including those not listed in this leaflet, you must stop taking the drug and consult a doctor. Storage conditions In a place protected from moisture and light at a temperature not exceeding 25 ° C. Keep out of the reach of children. Shelf life 3 years. Do not use after the expiration date indicated on the package. Buy Losartan-LF tablets p/o 50mg No. 10x6