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    3. Losartan-Teva 100mg 30 tablets — Made in Hungary — Free Delivery

    Losartan-Teva 100mg 30 tablets — Made in Hungary — Free Delivery


    Brand: TEVA
    Product Code: Losartan-Teva
    Availability: In Stock
    $20.72
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    Pharmacological properties

    Pharmacodynamics. Losartan is a synthetic antagonist of angiotensin II (ara) receptors (type at1) for oral administration. Angiotensin II is a potent vasoconstrictor, an active hormone of the renin-angiotensin-aldosterone system (raac) and one of the most important factors in the pathophysiology of ag.
    Angiotensin II binds to AT1 receptors in many tissues (eg, vascular smooth muscle, adrenal gland, kidney, and heart) and has a number of important biological effects, including vasoconstriction and aldosterone release. Angiotensin II also stimulates smooth muscle cell proliferation.
    Losartan binds selectively to AT1 receptors. In in vitro and in vivo studies, losartan and its pharmacologically active metabolite, carboxylic acid (E-3174), block all physiologically significant effects of angiotensin II, regardless of the source or route of its synthesis.
    Losartan does not bind or block other hormone receptors or ion channels, which play an important role in the regulation of the functioning of the cardiovascular system. Losartan does not inhibit ACE (kinase II), an enzyme that promotes the breakdown of bradykinin. Therefore, there is no increase in the undesirable effects associated with bradykinin.
    With the use of losartan, the inhibition of the negative feedback effect of angiotensin II on the secretion of renin is observed, which leads to an increase in renin activity in the blood plasma. An increase in renin activity in blood plasma leads to an increase in the concentration of angiotensin II in blood plasma. Despite this, antihypertensive activity and a decrease in the concentration of aldosterone in the blood plasma persist, which indicates an effective blockade of angiotensin II receptors. After discontinuation of losartan treatment, plasma renin activity and angiotensin II concentration return to their original values ​​within 3 days.
    Losartan and its main active metabolite show a higher affinity for AT1 receptors than for AT2 receptors. The active metabolite is 10-40 times more active than losartan.
    Based on these studies, it is known that the simultaneous use of ACE inhibitors with ARA in patients with a history of cardiovascular or cerebrovascular diseases, or type II diabetes mellitus with signs of target organ damage did not have a significant positive effect on renal function and / or cardiovascular vascular system and mortality rates, while there was an increased risk of hyperkalemia, acute kidney damage and / or arterial hypotension compared with monotherapy. Given the above, you should not simultaneously use ACE inhibitors and ARBs in patients with diabetic nephropathy.
    In a study that examined the simultaneous use of aliskiren with ACE inhibitors or ARBs in patients with type II diabetes mellitus and chronic kidney disease or cardiovascular diseases, a high risk of adverse outcomes was determined, and the study was stopped. Deaths due to cardiovascular disease and stroke occurred much more often in the aliskiren group than in the placebo group; in addition, adverse events and serious side effects such as hyperkalemia, arterial hypotension and renal impairment were also more common in the aliskiren group than in the placebo group.
    Pharmacokinetics. Absorption. After oral administration, losartan is well absorbed and undergoes first-pass metabolism with the formation of an active metabolite - carboxylic acid and inactive metabolites. The systemic bioavailability of losartan tablets is approximately 33%. Average Cmax of losartan and its active metabolite are reached after 1 and 3-4 hours, respectively.
    Distribution. More than 99% of losartan and its active metabolite bind to blood plasma proteins, primarily albumin. The volume of distribution of losartan is 34 liters.
    Biotransformation. About 14% of losartan, when administered intravenously or orally, is converted into an active metabolite. After i.v. and oral administration of losartan potassium, labeled with 14C, radioactivity in circulating blood plasma is usually associated with losartan and its metabolite. The minimal conversion of losartan to its active metabolite was observed in about 1% of cases. In addition to the active metabolite, inactive metabolites are also formed.
    Excretion. Plasma clearance of losartan and its active metabolite is 600 and 50 ml / min, respectively. The renal clearance of losartan and its active metabolite is approximately 74 and 26 ml / min, respectively. With oral administration of losartan, about 4% of the dose is excreted unchanged in the urine and about 6% of the dose is excreted in the urine as an active metabolite. The pharmacokinetic properties of losartan and its active metabolite are linear at oral doses of losartan potassium up to 200 mg.
    Elderly patients. The concentrations of losartan and its active metabolite in the blood plasma of elderly patients with hypertension do not significantly differ from those given in young patients with hypertension.
    Floor. Plasma concentrations of losartan were 2 times higher in women with hypertension compared with men, while plasma concentrations of the active metabolite in men and women did not differ significantly.
    Dysfunction of the liver and kidneys. When taken orally by patients with mild and moderate alcoholic cirrhosis of the liver, the concentrations of losartan and its active metabolite in the blood plasma were 5 and 1.7 times higher, respectively, than in young male volunteers.
    Plasma concentrations of losartan in patients with creatinine clearance of 10 ml / min did not differ from those in individuals with normal renal function. The AUC of losartan in patients with normal renal function is approximately 2 times that of patients on hemodialysis.
    Plasma concentrations of the active metabolite do not change in patients with impaired renal function or in patients on hemodialysis.
    Losartan and its active metabolite cannot be removed by hemodialysis.
    Pharmacokinetics in children. The pharmacokinetics of losartan was studied with the participation of 50 children with hypertension aged 1 month to 16 years after oral administration once a day at doses from 0.54 to 0.77 mg / kg (average doses).
    The results showed that the active metabolite of losartan is formed in patients of all age groups.
    The pharmacokinetic parameters of losartan after oral administration in newborns and children of preschool and school age were similar.
    The pharmacokinetic parameters of the metabolite differed more depending on the age group. When comparing preschool children and adolescents, such differences were statistically significant. Exposure in newborns and children under 2 years of age was relatively high.

    Indications

    Treatment of essential arthritis in adults, as well as in children over the age of 6 years; treatment of kidney disease in adult patients with ag and type II diabetes mellitus with proteinuria ≥0.5 g / day - as part of combination antihypertensive therapy; treatment of chronic heart failure in adults, when the use of APF inhibitors is considered impossible due to incompatibility, especially when coughing, or is contraindicated. patients with heart failure who have stabilized with an APF inhibitor should not be treated with losartan. in the treatment of chronic heart failure in a patient, the left ventricular ejection fraction should be ≤40%, the condition should be clinically stable; Reducing the risk of stroke in adult patients with arthritis and left ventricular hypertrophy documented by ECG.
    Application
    Take losartan tablets with a glass of water. the use of the preparation does not depend on food intake.
    AG. The usual starting 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. For some patients, it may be beneficial to increase the dose of the preparation to 100 mg once a day (in the morning).
    Losartan 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 recommended starting dose is 50 mg once a day. The dose can be increased to 100 mg once a day, depending on what the blood pressure values ​​are 1 month after the start of treatment. Losartan can be used with other antihypertensive preparations (for example, diuretics, calcium channel blockers, blockers of α- or β-adrenergic receptors, and centrally acting preparations), as well as insulin and other hypoglycemic preparations (for example sulfonylureas, glitazones and glucosidase inhibitors).
    Heart failure. For patients with chronic heart failure, it is recommended to prescribe an initial dose of losartan 12.5 mg once a day. As a rule, the dose is titrated at weekly intervals (namely: 12.5; 25; 50, 100 mg 1 time per day to a maximum dose of 150 mg 1 time per day), depending on individual tolerance.
    Reduced risk of stroke in patients with hypertension and left ventricular hypertrophy, as documented by ECG. The recommended starting dose is 50 mg of losartan 1 time per day. Depending on changes in blood pressure, low-dose hydrochlorothiazide should be added to treatment and / or the dose of losartan should be increased to 100 mg once a day.
    Application in patients with reduced BCC. Patients with reduced BCC (for example, due to treatment with high doses of diuretics) should begin 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 losartan to patients with impaired renal function and those undergoing hemodialysis sessions, the initial dose adjustment is not necessary.
    Use in patients with impaired liver function. For patients with a history of liver dysfunction, consideration should be given to prescribing a lower dose of the preparation. There is no experience in the treatment of patients with severely impaired liver function, therefore losartan is contraindicated in this group of patients.
    Application in children. Data on the efficacy and safety of losartan in children over 6 years of age for the treatment of hypertension are limited.
    For children who can swallow tablets and who have a body weight of 20 and 50 kg, the recommended dose is 25 mg once a day. In exceptional cases, the dose can be increased to a maximum of 50 mg once a day. The dose should be adjusted depending on the effect on the blood pressure level.
    In patients weighing 50 kg, a single dose is usually 50 mg once a day. In exceptional cases, the dose can be increased to a maximum of 100 mg once a day. The use of doses exceeding 1.4 mg / kg (or 100 mg) per day has not been studied in children. Losartan is not recommended for use in children under 6 years of age, since there is 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 (GFR) of 30 ml / min / 1.73 m2, since there are no relevant data on use. Losartan is also not recommended for use in children with impaired liver function.
    Use in elderly patients. As a rule, there is no need to adjust the initial dose for elderly patients, although the possible prescription of the preparation at an initial dose of 25 mg to patients over the age of 75 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 (GFR 60 ml / min / 1.73 m2), lactation period, children under 6 years of age.

    Side effects

    The most common adverse event with losartan was dizziness.
    From the circulatory and lymphatic system: anemia, thrombocytopenia.
    From the immune system: hypersensitivity reactions, anaphylactic reactions, angioedema * and vasculitis **.
    From the side of the psyche: depression.
    From the nervous system: dizziness, drowsiness, headache, sleep disturbance, paresthesia, migraine, dysgeusia.
    From the organs of hearing and balance: vertigo, ringing in the ears.
    From the side of the cardiovascular system: heart palpitations, angina pectoris, syncope, atrial fibrillation, acute cerebrovascular accident, orthostatic hypotension *** (including dose-dependent orthostatic effects) II.
    From the respiratory system, chest and mediastinal organs: shortness of breath, cough.
    From the digestive system: abdominal pain, intestinal obstruction, diarrhea, nausea, vomiting.
    From the hepatobiliary system: pancreatitis, hepatitis, liver dysfunction.
    On the part of the skin and subcutaneous tissue: urticaria, itching, rash, photosensitivity.
    From the musculoskeletal system and connective tissue: myalgia, arthralgia, rhabdomyolysis.
    On the part of the kidneys and urinary system: impaired renal function, renal failure.
    Reproductive system disorders: erectile dysfunction / impotence.
    General disorders: asthenia, fatigue, edema, malaise.
    The results of laboratory studies: hyperkalemia, an increase in the level of ALTg, an increase in the level of urea in the blood, creatinine and potassium in the blood plasma, hyponatremia, hypoglycemia.
    * Including swelling of the larynx, glottis, face, lips, pharynx and / or tongue (causing airway obstruction); in some patients from this number, cases of angioedema in history were reported associated with the use of other preparations, including ACE inhibitors.
    ** Including Shenlein-Henoch disease.
    *** Hypotension is not a common side effect in hypertensive patients, but is common in patients with heart failure and type II diabetes mellitus with kidney disease and hypertension.
    II Especially in patients with reduced BCC, in particular patients with severe heart failure or receiving high doses of diuretics.
    § Usually disappears after stopping treatment.
    In patients receiving losartan, more often than in patients receiving placebo, additional adverse reactions occurred: back pain, urinary tract infections and flu-like symptoms.
    On the part of the kidneys and urinary system: as a result of inhibition of the RAAS in patients from the high-risk group, changes in renal function were observed. Such changes can be reversible and disappear after discontinuation of therapy.
    Application in pediatrics. The profile of adverse reactions observed in children and adolescents is similar to that in adults. Data on the use of the preparation in pediatrics are limited.

    Special instructions

    Hypersensitivity. possibly the occurrence of angioedema. the condition of patients with angioedema (swelling of the face, lips, throat and / or tongue) in history should be especially carefully monitored.
    Arterial hypotension and water-electrolyte imbalance. Symptomatic hypotension, especially after the first dose of the preparation or after increasing the dose, can 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 losartan or reducing the initial dose of the preparation. The same recommendations apply to children from 6 years old.
    Electrolyte imbalance. Electrolyte imbalance is often seen in patients with impaired renal function (with or without diabetes mellitus), which should be taken into account. It has been reported that in patients with type II diabetes mellitus and nephropathy, the incidence of hyperkalemia was higher with losartan than with placebo. Therefore, it is necessary to regularly monitor the concentration of potassium in the blood plasma and indicators of creatinine clearance, especially in patients with heart failure and creatinine clearance of 30-50 ml / min.
    The simultaneous use of losartan and potassium-sparing diuretics, supplements and salt substitutes containing potassium is not recommended.
    Liver dysfunction. Based on pharmacokinetic data indicating a significant increase in the concentration of losartan in the blood plasma of patients with liver cirrhosis, consideration should be given to reducing the dose for patients with a history of liver dysfunction. There is no experience of the therapeutic use of losartan in patients with severely impaired liver function, therefore, losartan should not be taken in such patients.
    Losartan is not recommended for use in children with impaired liver function.
    Impaired renal function. It was reported about the occurrence of changes in renal function, including renal failure, which were associated with inhibition of the RAAS (especially in patients with dependence of renal function on the RAAS, that is, patients with severe heart failure or with pre-existing renal dysfunction).
    Preparations that affect the RAAS can cause an increase in plasma urea and creatinine levels in patients with bilateral renal artery stenosis or stenosis of a solitary kidney artery. These changes in renal function may be reversible after discontinuation of therapy. Losartan should be used with caution in patients with bilateral renal artery stenosis or stenosis of a solitary kidney artery.
    Use in children with impaired renal function. Losartan is not recommended for use in children with a GFR of 30 ml / min / 1.73 m2, as there is no relevant data on its use.
    During the period of losartan use, kidney function should be monitored regularly, since it may deteriorate. This is especially true when 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 impairs renal 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 RAAS. Therefore, losartan is not recommended for this group of patients.
    Diseases of the coronary arteries and cerebrovascular diseases. As with other antihypertensive preparations, an excessive decrease in blood pressure in patients with coronary artery disease and cerebrovascular disease can lead to the development of myocardial infarction or stroke.
    Heart failure. As with the use of other preparations that affect the RAAS, patients with heart failure with or without renal impairment are at risk of developing severe arterial hypotension and (often acute) renal impairment.
    There is insufficient therapeutic experience with the use of losartan in patients with heart failure and concomitant severe renal impairment, severe heart failure (NYHA class IV), 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 receptor blockers should be used with caution.
    Stenosis of the aortic and mitral valves, obstructive hypertrophic cardiomyopathy. As with the use of other vasodilators, the preparation is prescribed with extreme caution in patients with stenosis of the aortic or mitral valve or obstructive hypertrophic cardiomyopathy.
    Double blockade of the RAAS. There is evidence that the combined use of ACE inhibitors, ARBs or aliskiren increases the risk of arterial hypotension, hyperkalemia and renal dysfunction (including ARF). Due to the double blockade of the RAAS, the simultaneous use of aliskiren and ARA or ACE inhibitors is not recommended (see INTERACTIONS). If a double blockade of the RAAS is absolutely necessary, renal function, blood electrolyte levels and blood pressure should be carefully monitored. ARBs and ACE inhibitors should not be used simultaneously in patients with diabetes mellitus. Therefore, double blockade of RAAS by the combined use of ACE inhibitors, ARA or aliskiren is not recommended.
    In cases where double blockade is considered extremely necessary, it should be carried out exclusively under the supervision of a specialist with careful monitoring of renal function, water and electrolyte balance and blood pressure. ACE inhibitors and ARBs should not be administered simultaneously to patients with diabetic nephropathy.
    Pregnancy. Losartan should not be administered to women who are pregnant or planning to become pregnant. If continued therapy with losartan is necessary, patients planning a pregnancy should be prescribed alternative antihypertensive therapy with an established safety profile for use during pregnancy. If pregnancy is confirmed during treatment with this preparation, its use should be stopped immediately and replaced with another preparationapproved for use in pregnant women (see CONTRAINDICATIONS and Use during pregnancy or lactation).
    Other warnings and cautions. 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.
    Losartan-Teva contains lactose. Patients with rare hereditary forms of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption should not use this preparation.
    Use during pregnancy or lactation
    Pregnancy. The preparation is contraindicated for use in pregnant women or women planning pregnancy.
    Patients planning to become pregnant should be transferred to treatment with alternative antihypertensive preparations with an established safety profile if used during pregnancy. If pregnancy is confirmed, treatment with losartan should be discontinued immediately and, if necessary, therapy with alternative agents should be initiated.
    It was found that the use of ARA in the II and III trimester of pregnancy induces fetotoxicity in humans (decreased renal function, oligohydramnios, delayed ossification of the skull bones) and neonatal toxicity (renal failure, arterial hypotension, hyperkalemia).
    If in the period starting from the second trimester of pregnancy, cases of the use of losartan were noted, it is recommended to conduct an ultrasound scan to check the function of the kidneys and the condition of the bones of the skull.
    The condition of newborns whose mothers took losartan during pregnancy should be carefully monitored to determine signs of arterial hypotension.
    Breastfeeding period. Losartan should not be used during breastfeeding. During lactation, alternative medicines with better understood safety profiles for use during breastfeeding should be prescribed.
    Children. Losartan is not recommended for use in children under 6 years of age, as data are limited for this group of patients.
    The ability to influence the reaction rate when driving or working with other mechanisms. No studies have been conducted on the effect of the preparation on the ability to drive vehicles and other mechanisms. However, one should remember about the possibility of developing such adverse reactions as dizziness and drowsiness, especially at the beginning of treatment and when the dose of the preparation is increased.

    Interactions

    Other antihypertensive preparations may enhance the antihypertensive effect of losartan. 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 increase in the risk of arterial hypotension.
    Losartan is metabolized mainly with the participation of the cytochrome P450 (CYP) 2C9 system with the formation of an active metabolite of carboxylic acid. Fluconazole (a CYP 2C9 inhibitor) has been reported to reduce exposure to the active metabolite by about 50%. It was found 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 with the simultaneous use of losartan and fluvastatin (a weak inhibitor of CYP 2C9).
    As with other preparations that block angiotensin II or its effects, the simultaneous use of preparations that retain potassium in the body (for example, potassium-sparing diuretics: spironolactone, triamterene, amiloride) or that increase potassium levels (for example heparin), or supplements or substitutes for salt with potassium, may lead to an increase in plasma potassium levels. The simultaneous use of such funds is not recommended.
    A reversible increase in the concentration of lithium in the blood plasma and the occurrence of toxic manifestations have been reported with the simultaneous use of lithium with ACE inhibitors. Also, very rarely, such manifestations have been reported with the use of ARA. Simultaneous treatment with lithium preparations and losartan should be carried out with caution. If the use of such a combination is considered necessary, it is recommended to check the blood plasma lithium level during the combination treatment.
    With the simultaneous use of ARBs and NSAIDs (for example, selective inhibitors of 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 ARBs or diuretics with NSAIDs can lead to an increased risk of renal dysfunction, including the possible development of acute renal failure, as well as an increase in the level of potassium in the blood plasma, especially in patients with pre-existing renal dysfunction. This combination should be used with caution, especially in elderly patients. Patients should be adequately dehydrated, and monitoring of renal function should be considered after the start of concomitant use of preparations and periodically during treatment.
    Studies have shown that, as a result of double blockade of the RAAS, while the use of ACE inhibitors, ARBs or aliskiren is associated with a higher incidence of the risk of side effects, such as arterial hypotension, hyperkalemia and changes in renal function, including ARF, compared with the use of a single RAAS agent

    Overdose

    Symptoms data on overdose of losartan are limited. depending on the degree of intoxication, symptoms such as arterial hypotension, tachycardia, bradycardia may appear, which may result from parasympathetic (vagal) stimulation.
    Treatment. Therapeutic measures depend on the length of time elapsed after taking the preparation, the nature and severity of the symptoms. If symptomatic hypotension occurs, supportive therapy should be given. Stabilization of cardiovascular function should be a priority. After an overdose, when taken orally, the use of activated carbon in an appropriate dose is indicated. Recommended measures are to induce vomiting and gastric lavage. In the future, you should monitor the main indicators of the body's vital functions and, if necessary, correct them. Losartan and its active metabolites are not removed during hemodialysis.

    Storage conditions

    At a temperature not exceeding 25 ° c.
    After oral administration, plasma concentrations of losartan and its active metabolite decrease polyexponentially with a final T½ of about 2 and 6-9 hours, respectively. At a dose of 100 mg, applied once a day, losartan and its active metabolite do not accumulate in blood plasma in significant amounts.
    Losartan and its metabolites are excreted in both bile and urine. After oral administration of 14C-labeled losartan, about 35/43% of the radioactively labeled preparation was detected in urine and 58/50% in feces.
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