Losartan Plus-Teva 50mg/12.5mg 30 tablets — Made in Hungary — Free Delivery

(Losartan Plus-Teva)

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Description Losartan Plus-Teva 50mg/12.5mg 30 tablets — Made in Hungary — Free Delivery

Pharmacological properties

Pharmacodynamics

Losartan potassium / hydrochlorothiazide. It is known that the components of the preparation losartan potassium / hydrochlorothiazide have an additive hypotensive effect, lowering the blood pressure level to a greater extent than each of the components separately. It is believed that this effect is due to the complementary influence of both components. In addition, as a result of the diuretic action, hydrochlorothiazide increases the activity of renin and the secretion of aldosterone, reduces the potassium content and increases the level of angiotensin II in the blood plasma. Losartan blocks all physiologically significant effects of angiotensin II and by inhibiting aldosterone, helping to reduce the loss of potassium ions caused by a diuretic.

Found that losartan has a weak temporary uricosuric effect. Hydrochlorothiazide is known to cause a moderate increase in plasma uric acid levels; the combination of losartan and hydrochlorothiazide helps to reduce the severity of hyperuricemia associated with taking a diuretic.

The antihypertensive effect of losartan potassium / hydrochlorothiazide lasts for 24 hours and persists with continuous treatment. The preparation has no clinically significant effect on heart rate. It is known that after 12 weeks of using a combination of losartan potassium and hydrochlorothiazide (50 mg / 12.5 mg), the minimum diastolic blood pressure in the sitting position decreased by an average of 13.2 mm Hg. Art.

Losartan potassium / hydrochlorothiazide is an effective preparation for lowering blood pressure in men and women, blacks and other races, young and elderly patients (65 years) with any severity of hypertension.

Losartan. Losartan is a synthetic antagonist of angiotensin II receptors (ARA) (type AT1) for oral administration. Angiotensin II is a potent vasoconstrictor, the main active hormone of the renin-angiotensin-aldosterone system (RAAS) and an important factor in the pathophysiology of hypertension. 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 selectively blocks AT1 receptors. In in vitro and in vivo studies, losartan and its pharmacologically active metabolite, carboxylic acid (E3174), block all physiologically significant effects of angiotensin II, regardless of the source or route of its synthesis.

Losartan does not have an agonistic effect and does not block other hormone receptors or ion channels that play an important role in the regulation of the functioning of the cardiovascular system. In addition, losartan does not inhibit ACE (kininase 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 leads to an increase in the concentration of angiotensin II in the 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. In terms of weight, the active metabolite is 10–40 times more active than losartan.

It is known that the incidence of cough in patients receiving losartan or hydrochlorothiazide is similar and was significantly lower than when using ACE inhibitors.

In nondiabetic patients with hypertension and proteinuria, when using losartan potassium, a significant decrease in the level of proteinuria, fractional excretion of albumin and IgG in the blood plasma was noted. Losartan maintains the level of glomerular filtration and reduces the filtration fraction. In general, losartan helps to reduce the concentration of uric acid in the blood plasma (usually 0.4 mg / dL), which persists during long-term therapy.

Losartan does not affect autonomic reflexes and does not have a sustained effect on the level of norepinephrine in the blood plasma.

In patients with left ventricular heart failure, on the background of the use of losartan in doses of 25 and 50 mg, positive hemodynamic and neurohormonal effects were noted, which are characterized by an increase in the cardiac index and a decrease in the wedge pressure in the pulmonary capillaries, systemic vascular resistance, mean blood pressure and heart rate, as well as a decrease in the level of circulating aldosterone and norepinephrine, respectively. The occurrence of arterial hypotension in patients with heart failure depends on the dose.

Pharmacokinetics

Losartan. Absorption. After oral administration, losartan is well absorbed and undergoes first-pass metabolism with the formation of an active metabolite of carboxylic acid and other inactive metabolites. The systemic bioavailability of losartan tablets is ≈33%. Cmax of losartan and its active metabolite is reached within 1 hour and 3-4 hours, respectively. When taking the preparation with meals, there was no clinically significant effect on the concentration of losartan in blood plasma.

Distribution. More than 99% of the dose of losartan and its active metabolite binds to blood plasma proteins, mainly albumin. The volume of distribution of losartan is 34 liters. It is known from animal studies that losartan penetrates in small quantities through the BBB or does not penetrate.

Metabolism. Approximately 14% of a dose of losartan administered intravenously or taken orally is converted to its active metabolite. After taking and intravenous administration of radioactively labeled 14C-losartan potassium, the radioactivity of the circulating blood plasma was primarily associated with the presence of losartan and its active metabolite. In addition to the active metabolite, inactive metabolites are also formed, including two main ones, formed in the process of hydroxylation of the butyl radical, and one minor metabolite, N-2-tetrazole-glucuronide.

Excretion. Plasma clearance of losartan and its active metabolite is about 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 in the urine as an active metabolite. Losartan and its active metabolite have linear pharmacokinetics after oral administration of losartan potassium in doses up to 200 mg.

After oral administration, the concentration of losartan and its active metabolite in the blood plasma decreases polyexponentially with a final T1 / 2 ≈2 and ≈6-9 hours, respectively. When taking the preparation at a dose of 100 mg 1 time per day, there is no significant accumulation in the blood plasma of either losartan or its active metabolite.

The excretion of losartan and its metabolites occurs in the bile and urine. After oral administration of radiolabeled 14C-losartan, approximately 35% of the radioactive label was detected in urine and approximately 58% in feces.

Hydrochlorothiazide. Distribution. Hydrochlorothiazide crosses the placental barrier and into breast milk, but does not cross the BBB.

Excretion. Hydrochlorothiazide is not metabolized and is rapidly excreted by the kidneys unchanged. When analyzing the level of the preparation in the blood plasma within 24 hours, it was found that T½ is in the range from 5.6 to 14.8 hours. After oral administration, at least 61% of the dose is excreted in the urine unchanged within 24 hours.

Pharmacokinetics in special patient groups. The concentration of losartan and its active metabolite in the blood plasma, as well as the degree of absorption of hydrochlorothiazide in elderly patients and younger patients with hypertension, do not differ significantly.

After oral administration, the concentration of losartan and its active metabolite in the blood plasma of patients with mild and moderate alcoholic cirrhosis was 5 and 1.7 times higher, respectively, compared with those in young volunteers.

During hemodialysis, losartan and its active metabolite are not removed from the body.

Indications

Essential arterial hypertension in patients in whom monotherapy with losartan or hydrochlorothiazide does not adequately control blood pressure.

Application

The preparation can be taken with or without food. the tablet should be swallowed whole with water.

The preparation can be prescribed in combination with other antihypertensive preparations (see SPECIAL DIRECTIONS and INTERACTIONS).

The combination of losartan and hydrochlorothiazide is not used as an initial therapy, but is prescribed to patients in whom adequate blood pressure control cannot be achieved with losartan or hydrochlorothiazide monotherapy.

It is recommended to determine the dose by selecting doses for each component of the preparation separately (for losartan and hydrochlorothiazide). In clinically acceptable cases, the feasibility of switching from monotherapy to a fixed combination should be considered for patients who do not have adequate blood pressure control.

The initial and maintenance dose is 50 mg of losartan potassium and 12.5 mg of hydrochlorothiazide once a day. For patients without an adequate therapeutic response, the dose of the combination may be increased to 100 mg losartan potassium / 25 mg hydrochlorothiazide once a day.

The maximum dose is 1 tablet of 100 mg losartan potassium / 25 mg of hydrochlorothiazide once a day. As a rule, a stable antihypertensive effect is achieved within 3-4 weeks from the start of treatment.

Use in patients with impaired renal function and patients on hemodialysis. Patients with moderate renal impairment (creatinine clearance - 30-50 ml / min) do not require adjustment of the initial dose. Patients on hemodialysis are not advised to take pills containing losartan and hydrochlorothiazide. It is contraindicated for persons with severe renal impairment (creatinine clearance 30 ml / min) (see CONTRAINDICATIONS).

Use in patients with intravascular hypovolemia. Before using the preparation, you should first correct intravascular hypovolemia and / or hyponatremia.

Use in persons with impaired liver function. The preparation is contraindicated in patients with severe liver dysfunction (see CONTRAINDICATIONS).

Use in elderly patients. As a rule, the use of the preparation in elderly patients does not require dose adjustment.

Contraindications

Hypersensitivity to losartan or to the components of the preparation; hypersensitivity to sulfonamide derivatives; therapy-resistant hypokalemia or hypercalcemia; severe liver dysfunction: cholestasis and disorders associated with obstruction of the biliary tract; symptomatic hyperuricemia / gout; severe renal dysfunction (creatinine clearance 30 ml / min); anuria; refractory hyponatremia; pregnancy and planning of pregnancy (see use during pregnancy and lactation); lactation; childhood; combined use of the preparation with preparations containing aliskiren in the presence of diabetes mellitus or impaired renal function (scf 60 ml / min / 1.73 m2) (see interactions).

Side effects

In clinical studies using losartan and hydrochlorothiazide, no adverse reactions unusual for this combination of substances were observed. adverse reactions were limited to those previously observed with the use of potassium salt of losartan and / or hydrochlorothiazide.

In controlled clinical trials of essential hypertension, the only side effect associated with the use of the combined preparation, noted with a higher frequency with the preparation than with the placebo, was dizziness.

During the post-marketing period, the following adverse reactions were observed:

from the nervous system: dysgeusia;
from the digestive system: hepatitis;
according to the results of laboratory tests: hyperkalemia, an increase in the level of ALT.

The adverse reactions presented below have been noted with the use of active substances as monotherapy, and they may occur with the use of the preparation losartan potassium / hydrochlorothiazide.

Losartan:

on the part of the circulatory and lymphatic system: anemia, Shenlein's purpura - Genoch, ecchymosis, hemolysis, thrombocytopenia;
from the immune system: anaphylactic reactions, angioedema, urticaria;
from the side of metabolism: anorexia, gout;
on the part of the psyche: insomnia, anxiety, anxiety neurosis, panic syndrome, confusion, depression, abnormal dreams, sleep disturbances, drowsiness, memory impairment;
from the nervous system: headache, dizziness, nervousness, paresthesia, peripheral neuropathy, tremor, migraine, syncope;
on the part of the organ of vision: blurred vision, burning / tingling sensation in the eyes, conjunctivitis, decreased visual acuity;
on the part of the organ of hearing and balance: vertigo, noise / ringing in the ears;
from the heart: arterial hypotension, orthostatic hypotension, sternalgia, angina pectoris, AV block II degree, cerebrovascular disorders, myocardial infarction, heart palpitations, arrhythmia (atrial fibrillation, sinus bradycardia, tachycardia, ventricular tachycardia of the ventricles, fibrillation)
on the part of the vessels: vasculitis, dose-dependent orthostatic effects;
from the respiratory system, chest and mediastinal organs: cough, upper respiratory tract infections, nasal congestion, sinus disease, sinusitis, a feeling of discomfort in the pharynx, pharyngitis, laryngitis, shortness of breath, bronchitis, nosebleeds, rhinitis, congestion in the lungs ;
from the digestive system: abdominal pain, nausea, vomiting, diarrhea, dyspepsia, toothache, dry mouth, flatulence, gastritis, pancreatitis, constipation, intestinal obstruction;
from the hepatobiliary system: impaired liver function;
on the part of the skin and subcutaneous tissue: alopecia, dermatitis, dry skin, erythema, hyperemia, photosensitivity, itching, rash, urticaria, excessive sweating.
from the musculoskeletal system and connective tissue: muscle cramps, back pain, leg pain, myalgia, pain in the arms, shoulders, joint swelling, knee pain, musculoskeletal pain, joint stiffness, arthralgia, arthritis, pain in hip joints, fibromyalgia, muscle weakness, rhabdomyolysis.
on the part of the kidneys and urinary system: impaired renal function, renal failure, nocturia, pollakiuria, urinary tract infections;
from the reproductive system: decreased libido, erectile dysfunction / impotence.
general disorders: asthenia, fatigue, chest pain, facial edema, fever, flu-like symptoms, general malaise, edema.

laboratory results: hyperkalemia, a slight decrease in hematocrit and hemoglobin, hypoglycemia, a slight increase in the level of urea and creatinine in the blood plasma, an increase in the level of liver enzymes and bilirubin, hyponatremia.

Hydrochlorothiazide:

from the circulatory and lymphatic systems: agranulocytosis, aplastic anemia, hemolytic anemia, leukopenia, purpura, thrombocytopenia;
from the immune system: rash, anaphylactic reactions;
from the side of metabolism: anorexia, hyperglycemia, hyperuricemia, hypokalemia, hyponatremia;
from the side of the psyche: insomnia;
from the nervous system: headache;
on the part of the organ of vision: transient loss of clarity of vision, xanthopsia;
from the side of the vessels: necrotizing angiitis (vasculitis, cutaneous vasculitis);
from the respiratory system, chest and mediastinal organs: respiratory distress syndrome, including pneumonia and pulmonary edema;
from the digestive system: sialoadenitis, cramps, stomach irritation, nausea, vomiting, diarrhea, constipation, pancreatitis;
from the hepatobiliary system: jaundice (intrahepatic cholestasis);
on the part of the skin and subcutaneous tissue: urticaria, photosensitivity, toxic epidermal necrolysis, systemic lupus erythematosus.
from the musculoskeletal system and connective tissue: muscle cramps.
on the part of the kidneys and urinary system: glucosuria, interstitial nephritis, impaired renal function, renal failure.
general disorders: fever, dizziness.

Special instructions

Losartan-related

Angioedema. Patients with a history of angioedema (swelling of the face, lips, pharynx and / or tongue) should be closely monitored (see SIDE EFFECTS).

Arterial hypotension and decrease in intravascular volume. Patients with BCC deficiency and / or hyponatremia caused by intensive use of diuretics, restriction of salt intake, diarrhea or vomiting may develop symptomatic hypotension, especially after taking the first dose of the preparation. These conditions must be corrected before taking the preparation (see APPLICATION, CONTRAINDICATIONS).

Electrolyte imbalance. It should be borne in mind that electrolyte imbalance is common in patients with impaired renal function and concomitant diabetes mellitus. Plasma potassium and creatinine clearance should be carefully monitored, especially in patients with heart failure and creatinine clearance of 30-50 ml / min.

It is not recommended to concomitantly use potassium-sparing diuretics, dietary supplements and salt substitutes containing potassium with losartan / hydrochlorothiazide (see INTERACTIONS).

Liver dysfunction. Given the pharmacokinetic data indicating a significant increase in the concentration of losartan in the blood plasma of patients with liver cirrhosis, caution should be exercised when taking losartan / hydrochlorothiazide in patients with a history of mild or moderate hepatic impairment. There is no experience with the use of losartan for the treatment of patients with severe liver dysfunction. Therefore, losartan / hydrochlorothiazide is contraindicated in persons with severely impaired liver function (see CONTRAINDICATIONS, PHARMACOLOGICAL PROPERTIES).

Impaired renal function. Changes in renal function associated with inhibition of the RAAS, in particular renal failure, have been reported in patients in whom renal function depends on the RAAS, both in severe heart failure and in the presence of renal dysfunction before treatment.

As with the use of other preparations that affect the RAAS, increased levels of urea and creatinine in blood plasma have been reported in patients with bilateral renal artery stenosis or stenosis of an artery of a single kidney. Such changes in renal function may be reversible and disappear after discontinuation of therapy. Care should be taken to prescribe losartan to patients with bilateral renal artery stenosis or stenosis of a solitary kidney artery.

Kidney transplant. There is no experience with the preparation in patients who have recently undergone kidney transplantation.

Primary hyperaldosteronism. For patients with primary hyperaldosteronism, antihypertensive preparations that inhibit the RAAS are usually ineffective. Therefore, it is not recommended to prescribe pills containing losartan potassium / hydrochlorothiazide to these patients.

Ischemic heart disease and cerebrovascular accidents. Like any antihypertensive preparation, losartan can cause a significant decrease in blood pressure in patients with coronary artery disease and cerebrovascular insufficiency, which can lead to myocardial infarction or stroke.

Heart failure. In patients with heart failure (with or without concomitant renal failure), as with the use of other preparations that affect the RAAS, there is a risk of severe arterial hypotension and renal failure (often ARF).

Stenosis of the aortic and mitral valves, obstructive hypertrophic cardiomyopathy. Caution should be exercised when prescribing losartan potassium / hydrochlorothiazide in patients with stenosis of the aortic or mitral valves or obstructive hypertrophic cardiomyopathy.

Ethnic characteristics. It is known that ACE inhibitors, losartan and other ARBs show lower efficiency in lowering blood pressure in patients of the Negroid race than in representatives of other races. This is probably due to the fact that among the representatives of the Negroid race with AH, persons with low renin activity predominate.

Pregnancy. Losartan should not be administered to women who are pregnant or planning to become pregnant. If continuation of ARA therapy 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 discontinued and replaced with another preparation approved for use in pregnant women (see CONTRAINDICATIONS and Use during pregnancy or lactation).

Double blockade of the RAAS. There is evidence that with the simultaneous use of ACE inhibitors, ARBs or aliskiren, the risk of arterial hypotension, hyperkalemia and renal dysfunction (including ARF) increases. Therefore, double blockade of the RAAS by the combined use of ACE inhibitors, ARBs, or aliskiren is not recommended (see INTERACTIONS).

If double blockade of the RAAS is extremely necessary, it must be carried out exclusively under the supervision of a specialist with the provision of careful monitoring of renal function, water and electrolyte balance and blood pressure. ACE inhibitors and ARBs should not be administered concurrently to patients with diabetic nephropathy.

Hydrochlorothiazide-related

Arterial hypotension and imbalance in water and electrolyte balance. As with any antihypertensive preparation, symptomatic hypotension may develop in some patients. The health of these patients should be carefully monitored to identify clinical signs of imbalance in water and electrolyte balance, in particular hypovolemia, hyponatremia, hypochloremic alkalosis, hypomagnesemia or hypokalemia, which may occur with concomitant diarrhea or vomiting. These patients should regularly, at regular intervals, monitor the level of electrolytes in the blood plasma. In hot weather, people with edema may develop dilution hyponatremia.

Metabolic and endocrine effects. Thiazide group preparations can impair glucose tolerance. Dose adjustment of antidiabetic preparations, including insulin, may be required (see INTERACTIONS). During treatment with thiazides, latent diabetes mellitus may appear. Thiazide diuretics can reduce the excretion of calcium in the urine and cause a periodic slight increase in the level of calcium in the blood plasma. Severe hypercalcemia may be a sign of latent hyperparathyroidism. The use of preparations of the thiazide group should be discontinued before conducting studies of the function of the parathyroid glands.

The use of thiazide diuretics can provoke an increase in the level of cholesterol and triglycerides in the blood plasma.

The use of thiazide diuretics may contribute to the development of hyperuricemia and / or gout in selected patients. Since losartan reduces the level of uric acid, when using losartan in combination with hydrochlorothiazide, there is a decrease in hyperuricemia caused by taking diuretics.

Liver dysfunction. Thiazide preparations should be used with caution in patients with impaired liver function or progressive liver disease, since there is a risk of intrahepatic cholestasis, and minor changes in the water-electrolyte balance can provoke the development of hepatic coma.

Losartan potassium / hydrochlorothiazide is contraindicated in patients with severe hepatic impairment (see CONTRAINDICATIONS, PHARMACOLOGICAL PROPERTIES).

Other caveats. In patients taking thiazide diuretics, hypersensitivity reactions may occur even in the absence of a history of allergy or asthma symptoms. It has been reported about the exacerbation or progression of systemic lupus erythematosus while taking thiazides.

Associated with excipients. Patients with rare hereditary galactose and lactose intolerance or glucose-galactose malabsorption should not take this preparation.

Use during pregnancy or lactation

Pregnancy. ARA. The use of ARA during pregnancy is contraindicated (see CONTRAINDICATIONS, SPECIAL INSTRUCTIONS). Epidemiological data on the risk of teratogenic effects of ARA when used in the first trimester of pregnancy are insufficiently studied and do not exclude an increased risk of teratogenicity. Patients planning a pregnancy should be transferred to treatment with alternative antihypertensive preparations with an established safety profile if they are used during pregnancy. In case of pregnancy, ARA treatment should be stopped immediately and, if necessary, alternative therapy should be started. It was found that the use of ARA in the II and III trimester of pregnancy contributes to increased fetotoxicity (deterioration of renal function, oligohydramnios, slowing of ossification of the skull bones) and neonatal toxicity (renal failure, arterial hypotension, hyperkalemia). If ARA was taken from the second trimester of pregnancy, it is necessary to perform an ultrasound of the kidneys and the state of the bones of the skull of the newborn.

Infants whose mothers received ARA treatment during pregnancy should be under close medical supervision due to the risk of arterial hypotension (see SPECIAL INSTRUCTIONS).

Hydrochlorothiazide. The experience of using hydrochlorothiazide during pregnancy is limited, especially in the first trimester. Animal studies are also limited. It is known that hydrochlorothiazide crosses the placental barrier. Given the pharmacological mechanism of action of hydrochlorothiazide, its use in the II and III trimester of pregnancy can adversely affect the placental blood supply and lead to the occurrence in the fetus and newborn of disorders such as jaundice, electrolyte imbalance and thrombocytopenia.

Hydrochlorothiazide should not be used for edema in pregnant women, hypertension of pregnant women or preeclampsia, since such use is associated with the risk of a decrease in blood plasma volume and the development of placental hypoperfusion without any beneficial effect on the course of the disease. Hydrochlorothiazide should not be used to treat essential hypertension in pregnant women.

Lactation. The use of losartan potassium / hydrochlorothiazide during breastfeeding is contraindicated.

If treatment is necessary, breastfeeding should be discontinued. During breastfeeding, another preparation with an established safety profile should be taken.

Children. The safety and efficacy of losartan potassium / hydrochlorothiazide in children have not been established; use in children is contraindicated.

The ability to influence the reaction rate when driving or working with other mechanisms. Studies of the effect on the ability to drive vehicles and work with other mechanisms have not been carried out. However, patients planning to drive vehicles or work with other mechanisms should remember that during therapy with this preparation, dizziness or drowsiness may sometimes occur, in particular at the beginning of treatment and when the dose is increased.

Two large placebo-controlled trials (ONTARGET and NEPHRON D) investigated the benefits of the combined use of ACE inhibitors and ARBs. It is known from studies that the simultaneous use of ACE inhibitors with ARBs 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 the function of the kidneys and / or the cardiovascular system, and mortality rates, with an increased risk of hyperkalemia, acute kidney damage and / or arterial hypotension compared with monotherapy. In this regard, the combined use of ACE inhibitors and ARBs in patients with diabetic nephropathy is not recommended.

The ALTITUDE study, which was conducted to test the benefits of adding aliskiren to standard therapy with ACE inhibitors or ARBs in patients with type II diabetes and chronic kidney and / or cardiovascular disease, found a high risk of adverse outcomes and the study was discontinued. Cardiovascular death and stroke were much more common in the aliskiren group than in the placebo group, and 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.

Hydrochlorothiazide. Hydrochlorothiazide belongs to the group of thiazide diuretics with an unclear mechanism of antihypertensive action. Thiazides affect the renal tubular mechanism of electrolyte reabsorption, thereby directly increasing the excretion of sodium and chlorine in approximately equal amounts. Due to the diuretic action of hydrochlorothiazide, the volume of blood plasma decreases, the activity of renin in the blood plasma and the secretion of aldosterone increase, followed by an increase in the excretion of potassium and bicarbonate in the urine and a decrease in the level of potassium in the blood plasma. Probably due to the blockade of the RAAS, the simultaneous use of ARBs reduces the loss of potassium associated with the use of thiazide diuretics.

After administration, the diuretic effect is observed within 2 hours, reaching a peak after about 4 hours and lasts about 6-12 hours. The antihypertensive effect lasts up to 24 hours.

Interactions

Losartan. it was reported that the use of rifampicin and fluconazole reduce the concentration of the active metabolite of losartan in blood plasma. the clinical consequences of this interaction have not been studied.

As with the use of other preparations that block angiotensin II or its effects, concomitant use with potassium-sparing diuretics (for example, spironolactone, triamterene, amiloride), supplements or table salt substitutes containing potassium can lead to an increase in the concentration of potassium in the blood plasma. The simultaneous use of these combinations is not recommended.

As with the use of other preparations that affect the excretion of sodium from the body, it is possible to reduce the rate of excretion of lithium. Therefore, it is necessary to carefully monitor the level of lithium in the blood plasma if it is necessary to simultaneously use lithium salts with ARA.

When using ARA in combination with NSAIDs (for example, selective COX-2 inhibitors, acetylsalicylic acid in anti-inflammatory doses) and non-selective NSAIDs, the antihypertensive effect may be weakened. The simultaneous use of ARBs or diuretics and NSAIDs can lead to an increased risk of deterioration in renal function with the development of acute renal failure and an increase in potassium levels, especially in patients with existing renal dysfunction before starting therapy. Elderly people should take the above combination of preparations with caution. It is necessary to ensure adequate hydration of patients and monitor renal function after starting combination therapy and periodically thereafter.

In some patients with impaired renal function receiving treatment with NSAIDs, including selective COX-2 inhibitors, the simultaneous use of ARBs can lead to an even greater deterioration in renal function. This effect is usually reversible.

The results of a clinical study showed that double blockade of the RAAS with the simultaneous use of ACE inhibitors, ARBs or aliskiren is associated with an increased incidence of side effects such as arterial hypotension, hyperkalemia and deterioration of renal function (including ARF), compared with monotherapy with any RAAS blocker ...

With simultaneous use with preparations such as tricyclic antidepressants, antipsychotics, baclofen, amifostine, the main or side effect of which is to lower blood pressure, the risk of arterial hypotension increases.

Hydrochlorothiazide. With simultaneous use with thiazide diuretics, the following interactions may occur.

Alcohol, barbiturates, preparations, or antidepressants. Increased orthostatic hypotension is possible.

Antidiabetic preparations (oral or insulin). Thiazide group preparations are capable of impairing glucose tolerance. Dose adjustment of antidiabetic preparations may be required. Metformin should be used with caution because of the risk of lactic acidosis due to possible functional renal failure associated with hydrochlorothiazide.

Other antihypertensive preparations. Additive effect.

Cholestyramine and colestipol. The absorption of hydrochlorothiazide is impaired by the action of anion exchange resins. Single doses of cholestyramine or colestipol bind hydrochlorothiazide and reduce its absorption in the gastrointestinal tract by about 85 and 43%, respectively.

Corticosteroids, ACTH. Increased electrolyte imbalance, in particular the occurrence of hypokalemia.

Pressor amines (eg adrenaline). A decrease in the effectiveness of pressor amines is possible, but not so significant as to discontinue their use.

Non-depolarizing muscle relaxants (eg tubocurarine). Strengthening the action of muscle relaxants is possible.

Lithium preparations. Diuretics decrease renal clearance of lithium and further increase the risk of lithium toxicity. Their simultaneous use is not recommended.

Preparations used to treat gout (probenecid, sulfinpyrazone, and allopurinol). It may be necessary to adjust the dose of uricosuric preparations, since hydrochlorothiazide can increase the level of uric acid in the blood plasma. Increasing the dose of probenecid or sulfinpyrazone may be required. With the simultaneous use of thiazides, the frequency of hypersensitivity reactions to allopurinol may increase.

Anticholinergics (eg atropine, biperiden). Due to the weakening of gastrointestinal motility and a decrease in the rate of evacuation of gastric contents, the bioavailability of thiazide diuretics increases.

Cytotoxic preparations (eg cyclophosphamide, methotrexate). Thiazide diuretics can reduce the excretion of cytotoxic preparations from the body by the kidneys and enhance their myelosuppressive effects.

Salicylates. When salicylates are used in high doses under the action of hydrochlorothiazide, their toxic effect on the central nervous system may increase.

Methyldopa. Some cases of hemolytic anemia have been reported with the simultaneous use of hydrochlorothiazide and methyldopa.

Cyclosporine. With the combined use of cyclosporine, an increase in the risk of developing hyperuricemia and complications resembling gout is possible.

Digitalis glycosides. Hypokalemia or hypomagnesemia, which occurs as a result of treatment with thiazide preparations, can cause the development of cardiac arrhythmias caused by the use of digitalis preparations.

Medicines, the effectiveness of which is affected by changes in the level of potassium in the blood plasma. Periodic monitoring of the level of potassium in the blood plasma and ECG examination are recommended if losartan potassium / hydrochlorothiazide is used simultaneously with preparations whose effectiveness is influenced by changes in the level of potassium in the blood plasma (such as digitalis glycosides and antiarrhythmics), or with the following preparations that induce the occurrence of polymorphic pirouette-type ventricular tachycardia, including some antiarrhythmic preparations, since hypokalemia is a factor contributing to the development of pirouette-type ventricular tachycardia:

class Ia antiarrhythmics (e.g. quinidine, hydroquinidine, disopyramide);

class III antiarrhythmics (eg amiodarone, sotalol, dofetilide, ibutilide);

certain antipsychotics (for example, thioridazine, chlorpromazine, levomepromazine, trifluoperazine, cyamemazine, sulpiride, sultopride, amisulpride, tiapride, pimozide, haloperidol, droperidol);

other preparations (for example, bepridil, cisapride, diphemanil, erythromycin for IV administration, halofantrine, mizolastine, pentamidine, terfenadine, vincamine for IV administration).

Calcium salts. Thiazide diuretics can increase plasma calcium levels by decreasing its excretion from the body. If it is necessary to prescribe food supplements containing calcium, the level of calcium in the blood plasma should be monitored and corrected.

Influence on the results of laboratory tests. Since thiazides affect calcium metabolism, they can interfere with the results of the assessment of the function of the parathyroid glands.

Carbamazepine. The risk of developing symptomatic hyponatremia. Clinical and biological monitoring should be performed.

Iodine contrast agents. In the case of diuretic-induced dehydration, the risk of developing acute renal failure increases, especially when using iodine-containing preparations in high doses.

Before the introduction of such funds, it is necessary to restore the volume of fluid in the patient's body.

Amphotericin B (for parenteral use), stimulant laxatives, or glycyrrhizin (from licorice root). Hydrochlorothiazide can disturb the electrolyte balance, in particular, cause hypokalemia.

Β-adrenergic receptor blockers and diazoxide. The simultaneous use of thiazide diuretics, including hydrochlorothiazide, with β-adrenergic receptor blockers may increase the risk of hyperglycemia. Thiazide diuretics, including hydrochlorothiazide, can enhance the hyperglycemic effect of diazoxide.

Amantadine. Thiazide diuretics, including hydrochlorothiazide, may increase the risk of side effects from amantadine.

Overdose

There are no data regarding specific treatment for preparation overdose. if necessary, symptomatic and supportive treatment is carried out. in case of overdose, therapy should be discontinued, and the patient's health should be monitored. if the preparation is recently taken, it is required to induce vomiting and take measures aimed at eliminating dehydration, electrolyte imbalance, hepatic coma and arterial hypotension in accordance with generally accepted standards of treatment.

Losartan. Data on overdose of losartan in humans are limited. The most likely symptoms of an overdose are arterial hypotension and tachycardia. Bradycardia can develop as a result of parasympathetic (vagal) stimulation. In the case of symptomatic arterial hypotension, supportive therapy is indicated. Losartan and its active metabolite are not removed from the body by hemodialysis.

Hydrochlorothiazide. Overdose symptoms are often observed due to electrolyte deficiency (hypokalemia, hypochloremia, hyponatremia) and dehydration due to polyuria.

With the simultaneous use of digitalis preparations, hypokalemia can exacerbate cardiac arrhythmias. Hydrochlorothiazide is removed by hemodialysis, but the extent of elimination has not been established.

Storage conditions

At a temperature not exceeding 25 ° c.

Tags: Losartan

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