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Cozaar

Cozaar
Cozaar is used as an antihypertensive agent. It is a non-peptide angiotensin II receptor blocker. Possesses high selectivity and affinity for AT1-type receptors (with the participation of which the main effects are realized

Brand: Losartan

Availability: In Stock
Average Delivery Time: 9 Days
Exp. Date: September 2023
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Cozaar 100 mg
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Cozaar 50 mg
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Product description

Pharmacodynamics of Cozaar

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Losartan inhibits the increase in systolic and diastolic blood pressure observed with the introduction of angiotensin II. At the time Cmax of losartan in blood plasma after taking losartan at a dose of 100 mg, the above effect is suppressed by approximately 85%; and 24 hours after single and multiple doses - by 26–39%.

During the period of losartan administration, the elimination of the negative feedback, which consists in the suppression of renin secretion by angiotensin II, leads to an increase in the activity of blood plasma renin (ARP). An increase in ARP is accompanied by an increase in plasma angiotensin II concentration. With long-term (6-week) treatment of patients with arterial hypertension with losartan at a dose of 100 mg / day, a 2-3-fold increase in the concentration of angiotensin II in the blood plasma was observed at the time the Creachedmax of losartan was; in some patients, an even greater increase in concentration was observed, especially with a short duration of treatment (2 weeks). In the course of treatment, antihypertensive activity and a decrease in the concentration of aldosterone in the blood plasma were manifested after 2 and 6 weeks of therapy, which indicates an effective blockade of angiotensin II receptors. After discontinuation of losartan, ARP and the concentration of angiotensin II decreased within 3 days to the initial values ​​observed before the start of the drug intake.

Since losartan is a specific antagonist of the AT1receptors of angiotensin II, it does not inhibit ACE (kininase II), an enzyme that inactivates bradykinin. A study comparing the effects of 20 mg and 100 mg losartan with the effects of an ACE inhibitor on the response to angiotensin I, angiotensin II and bradykinin showed that losartan blocks the effects of angiotensin I and angiotensin II without affecting the effects of bradykinin, which is due to a specific mechanism actions of losartan. In contrast, an ACE inhibitor blocked responses to angiotensin I and increased the severity of responses to bradykinin, without affecting the severity of responses to angiotensin II, which demonstrates the pharmacodynamic difference between losartan and ACE inhibitors.

Plasma concentrations of losartan and its active metabolite, as well as the antihypertensive effect of losartan, increase with increasing dose of the drug. Since losartan and its active metabolite are angiotensin II receptor antagonists (ARA II), they both contribute to the antihypertensive effect.

In a study with a single dose of 100 mg of losartan, which included healthy volunteers (men), ingestion of the drug under conditions of a high- and low-salt diet did not affect the glomerular filtration rate (GFR), effective renal plasma flow and filtration fraction. Losartan has a natriuretic effect, which was more pronounced with a low-salt diet and, apparently, was not associated with the suppression of early sodium reabsorption in the proximal renal tubules. Losartan also caused a transient increase in renal excretion of uric acid. In patients with arterial hypertension, proteinuria (≥2 g / 24 h), not suffering from diabetes mellitus and taking losartan for 8 weeks at a dose of 50 mg with a gradual increase to 100 mg, there was a significant decrease in proteinuria by 42%, fractional excretion of albumin and immunoglobulins (IgG). In these patients, losartan stabilized the GFR and reduced the filtration fraction.

In postmenopausal women with arterial hypertension, who took losartan at a dose of 50 mg / day for 4 weeks, no effect of therapy on the renal and systemic levels of PH was revealed.

Losartan does not affect autonomic reflexes and does not have a long-term effect on the concentration of norepinephrine in blood plasma.

In patients with arterial hypertension, losartan in doses up to 150 mg / day does not cause clinically significant changes in the concentration of fasting triglycerides, total cholesterol and HDL cholesterol. In the same doses, losartan has no effect on fasting blood glucose concentration.

Theclinical study HEAAL evaluating the effect of high and low doses of ARA II (losartan) on the outcome of treatment of patients with chronic heart failure (CHF) included patients (n = 3834) with CHF (NYHA functional class II – IV) who were tolerant to therapy with ACE inhibitors. Patients were followed up for 4 years (median follow-up was 4.7 years) to compare the effect of losartan at a dose of 50 mg / day with a dose of 150 mg / day on the reduction of all causes of death or hospitalization for heart failure. This study showed that losartan 150 mg / day significantly reduced the risk of all-cause mortality or hospitalization for heart failure compared with 50 mg / day (hazard ratio (RR) 0.899; p = 0.027).

In general, losartan caused a decrease in serum uric acid concentration (usually <0.4 mg / dL), which persisted with long-term treatment. In controlled clinical trials involving patients with arterial hypertension, there have been no cases of drug withdrawal due to an increase in creatinine concentration or serum potassium content.

A 12-week parallel study, which included patients with left ventricular failure (NYHA functional class II – IV), and most of whom were taking diuretics and / or cardiac glycosides (digitalis), compared the effects of losartan at doses of 2.5, 10 , 25 and 50 mg / day with placebo. At doses of 25 and 50 mg / day, the drug showed positive hemodynamic and neurohormonal effects, which persisted throughout the study. Hemodynamic effects included an increase in cardiac index and a decrease in pulmonary capillary wedge pressure, as well as a decrease in TPR, mean systemic blood pressure and heart rate. The incidence of arterial hypotension in these patients depended on the dose of the drug. Neurohormonal effects included decreased blood levels of aldosterone and norepinephrine.

Pharmacokinetics

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Absorption. When taken orally, losartan is well absorbed and metabolized during the initial passage through the liver, resulting in the formation of an active carboxylated metabolite and inactive metabolites. The systemic bioavailability of losartan in tablet form is approximately 33%. Average Cmax of losartan and its active metabolite are reached after 1 and 3-4 hours, respectively. When losartan was taken with a normal meal, no clinically significant effect on the plasma concentration of losartan was found.

Distribution. Losartan and its active metabolite bind to blood plasma proteins (mainly albumin) by more than 99%. Vd losartan is 34 liters. Studies in rats have shown that losartan practically does not penetrate the BBB.

Metabolism. Approximately 14% of a dose of losartan administered intravenously or orally is converted to its active metabolite. After oral administration or intravenous administration of radioactive carbon-labeled losartan (14C-losartan), the radioactivity of the circulating blood plasma is primarily due to the presence of losartan and its active metabolite in it.

Low efficiency of conversion of losartan to its active metabolite was observed in about 1% of patients included in the data analysis.

In addition to the active metabolite, biologically inactive metabolites are formed, incl. two major metabolites resulting from hydroxylation of the butyl side chain, and one minor, 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. When losartan is taken orally, about 4% of the dose is excreted by the kidneys unchanged, and about 6% of the dose is excreted by the kidneys as an active metabolite. Losartan and its active metabolite have linear pharmacokinetics when administered orally with losartan in doses up to 200 mg. After oral administration, the plasma concentrations of losartan and its active metabolite decrease polyexponentially with a final T1/2 of approximately 2 and 6-9 hours, respectively. With the dosage regimen of the drug 100 mg once a 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 through the intestines with bile and kidneys. After oral administration of 14C-losartan in men, about 35% of radioactivity is found in urine and 58% in feces. Afteradministration of 14intravenousC-losartan in men, approximately 43% of radioactivity is found in urine and 50% in feces.

Pharmacokinetics in special patient groups

Elderly patients. Plasma concentrations of losartan and its active metabolite in elderly male patients with arterial hypertension do not significantly differ from these indicators in young male patients with arterial hypertension.

Floor. The values ​​of the concentration of losartan in the blood plasma in women with arterial hypertension were 2 times higher than the corresponding values ​​in men with arterial hypertension. The concentrations of the active metabolite did not differ in men and women. This clear pharmacokinetic difference, however, has no clinical significance.

Patients with impaired liver function. When losartan was 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, respectively, 5 and 1.7 times higher than in young healthy male volunteers.

Patients with impaired renal function. Plasma concentrations of losartan in patients with Cl creatinine above 10 ml / min did not differ from those in patients with unchanged renal function. The AUC of losartan in patients on hemodialysis was approximately 2 times higher than the AUC of losartan in patients with normal renal function. Plasma concentrations of the active metabolite did not change in patients with impaired renal function or in patients on hemodialysis. Losartan and its active metabolite are not excreted by hemodialysis.

Indications of the drug Cozaar®

  • arterial hypertension;

  • a reduction in the risk of associated cardiovascular morbidity and mortality in patients with arterial hypertension and left ventricular hypertrophy, manifested by a cumulative reduction in the incidence of cardiovascular mortality, stroke and myocardial infarction;
  • protection of renal function in patients with type 2 diabetes mellitus with proteinuria - slowing the progression of renal failure, manifested by a decrease in the incidence of hypercreatininemia; the incidence of end-stage chronic renal failure (CRF) requiring hemodialysis or kidney transplantation and mortality rates;
  • chronic heart failure with the ineffectiveness of treatment with ACE inhibitors or intolerance to ACE inhibitors.

Method of administration and dosage of Cozaar

Inside, regardless of food intake.

Cozaar can be taken in combination with other antihypertensive drugs. To ensure the required dosing regimen, it is possible to take the drug Cozaar at a dose of 50 mg.

Arterial hypertension. The standard initial and maintenance dose for most patients is 50 mg of Cozaar once a day.

The maximum antihypertensive effect is achieved within 3-6 weeks from the start of therapy. In some patients, to achieve a greater effect, the dose can be increased to a maximum daily dose of 100 mg of Cozaar once a day. In patients with reduced BCC (for example, when taking large doses of diuretics), the initial dose of losartan should be reduced to 25 mg 1 time per day (see "Special instructions").

It is not necessary to select an initial dosage in elderly patients and patients with renal insufficiency, including patients on dialysis.

Patients with a history of liver disease are advised to prescribe lower doses of the drug (see "Special instructions").

Reducing the risk of associated cardiovascular morbidity and mortality in patients with arterial hypertension and left ventricular hypertrophy. The standard starting dose of Cozaar is 50 mg once a day. In the future, it is recommended to add hydrochlorothiazide in low doses or increase the dose of Cozaar to a maximum daily dose of 100 mg 1 time per day, taking into account the degree of blood pressure reduction.

Kidney protection in patients with type 2 diabetes and proteinuria. The standard starting dose of Cozaar is 50 mg once a day. In the future, it is recommended to increase the dose of Cozaar to the maximum daily dose of 100 mg 1 time per day, taking into account the degree of blood pressure reduction.

The drug Cozaar can be prescribed in combination with other antihypertensive drugs (diuretics, CCBs, α- and β-adrenergic blockers, antihypertensive drugs of central action for oral administration), insulin and other hypoglycemic agents (sulfonylurea derivatives, glitazones and glucosidase inhibitors).

Chronic heart failure. The initial dose of the drug Cozaar for patients with CHF is 12.5 mg 1 time per day. As a rule, the dose is titrated at weekly intervals (i.e. 12.5, 25, 50, 100 mg / day, up to a maximum dose of 150 mg once a day), depending on individual tolerance.


Contraindications

  • Hypersensitivity to any of the components of this drug;
  • simultaneous use with aliskiren in patients with diabetes mellitus (see "Interaction");
  • severe liver dysfunction (no experience with use);
  • hereditary lactose intolerance, lactase deficiency, glucose-galactose malabsorption syndrome;
  • pregnancy and the period of breastfeeding;
  • age up to 18 years (efficacy and safety of use have not been established).

With care: bilateral stenosis of the renal arteries or stenosis of the artery of a single kidney; hyperkalemia; conditions after kidney transplantation (no experience with use); aortic or mitral stenosis; obstructive hypertrophic cardiomyopathy; heart failure with concomitant severe renal failure; severe heart failure (NYHA functional class IV); heart failure with life-threatening arrhythmias; cardiac ischemia; cerebrovascular diseases; primary hyperaldosteronism; a history of angioedema. Patients with reduced BCC (for example, receiving treatment with high doses of diuretics) - symptomatic arterial hypotension may occur.

Application during pregnancy and breastfeeding

The use of drugs acting directly on the RAAS in the II and III trimesters of pregnancy can cause serious damage and even death of the developing fetus, therefore, when pregnancy is diagnosed, the drug Cozaar should be immediately canceled and, if necessary, alternative antihypertensive therapy should be prescribed ...

Cozaar therapy should not be started during pregnancy. If patients planning a pregnancy, continued therapy with losartan is deemed necessary, losartan should be replaced with alternative antihypertensive drugs that have an established safety profile when used during pregnancy.

Although there is no experience with the use of Cozaar in pregnant women, preclinical animal studies have shown that taking Cozaar leads to the development of serious embryonic and neonatal injuries and death of the fetus or offspring. It is believed that the mechanism of these phenomena is due to the impact on the RAAS.

Renal perfusion in the fetus, depending on the development of the RAAS, appears in the II trimester, therefore the risk to the fetus increases if Cozaar is used in the II or III trimesters of pregnancy. The use of ARA II in the II or III trimesters of pregnancy has a toxic effect on the fetus (decreased renal function, development of oligohydramnios, slowing of cranial ossification) and the newborn (renal failure, arterial hypotension, hyperkalemia). If Cozaar was used in the II trimester of pregnancy and later, an ultrasound of the skull and renal function is recommended.

Newborns whose mothers took Cozaar during pregnancy should be carefully examined for arterial hypotension.

It is not known whether losartan is excreted in breast milk. Since many drugs are excreted in breast milk and there is a risk of potential adverse effects in a breastfed baby, a decision should be made whether to stop breastfeeding or discontinue the drug, taking into account the need for the mother to take the drug.

Interaction

In clinical studies on the study of pharmacokinetic interactions of drugs, no clinically significant interactions of losartan with hydrochlorothiazide, digoxin, warfarin, cimetidine, phenobarbital and erythromycin were detected.

Rifampicin, being an inducer of drug metabolism, reduces the concentration of the active metabolite of losartan in the blood. The clinical significance of this interaction has not been established.

In clinical studies, the use of two inhibitors of the isoenzyme P450 3A4: ketoconazole and erythromycin was studied. Ketoconazole did not affect the metabolism of losartan to the active metabolite after intravenous administration of losartan. Erythromycin did not have a clinically significant effect when losartan was taken orally.

Fluconazole, an inhibitor of the P450 2C9 isoenzyme, reduces the concentration of the active metabolite of losartan, however, the pharmacodynamic significance of the simultaneous use of losartan and inhibitors of the P450 2C9 isoenzyme has not been studied. It has been shown that patients who do not metabolize losartan into an active metabolite have a very rare and specific defect of the P450 2C9 isoenzyme. These data suggest that the metabolism of losartan to the active metabolite is carried out by the P450 2C9 isoenzyme, and not the P450 3A4 isoenzyme.

The simultaneous use of losartan, as well as other drugs that block angiotensin II or its effects, with potassium-sparing diuretics (for example, spironolactone, triamterene, amiloride), potassium-containing supplements or potassium salts can lead to an increase in serum potassium.

As with other drugs that affect sodium excretion, losartan can reduce the excretion of lithium. Therefore, with the simultaneous use of lithium and ARA II preparations, it is necessary to carefully monitor the concentration of lithium in the blood serum.

NSAIDs, incl. selective inhibitors of COX-2, can reduce the effect of diuretics and other antihypertensive drugs. Therefore, the antihypertensive effect of ARA II or ACE inhibitors can be weakened by simultaneous use with NSAIDs, incl. with selective COX-2 inhibitors.

In some patients with impaired renal function (for example, elderly patients or patients with dehydration, including those taking diuretics), receiving NSAID therapy, incl. selective inhibitors of COX-2, the simultaneous use of ARA II or ACE inhibitors can cause further deterioration of renal function, including the development of acute renal failure. These effects are usually reversible. Therefore, the simultaneous use of these drugs should be carried out with caution in patients with impaired renal function.

Double blockade of RAAS with the use of ARA II, ACE inhibitors, or aliskiren (renin inhibitor) is associated with an increased risk of arterial hypotension, hyperkalemia and renal impairment (including the development of acute renal failure) compared with monotherapy. Regular monitoring of blood pressure, renal function and blood electrolytes is required in patients taking Cozaar and other drugs that affect the RAAS at the same time. Cozaar should not be used concomitantly with aliskiren in patients with diabetes mellitus. The simultaneous use of the drug Cozaar and aliskiren should be avoided in patients with renal insufficiency (glomerular filtration rate less than 60 ml / min).

Overdose

Symptoms: information on overdose is limited. The most likely manifestation of an overdose is a pronounced decrease in blood pressure and tachycardia; bradycardia can result from parasympathetic (vagal) stimulation.

Treatment: symptomatic therapy. Losartan and its active metabolite are not removed from the bloodstream by hemodialysis.

Special instructions

Hypersensitivity reactions. Angioneurotic edema (see "Side Effects").

Arterial hypotension and a violation of water and electrolyte balance or a decrease in BCC. In patients with reduced BCC (for example, those receiving treatment with high doses of diuretics), symptomatic arterial hypotension may occur. Correction of such conditions must be carried out before the appointment of the drug Cozaar or start treatment with a lower dose of the drug Cozaar (see "Dosage and Administration").

Impaired water and electrolyte balance is characteristic of patients with renal failure with or without diabetes mellitus, therefore careful monitoring of these patients is necessary. In clinical trials involving patients with type 2 diabetes mellitus with proteinuria, the number of cases of hyperkalemia was greater in the Cozaar group than in the placebo group. Several patients discontinued therapy due to the onset of hyperkalemia (see "Side effects", "Laboratory indicators").

During treatment with Cozaar, patients should not take potassium supplements or potassium-containing table salt substitutes without prior consultation with the doctor.

Aortic or mitral stenosis, obstructive hypertrophic cardiomyopathy. As with all drugs with a vasodilating effect, ARA II should be used with caution in patients with aortic or mitral stenosis, or obstructive hypertrophic cardiomyopathy.

Ischemic heart disease and cerebrovascular diseases. Like all drugs with a vasodilating effect, ARA II should be prescribed with caution in patients with coronary artery disease or cerebrovascular disease, since an excessive decrease in blood pressure in this group of patients can lead to the development of myocardial infarction or stroke.

Chronic heart failure. As with the use of other drugs that have an effect on the RAAS, in patients with CHF and with or without impaired renal function, there is a risk of severe arterial hypotension or acute renal failure.

There is insufficient experience with the use of Cozaar in patients with heart failure and concomitant severe renal failure, in patients with severe heart failure (NYHA functional class IV), as well as in patients with heart failure and symptomatic life-threatening arrhythmias. Therefore, the drug Cozaar should be prescribed with caution to patients of these groups.

Primary hyperaldosteronism. In patients with primary hyperaldosteronism, as a rule, there is no positive response to therapy with antihypertensive drugs that act by inhibiting the RAAS, therefore, the use of Cozaar is not recommended in this group of patients.

Liver dysfunction. The data of pharmacokinetic studies indicate that the concentration of losartan in the blood plasma in patients with liver cirrhosis increases significantly, therefore, patients with a history of liver disease should be prescribed a lower dose of the drug. There is no experience of using the drug Cozaar in patients with severely impaired liver function, therefore the drug should not be used in this group of patients (see Pharmacodynamics, Pharmacokinetics; Contraindications; Dosing and Administration).

Impaired renal function. Due to the inhibition of the RAAS, changes in renal function were observed in some predisposed patients, including the development of renal failure. These changes can take place after stopping treatment.

Some drugs that affect the RAAS can increase the concentration of urea in the blood and serum creatinine in patients with bilateral renal artery stenosis or renal artery stenosis of a single kidney. It was reported about the occurrence of similar effects when taking the drug Cozaar. Such renal dysfunction can be reversible after discontinuation of therapy.

Special patient groups

Race. Analysis of data from the entire population of patients included in the LIFE study to study the effect of losartan on reducing the incidence of the main criterion for evaluating the study in patients with hypertension (n = 9193) showed that the ability of losartan, compared with atenolol, to reduce the risk of stroke and myocardial infarction, and also reduce the rate of cardiovascular mortality in patients with hypertension and left ventricular hypertrophy (by 13%, p = 0.021) does not apply to black patients, although both therapy regimens effectively reduced blood pressure in these patients. Moreover, black patients who received atenolol had a lower risk of developing the main composite evaluation of the study (i.e., a lower combined incidence of cardiovascular mortality, stroke, and myocardial infarction) compared with patients of the same race who received losartan (p = 0.03).

On the basis of observations, apparently, it can be concluded that ACE inhibitors and angiotensin antagonists are less effective in lowering blood pressure in patients of the Negroid race than in patients of other races. This effect may be due to the high prevalence of patients with reduced plasma renin concentration in the population of Negroid patients with hypertension.

Children and adolescents. The efficacy and safety of using the drug Cozaar in children and adolescents under 18 years of age have not been established.

Elderly patients. Clinical studies have not revealed any features regarding the safety and efficacy of losartan in elderly patients (over 65 years).

Influence on the ability to drive vehicles and work with mechanisms. No studies have been conducted to assess the effect on the ability to drive vehicles and work with mechanisms, however, some undesirable effects observed when using the drug Cozaar can affect the ability to drive vehicles and work with mechanisms (see "Side effects").


Side effects

In general, the drug Cozaar is well tolerated by patients with arterial hypertension, the adverse events are mild and transient and do not require discontinuation of the drug. The total incidence of side effects of the drug Cozaar is comparable to this indicator when taking placebo. In controlled clinical trials of the drug in patients with arterial hypertension, the only adverse reaction associated with treatment and observed more often than with placebo was dizziness, recorded in the treatment groups with Cozaar with a frequency of ≥1%. In addition, ≤1% of patients had dose-dependent orthostatic reactions. Rarely (≥ 0.01% and <0.1% of cases), skin rashes were reported, but the incidence was less than with placebo.

In these studies, ≥1% of patients with hypertension experienced the following adverse events while taking Cozaar (n = 2085) or placebo (n = 535), regardless of their relationship to treatment.

General: pain in the stomach - 1.7% (placebo - 1.7%); weakness and increased fatigue - 3.8% (placebo - 3.9%); chest pain - 1.1% (placebo - 2.6%); peripheral edema - 1.7% (placebo - 1.9%).

On the part of the CVS: palpitations - 1% (placebo - 0.4%); tachycardia - 1% (placebo - 1.7%).

From the digestive tract: diarrhea - 1.9% (placebo - 1.9%); dyspepsia - 1.1% (placebo - 1.5%); nausea - 1.8% (placebo - 2.8%).

From the side of the musculoskeletal system: back pain - 1.6% (placebo - 1.1%); muscle cramps - 1% (placebo - 1.1%).

From the side of the central nervous system: dizziness - 4.1% (placebo - 2.4%); headache - 14.1% (placebo - 17.2%); insomnia - 1.1% (placebo - 0.7%).

Respiratory system: cough - 3.1% (placebo - 2.6%); swelling of the nasal mucosa - 1.3% (placebo - 1.1%); pharyngitis - 1.5% (placebo - 2.6%); sinusitis 1% (placebo 1.3%); upper respiratory tract infections - 6.5% (placebo - 5.6%).

Controlled clinical studies have shown that Cozaar is generally well tolerated by patients with arterial hypertension and left ventricular hypertrophy. The most frequent adverse reactions associated with taking the drug were systemic and non-systemic dizziness, asthenia / weakness.

Controlled clinical trials have shown that Cozaar is generally well tolerated by patients with type 2 diabetes and proteinuria. The most common adverse reactions associated with taking the drug were dizziness, asthenia / weakness, a marked decrease in blood pressure and hyperkalemia.

Controlled clinical studies have shown that the drug Cozaar is generally well tolerated by patients with CHF. Adverse events observed in clinical trials were typical for this group of patients. The most common adverse reactions associated with taking the drug were dizziness and a marked decrease in blood pressure.

In theclinical study HEAAL (see Pharmacodynamics), the following clinically significant adverse reactions associated with the drug were observed more frequently in the group of patients taking Cozaar at a dose of 150 mg, compared with the group of patients taking the drug Cozaar at a dose of 50 mg : hyperkalemia, acute renal dysfunction, acute renal failure, a marked decrease in blood pressure and an increase in the concentration of creatinine, urea and potassium in the blood. These adverse reactions did not lead to significantly more frequent discontinuations of therapy in patients taking Cozaar 150 mg.

The following adverse reactions have been observed in clinical practice in the post-marketing period.

Hypersensitivity reactions: in patients taking losartan, anaphylactic reactions, angioneurotic edema involving the larynx and pharynx, causing airway obstruction and / or edema of the face, lips, pharynx and / or tongue were rarely observed. Some of these patients had a history of having experienced angioedema while taking other drugs, including ACE inhibitors. Occurrence of vasculitis, including Schönlein-Henoch purpura, has rarely been reported.

From the digestive tract: hepatitis (rarely), abnormal liver function, vomiting.

General disorders and disorders at the injection site: general discomfort.

From the side of the blood system: anemia, thrombocytopenia (rarely).

From the musculoskeletal system: myalgia, arthralgia.

From the side of the central nervous system: migraine, dysgeusia.

From the genitals and breast: erectile dysfunction / impotence.

From the respiratory system: cough.

On the part of the skin: urticaria, pruritus, skin redness, photosensitivity.

Laboratory indicators

When conducting controlled clinical trials in patients with arterial hypertension, clinically significant changes in standard laboratory parameters were rarely associated with taking Cozaar. Hyperkalemia (serum potassium> 5.5 mEq / L) was noted in 1.5% of patients.

In a study in patients with type 2 diabetes mellitus with proteinuria, hyperkalemia developed in 9.9% of patients receiving Cozaar and 3.4% of patients receiving placebo (see "Special instructions", Electrolyte imbalance). Elevated ALT levels have been reported in rare cases and usually returned to normal after discontinuation of therapy.