Cozaar 100mg Organon treats hypertension, reduces the risk of infection and death from cardiovascular disease (3 blisters x 10 tablets)

Dosage form Box of 3 blisters x 10 tablets
Specifications Losartan Potassium
Ingredient Organon Hong Kong Limited

Ingredient

Composition information	Content
Losartan Potassium	100mg

Uses

indications

Hypertension:

Initial and maintained dose for most patients is 50mg, taken once a day. The maximum effect of treating hypertension reaches 3-6 weeks after starting the medication. Increasing dose to 100mg, once a day can be helpful for some patients.

For patients with reduced volume of circulatory (for example, high -dose dosage medications), should consider the starting dose of 25mg, once a day (see caution).

No need to adjust the starting dose for elderly patients or kidney failure even people who are hemolysis. Need to consider lower doses for you with a history of liver failure (see caution).

Reducing the risk of cardiovascular disease and cardiovascular death for adult patients with hypertension with left ventricular hypertrophy:

Normally, the starting dose is 50mg of cozaar, drink once a day. Low -dose Hydrochlorothiazide can be added and/or increased cozaar dose to 100mg, once a day depending on the response on blood pressure.

Treatment of kidney disease in adult patients with hypertension and type 2 diabetes, with proteinuria greater than 0.5g/day:

Normally, the starting dose is 50mg of cozaar, drink once a day. Cozaar dose can be increased to 100mg, once a day depending on the response on blood pressure. Cozaar can be used with other hypertension drugs (for example: diuretics, calcium channel blockers, alpha or beta blockers, and central acting drugs) as well as insulin and other common hypoglycemic drugs (such as sulfonylurea, glitazone and glucosidase inhibitors).

Chronic heart failure:

The normal starting dose for patients with heart failure is 12.5mg once a day. This dose should be adjusted slowly each week (e.g. 12.5mg per day, 25mg per day, 50mg per day, 100mg per day, to the maximum dose of 150mg per day per day depending on the tolerance of the patient.

Pharmacokology

Pharmacology

Cozaar (Losartan Kali), the first substance of a new group of drugs for treatment of hypertension, is Angiotensin II receptor receptor. Cozaar also reduces the risk of coordination of death due to cardiovascular disease, stroke and myocardial infarction in patients with hypertension with left ventricular hypertrophy and protecting kidneys for people with diabetes 2 with proteinuria.

Pharmacokology

Losartan is Angiotensin II receptor antagonist (type AT1), orally. Angiotensin II is attached to the AT1 receptor, in many types of tissues (for example, blood vessel, adrenal, kidney, heart) and produce important biological effects, including vasoconstriction and aldosterone secretion. Angiotensin II also stimulates smooth muscle cell proliferation. Biological trials on cohesion and pharmacological have shown that Losartan is selected into the AT1 receptor.

Through in vito and in vivo results, both Losartan and carboxylic acid metabolites with pharmacological activity (E-3174) will seal all the above physiological effects of Angiotensin II, regardless of the origin or synthetic path of Angiotensin II.

When using Losartan, the negative response of Angiotensin II for renin secretion will no longer exist, leading to increased renin activity in plasma and eventually increasing the angiotensin II in plasma. Despite increased concentration of these substances, the effect of lowering blood pressure and keeping the level of Aldosterone is not high in plasma is still maintained, proving the effective inhibiting the Angiotensin II receptor.

Losartan is selectively attached to the AT1 receptor, which is not attached or sealed with other hormone receptors or important ion channels in the cardiovascular regulation. Moreover, Losartan does not inhibit Angiotensin (ACE) (Kininase II), which is Bradykinin decomposition. Therefore, what effects are not related to the AT1 receptor closing, such as increasing the effect of Bradykinin intermediaries or the effect of edema (1.7%Losartan; Placebo 1.9%) does not occur when using Losartan.

Losartan inhibits response to angiotensin I and II response without affecting the response to Bradykinin, this finding is suitable for the specific mechanism of action of Losartan. In contrast, the ACE enzyme inhibitors are blocked with angiotensin I response and increases the response to Bradykinin without inhibiting response to angiotensin II. This is the difference in pharmacological resources between Losartan and ACE transfer inhibitors.

In a specially designed study to evaluate the cough ratio in patients with cozaar compared to patients with ACE enzyme inhibitors, the cough ratio in cozaar users or the Hydrochlorothiazide group is equal and significantly lower than in the ACE enzyme inhibitor group. In addition, an integrated analysis from 16 clinical trials designed in double over 4,131 patients showed that the cough ratio under the voluntary report in patients using Losartan (3.1%) is similar to that in patients using Placebo (2.6%) or hydrochlorothiazide (4.1%), while the cough ratio when using ACE transferring enamel is 8.8%.

In patients with hypertension without diabetes and proteinuria, Losartan significantly reduces proteinuria, reduces albumin and IgG. Losartan maintains glomerular filtration and reduces the filter volume. In general, Losartan reduces uric acid in serum (usually

Losartan has no effect on plant neurological reflexes and does not have a long -term effect on plasma norepinephrine.

For patients with left ventricular failure, dose of 25mg and 50mg Losartan causes positive effects on hemodynamics and nerves, characterized by an increase in the heart index and decreased pulmonary capillary pressure, body blood vessels, average body blood pressure, heart rate and decrease in respectively aldosterone and norepinephrine in blood. Hypotension in people with heart failure depends on the dose.

In clinical studies, using Cozaar once a day in patients with mild and medium -sized hypertension has reduced the significance of diastolic and systolic blood pressure; Hypotension effects are maintained up to one year in clinical studies. Measure blood pressure at the bottom of the bottom (24 hours after taking the medication) compared to the peak (5 - 6 hours after taking the drug) proved to have a stable reduction of blood pressure throughout 24 hours. Hypotension effects corresponding to blood pressure biology. The effect of reducing blood pressure at the end of the dose is about 70-80% of the effect achieved after the drug 5-6 hours. Stop using Losartan in people with hypertension does not cause blood pressure to rise suddenly again. Despite the significant reduction in blood pressure, using cozaar has no clinical effects on the heart rate.

Oral Cozaar 50 - 100mg, once a day, will cause more obvious hypotension than Captopril 50 - 100mg, once a day. The hypotension effect of Cozaar 50mg is equivalent to the effect of Enalapril 20mg, taken once a day. The hypotension effect of cozaar 50 - 100mg once oral or taken can compare equivalent to Atenolol 50 - 100mg, taken once a day. The effect of Cozaar 50 - 100mg, oral once a day is equivalent to Felodipine, which lasts 5 - 10mg in elderly patients with hypertension (≥ 65 years) after 12 weeks of treatment.

Cozaar is equivalent to use in men as well as women, in young people (

When combined with the diuretics of the thiazide group, Cozaar has the effect of lowering blood pressure.

Life research

Life research (Losartan intervention for endpoint reduction in hypertension - Research and evaluate the effectiveness of reducing blood pressure when intervention with losartan) in patients with hypertension is a major study, multicolized, multinational, random design, comparison with other drugs, conducted over 9,193 patients with hypertension, age 55 (average age) Among the selected patients, 1,195 people had diabetes (13%) initially, 1,326 people suffering from systolic hypertension (14%), 1,468 (17%) of coronary artery disease and 728 (8%) with cerebrovascular disease. The purpose of the study is to prove that Cozaar's cardiovascular protection effect is more than Atenolol and beyond the benefits of blood pressure control (blood pressure measured at the bottom time). To achieve that goal, the study is designed so that both treatment groups achieve the same blood pressure. The patient is randomly selected to drink once a day Cozaar 50mg or Atenolol 50mg. If the target blood pressure is not achieved ( In both treatment groups, blood pressure decreases significantly to the equivalent level and the proportion of patients with target blood pressure is equivalent. The average tracking time is 4.8 years.

Main criteria for combination of cardiovascular incidence and death rates are assessed by a decrease in the combination of cardiovascular death, stroke and myocardial infarction. The results show that the use of cozaar reduces 13.0% of the risk (P = 0.021) compared to the patient using Atenolol in patients who meet the main criteria (see Figure 1 in the drug managing sheet).

Figure 1. The Kaplan-Meier chart in terms of the main criterion of coordinating cardiovascular mortality, stroke or myocardial infarction in groups using Cozaar and Atenolol, corrected according to the initial framingham score of risk and ventricular hypertrophy on the electrocardiogram.

Use Cozaar to reduce the risk of stroke by 25% compared to Atenolol (P = 0.001). The rate of cardiovascular death and myocardial infarction is not different between the two treatment groups. The effect of cozaar on the main criterion seems to be more dominant and beyond the mere blood pressure control benefits (see the following table).

The evaluation criteria of Life study

results cozaar (n = 4.605) n (%) ratio* Rate* P Hop (5%)

10.6

11% 0.206 (7%) 14.5 25% 0.001 (4%) 8.7 -7% 0.491
** Adjustment based on the initial framingham score of risk and level of left ventricular hypertrophy on the center of electrocardiogram.
Other clinical evaluation criteria of Life study include: total mortality rate, hospital stay due to heart disease or angina, coronary blood and peripheral blood vessels and cardiac arrest. There is no significant difference in the rate of these events between research groups. The patient using Cozaar has significantly reduced the electrocardiography indicators of left ventricular hypertrophy, compared to the atenolol group.
The effect of cozaar compared to Atenolol on the incidence and cardiovascular death is observed on the groups of patients with a history of diabetes (n = 1,195) or mental hypertension alone (n = 1,326). The results of the main criteria in these subgroups are in accordance with the statement of cozaar treatment benefits in the general population of the study: 24% reduction of risk (P = 0.03) in diabetes and 25% reduced risk (P = 0.06) in people with centrifugal hypertension alone. In accordance with the results in the general population, stroke reduction is also an important contribution to the observation benefits in people with diabetes or mental hypertension.
Race
According to Life research, the benefit of Cozaar on the incidence and death compared to Atenolol does not apply to black skin hypertension and left ventricular hypertrophy, although both treatment regimens reduce blood pressure effectively in black skin patients. In Life study, Cozaar reduces the risk of disease and death compared to Atenolol in patients who are not black with hypertension with left ventricular hypertrophy (n = 8.660) is assessed by the criteria of coordinating the rate of cardiovascular mortality, stroke and myocardial infarction (P = 0.003). However, in this study, black skin patients using Atenolol have a lower risk of the main coordination criteria than in black skin patients using Cozaar (P = 0.03). In the division of black skin patients (n = 533; accounting for 6%of the total number of patients participating in Life Research), there are 29 main coordination events among 263 Atenolol users (11%; 25.9/1,000 patients-Ham) and 46 main coordination events among 270 patients using COZAAR (17%; 41.8/1,000 patients-1,000 patients).
In this study, Cozaar is generally better tolerated and better tolerated than Atenolol, because of the rate of stopping drugs due to the lower adverse effect.
Renaal research
Renaal Research (Reduction of Endpoints in Niddm with the angiotensin II Receiptor Antagonist Losartan - Research and assess the effectiveness of reduced events when treated with Angiotensin II receptor inhibitors is Losartan for people with non -insulin -dependent diabetes) is a large, multi -central, random, unsuccessful, controlled study In 1,513 people with type 2 diabetes with proteinuria (751 users of cozaar) and have or without hypertension attached. The purpose of the study is to prove that the kidney protection effect of Cozaar is superior and beyond the effect of blood pressure control. To achieve this goal, the study is designed so that the two treatment groups reach the same level of blood pressure control. Patients with proteinuria and serum creatinine are 1.3-3.0mg/DL randomly selected using cozaar 50mg, one daily taken and adjust the dose according to the response of blood pressure, or use Placebo, to supplement an ordinary antihypertensive drug in use, except for ACE enzyme inhibitors and Angiotensin II antagonists. Researchers are required to adjust the research dose of up to 100mg, once a day accordingly. 72% of patients take a dose of 100mg of Cozaar per day for most of the research time. Other hypotension may be added, if necessary, for both groups (diuretics, calcium channel blockers, alpha and beta blockers, central nerve effects). Patients are monitored for up to 4.6 years (average 3.4 years).
The main criterion of this study is the criteria for coordinating the assessment of the increase in serum creatinine levels, end -stage kidney disease (blood decomposition or kidney transplantation), or death. The results show that Cozaar (327 events) compared to Placebo (359 events) reduced by 16.1% (P = 0.022) The risk among the patients with the main criteria of coordination. The results also showed that the risk of each component of the main criteria or general evaluation in the group used Cozaar was as follows: reduced by 25.3% of the risk of doubling serum creatinine levels (P = 0.006); reducing 28.6% of the risk of progress to end -stage kidney disease (P = 0.002); Decreased 19.9% of the risk of end -stage kidney disease or death (P = 0.009); Decreased 21.0% of the risk of doubling serum or end -stage kidney disease (P = 0.010). The mortality rate due to all causes is not significantly different between the two treatment groups.
The sub -criteria of this study are: Changes in proteinuria, renal disease progression, incidence and synthetic death due to cardiovascular causes (hospitalization due to heart disease, myocardial infarction, blood refinancing procedure, stroke, hospitalized due to unstable angina or death due to cardiovascular disease). The results showed that the average decreased by 34.3% of the proteinuria level in the group used Cozaar (P
In this study, Cozaar is generally tolerated based on evidence that the percentage of drug stops due to adverse effects between the groups of Cozaar and Placebo is similar.
Heaal Research: Research and evaluate the effect of Angiotensin II Losartan receptor blockers on heart failure (Heaal) is a controlled clinical study conducted in the world with 3,834 patients aged 18 to 98 with heart failure (II-IV as classified by NYHA) intolerant to medical inhibitor treatment. The patient is randomly divided into the Losartan group 50mg once daily or Losartan 150mg, on the background of classic treatment except not using enzyme inhibitors.
Patients are monitored over 4 years (an average of 4.7 years). The main ending of the study is the criteria for coordination of death due to all causes or hospitalization for heart failure.
The results showed that treatment with 150mg of Losartan (828 events) reduced 10.1% (P = 0.027 95% of reliability of 0.82-0.99) The risk among patients with the main criteria of coordination. This result is mainly due to a reduction in hospital stay due to heart failure. Treatment with 150mg of Losartan reduces the risk of hospitalization due to heart failure by 13.5% compared to 50mg of Losartan (P = 0.025 95% of reliability 0.76-0.98). The mortality rate due to all causes is not significant difference between treatment groups. Kidney failure, hypotension and hyperkalemia is more common in the group using 150mg compared to the 50mg group, but these adverse effects do not increase the rate of stopping drugs in the group using 150mg.
Research Elite I and Elite II
In the 48-week Elite study in patients with heart failure (n = 722) (level II-IV according to NYHA classification), no difference in the main criterion is prolonged renal failure in patients treated with cozaar and patients treated with captlil. Cozaar's superior benefits compared to Captopril in reducing the risk of death observed in this Elite study were not confirmed in the final research Elite II on the survival rate described below.
In a study on patients with heart failure designed over time to evaluate the mortality rate (Elite II), a treatment regime with cozaar 50mg once a day (starting with a dose of 12.5mg increases to 25mg and 50mg once) compared to Captopril 50mg 3 times daily (starting at a dose of 12.5mg and increasing to 25mg and 50mg 3 times daily). In this study (n = 3.152), patients with heart failure (Grade II-IV according to the classification of NYHA) are monitored for approximately 2 years (the median time is 1.5 years) to evaluate Cozaar more effectively in Captoril in reducing the total mortality rate or not. The main evaluation criteria show that there is no statistical difference between Cozaar and Captopril in reducing the general mortality rate (17.7% for cozaar and 15.9% for captopril, P = 0.16). The second assessment criterion shows that there is no statistical difference in a sudden decline in cardiovascular and/or cardiac arrest (9.0% for cozaar and 7.3% for captopril, p = 0.08). The third assessment criteria for mortality and/or hospitalized rates for all causes showing that there is no statistical difference between Cozaar and Captopril (47.7% for cozaar and 44.9% for captopril, p = 0.18). Overall, other criteria for assessment of incidence and death include improvement according to the classification of NYHA are no different between treatment groups. In both clinical trials with control patients with heart failure, Cozaar is well tolerated and the characteristics of Cozaar's tolerance better than captopril, which is evaluated based on the ratio of treatment due to side effects and significantly lower cough ratios.
Race
Based on the study of the effectiveness of reducing blood pressure when intervention with Losartan (Losartan Intermedion for Endpoint Reduction in Hypertension (Life), the benefit reduces the incidence and mortality due to cardiovascular disease in patients with cozaar patients compared to the atenolol group that cannot be applied to the black skin hypertension patient group, both effectively wearing both black and hyperplasmic patients, both effective. The same. For the general population of the Life study (N = 9.193), Cozaar reduced 13.0% risk (P = 0.021) compared to the use of Atenolol for the main criteria of coordinating deaths due to cardiovascular, stroke and myocardial infarction. In this study, Cozaar reduced the risk of cardiovascular disease and cardiovascular death compared to the use of Atenolol for patients not in the black racial group, suffering from hypertension with left ventricular hypertrophy (n = 8.660), assessed by the main criterion of coordinating cardiovascular deaths, stroke, myocardial infarction (P = 0.003). However, in this study, black skin patients treated with Atenolol are less likely to have more coordinated events than the group of black skin patients using Cozaar (P = 0.03). In the division of black skin patients (n = 533, accounting for 6%of the patient in Life study), there were 29 cases of 263 patients using Atenolol encountered this group of incidents (11%;
Subclinical tests
In clinical trials with controlled hypertension, changes that are of clinical significance of testing parameters rarely relate to the use of cozaar. In clinical trials on hypertension, hyperkalemia (serum potassium> 5.5 MEQ/L) is seen in 1.5% of patients. In a clinical study conducted in patients with type 2 diabetes with proteinuria had hyperkalemia in 9.9% of patients using Cozaar and 3.4% of patients using Placebo (see caution, lower blood pressure and water/electrolyte imbalance). Rarely cases of increasing ALT and often recovered when stopping the drug.
Pharmacokinetics

absorption
After drinking, Losartan absorbs well and through the first metabolism that creates carboxylic acid metabolites and is active and other non -active metabolites. The whole body of Losartan tablets is about 33%. The average peak concentration of Losartan and of the metabolites is activity achieved after one hour (with Losartan) and 3-4 hours (with metabolites). There is no clinical effect on losartan levels in plasma, when taking the drug with normal meals.
Distribution
Both Losartan and metabolites have an activity attaching ≥ 99% to plasma proteins, mainly on albumin. Losartan's VD distribution is 34 liters. Research on rats shows that Losartan is very poor in blood barrier, may not be over.
Metabolism
About 14% of the intravenous or oral dose of Losartan is converted into biological metabolites. After drinking and intravenously Losartan Kali, which marks 14C, the cycle marks in plasma are mainly losartan and active metabolites. The minimum metabolism of Losartan into an active metabolite is about 1% of researchers.
In addition to active metabolites, there are also non-active metabolites formed, including two main substances created by the Butyl branch hydroxylation and auxiliary metabolic substance, N-2 Tetrazole Glucuronide.
Elimination
Losartan's plasma purification is 600ml/min, of the active metabolite is 50ml/minute. Losartan's kidney purification is about 74ml/minute and of an active metabolite of 26ml/minute. When using Losartan by oral, about 4% of the dose will be excreted intact through the urine and about 6% of the dose will be through the urine in the form of active metabolites. The pharmacokinetics of Losartan and the metabolites are linear with the oral dose of Losartan Kali to 200mg.
After drinking, the concentration of Losartan and of the metabolites is active in plasma decreases with multi-exponential functions with the final semi-exhaust time about 2 hours (with Losartan) and 6-9 hours (with metabolites). With a daily dose of 100mg, both Losartan and metabolites and active active are not significantly accumulated in plasma.
Losartan and metabolites are discharged through bile and urine. After taking a dose of Losartan marked with 14C, about 35% of the markers found in the urine, 58% found in feces.
Characteristics of patients
In patients with mild and moderate cirrhosis due to alcoholism, Losartan concentration and of plasma metabolites are 5 times higher (with Losartan) and 1.7 times (with metabolic) compared to healthy volunteers after taking medicine.
Can not remove Losartan and metabolites that are active from the body by hemolysis.

Before taking Cozaar 100mg Organon treats hypertension, reduces the risk of infection and death from cardiovascular disease (3 blisters x 10 tablets)

How to use

Take oral use.

Can take cozaar when hungry or full.

Can take cozaar along with other hypertension medications.

Dosage

Hypertension:

For patients with reduced volume of circulatory (for example, high -dose dosage medications), should consider the starting dose of 25mg, once a day (see caution).

No need to adjust the starting dose for elderly patients or kidney failure even people who are hemolysis. Need to consider lower doses for you with a history of liver failure (see caution).

Reducing the risk of cardiovascular disease and cardiovascular death for adult patients with hypertension with left ventricular hypertrophy:

Treatment of kidney disease in adult patients with hypertension and type 2 diabetes, with proteinuria greater than 0.5g/day:

Chronic heart failure

What to do when overdose? The most common expression of overdose is hypotension and fast heartbeat; It is also possible to have a slow heartbeat due to sympathetic nerve stimulation (vagus nerves). If symptomatic hypotension occurs, it is necessary to take supportive treatments.

Cannot remove Losartan or metabolites that are still active of Losartan by blood decentralization.

What to do when forgetting a dose?

Side Effects

In clinical trials on controlled hypertension, cozaar is generally tolerated. Adultery effects are usually light and transient, without stopping the drug. The general ratio of adultery effects of Cozaar can be comparable to the Placebo.

In clinical trials with controlled hypertension, in some patients treated with cozaar, dizziness is the only adverse effect related to drugs reported at a rate of ≥ 1%, higher than Placebo. In addition, the effect of lowering blood pressure is related to the dose only ≤ 1% of the patients. Rarely erythematosus, however, the ratio in clinical trials is lower than in Placebo.

In double blind clinical trials with idiopathic hypertension, the following adverse effects are reported to Cozaar, which occurs at ≥ 1% of the patient, regardless of the drug. cozaar

Placebo Body Height = "20"> chest pain 1.1 2.6 Breaking the chest drum 1

0.4

> 1.8 2.8 broken) 1 1.1 Height = "20"> headache 14.1 17.2 Ho 3.1 2.6 > 1.5 2.6 > 5.6 The most common adverse effects related to drugs are dizzy, weak/ tired and dizzy.

In Life study, among the patients without diabetes before the study, the new incidence of diabetes in the group using Cozaar is lower than the Atenolol group (corresponding to 242 compared to 320 patients, P

In a controlled clinical study in type 2 diabetes with proteinuria, generally cozaar is well tolerated. The most common adverse effects related to drugs are weakness/fatigue, dizziness, hypotension and hyperkalemia (see caution, hypotension and water/electrolyte imbalance).

Cozaar is generally tolerated through control clinical studies on heart failure patients. Observing adverse experience is the specific effect known in this group of patients. The most common side effects related to drugs are dizziness and hypotension.

In the Heaal study (Heart Failure Endpoint Eval and increased blood urea. These adultery effects do not increase the meaning of the percentage of drug suspension in patients being treated with cozaar 150mg.

There are the following adverse effects reported after the drug is marketed:

Hypersensitivity: Anaphylactic reactions, angels, including larynx edema and drum jams, or/or face edema, lips, throat and tongue have been reported in a rare number of patients using Losartan, some of these patients who had previously had angels when using other drugs including shifting inhibitors. Vascular inflammation, including Henoch-Schoenlein, has been reported, although rare.

Gastrointestinal: Hepatitis (rare), abnormal liver function, vomiting.

Systemic disorders or at the place of use: uncomfortable.

Hematology: Anemia, thrombocytopenia (rare).

musculoskeletal: muscle pain, joint pain.

Nervous/mental system: migraine (migraine), taste rebellion.

Reproductive and chest disorders: erectile/helpless dysfunction.

Respiratory: cough.

Skin: urticaria, itching, body redness, sensitive to light.

Warnings

Before using the drug you need to read the instructions carefully and refer to the information below.

Contraindicated

hypersensitivity to active ingredients or any excipients listed in the ingredients.

The three months between and the last three months of pregnancy

Severe liver failure.

Conventional control of Losartan with Aliskiren -containing products in diabetes patients or kidney failure (glomerular filtration speed (GFR)

Be cautious when using

toxicity with pregnancy:

The use of drugs on the Renin-Anotensin system in the middle and last three months of pregnancy reduces the kidney function of the fetus, increases disease and death in the fetus and babies. The result of amniotic fluid may be associated with lung reduction and skeletal deformation in fetus. The possible side effects in newborns include reducing skull production, anuria, hypotension, renal failure and death. When detected pregnancy, must stop cozaar as soon as possible. (View used during pregnancy).

sensitivity: eagle (see adverse effects).

Hypotension and water/ electrolyte imbalance

In patients, the patient reduces the volume of circulatory (such as a high -dose diuretic treatmenter) may occur symptomatic hypotension. These conditions must be adjusted before using cozaar, or the starting dose must be lower (see the dose and usage).

Common electrolyte imbalance on kidney failure patients, with or without diabetes and this is a problem to be solved. In a clinical study conducted in patients with type 2 diabetes, proteinuria, hyperkalemia rate in the cozaar treatment group higher than the control group; However, only few patients have to stop treating due to hyperkalemia (see adverse effects and subclinical tests).

Liver function

Based on the pharmacokinetic data on Losartan concentration in plasma significantly increased in patients with cirrhosis, it is necessary to consider lower doses for patients with a history of liver failure (see dosage and clinical use and pharmacokinetics).

Renal function

As a result of the inhibition of the renin-anidensin system, changes in renal function including kidney failure have been reported (especially in patients with renal function depending on the renin-angiotensin-krosteron system as patients with severe heart failure or renal dysfunction before before). As with other drugs, it affects the renin-ankiotensin-aldosteron system, increased blood urea and serum creatinine has also been reported in patients with narrowed kidney stenosis on both sides or kidney stenosis in a single kidney; These changes in the kidney function can recover when stopping treatment. Be careful when taking Losartan in patients with kidney stenosis on both sides or kidney stenosis on a single kidney.

Used in patients with kidney failure

It is not recommended to use Losartan in children with the filtration speed of glomerular

Should regularly monitor kidney function while treating with Losartan as it can deteriorate. This applies especially when Losartan is used with the presence of other conditions (fever, dehydration) that can reduce the kidney function.

Simultaneous use of losartan and enzyme inhibitors (ACE) has shown to reduce kidney function. Therefore, it is not recommended to use simultaneously.

kidney transplant

No experience in recent kidney transplant patients.

Cuong Aldosteron Tien Phat

Patients with primary Aldosteron intense will often not respond to hypertension drugs effected through inhibition of the renin-angiotensin system. Therefore, it is not recommended to use Losartan.

Coronary artery disease and cerebrovascular disease

Like any hypertension, excessive hypoglycemia in patients with cardiovascular disease and ischemia can lead to myocardial infarction or stroke.

heart failure

In patients with heart failure, with or without kidney failure, as well as other drugs that affect the renin -ankiotensin system - there is a risk of severe arterial hypotension and kidney failure (usually acute).

There is no full experience with Losartan in patients with severe renal failure and kidney failure at the same time, in patients with severe heart failure (Grade IV according to the functional classification of the New York Heart Association (NYHA)) as well as in patients with heart failure and arrhythmia threatening life. Therefore, it is necessary to be cautious when using Losartan in these patients. Be careful when using Losartan combination with beta blockers.

Aortic stenosis and narrow mitral stenosis, hypertrophic cardiomyopathy

As with other vasodilators, it is necessary to be particularly cautious in patients with aortic stenosis or mitral stenosis or obstruction of myocardial disease.

excipients

This drug contains lactose. Patients with rare genetic problems are galactose intolerance, lactase deficiency or Glucose-Galactose should not take this drug.

Warning and caution

As observed for Angiotensin, Losartan and Angiotensin antagonistic drugs inhibitors seem less effective in reducing blood pressure in blacks compared to not black people, maybe due to higher rates of low lenin in the population of black hypertension

Dual inhibitor Renin-Anotensin-Aldosteron (RAAS)

There is evidence that the simultaneous use of Angiotensin (ACE), Angiotensin II or Aliskiren receptor blockers increases the risk of hypotension, hyperkalemia and reducing kidney function (including acute renal failure). Due to the red recommendation of the Renin-Anotensin-Aldosteron (RAAS) inhibitor through the use of a combination of enzyme inhibitors, Angiotensin II or Aliskiren receptor blockers.

If the double inhibited therapy is considered absolutely necessary, this should only occur under the supervision of the expert and suffer the regular monitoring regularly about kidney function, electrolyte and blood pressure. Should not be used simultaneously inhibitors of enzyme and Angiotensin II receptor blockers in patients with diabetes kidney disease.

The effect of the drug on the ability to drive and operate machinery

There is no data that shows Cozaar affecting the ability to drive and operate machinery.

Use drugs for women during pregnancy and lactation

used during pregnancy

Medicines directly acting on the Renin-Anotensin system can cause damage and developing pregnancy. When detected pregnancy, must stop cozaar as soon as possible.

Although there is no experience in the use of cozaar for pregnant women, studies with Losartan Kali have shown damage in the fetus, babies, and death, the mechanism of this effect is thought to be due to the intermediate pharmacological properties acting on the renin-anidensin system.

In humans, the fetal kidney perfusion depends on the development of the renin-ankiotensin system, starting in the middle of the middle of pregnancy, so the risk of the fetus increases if used in COZAAR in the middle of the middle or the last three months of pregnancy.

Babies can occur in infants, including reducing skull production, anuria, hypotension, renal failure and death. When detected pregnancy, must stop cozaar as soon as possible.

These harmful results are often associated with the use of these drugs in the middle and the last three months of pregnancy. Most epidemiological studies survey abnormalities in fetuses after exposure to anti-hypertension drugs used in the first three months of pregnancy, regardless of drugs that affect the renin-angiotensin system with other anti-hypertension drugs. The appropriate management of hypertension in the mother during pregnancy is important to optimize the results for both mother and pregnancy.

In special cases, when there is no appropriate replacement treatment for drug treatments that affect the renin-ankiotensin system for a separate patient, to tell the mother about the risk that may occur for the fetus, it is necessary to perform a massive ultrasound test to assess the environment in the amniotic fluid. Stop using cozaar if observed the lack of amniotic fluid unless this drug is considered a medicine to save life for the mother. Pregnancy tests may be appropriate, based on the week of gestational age. However, doctors and patients should know that the lack of amniotic fluid may not manifest until the pregnancy has been injured for a long time, it is necessary to closely monitor babies with a history of cozaar exposure in the uterus on manifestations of hypotension, urinary and hyperiemia.

breastfeeding women

It is unclear whether Losartan will be secreted into the mother's milk. Because many drugs are secreted into the mother's milk and due to the potential for adultery effects, they should decide or stop the drug or stop breastfeeding, consider the importance of the drug for the mother.

Drug interaction

through clinical pharmacokinetics tests, no clinical drug interactions between losartan and the following drugs: hydrochlorothiazide, digoxin, warfarin, cimetidine, phenobarbital, ketoconazole and erythromycin. There was a report that rifampin and fluconazole reduce the content of metabolites. The clinical significance of these interactions has not been evaluated. Like other drugs in the Angiotensin II blocker group or inhibiting the effects of angiotensin II, if used with potassium diuretics (such as spironolactone, triamterene, amiloride), potassium supplements or salt -containing salt substitutes, it can lead to hyperpassia in serum.

As well as other drugs that affect sodium elimination, lithium elimination may be reduced. Therefore, it is necessary to carefully monitor serum lithium concentration if used simultaneously containing lithium salt with Angiotensin II receptor antagonists.

NSAID anti-inflammatory drugs (NSAIDs) include cyclooxygenase-2 (COX-2) antagonists that can reduce the effects of diuretics and other hypertension drugs. Therefore, the lowering effects of Angiotensin II receptor antagonists or enzyme inhibitors may be reduced by NSAIDs including COX-2-selected antagonists.

In some patients with kidney function damage (for example, the elderly, or patients with a decrease in the volume of circulatory, including those who are taking diuretics) are being treated with nonsteroidal anti-inflammatory drugs, including COX-2 selective counterparts, simultaneous use of angiotensin II receptor anti-receptor drugs can increase impaired renal impairment. These effects are often recovered. Therefore, be careful when using combined drugs in patients with damaged kidney function.

The literature has been recorded in patients who have atherosclerosis, heart failure, or diabetes with the target organs, the double-glocated drugs that the renin-angiotensin-aldosterone system comes with a higher frequency of lowering blood pressure, fainting, hyperkalemia and changes in renal function (including acute renal failure) compared to the use of the lenin-angiotensin-aldosterone system. Double blockade (for example: ACE supplementation with an angiotensin II receptor inhibitor) should be used for limited cases that need to closely monitor kidney function.

Storage

Leave a cool place, avoid light, temperatures below 30⁰C.

To be out of reach of children, read the instructions carefully before use.

Other drugs

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