Bonsartine 25 Tablet Square treatment for hypertension, diabetes (5 blisters x 10 tablets)

Dosage form Box of 5 blisters x 10 tablets
Specifications Losartan
Ingredient High blood pressure

Ingredient

Composition information	Content
Losartan	25mg

Uses

indications

25 -tablet bonsartine drugs are indicated in the following cases:

Hypertension.

Reduce the risk of cardiovascular disease and cardiovascular death for patients with hypertension with left ventricular hypertrophy.

Reduce the risk of cardiovascular disease and death by combined events such as cardiovascular death, stroke, myocardial infarction in patients with hypertension with left ventricular hypertrophy.

Renal protection for people with type 2 diabetes with proteinuria: slow down the process of progression of kidney disease, determined by a decrease in the incidence of coordination doubled blood content, the end stage of kidney disease (dialysis dialysis or kidney transplantation), or death and reduce proteinuria. Anti -hypertension, which is an Angiotensin II receptor antagonist. Angiotesin II, made up of angiotensin I in the enzyme reaction, switch Angiotensin (ACE) catalyst, is a strong vasoconstriction, which is an important component in the pathophysiology of hypertension.

angiotensin II also stimulates the adrenal glands of aldosteron. Losartan and the main metabolites have a clogged and aldosteron secretion of angiotensin II by preventing the Angiotensin II filtering HCON, not attaching to the AT1 receptor in many tissues. Losartan is a competitive, reversible inhibitor of the AT1 receptor. The metabolites have the activity of drugs 10 to 40 times stronger than Losartan.

Dynamic pharmacokinetics

Losartan is easily absorbed through the gastrointestinal tract when taken but significantly metabolized through the liver for the first time, leading to the bioavailability of the whole body is only about 33%. The drug is metabolized into metabolites that have the activity of carboxylic acid derivative E - 3174 (exp - 3174), which has a stronger pharmacological activity than Losartan; Some non -active metabolites are also formed.

The metabolism is mainly due to the isoenzyme of Cytochrome P450 is CYP2C9 and CYP3A4. After a dose of oral, the peak concentration of Losartan's plasma is reached within 1 hour and E - 3174 is reached in the range of 3-4 hours.

Both Losartan and E - 3174 are more than 98%of plasma proteins. Losartan is excreted in urine and in the stool through the bile duct in a constant form and the form of metabolites. After drinking, about 4% of the dose is excreted in the form of constant and about 6% excreted in the form of metabolites that are active in urine. Losartan's final waste time is about 1.5 - 2.5 hours and of E - 3174 is about 3 - 9 hours.

Before taking Bonsartine 25 Tablet Square treatment for hypertension, diabetes (5 blisters x 10 tablets)

How to use

oral medication.

Can drink Losartan Potassium alone or with food.

Dosage

Hypertension

Initial and maintained dose for most patients is 50 mg, taken once a day. The maximum effect of treating hypertension reaches 3-6 weeks after starting the medication. Increasing the dose to 100 mg, taken once a day may be useful for some patients. For patients who reduce the volume of intravascular fluid (for example, high -dose dosage treatments), should consider the starting dose of 25 mg, taken once a day.

No need to adjust the starting dose for elderly patients or kidney failure even if the person is dialysis.

It is necessary to consider lower doses for patients with a history of liver failure.

Reducing the risk of cardiovascular disease and cardiovascular death for people with hypertension with left ventricular hypertrophy

Normally, the starting dose is 50 mg of Losartan potassium, taken once a day. Low -dose Hydrochlorothiazide can be added and/or increase the dose of Losartan Kali to 100 mg daily, drink once a day depending on the response on blood pressure.

Renal protection for people with type 2 diabetes with proteinuria

Normally, the starting dose is 50 mg of Losartan potassium, taken once a day. Losartan kali dose can be increased to 100 mg, taken once a day depending on the response on blood pressure. Losartan potassium can be used with other blood pressure medications (for example: diuretics, calcium channel blockers, alpha or beta blockers, and central impact drugs) as well as insulin and other common blood gurges (such as sulfonylreas, glitazones and glucosidase inhibitors).

Note: The above dose is for reference only. Specific dosage depends on the condition and level of progression of the disease. For a suitable dose, you need to consult a doctor or medical specialist.What do

do when using overdose? The most common manifestation of overdose is hypotension and tachycardia; Slow heart rate can also occur due to sympathetic nerve stimulation (vagus nerves).

If symptomic hypotension occurs, supportive treatments should be taken. Can not remove Losartan or metabolites that are active by hemolysis.

In an emergency, call the 115 emergency center immediately or go to the nearest local health station.

What to do when you forget a dose? However, if close to the next dose, skip the forgotten dose and take the next dose at the time as planned. Note that it should not be used double the prescribed dose.

Side Effects

When using 25 tablet bonsartine drugs, you may experience unwanted effects (ADR).

In clinical trials on hypertension with control, in general, Losartan potassium tolerates well. Adultery effects are usually light and transient, without stopping the drug. The entire ratio of the adverse effects of Losartan Kali is nearly the ratio of the placebo.

In clinical trials with controlled hypertension, in the number of patients treated with Losartan Kali, dizziness is the only adverse effect related to drugs in groups with a higher ratio of placebo on a percent. In addition, the effects of the standing potential related to the dose are only below one percent of the patient.

Rarely erythematosus, however, the rate of controlled clinical trials is lower than in placebo. In double blind clinical trials with controlled hypertension, the following adverse effects are reported to Losartan Kali, which occurs at ≥ 1% of the patient, regardless of the drug.

In control clinical trials on patients with hypertension with left ventricular hypertrophy, in general, Losartan Kali tolerates well. The most common adultery effects are dizzy, depression/fatigue and dizziness.

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

In a controlled clinical study on patients with type 2 diabetes with proteinuria, in general, Losartan Kali tolerates well. The adverse effects related to drugs are often weak/tired, dizzy, hypotension and hyperkalemia.

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

Hypersensitivity: Anaphylaxis reactions, angels, including larynx edema and airway congestion and/or facial edema, lips, throat and/or tongue have been reported in some rare patients treated with Losartan, some of these patients who had previously had angels with other drugs including ACE inhibitors. Vascular inflammation, including the Schoenlein - Henoch, has been reported, although rare.

digestive: Hepatitis (rare), abnormal liver function.

Hematology: Anemia.

Muscle muscles: Đau Mechanical.

Nervous/mental system: The first half.

Respiratory: Cough.

skin: urticaria, itching.

Subclinical tests

In clinical trials with controlled hypertension, changes that are important clinical significance of testing parameters rarely related to the use of Losartan Kali. In clinical trials on hypertension, hyperkalemia (serum potassium> 5.5 Meq/l) is seen at 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 Losartan potassium and 3.4% of the patient was placebo.

Instructions on how to handle ADR

When experiencing side effects of the drug, it is necessary to stop using and notify the doctor or go to the nearest medical facility for timely treatment.

Warnings

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

contraindicated

25 -tablet bonsartine drugs in the following cases:

Hypersensitivity to any ingredients of the drug.

Be cautious when using

sensitive

Thich vascular.

Hypotension and imbalance of fluid/electrolytes

In patients with a decreased volume of intravascular fluid (for example, high -dose diuretic treatments) may occur symptomatic hypotension. These conditions must be adjusted before using Losartan potassium, or the starting dose must be lower.

The electrolyte imbalance is often subject to diabetes or not, and this is a matter of diabetes. In a clinical study conducted in type 2 diabetes, proteinuria, hyperkalemia rate in the Losartan treatment group higher than the control group; However, only few patients have to stop treating due to hyperkalemia.

Liver function

Based on dynamic pharmacokinetic data, the Losartan concentration in plasma increases in patients with cirrhosis, which should be considered lower doses for patients with a history of liver failure.

Renal function

Due to the inhibition of the Renin - Angiotensin system, there have been reports on renal function changes, including kidney failure in sensitive people, these kidney function changes can recover when stopping the drug. The drugs that act on the Renin - Angiotensin system can cause hyper urea and serum creatinine in patients with kidney stenosis on both sides or kidney stenosis in humans with a single kidney. There has been a report on this effect in patients using Losartan Kali, these kidney function changes can recover when stopping the drug.

used in pediatrics

has not determined the safety and effectiveness of the drug for children.

used in geriatrics

In clinical studies, there is no difference in effectiveness and safety of Losartan related to age.

Race

Based on the study to evaluate the effect of reducing the event when intervention with Losartan for people with hypertension (Losartan Intervention for Endpoint Reduction in Hypertension (Life), Conclusion on the benefits reducing the incidence of cardiovascular disease in patients with Losartan Kali compared to the atenolol group that does not apply for hypertension with black skin hypertrophy Pressure on both groups of black skin patients are the same.

For the entire population of the Life study (n = 9193), Losartan Kali reduces 13.0% of the risk (P = 0.021) compared to the use of Atenolol for the combined results of cardiovascular death, stroke and myocardial infarction. In this study, Losartan Kali reduced the risk of cardiovascular disease and cardiovascular death compared to the use of Atenolol for patients who are not in the black racial group, suffer from hypertension with left ventricular hypertrophy (n = 8660), which is assessed by the results of the main events of cardiovascular death, stroke, myocardial infarction (P = 0.003).

However, in this study, black skin patients treated with Atenolol are less likely to experience events that coordinate more than a group of black skin patients using Losartan Kali (P = 0.03). In the division of black skin patients (n = 533, accounting for 6%of the patient in Life research), there were 29 cases of 263 patients using Atenolol encountering this group of incidents (11%; 25.9 for each patient/year) and 46 cases among 270 patients using Losartan Kali (17%; 41.8 for each patient/year).

The ability to drive and operate machinery

There has been no research on reactions on the ability to drive and operate machinery. However, when driving or operating machinery must pay attention to dizziness and drowsiness can sometimes occur during hypertension treatment, especially when starting treatment or when increasing the dose.

Pregnancy

When used in the second and third quarters of pregnancy, drugs that work directly on the Renin - Angiotensin system can cause damage, even death for the developing fetus. When detecting pregnancy, it is necessary to stop Losartan potassium as soon as possible.

Despite the experience of using Losartan Kali in pregnant women, animal studies with Losartan Kali have shown damage and death for the fetus and neonatal, the mechanism considered to be due to the impact of the drug through the effect on the Renin - Angiotensin system.

In humans, the excretion of the fetal kidney depends on the development of the Renin - Angiotensin system, starting from the second quarter of pregnancy; Therefore, the risk for pregnancy increases, if the mother drinks Losartan Kali in the second and third quarters of pregnancy.

The period of breastfeeding

It is unknown whether Losartan is excreted through breast milk, but because many drugs are excreted through human milk and due to the ability to be harmful to breastfed babies, it is necessary to decide whether to stop breastfeeding or stopping the drug, depending on the importance of the drug for the mother.

Drug interaction

Through clinical pharmacokinetics tests, there has been no clinical interactions between losartan and the following drugs: hydrochlorothiazide, digoxin, warfarin, cimetidine, phenobarbital, ketoconazole and erythromycin. It has reported that Rifampin and Fluconazole reduce the content of metabolites that are active. The clinical significance of these interactions has not been fully assessed.

As well as other drugs belonging to the Angiotensin II blockers or similar effects, if used with potassium diuretics (such as Spironolacton, Triamterene, Amiloride), Potassium Supplements, Salt Supplies containing potassium, can lead to hyperpass in serum. Like other hypertension medications, the effect of reducing blood pressure may be reduced when using indomethacin, an non -steroid anti -inflammatory drug.

Storage

Store in closed packaging, dry place, avoid light. The temperature does not exceed 30 ° C.

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