Nerazzu 50 Davipharm treat hypertension (3 blisters x 10 tablets)

Dosage form Box of 3 blisters x 10 tablets
Specifications Losartan

Ingredient

Composition information	Content
Losartan	50mg

Uses

indications

NERAZZU 50 drugs are indicated in the following cases:

Treatment of idiopathic hypertension in adults, children from 6 to 18 years old.

Treatment of kidney disease in patients with hypertension type 2 diabetes with proteinuria> 0.5 g/ 24 hours.

Treatment of chronic heart failure in patients is not suitable for treatment with angiotensin transferring enzyme inhibitors (ACE), especially coughing, contraindications. Patients with heart failure have been treated stably with ACE inhibitors should not switch to Losartan. Patients should have left ventricular blood emulses ≤ 40%, stable clinical condition and need to follow a treatment regimen that has been established for chronic heart failure.

Reducing the risk of stroke in hypertension patients with left ventricular hypertrophy proved on ECG.

Pharmacokology

Pharmacological group: AT, Angiotensin II receptor antagonist. ATC code: C09CA01.

Losartan is the first substance of the new anti -hypertension drug group, which is a receptor antagonist (Typ,) Angiotensin II. Angiotensin II, made up of angiotensin I in the reaction due to enzymes that switch angiotensin (ACE), is a strong vascular contract; It is the main hormone that activates the Renin-Anotensin system, and 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 clogging and aldosteron secretion of angiotensin II by preventing Angiotensin II selectively, not attached to AT receptors, found in many tissues (for example, blood vessel muscles, adrenal glands). In many tissues, there is also a AT receptor, but it is unclear whether this receptor is related to the cardiovascular air conditioner. Both Losartan and the main active metabolites do not show the local dominant effect in the AT receptor, and have the affinity for the AT receptor, much larger (about 1,000 times) than the AT2 receptor. Losartan is a competitive, reversible inhibitor of the AT receptor. The metabolic substance has the activity of the drug 10 to 40 times stronger than Losartan, calculated by weight and is a non -competitive, reversible inhibitor of the AT receptor. Angiotensin II antagonists also have hemodynamic effects such as ACE inhibitors.

Dynamic pharmacokinetics

absorption

After drinking, Losartan is well absorbed and the first metabolism forms a carboxylic acid metabolism and other non -activity metabolites. The bioavailability of Losartan tablets is about 33%. The peak concentration of Losartan and the active metabolites achieved after 1 hour and 3-4 hours respectively.

distribution

Both Losartan and its active metabolites are associated with plasma proteins ≥ 99%, mainly albumin. Losartan's distribution volume is 34 liters.

transformation

About 14% of the intravenous or oral dose of Losartan is converted into active metabolites. After taking or intravenously Losartan Kali is marked by 14C, the radioactive level in plasma is mainly caused by Losartan and its active metabolites. The minimum metabolism of Losartan into its active metabolic substance has been seen in about one percent of the researcher.

In addition, Losartan is converted into non -active metabolites.

Elimination

Losartan clearance and its active metabolites are 600 ml/min and 50 ml/min. The kidney clearance of Losartan and the metabolites of Losartan and the metabolites are active of 74 ml/ min and 26 ml/ min. After taking Losartan, about 4% of the dose is excreted in the urine in the form of unchanged, about 6% of the dose is excreted in the form of active metabolites. The pharmacokinetics of Losartan and metabolites have linear activity with the oral Losartan dose of oral to 200 mg.

After drinking, Losartan's plasma concentrations and its active metabolites decrease with the exponent function, the sale time is about 2 hours and 6 - 9 hours. With a dose of 100 mg x 1 time/ day, both Losartan and metabolites have negligible accumulation in plasma.

Losartan and its metabolites are excreted through bile and urinary tract. After oral or intravenous losartan is marked by 14C in men, about 35%/ 43% of radioactive intensity are found in urine and 58%/ 50% in feces.

Special subjects

In elderly patients with hypertension, Losartan's plasma concentrations and metabolites are basically not different from young people.

In patients with hypertension women, Losartan's plasma concentrations are twice as high as in male patients with hypertension, while the concentration of plasma metabolites is no different from men and women.

In patients with mild to medium alcoholic cirrhosis, Losartan's plasma concentrations and active metabolites after drinking increased by 5 and 1.7 times compared to healthy volunteers.

Losartan concentration in plasma does not change in patients with creatinine clearance above 10 ml/min. In patients with hemorrhage, Losartan's AUC increased by 2 times compared to patients with normal renal function.

The plasma concentration of metabolites is active in patients with kidney failure and patients must be clinical.

Losartan and metabolites have the same type of stubborn properties that remove by blood separation.

Children's Humanity

Losartan pharmacokinetics have been studied over 50 children from> 1 month old to

The results show that Losartan turns into active metabolites in all age groups. The results also show that Losartan's dynamic parameters used oral almost similarly in infants, newborn children, kindergarten children, children in school age and teenagers. The pharmacokinetics parameters of metabolites vary at greater levels between age groups. When comparing children in kindergarten age with teenagers, these differences have statistical significance. The exposure in newborns and newborn children is relatively high.

Before taking Nerazzu 50 Davipharm treat hypertension (3 blisters x 10 tablets)

How to use

oral medication, should take whole tablets with 1 cup of water.

Nerazzu 50 can be used or not accompanied by food.

Dosage

Treatment of hypertension in adults:

The starting and maintenance dose is 50 mg x 1 time/day in most patients. The maximum treatment effect is achieved after 3-6 weeks of treatment. In some patients may increase the dose to 100 mg daily (in the morning).

Losartan can be used with some other hypertension medications, especially diuretics (such as hydrochlorothiazid).

Patients with hypertension with type 2 diabetes with proteinuria> 0.5 g/day.

The starting dose is usually 50 mg x 1 time/day. The dose may increase to 100 mg/day based on blood pressure achieved after 1 month of treatment. Losartan can be used simultaneously with other medications for hypertension (such as diuretics, calcium channel blockers, alpha or beta blockers, central nervous effects) as well as insulin and other hypoglycemia (such as sulfonylure, glitazon and glucosidase inhibitors).

heart failure

The usual starting dose of Losartan is 12.5 mg x 1 time/day. The dose should be adjusted weekly (for example, 12.5 mg/day, 25 mg/day, 50 mg/day, 100 mg/day and a maximum of 150 mg/day) due to tolerance in patients.

Reducing the risk of stroke in hypertension patients with left ventricular hypertrophy proved on ECG.

The usual starting dose of Losartan is 50 mg x 1 time/day. Low -dose hydrochlorothiazid should be added and/or increase the dose of Losartan to 100 mg x 1 time/day depending on the patient's blood pressure.

Special subjects

Patients with intravascular fluid loss

In patients with a decrease in internal fluid volume (for example, being treated with high dosage diuretics), the starting dose may consider 25 mg x 1 time/day.

Patients with kidney failure and patients with hemorrhage

No need to adjust the dose in patients with renal impairment and patients with hemorrhage.

Patients with liver failure

Consider reducing the dose in patients with a history of liver failure. There is no treatment experience in patients with severe liver failure. That, contraindicated use of losartan in patients with severe liver failure.

Children (6 months old to

Safety and efficiency for children from 6 months to 6 years of age has not been established.

Currently, there is no recommended dose for this age group.

Children (6 years old to 18 years old)

For patients who can swallow the tablet, the recommended dose is 25 mg x 1 time/day for patients with a weight of 20-50 kg (in the exception, the dose may increase to a maximum of 50 mg x 1 time/day). The dose should be adjusted based on blood pressure.

In patients> 50 kg, the usual dose is 50 mg x 1 time/day. In the exception, the dose may increase to a maximum of 100 mg x 1 time/day. The dose of over 1.4 mg/kg/day (or exceeding 100 mg/day) has not been studied in children.

It is not recommended to use Losartan for children under 6 years old because there is little information for this age group.

It is not recommended to use Losartan for children with glomerular filtration

Elderly

Should consider using the starting dose 25 mg 1 time/day in patients over 75 years old, but often do not need to adjust the dose in the elderly.

Losartan is also not recommended for children with liver failure.

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 expression of overdose is probably hypotension and tachycardia; It is also possible to experience a slow heartbeat due to sympathetic stimulation (vagus nerve). If symptoms of hypotension occur, supportive treatment. Both Losartan and metabolites are active, they cannot be removed by hemolysis.

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

What to do when you forget 1 dose? However, if the time to relax with the next dose is too short, skip the dose and continue the calendar of the drug. Do not use double doses to compensate for missed dose.

Side Effects

When using Nerazzu 50 you may experience unwanted effects (ADR):

Most of the undesirable effects are light and lost over time.

Common, ADR ≥ 1/100

Hematology: Anemia Blood.

Neurological: Sleep disorders, headaches, dreaming, drowsiness. Tired.

Rare, 1/10 000 ≤ ADR

immunity: allergic reactions, hypersensitivity, angiography and vascular inflammation.

Hematology: thrombocytopenia, anemia.

Mental: depression. Pepper pattern, back pain kidney. Changes in kidney function can be reversed when stopped treatment.

Children

Unwanted effects are recorded in children similar to adult patients. Data on children is still limited.

Instructions on how to handle ADR:

Notify the physician with unwanted effects when using the drug.

Warnings

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

contraindicated

NERAZZU 50 drug contraindicated in the following cases:

Patients with Losartan Kali or any ingredient of the drug.

Be cautious when using

need to be very careful when taking the drug for patients in the following cases:

Hypersensitivity:

Need to monitor carefully in patients with a history of veins (face, lips, throat, and/or tongue).

Reducing blood pressure and imbalance of water/electrolytes:

Symptoms of blood pressure lower, especially after taking the first dose or after increasing the dose, may occur in patients with reduced fluid volume and/or sodium due to strong diuretics, a diet of low salt, diarrhea or vomiting. The above conditions should be overcome before starting treatment with Losartan or should use a lower starting dose.

This also applies to children from 6 to 18 years old.

Electrolyte imbalance:

Electrolyte imbalance is usually common in patients with attached kidney failure/without diabetes. In a clinical study conducted in patients with type 2 diabetes with kidney disease, the incidence of hyperkalemia is higher than the losartan group than the placebo group. Therefore, closely monitor potassium concentration in plasma as well as creatinine clearance, especially in patients with heart failure and patients with creatinine clearance in about 30-50 ml/min.

It is not recommended to simultaneously use potassium diuretics, potassium supplements and salt containing potassium along with losartan.

Hepatic failure:

Based on dynamic pharmacokinetics, the Losartan concentration in plasma increases significantly in cirrhosis patients, so it is necessary to consider lower doses for patients with a history of liver failure. There is no experience in treatment with Losartan in patients with severe liver failure. Therefore, contraindicated use of Losartan in patients with severe liver failure.

Do not recommend using Losartan for children with liver failure.

kidney failure:

The consequences of inhibition of the renin-anidensin system causing renal function change have been reported (especially in patients with renal function depending on the renin-angiotensin-krosteron system as patients with severe heart failure or a history of kidney dysfunction). Like other drugs that affect the renin-ankiotensin-aldosteron system, hyperurine and serum creatinine have been recorded in people with kidney artery stenosis on both sides or one side, only one kidney.

Renal function changes may be reversed when discontinued. Losartan should be used carefully in patients with kidney stenosis on both sides or one side, only one kidney.

Used in children with kidney failure:

It is not recommended to use in children with GFR

Need to monitor kidney function regularly when treating with Losartan due to decline. Especially when using Losartan in a state of renal failure (fever, dehydration).

Sharing losartan and enzyme inhibitors Angiotensin transferred to impaired kidney function. Do not recommend shared.

Patients with kidney transplantation:

No experience used in new kidney transplant patients.

primary Aldosterol:

Patients with primary Aldosterol strength not respond to anti-blood pressure drugs inhibiting the renin-anidensin system. Therefore, it is not recommended to use.

coronary artery disease and cerebrovascular disease:

Similar to other antihypertensive drugs, excessive reducing blood pressure in patients with blood vessel ischemia in the heart or cerebral vessels can cause myocardial infarction or stroke.

heart failure:

Similar to drugs that act on the renin-angiotensin system, in patients with heart failure, with or without renal failure, there is a risk of serious arterial hypotension, and kidney failure (usually acute).

There is no clinical experience using Losartan in patients with heart failure along with severe renal failure, in patients with severe heart failure (NYHA level IV) as well as patients with heart failure and arrhythmia that are symptomatic life. Hence use caution on the above objects. Be cautious when sharing Losartan with beta blockers.

Aortic stenosis and mitral valve, hypertrophic myocardial disease:

Similar to other vasodilators, especially cautious when used for patients with aortic stenosis or mitral valve, or hypertrophic cardiomyopathy.

Other caution:

Losartan, other Angiotensin antagonists and ACE inhibitors effectively reduce blood pressure in black people, may be due to lower renoces that are more common in black blood pressure.

Double inhibition of the renin-ankiotensin-aldosteron (RAAS):

Dual inhibitor Renin-Anotensin-Aldosteron (RAAS) by combining angiotensin transfer enzyme inhibitors, Angiotensin or Aliskiren receptor inhibitors may increase the risk of unwanted effects such as reducing blood pressure, hyperboly and impaired renal function (including kidney failure). Do not recommend the use of ACE inhibitors, Angiotensin or Aliskiren receptors.

Warning related to excipients:

Nerazzu 50 contains lactose, patients with galactose tolerance disorders, lagl lactase deficiency or glucose-galactose absorption disorders should not be used.

The effect of drugs on driving and operating machinery

There has been no research on the effect of the drug on the ability to drive and operate machinery. However, medications for hypertension can cause hypotension, dizziness, and drowsiness. Should be cautious when driving or operating machinery.

Use drugs for women during pregnancy and lactation

Pregnancy

It is not recommended to use Losartan in the first 3 months of pregnancy. Contraindications to use Losartan in the middle and late pregnancy.

Epidemiological evidence about the risk of teratogenicity after exposure to ACE inhibitors in the first 3 months of pregnancy has not been concluded. However, it is not possible to be eliminated to increase risks. Although there is no epidemiological data that controls the risk of Angiotensin II receptor inhibitors (AIIRI), these drug groups may have similar risks. Unless the continuation of Allra therapy is considered necessary, patients who have a plan to become pregnant should change to other hypertension therapy have been proven to be safe during pregnancy. When detecting pregnancy, the treatment with Losartan should be stopped immediately and started the replacement therapy if necessary.

Exposure to AIIRA substances in the middle 3 months and the end of pregnancy can cause fetal poisoning (impaired renal function, causing less amniotic fluid, slow bone formation) and toxicity for babies (kidney failure, hypotension, hyperkalemia).

If exposed to Losartan occurs in 3 months between pregnancy, it is recommended to check for kidney and skull function.

Newborns are exposed to Losartan during pregnancy should be closely monitored because of the risk of hypotension.

Breastfeeding period

Because there is no information on the use of Losartan during breastfeeding, it is not recommended to use Losartan and alternative therapies that have been proven to be safe during breastfeeding, so it is applied, especially for newborns and children with shortage.

Interaction

Losartan's hypotension effects: other drugs that cause hypotension, drugs that can cause unwanted effects of lowering blood pressure (such as three -ring antidepressants, anti -psychotic drugs, Baclofen and amifostin).

Losartan is metabolized mainly by CYP2C9 into metabolites with carboxylic acid activity. Fluconazole (CYP2C9 inhibitor) reduces the exposure of metabolites with activity of Losartan nearly 50%. Rifampicin (CYP2C9 induction) reduced 40% of plasma concentrations of active metabolites. Clinically unknown influence. Losartan exposure does not change when used with fluvastatin (weak inhibitor CYP2C9).

Hyperbonemia when used simultaneously with potassium drugs (potassium diuretics:

Amilorid, Triamteren, Spironolacton), or can cause potassium (such as heparin), potassium supplements, alternative salt containing potassium.

Serum concentration and toxicity of lithium increases when used simultaneously with ACE inhibitors. Very rare cases are reported to Angiotensin II receptor antagonists. Be careful when using Losartan simultaneously with lithium. If the combination is necessary, lithium concentration is needed in the serum during treatment.

Anti-inflammatory and pain relievers (NSAID) especially COX-2 used in combination with Losartan can cause kidney failure, so kidney function should be monitored.

Losartan increases the effect of drugs: amifostin, hypotension drugs, carvedilol, hypoglycemic drugs, lithium, diuretics holding potassium, rituximab.

rifampicin, aminoglutethimide, carbamazepin, nafcilin, nevirapin, phenytoin, reducing losartan concentration and metabolites in plasma when used simultaneously.

Take Losartan along with cimetidine increases the area under the concentration curve over time (AUC) of Losartan by about 18%, but does not affect the pharmacokinetics of the active metabolites of Losartan.

Oral iosartan along with phenobarbital reduces about 20% of Losartan's AUC and of active metabolites.

There is no pharmacokinetic interaction between losartan and hydrochlorothiazide.

Losartan does not affect the pharmacokinetics of oral or intravenous digoxin.

Dual inhibitor Renin-Anotensin-Aldosteron (RAAS) by combining angiotensin transfer enzyme inhibitors, Angiotensin or Aliskiren receptor inhibitors may increase the risk of unwanted effects such as reducing blood pressure, increased blood potassium and impaired renal function (including kidney failure) than using only one effect on RAAS.

Storage

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

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

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