Bivitanpo 100 BV treats mild and medium -sized hypertension (3 blisters x 10 tablets)

Dosage form Box of 3 blisters x 10 tablets
Specifications Losartan Kali
Ingredient High blood pressure

Ingredient

Composition information	Content
Losartan Kali	100mg

Uses

Indications

Treatment of idiopathic hypertension in adults and children and adolescents aged 6-18.

Treatment of kidney disease in adults with hypertension and type II diabetes with proteinuria ≥ 0.5 g/day as part of anti -hypertension therapy.

Treatment of chronic heart failure in adults without tolerating angiotensin (ACE) transferring enzyme inhibitors, especially cough, or contraindicated. Patients with heart failure have been treated stably with enzyme inhibitors that should not be switched to Losartan. Patients must have left ventricular blood ratio

Reduce the risk of stroke in adults hypertension with left ventricular hypertrophy is recorded by electrocardiogram.

Pharmacokology

Code ATC: C09C A01.

Medication group: Angiotensin II receptor antagonistic drugs.

Losartan is an Angiotensin II receptor antagonist (AT1 type) synthesized orally. Angiotensin II, a strong vascular contract, is a main hormone of the Renin/ Angiotensin system and is an important decisive factor of hypertension physiology. Angiotensin II associated with AT1 receptors in many types of tissues (such as blood vessel muscles, adrenal glands, kidneys and hearts) and creates a number of important biological effects, including vascular contraction and release of Aldosteron. Angiotensin II also stimulates smooth muscle cell proliferation.

Losartan selectively inhibits AT1 receptors. On Vitro and In Vivo Losartan and carboxylic acid metabolites have E-3174 activity inhibits all the related physiological effects of Angiotensin II, regardless of the source or synthetic sugar. Losartan does not have the effect of transport nor inhibit other hormone receptors or important ion channels in other cardiovascular regulation. Moreover, Losartan does not inhibit ACE (Kininase II), enzymes that decompose Bradykinin. Therefore, there is no potential to cause intermediaries of Bradykinin.

During the use of Losartan, the elimination of negative reactions of angiotensin II on renin secretion leads to an increase in the activity of plasma renin, this incident leads to an increase in angiotensin II level in plasma. Despite this increase, hypotension and inhibition of plasma Aldosteron levels are still maintained, showing the effect of Angiotensin II receptor inhibitors. After stopping the use of losartan, plasma renin activity and angiotensin II level decrease to the original level within three days.

Both Losartan and its main metabolites have high affinity with AT1 receptors than AT2 receptors. The metabolic substance is active 10 to 40 times stronger than Losartan calculated by weight.

In control clinical trials, using Losartan once a day for patients with immoral hypertension from mild to medium shows significant decrease in systolic and diastolic blood pressure. Measurement of blood pressure 24 hours after taking the drug is equivalent to 5-6 hours after using the drug, showing a decrease in blood pressure for 24 hours; And restore the natural span daily. The decrease in blood pressure at the end of the drug time is 70-80% of the effect obtained after 5-6 hours of medication.

Discontinuing Losartan in patients with hypertension does not lead to sudden hypertension. Despite the significant drop in blood pressure, Losartan does not significantly affect the clinical heart rate. Losartan is equally effective in men and women, and in young people (under 65 years old) as well as the elderly with hypertension.

Pharmacokinetics

absorption

Losartan is well absorbed after drinking, and initially metabolizes through the liver to form a carboxylic acid metabolism. Biological bioavailability is 33%.

The average peak concentration of Losartan is reached within 1 hour and of metabolites with activity within 3-4 hours.

Distribution

Both Losartan and active metabolites have a lot of cohesion (≥ 99%) with plasma proteins, mainly albumin. Losartan's distribution volume is about 34 liters.

Metabolism

About 14% of intravenous dose or losartan oral dose is converted into active metabolites, in addition, there are also inactive metabolites formed.

Elimination

Losartan's plasma clearance is about 600 ml/ minute and the metabolites are active of 50 ml/ minute; Their clearance in the kidney is about 74 ml/ min and 24 ml/ min. After taking Losartan about 4% of the dose is excreted in urine in the form of constant and about 6% in the form of active metabolites.

The pharmacokinetics of Losartan Kali and its metabolites are linearly within the dose of up to 200 mg.

After taking the drug, the plasma concentration of Losartan and the metabolites have a very fast decrease in activity, with time

Semi-waste is about 2 hours and 6-9 hours respectively. When using a single dose of 100 mg per day, both losartan or metabolites of

It does not accumulate significantly in plasma.

Losartan and its metabolites are excreted through both molasses and urine. After the dose of oral or intravenous losartan marks 14C in humans, about 35%/43% of radioactive material is found in urine and 58%/50% in feces.

Special subjects

Elderly: Losartan concentration and active metabolites in plasma in the elderly have not changed compared to young people.

In women: Losartan levels in plasma in women are twice as higher in men while the concentration of active metabolites does not change.

People with hepatic failure: In patients with mild to medium cirrhosis due to alcohol. Losartan's plasma concentrations and metabolites are active, respectively 5 and 1.7 times higher in male volunteers.

Renal failure: Losartan concentration in plasma does not change in people with creatinine clearance above 10ml/ min. Compared to normal people, the area under the curve (AUC) of Losartan is 2 times higher in the blood separator. While the blood concentration of the active metabolites does not change. Losartan and active metabolites are not excluded by blood separation.

Children: Losartan's pharmacokinetics have been studied in 50 hypertension children from over 1 month of age to under 16 years of age after taking a dose of Losartan every day from 0.54 to 0.77mg/ kg (average dose).

The results show that the active metabolites formed from Losartan in all age groups. Mobile pharmacokinetic parameters are close to the same in newborns and newborn children, preschool children, school age children and teenagers. The pharmacokinetic parameters of metabolites are different from a greater level between age groups. When comparing kindergarten children with teenagers, these differences are statistically significant. The exposure to drugs in newborns/ newborn children is relatively high.

Before taking Bivitanpo 100 BV treats mild and medium -sized hypertension (3 blisters x 10 tablets)

How to use

oral medication, swallowing pills with 1 glass of water, together or not with food.

Note: In case of a 25 mg dose, you should choose the same type of product with a content of 25 mg or 50 mg to divide the dose. The dose of 50 mg is required to use 50 mg or 2 types of 100 mg.

Dosage

Hypertension

The starting and maintenance dose is usually 50 mg, once a day. The maximum hypotension is achieved from 3-6 weeks after the beginning of treatment. Increasing the dose up to 100 mg once a day (in the morning) can be more effective in some patients. Urinaryants/day

The normal starting dose is 50 mg, once a day. Other common blood sugar (such as sulfonylurea, glitazone and glucosidase inhibitors).

Heart failure

The starting dose is usually 12.5 mg, once a day. The weekly dose is needed (such as 12.5 mg, 25 mg, 50 mg, 100 mg and increased to a maximum of 150 mg, once a day) depending on the patient's tolerance.

Reduce the risk of stroke in hypertension patients with left ventricular hypertrophy

The starting dose is usually 50 USA, once a day. Combine an additional low dose of hydrochlorothiazid and/ or increase the dose of Losartan up to 100 mg, once a day depending on blood pressure.

Special subjects

Children: Safety and effectiveness when taking drugs for children under 6 years old has not been established. Children may be weighted by 50 kg or more using adult dose. There is no experience in treating patients with severe liver failure. Therefore, contraindicated for patients with severe liver failure. The most common expression of overdose is probably hypotension and tachycardia; It is also possible to experience a slow heart rate due to sympathetic nerve stimulation (vagus nerve).

Handling: If symptoms of hypotension occur, supportive treatment. Measures depend on the time of taking drugs on severity and type of symptoms. Priority should be given to the cardiovascular stability. First, give a large enough dose of activated carbon, then need to closely monitor the survival parameters and adjust if necessary.

Both Losartan and active metabolites cannot be eliminated by blood separator.

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

Unwanted effects are arranged according to the classification for each specified listed in the following table with the frequency of word change: Common (≥ 1/100 - Classification of side effects

frequency as prescribed

Hypertension Hypertension with left ventricular hypertrophy heart failure

Hypertension with diabetes with diabetes with diabetes Kidneys blood and lymphatic system The common face Common

Common Uncommon ears and pleasure Box less common atrial fibrillation rare Systemic pressure Uncommon Common Common Ho

Constipation rarely

Uncommon

kidney and urinary tract kidney failure Common Meet

Uncommon Common Uncommon Meet

Uncommon Common Common

Warnings

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

contraindicated

hypersensitivity to Losartan or any ingredient of the drug.

Women who are 3 months pregnant between and last 3 months.

Severe liver failure.

Use at the same time with Aliskiren -containing drugs that are contraindicated for patients with diabetes or renal failure (with GFR

Be cautious when using

too hypersensitivity

Thich vascular. Patients with a history of angioedema (swelling of the face, lips, throat, and/or tongue) should be closely monitored.

Hypotension and water/electrolyte imbalance

Symptomic hypotension, especially when the first dose is used and after increasing the dose, can occur in patients with a decrease in the volume of circulation and/ or sodium due to many diuretics, salt, diarrhea or vomiting. It is necessary to adjust this condition before taking this medication or should use the starting dose lower. This also applies to children from 6 to 18 years old.

Electrolyte imbalance

Electrolyte imbalance is common in patients with renal failure, with or without diabetes and need to be resolved.

In a clinical study in patients with type II diabetes with kidney disease, the rate of hyperkalemia is higher than the losartan drug group compared to the placebo group. Therefore, the concentration of blood potassium and creatinine clearance should be closely monitored, especially those with heart failure and have creatinine clearance from 30-50 ml/ min.

Concomplifying the use of potassium -saving diocesia, potassium supplements and replacement salt containing potassium with Losartan is not recommended.

Hepatic failure

Based on pharmacokinetic data, the Losartan concentration in plasma increases significantly in cirrhosis patients,

It is necessary to consider lower doses for patients with a history of liver failure. There is no experience in using Losartan for patients with severe liver failure. So Losartan is not used in patients with severe hepatic impairment. Losartan is not used in children with liver failure.

kidney failure

Due to the inhibition of the renin-ankiotensin system, renal function changes including kidney failure have been reported (especially in patients with renal function depending on the Renin angiotensin-aldosteron system as severe heart failure or previous kidney dysfunction). As well as other drugs that affect the renin-analiotensin-aldosteron system, blood urea and serum creatinine have also been reported in patients with kidney stenosis on both sides or one-sided kidney stenosis in humans only one kidney; These renal function changes can recover when stopping the drug. Losartan should be used carefully in patients with narrowed kidney stenosis on both sides or one side narrowing of the kidneys on the one on the body is only one kidney.

Used in children with renal failure

Due to no research documents, Losartan is not recommended for children with glomerular filtration

Kidney function must be monitored regularly during treatment with Losartan as it can worsen. This is specially applied when using Losartan when there is a presence of some other cases (fever, dehydration) capable of reducing kidney function.

Suitable for Losartan and Angiotensin transfer enzyme inhibitors have shown to reduce kidney function.
Therefore, it is not recommended to use combined.

kidney transplant

Inexperienced use of this medication for new kidney transplant patients.

primary Aldosteron

Patients with primary Aldosteron generals in general often do not respond to antihypertensive drugs effected by inhibiting
Renin-Anotensin system. Therefore, the use of Losartan is not recommended.

Coronary artery disease and cerebrovascular disease

Like other antihypertensive drugs, excessive decrease in blood pressure in patients with ischemia and cerebrovascular disease can lead to myocardial or stroke.

heart failure

As well as with other drugs on the Renin-Anotensin system, in patients with heart failure, with or without kidney failure, there is a risk of severe arterial hypotension and kidney failure (usually acute).

There is no enough experience to use Losartan for patients with heart failure and severe renal failure at the same time, in patients with severe heart failure (NYHA type IV) as well as in patients with heart -threatening heart failure and arrhythmia. Therefore, Losartan should be used carefully in these patients. The combination of Losartan with beta inhibitors must be used carefully.

Aortic stenosis and mitral valve, congested myocardial hypertrophy

As other vascular stretchers should be used carefully for aortic stenosis or mitral valve, congested myocardial hypertrophy.

pregnancy

Do not use drugs for pregnant women, unless it is necessary. Patients who plan to become pregnant should be replaced with other antihypertensive drugs that have been established safety records. When a diagnosis of pregnancy, this medication must be stopped immediately, and start using another alternative therapy. Double inhibition of the renin-angiotensin system --astosteron (RAAS)

There is evidence that the simultaneous use of enzyme inhibitors, Angiotensin II or Aliskiren receptor inhibitors increase the risk of hypotension, hyperkalemia and impaired renal function (including acute renal failure). The double inhibition of the Renin - Angiotensin II - Aldosteron (RAAS) system through the use of the combination of drugs as mentioned above is not recommended.

If the double inhibited therapy is really necessary, it is necessary to have professional supervision and to regularly monitor regular kidney function, electrolytes and blood pressure.

Do not simultaneously inhibit the transferred enzyme and Angiotensin receptor antagonist in patients with diabetic kidney disease.

Black people

Losartan and homosexual drugs often have a lesser hypotension effect in blacks than other strains may be due to lower renoces in black blood pressure.

lactose

Because the product contains lactose excipients. This drug should not be used for patients with rare genetic problems in galactose intolerance, lactase lack of lactase or malventic-galactose.

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

There has been no research on using drugs for drivers or operating machinery. However, it should be remembered that when taking antihypertensive drugs, it may occasionally get dizzy or drowsiness, especially when starting to take the drug or when the dose is first increased.

Use drugs for women during pregnancy and lactation

Pregnant women

It is not recommended to use drugs for women in the first 3 months of pregnancy. Contraindicated drug for women in the middle 3 months and the last 3 months of pregnancy.

breastfeeding women

Do not have adequate information about safety. Do not use medication for women who are breastfeeding, especially newborns or monthly births.

Interactive drug

Other anti -hypertension drugs may increase Losartan's hypotension. Simultaneous use with other substances that have side effects that cause hypotension (such as three -round antidepressants, psychotic anti -dysplasia, Baclofen and amifostin) may increase the risk of hypotension.

Losartan is mainly metabolized by cytochrom P450 (CYP) 2C9 into carboxy-acid metabolites.

In a clinical trial, fluconazole (CYP2C9 inhibitor) reduces exposure to active metabolites by about 50%. It is found that simultaneous treatment of losartan with rifampicin (induction substance of metabolic enzymes) reduces 40% of the plasma concentration of active metabolites. The clinical relevance of this effect is unknown. There is no difference in exposure when treated simultaneously with fluvastatin (weak CYP2C9 inhibitors).

As well as other drugs inhibit Angiotensin II or its effects, use at the same time with potassium -keeping drugs (such as potassium -saving diuretic: amilorid, triamteren, spironolacton) or may increase potassium concentration (such as heparin), potassium supplements or replacement salt that contain potassium that can lead to hyperboly. Do not use combination.

Increased concentration and recovery lithium toxicity have been reported when using simultaneously lithium with angiotensin transferred enzyme inhibitors. Very rare cases are reported to Angiotensin II receptor drugs.

Be careful when using Lithium and Losartan at the same time. If this combination is really necessary, the lithium concentration must be monitored in the serum when using a combination.

When simultaneous use of Angiotensin II antagonists with nonsteroidal anti-inflammatory drugs (NSAID) (including selective and non-selective anti-inflammatory drugs, COX-2, acetylsalicylic acid), can reduce the lowering effect of the drug. Simultaneous use of Angiotensin II antagonists or diuretics and NSAID drugs can lead to an increased risk of impaired renal function, including acute renal failure and hyperkalemia, especially in patients with poor kidney function before. The combination needs to be cautious, especially in the elderly. Patients should be fully rehydrated and should monitor kidney function after starting combination and periodic treatment.

Clinical trials shows the double inhibition of the renin-analotensin-aldosteron system through the combination of Angiotensin transferred enzyme inhibitors, Angiotensin II or Aliskiren antagonists related to higher frequency of side effects such as hypotension, hyperchemistry, and reduced kidney function (including acute renal insufficiency) compared to an inhibitor - Aldosteron alone.

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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