Savi Losartan 50 medicine treatment for primary 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

Savi Losartan 50 mg is indicated in the following cases:

Treatment of hypertension in adults and children 6 years of age: can be used alone or in combination with other anti -hypertension drugs (for example, thiazid diuretics). Losartan should be used for patients who do not tolerate ACE inhibitors.

Treatment heart failure . Losartan is the first substance of the new anti -hypertension drug group, which is a receptor antagonist (Typ1) Angiotensin II. Angiotensin II, made up of Angiotensin I in the reaction of the catalytic enzyme, is a strong vascular contract; It is the main hormone that activates the Renin - Angiotensin system and is an important component in the pathophysiology of hypertension. Angiotensin II also stimulates the adrenal glands of Aldosteron.

Losartan and main metabolites have the activity blocking vascular shrinkage and aldosteron secretion of angiotensin by preventing selective angiotensin II, not attached to the AT1 receptor in many tissues (for example, blood vessel muscle, adrenal glands).

Both Losartan and the main active metabolites do not show the local owner's effect in the AT1 receptor and have a much larger AT1 receptor (about 1,000 times) than the AT2 receptor.

Losartan is a competitive, reversible inhibitor of the AT1 receptor. The metabolic substance has the activity of drugs 10 to 40 times stronger than Losartan, calculated by weight and is a non -competitive, reversible inhibitor of the AT1 receptor.

Angiotensin antagonists also have hemodynamic effects such as ACE inhibitors, but there is no unwanted effect of the common ACE inhibitors are dry cough.

pharmacokinetics

After drinking, Losartan absorbs well and initially metabolized through the liver thanks to the cytochrom P450 enzymes (CYP2C9 and CYP3A4).

Losartan's bioavailability is approximately 33%. About 14% of Losartan dose oral into active metabolites, this substance is mostly opposite Angiotensin II.

Losartan waste time is about 2 hours, and of metabolites about 6 - 9 hours.

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

Both Losartan and active metabolites are highly linked to plasma proteins, mainly albumin and they do not go through blood -brain barriers.

Losartan's distribution volume is about 34 liters and of metabolites with activity about 12 liters.

Losartan's total plasma clearance is about 600 ml/min and of the active metabolites of 50 ml/minute; Their clearance in the kidney corresponds to about 75 ml/min and 25 ml/min. Losartan eliminates 35% in urine and is about 60% in feces.

Dynamic pharmacokinetics of special cases: In patients with mild to medium cirrhosis, the area under the curve (AUC) of Losartan and of the metabolitus is more active, corresponding, 5 times and 2 times higher than in patients with normal liver function.

Before taking Savi Losartan 50 medicine treatment for primary hypertension (3 blisters x 10 tablets)

How to use

Savi Losartan 50 Used orally. Can be taken with or not with food.

Dosage

Hypertension treatment

The starting and maintenance dose is usually 50 mg of Losartan, 1 time/day. The maximum hypotension effect is usually achieved after 3-6 weeks of treatment. In some patients, the dose can be increased to 100 mg/day. There is no need to change the dose of the kidney failure, including the person who is hemolysis. If using losartan alone without controlling blood pressure, adding low -doses of diuretics. Hydrochlorothiazid proves to have a plus effect. Losartan can be used with other lower blood pressure medications. Losartan is not coordinated with potassium diuretics, due to the risk of hyperkalemia.

Treatment of kidney disease in hypertension patients with diabetes, proteinuria> 0.5 g/day

The starting dose is usually 50 mg of Losartan, 1 time/day, which can increase the dose to 100 mg/day based on the patient's response. Savi Losartan 50 can be used with other antihypertensive drugs (diuretics, calcium blockers, α blockers, β blockers), with insulin or other hypoglycemic drugs (sulfonyleeds, glitazon, glucosidase enzyme inhibitors).

Heart failure treatment

The starting dose is usually 12.5 mg of Losartan, 1 time/day (should use the appropriate dosage form); Increase gradually every week. The highest dose is 150 mg Losartan/day.

Reducing the risk of stroke in patients with hypertension from left ventricular thickness

The starting dose is usually 50 mg of Losartan, 1 time/day. May be increased to 100 mg/day, depending on the response of the patient. Should be used in combination with low -dose hydrochlorothiazid.

Special patients

Children under 6 years old

The safety and effectiveness of Losartan has not been set in children under 6 years old, so it is not recommended to use Savi Losartan 50 in children under 6 years old.

Children 6 years of age and older

From 20 - 50 kg, recommended dose is 25 mg, 1 time/day. May be up to 50 mg, 1 time/day, depending on the response of the patient. (Should use the appropriate dosage form).

From 50 kg or more, the usual dose is 50 mg, 1 time/day. May be up to 100 mg, 1 time/day.

The dose of more than 1.4 mg/kg body weight/day (about 100 mg/day) has not been studied in children. It is not recommended to use Savi Losartan 50 for children with glomerular filtration

Patients with reduced circulatory volume (being treated with high -dose diuretics)

The recommended starting dose is 25 mg of Losartan, 1 time/day (not suitable for using Savi Losartan 50, should use a suitable dosage form).

Patients with kidney failure or dialysis

No need to adjust the dose.

Patients with liver failure

Needs to reduce the dose in patients with liver failure. No Savi Losartan 50 in people with severe liver failure.

Older people (over 75 years old)

The recommended starting dose is 25 mg Losartan, 1 time/day (should use the appropriate dosage form).

However, most cases for the elderly over 75 years old, do not need to adjust the dose.

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 to do when 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 symptomic hypotension occurs, supportive treatment must be treated. Both Losartan and metabolites are active, they cannot be removed by hemolysis.

What to do when forgetting 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 dose to compensate for missed dose.

Side Effects

When using Savi Losartan 5 mg , you may experience unwanted effects (ADR).

Common, ADR> 1/100

cardiovascular: Hypotension , chest pain.

Central nerve: insomnia, dizziness, fatigue.

endocrine - Metabolism: hyperkalemia, hypoglycemia.

digestive: diarrhea , indigestion.

Neuromiac - bone: back pain, leg pain, muscle pain.

kidney: lower blood uric acid (when taking high doses), urinary tract infections.

Respiratory: cough (less when using ACE inhibitors), nasal congestion, sinusitis.

Cardiovascular: Hypotension, chest pain, Block AV degree II, chest drum, sinus slow rhythm, tachycardia, facial edema, blushing.

Central nerve: anxiety, loss of air conditioning, confusion, depression , migraine, headache, sleep disorders, fever, dizziness.

Skin: Hair loss, dermatitis, dry skin, erythema, light sensitivity, itching, urticaria, bruises, foreign rash.

Endocrine - Metabolism: gout.

digestive: anorexia, constipation, flatulence, vomiting, loss of taste, gastritis.

Genital - Urinary: Help, sexual reduction, urination, night urine.

liver: Increase the test of liver function and slightly increase bilirubin.

musculoskeletal nerves: Perception, tremor, bone pain, muscle weakness, joint edema, muscle pain.

ear: tinnitus .

Kidney: Urine infections, slight increase in creatinine or urea.

Respiratory: Difficulty breathing, bronchitis, nosebleeds , rhinitis, airbodery, discomfort in the throat.

Other effects: sweating.

Instructions on how to handle ADR

Dose reduction or stopping drugs when unwanted effects appear.

Warnings

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

Contraindicated

Savi Losartan 50 mg contraindicated in the following cases:

Patients with hypersensitivity to Losartan or other ingredients of the drug.

The patient is pregnant.

Patients with severe liver failure.

Patients with diabetes or renal failure (glomerular filtration

Caution when using

Special monitoring and/or decreased dose in patients dehydrated, diuretic treatment and patients have other factors that can easily lead to hypotension.

Patients with kidney stenosis on both sides or one side, only one kidney has a high risk of unwanted effects to increase creatinine and blood urea) and should be closely monitored in treatment.

Due to the risk of hyperkalemia, monitoring of blood potassium levels should be monitored in the elderly and kidney failure, not using potassium diuretics.

Patients with liver failure must take lower doses.

Due to the presence of lactose in preparations, patients have rare genetic problems such as galactose intolerance, fructose intolerance due to lapp-lactase enzyme deficiency, glucose-galactose absorption disorders may experience lactose intolerance. Therefore should not be prescribed.

The ability to drive and operate machinery

Because the drug has side effects such as dizziness, hypotension, should be cautious when using Losartan for drivers and operating machinery.

Pregnancy

Use drugs directly on the Renin - Angiotensin system in the middle and the last three months of pregnancy can cause less amniotic fluid, lower blood pressure, anuria, face deformity and death in infants. Although, the use of drugs in the first three months of pregnancy has not seen the risk of the fetus, but when detected pregnancy, it must stop Losartan as soon as possible.

Breastfeeding period

It is unknown whether Losartan is secreted into breast milk or not, but there are significant amounts of Losartan and metabolites whether the drug's active in mice milk. Due to harmful potential for breastfeeding, deciding to stop breastfeeding or stopping the drug, taking into account the importance of the drug for the mother.

Drug interaction

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

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

Losartan oral with phenobarbital reduces about 20% of Losartan and of active metabolites.

Hyperbysical hyperka when used simultaneously with potassium diuretics, potassium supplements, salt replacement substitutes containing potassium.

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

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

There is no pharmacokinetic interaction between losartan and hydrochlorothiazide.

NSAIDs, including specialized inhibitors Cox-2 (cyclooxygenase-2), combined with Losartan, can cause kidney failure, so it is necessary to monitor the kidney function for patients.

Tyeum of drugs

Due to the absence of studies on the correlation of the drug, not mixing this drug with other drugs.

Storage

In the dry place, the temperature does not exceed 30 ° C. Avoid light.

Expiry date of 36 months from the date of manufacture.

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