Savi Irbesartan 75 Savipharm treat hypertension, kidney disease (3 blisters x 10 tablets)

Dosage form Box of 3 blisters x 10 tablets
Specifications Irbesartan

Ingredient

Composition information	Content
Irbesartan	75mg

Uses

indications

Savi Irbesartan is indicated in the following cases:

Treatment of arterial hypertension.

ATC code: C09CAD4.

Irbesartan is an Angiotensin II (AT,) receptor receptor receptor. Irbesartan inhibits the physiological effects of Angiotensin II, including the effect of aldosteron and vasoconstriction, due to selective inhibition of AT and Angiotensin II receptors in many tissues, including adrenal and smooth muscle glands.

The usual dose of Irbesartan has the effect of lowering blood pressure as the usual dose of Losartan, Enalapril or Atenolol, but unlike Losartan, Irbesartan is not a precursor and pharmacological effect not depending on the hydrolysis in the liver. Different from the enzyme inhibitors Angiotensin (Ace: Angiotensin Converting Enzyme), Irbesartan does not inhibit the enzyme that converts Angiotensin I into angiotensin II and thus does not inhibit the breakdown of Bradykinin and other kinins so it does not cause persistent dry cough, an unwanted effect when using enzyme inhibitors.

When using Irbesartan with recommended doses, blood potassium does not change much unless there is kidney failure and/or heart failure.

Medications that lower blood pressure but the heart frequency changes very little. Hypotension effect depends on the dose and tend to not lower when taking a dose higher than 300 mg/time/day. Maximum lower blood pressure for about 3-6 hours after drinking. Anti -hypertension effect maintained at least 24 hours. The anti-hypertension effect is manifested within 1-2 weeks, the maximum efficiency is achieved within 4-6 weeks from the start of treatment and maintenance when long-term treatment. If the treatment stops, the blood pressure gradually returns to the original value, but there is no sudden serious illness when stopping the drug.

Anti -blood pressure effects of Irbesartan and thiazid diuretics are in communion.

Dynamic pharmacokinetics

fast absorption through the gastrointestinal tract with bioavailability of 60-80%. Food does not change much to the bioavailability of the drug. The peak concentration of plasma is about 1-2 hours after a dose of oral. The concentration of medication in the blood reaches a stable equilibrium after 3 days of taking medicine.

Irbesartan binds 96% to plasma proteins. The distribution of the drug is about 53-93 liters.

After drinking, about 80-85% of Irbesartan is found in plasma in a constant form. Metabolic drugs in the liver through Glucuronid and oxidation pathway. The main metabolites in the circulation are Irbesartan Glucuronid (about 6%). Some in vitro studies show that Irbesartan is mainly oxidized by Cytochrom P450 ISOENZYM CYP2C9, Isoenzym CYP3A4 has an negligible impact on Irbesartan metabolism.

Dynamic pharmacokinetics of linear Irbesartan with the dose within the dose range from 10-600 mg. For the dose of over 600 mg (double the highest recommended dose), the ratio of Irbesartan's absorption is lower, the mechanism is not known. Irbesartan and its metabolites are excreted through bile and urine. Total clearance and kidney clearance are 157-176 ml/min and 3-3.5 ml/min. After drinking, about 20% of the drug excreted through urine in the form of metabolism and less than 2% in the form of no metabolism. The sale time is 11-15 hours.

pharmacokinetics in special subjects

Sex: There is a study that indicates that Irbesartan concentration in plasma in women with hypertension has increased slightly. However, the selling time and the accumulation of Irbesartan are constant in women, so it is not necessary to adjust the dose.

Elderly: AUC (Area Under the Curve) and CMAX in the elderly (≥ 65 years) are a bit higher than young people (18-40 years old). However, the sale time does not change. Therefore, there is no need to adjust the dose.

Children: Irbesartan's pharmacokinetics are rated on 23 children with hypertension after taking one or more daily doses of Irbesartan (2 mg/kg) up to a maximum dose of 150 mg/day for 4 weeks. The results show that CMAX, AUC and the same level of clearance in adult patients use 150 mg of Irbesartan per day.

Irbesartan is less accumulated in plasma (18%) when repeating the dose 1 time/day.

Renal failure: Irbesartan pharmacokinetic parameters change negligible in patients with renal impairment or dialysis. Irbesartan is not eliminated by hemolysis.

Hepatic failure: In patients with mild and medium liver failure, Irbesartan's pharmacokinetics change is not significant. Pharmacokinetics in patients with severe liver failure have not been studied.

Before taking Savi Irbesartan 75 Savipharm treat hypertension, kidney disease (3 blisters x 10 tablets)

How to use

oral, oral medication, oral or oral in or after eating. Swallow pills with water, do not chew or crush the pill. For a dose of 37.5 mg, Savi Irbesartan can be broken in a brick on the tablet.

Irbesartan's dosage must be adjusted to each patient based on clinical response.

Dosage

Adults:

Starting and maintenance dose is usually 150 mg/time/day. The dose of 150 mg/time/day has a better blood pressure control effect 75 mg/day/day. However, the starting dose of 75 mg may consider indicating patients with dialysis or patients who reduce blood volume and elderly over 75 years old.

If the dose of 150 mg/day is not enough to control blood pressure, it may increase the dose to 300 mg/day/day or use another anti -hypertension drug. For example, if combining Irbesartan with a diuretics such as hydrochlorothiazid will have an antihypertensive effect.

kidney failure:

No dose adjustment in people with renal impairment. For patients who have to dialysis the starting dose is 75 mg/day.

Hepatic failure:

No dose adjustments for patients with mild or moderate liver failure. There is no clinical experience with severe liver failure.

Elderly:

No dose adjustment for the elderly, however, the starting dose should be low at 75 mg/day/day for people over 75 years old.

Children:

Starting dose: 37.5 mg/day/day for children weighing 10-20 kg; 75 mg/time/day for children weighing 21 - 40 kg; 150 mg/time/day for children weighing> 40 kg. The dose may doubled if necessary.

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 overdose? In case of overdose, clinical symptoms are likely to occur as hypotension and tachycardia. The slow rhythm can also occur.

There is no specific therapy in the treatment of Irbesartan overdose. Patients need to be strictly monitored, symptomatic treatment and power.

Some can be applied such as vomiting and/or gastric lavage, using activated carbon. Irbesartan cannot be removed by hemorrhage.

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 Savi Irbesartan, you may experience unwanted effects (ADR) such as:

Research results show that the unwanted effect rate in the Irbesartan group (56.2%) is no different from the placebo group (56.5%). The ratio to stop using Irbesartan due to the unwanted effect of the drug is 3.3%. Irbesartan's undesirable effects do not depend on the dose, gender, age, race or treatment time.

Unwanted effects are classified according to the frequency occurring on the agency as below:

Very common, ADR ≥ 1/10

Testing: Hyperbonemia occurs more often in patients with diabetes using Irbesartan compared to placebo users. In patients with hypertension with diabetes with microalbuminin urine and normal renal function using Irbesartan, the rate of hyperkalemia (≥5.5 Meq/liter) occurs 29.4% and the placebo group is 22%. In patients with hypertension with diabetes with proteinuria and chronic kidney failure using Irbesartan, the rate of hyperkalemia increases (≥5.5 Meq/liter) occurs of 46.3% and the placebo group is 26.3%.

Common, 1/100

Nervous system disorders: dizziness, vertical posture.

Vascular disorders: Hypotension with a standing posture related to the dose.

Gastrointestinal disorders: Nausea, vomiting.

musculoskeletal and connective tissue disorders: muscle pain.

General disorder: fatigue.

Testing: 1.7% of Irbesartan users have a significant increase in plasma creatin kinase but not related to unwanted effects on clinical muscle.

In 1.7% of hypertension patients with kidney disease and diabetes are treated with Irbesartan, a hemoglobin reduction report, but this report is not clinically significant.

Uncommon, 1/1000

heart and blood vessel disorders: tachycardia, flushing.

Respiratory disorders: cough.

Gastrointestinal disorders: diarrhea, heartburn, gastrointestinal disorders.

Liver disorders: jaundice.

Breast disorders and reproductive system: Sexual impairment.

Common disorders: chest pain.

unknown frequency

Blood disorders and lymphatic systems: platelets.

The immune system disorders: Hypersensitivity reactions such as angiography, rash, urticaria.

Metabolic and nutrient disorders: Hemorrhage.

Nervous disorders: dizziness, headache.

Ear and ear disorders: Tinnitus.

Gastrointestinal disorders: taste disorders.

Hepatitis disorders: Hepatitis, abnormalities of liver function.

Skin disorders and subcutaneous tissues: Hypersensitivity vasculitis.

musculoskeletal and connective tissue disorders: joint pain, muscle pain (some cases related to increased plasma creatin kinase), muscle contraction.

Kidney and urinary disorders: impaired renal function.

Children

In a random study with a control of 318 children aged 6 to 16 with hypertension, the unwanted effect rate occurs during the double blind period lasting 3 weeks: headache (7.9%), hypotension (2.2%), dizziness (1.9%), cough (0.9%). In the 26 -week period, the frequency occurs in the test results are: increasing creatinine (6.5%) and increasing creatin kinase (2%).

Instructions on how to handle ADR:

Unwanted effects rarely occur, usually light, without any special treatment. If you start taking the drug, you should pay attention to reducing blood volume if any.

Notify the physician the 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

Savi Irbesartan drugs contraindicated in the following cases:

Hypersensitivity to the ingredients of the drug.

Be cautious when using

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

Reduce blood volume: In patients with hypotension such as salt loss and water due to strong diuretic groups, diarrhea or prolonged vomiting, may occur with symptoms, especially after taking the first dose. It is necessary to treat blood volume before using Irbesartan. Checking the concentration of potassium and blood creatinine is necessary. Using these drugs is not recommended. If it is necessary to coordinate these drugs, it is necessary to monitor and closely monitor kidney function, electrolytes and blood pressure. Ace ACE and Angiotensin II should not be used simultaneously in patients with diabetic kidney disease. For people with this patient should regularly check potassium. Avoid simultaneous use of Irbesartan with potassium diuretics. Hey. The treatment with transferred enzyme inhibitors or Angiotensin II receptor antagonists on the system have seen acute hypotension, hypercogenemia, urinary decrease or rarer than acute renal failure. As with any anti-hypertension, the sudden hypoglycemia in people with ischemic heart disease can lead to myocardial infarction or stroke.

The effect of drugs on driving and operating machinery

There has been no research on the influence of Irbesartan on the ability to drive and operate machinery. Based on pharmacological effects, Irbesartan is expected to not affect the ability to drive and operate machinery. However, because the drug has unwanted effects such as dizziness and headache, it is cautious when using Irbesartan for drivers and operating machines if these symptoms occur.

Use drugs for women during pregnancy and lactation

Pregnant women

contraindicated use for pregnant women. In the first 3 months of pregnancy contraindicated due to caution. In the middle 3 months or the last 3 months of pregnancy, the drug is toxic to the fetus (reducing the kidney function, less amniotic fluid, slow chemical chemistry) and toxic to babies (kidney failure, hypotension, hyperkalemia). When detected pregnancy, stop immediately Irbesartan and replace it with other drugs. If the drug has been used for a long time, it is necessary to check the skull and kidney function, ultrasound for the fetus.

breastfeeding women

contraindicated use for breastfeeding women.

Interactive drug

with other anti -hypertension drugs:

Other anti -hypertension drugs may increase the hypotension effect of Irbesartan. However, Irbesartan can still be combined with other anti -hypertension drugs such as beta blockers, calcium blockers or thiazide diuretics.

Pre -dosage treatment at high doses can create a decrease in blood volume and the risk of hypotension when taking Irbesartan.

Products containing Aliskiren and ACE inhibitors:

Research results show that the RAA system inhibitors through the use of ACE inhibitors, Angiotensin II or Aliskiren inhibitors increases the frequency of unwanted effects such as hypotension, hyperkalemia and impaired renal function compared to the group using only one RAA system inhibitor.

Products containing potassium or potassium diuretics:

Simultaneous use of irbesartan with potassium -containing products or potassium diuretics can increase potassium concentration.

Lithi:

Increasing serum and recovery lithium concentration has been reported when combined with transferred enzyme inhibitors.

Because the interaction has not been determined with Irbesartan and has not been eliminated, it is still necessary to closely monitor the concentration of blood lithium.

Steroid anti -inflammatory drugs:

When Angiotensin II antagonists are simultaneously used with nonsteroidal anti-inflammatory drugs (for example, cyclo-oxygenase type 2 (COX-2), acetylsalicylic acid (> 3 g/day) and non-selective nonsteroidal anti-inflammatory drugs, anti-hypertension effects of Irbesartan can be reduced. Simultaneously using Angiotensin II antagonists and non -selective anti -inflammatory substances can increase the risk of kidney function damage, which can lead to acute kidney failure and hyperkalemia, especially patients who have had kidney function before.

Other interactive information:

Digoxin's

pharmacokinetics are not changed when used simultaneously with Irbesartan.

Irbesartan pharmacokinetics are not changed when combined with hydrochlorothiazid.

Irbesartan is metabolized mainly by CYP2C9 and partly by the process of combined with glucuronic acid. There is no meaningful interaction and pharmacological interaction when Irbesartan is used simultaneously with Warfarin as a drug metabolized by CYP2C9. The effect of CYP2C9 induction substances, for example, Rifampicin on pharmacokinetics of Irbesartan has not been evaluated.

Tyeum of drugs

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

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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