Savi Valsartan 160 medicine for hypertension, myocardial infarction (3 blisters x 10 tablets)

Dosage form Box of 3 blisters x 10 tablets
Specifications Valsartan

Ingredient

Composition information	Content
Valsartan	160mg

Uses

Indications

Savi Valsartan 160 drugs are indicated in the following cases:

Treatment of hypertension in adults and children from 6 to 18 years old. Enzyme inhibitors) or beta blockers, the presence of non -mandatory standard treatments.

Pharmacy

High blood pressure

The active hormone of the Renin-Anotensin-Aldosteron (RAA) system is Angiotensin II, formed from Angiotensin I. Angiotensin II associated with some specific receptors on the cell membrane in tissues. Angiotensin II has many physiological effects including direct and indirect participation in regulating blood pressure. As a substance capable of causing vasoconstriction, Angiotensin II causes a direct vascular pressure response. In addition, it has the effect of increasing salt retention and stimulating aldosteron secretion. Valsartan uses oral activity with specific antagonistic activity with Angiotensin II receptor (ang.II). The drug works in a selective way on the AT1 receptor (angiotensin II receiver Type 1), this receptor controls the activity of Ang.II.

Ang.II concentration in serum when the AT1 receptor is inhibited with Valsartan, resulting in AT2 receptor activation, this receptor has a balanced effect with AT1 receptor. Valsartan does not have any operating activity for AT1 receptors but has a lot of AT1 receptor (20,000 times more) than the AT2 receptor. Valsartan does not inhibit Ace, also known as Kinase H, has the effect of converting Ang.i to ang.II and degenerating Bradykinin. Because it does not work on ACE and does not activate Bradykinin or P, Ang.II antagonists are not able to cause coughs. In Valsartan clinical trials compared to a ACE inhibitor, the rate of dry cough is significantly less (2.6% compared to 7.9% corresponding to P

The use of valsartan for hypertension patients leads to hypotension without affecting the heart rate.

On most patients, after taking a single dose, anti -hypertension effect is achieved within 2 hours and maximum hypotension is achieved within 4-6 hours. Anti -hypertension effect is maintained for more than 24 hours after taking the drug. In the process of repeating drugs, the maximum level of reducing blood pressure at any dose is achieved within 2-4 weeks and is maintained during the long -term treatment. If coordinated with hydrochlorothiazid, it is possible to achieve significant lower blood pressure.

The sudden stop use of Valsartan is not related to the sudden hypertension or clinical side effects. In multi -dose research in hypertension patients, Valsartan has no effects on total cholesterol, triglycerides when hungry, blood sugar when hungry or uric acid.

heart failure

hemodynamics and hormones:

Hemodynamics and neurotes in plasma are assessed in patients with heart failure II - IV (according to NYHA classification) with pulmonary capillary pressure ≥ 15 mmHg in 2 short -term studies, prolonged treatment. In a study, there is a long -term treatment patient with ACE inhibitors, single -dose doses and multi -dose treatments combined with valsartan with a transferred inhibitor, improved hemodynamics including pulmonary capillary pressure, inner pulmonary artery pressure, pulmonary artery pressure in the systolic center. Plasma and plasma aldosteron concentrations decreased after 28 days of treatment.

In the second study, patients only treated with ACE inhibitors at least 6 months before treatment with Valsartan, Valsartan significantly improves the pulmonary capillary pressure, vascular strength, cardiac power and pulmonary artery pressure in the heart after 28 days of treatment. In long-term Val-heft research, plasma norepinephrin and sodium peptid brain peptides are significantly reduced from the initial concentration of Valsartan treatment groups compared to the placebo group (Placebo).

Incidence and mortality rates

In multinational research, controlled and random in patients with heart failure treated with valsartan compared to placebo, about the situation of disease and death rate in patients with heart failure II (62%), III (36%) and IV (2%) as classified by NYHA with LVEF 2.9 cm/m2. Random study on 5010 patients in 16 countries, valsartan or placebo treatment along with other appropriate medications include ACE inhibitors (93%), diuretic (86%), digoxin (67%) and beta blockers (36%).

Average research time is nearly 2 years.

Valsartan's daily dose is 254 mg for patients with heart failure.

The research has come to the first two conclusions: all causes of death (time leading to death) and heart failure situation (the time of starting heart failure) is determined as death, sudden death and regaining consciousness, hospital stay for patients with heart failure, or intravenous medication to increase heart contract or vasodilators for 4 hours or hospitalized. All causes of death are the same in Valsartan or placebo.

The first benefit is to reduce 27.5% of the risk of the first hospital for heart failure treatment. The biggest benefit for patients is no need to be treated with ACE inhibitors or beta blockers, but the risk ratio when huge treatment is higher than the group of patients treated in combination with beta blockers, a ACE inhibitor and Valsartan. However, it is very difficult to see the real difference or the changing effects of the two groups of patients have been evaluated.

pharmacokinetic

absorption

After drinking, Valsartan is quickly absorbed, although the amount of drugs is absorbed very different. Valsartan's average bioavailability is 23%. Plasma concentrations in women as well as men. When using Valsartan with food, the coefficient of variable area under the concentration curve over time (AUC) of Valsartan decreases 48%, although after 8 hours of taking the drug, Valsartan concentration in plasma is similar to those who have eaten or fast. Despite the decrease in AUC but not significantly reduced in clinical effects in treatment, Valsartan can be used or not with food.

The pharmacokinetics of Valsartan is linearly corresponding to the test dose. There is no dynamic change of Valsartan when repeated, and accumulates very rarely a dose of a day. Plasma concentrations in women as well as men.

Distribution

Valsartan has high plasma protein binding capacity (94 - 97%), mainly serum albumin. The sustainable volume of low circulation (about 17 liters). Valsartan is not much distributed in tissue.

Metabolism

Only 20% of the metabolized valsartan dose. Hydroxy metabolites are found in plasma with low concentrations (

Elimination

Valsartan has a dynamic dynamic decomposition according to the exponent coefficient (t ½/2a

Average time to reach the peak concentration and the half -life of Valsartan in patients with heart failure as well as in healthy volunteers are corresponding to each other. The value of AUC and CMAX increases with linear lines and corresponds to the rate of treatment increase (40 to 160 mg twice a day). The average accumulation rate is about 1.7. The clearance coefficient of Valsartan is approximately 4.5 liters/hour. Age also does not change the clearance coefficient of patients with heart failure.

Special group

The elderly: Valsartan's body poisoning is observed in some older people in young people. However, this has no clinical significance.

Periodic impairment: It is thought that the drug excreted through the kidney only accounts for 30% of the total plasma clearance coefficient, and there is no association between the kidney function and the body poisoning of Valsartan. Therefore, the adjustment of the dose in patients with renal failure is unnecessary. No studies have shown that Valsartan can be eliminated by separation because Valsartan is strongly connected to plasma proteins.

Liver functional decline: About 70% of the absorption drug is excreted in biliary tract mainly in a constant form. Valsartan does not undergo biological changes, as predicted, the body poisoning due to Valsartan is not related to the level of liver functional impairment. It is not necessary to adjust the dose of valsartan for patients with liver disability due to the cause of the liver and not bile.

Before taking Savi Valsartan 160 medicine for hypertension, myocardial infarction (3 blisters x 10 tablets)

How to use

oral, during or outside meals. Drink whole tablets with water. Do not chew, crush or break. Should take medicine at the same time of the day.

Savi Valsartan 160 tablets are not suitable for 20 mg/time or 40 mg/time.

For a dose of 80 mg/time, it is possible to break the tablet in half of the carved lines.

Dosage

High blood pressure

The recommended dose of Valsartan is 80 mg/day/once, regardless of racism, age or gender.

In patients with unsatisfactory blood pressure, daily dose may increase to 160 mg or 320 mg depending on the response of the patient.

Children: Adjust the dose by weight. Maximum dose of 320 mg.

after myocardial infarction

In the patient, clinically stabilized, therapy can start as soon as 12 hours after myocardial infarction. The starting dose is 20 mg x 2 times/day, the dose will be increased gradually to a maximum dose of 160 mg x 2 times/day. The last dose depends on the response and tolerance of each patient.

heart failure

The initial dose recommended by Valsartan is 40 mg × 2 times/day.

Increase the dose every 2 weeks from 80 - 160 mg × 2 times daily to the highest dose depending on the patient's tolerance.

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? If you are new to medication, you should vomit.

On the other hand, conventional treatment is to conduct intravenous veins of the physiological saline solution. Dialysis cannot exclude Valsartan.

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 Valsartan 160, you may experience unwanted effects (ADR).

Common, ADR> 1/100

Central nervous system: dizziness, dizziness posture.

ears and vestibular: Dizziness

Respiratory: Ho

Other: fainting.

Unknown frequency

Blood and lymphatic system: Hemoglobin, reduced blood capacity, leukopenia, thrombocytopenia. liver energy.

Notify the doctor 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

Savi Valsartan 160 contraindications in the following cases:

Hypersensitivity to the ingredients of the drug.

Combined with Aliskiren -containing drugs in people with diabetes or renal failure (GFR

Precautions when using

Hemorrhage:

It is not recommended to share Valsartan with potassium supplements, potassium -saving diuretic or drugs that increase blood potassium (such as heparin). Blood potassium should be checked in Valsartan users.

Renal failure:

No dose adjustment for patients with renal impairment. However, in severe cases (creatinine clearance ratio

Hepatic failure:

Be cautious when using Valsartan in mild and medium liver failure.

Salt loss and/or fluid loss:

In patients with salt loss and/or severe loss of epidemic, if high doses of diuretics, may occur in symptomatic blood pressure in some rare cases after initially treated with valsartan.

Should cure salt loss and/or loss of fluid before treatment with valsartan, for example by reducing diuretics. If the blood pressure occurs, the patient should be left in the back, and if necessary, the veins of the physiological saline solution may be transmitted. The treatment can be continued when the blood pressure is stable.

Kidney artery stenosis:

Using Valsartan for 12 secondary hypertension patients due to one -sided kidney stenosis does not cause any hemodynamic changes, serum creatinine or blood urea (bun - blood urea nitrogen). However, because other drugs affect the Renin - Angiotensin - Aldosteron system can increase serum blood urea and creatinine in patients with kidney stenosis on both sides or one side, so it is necessary to monitor as a safety measure.

kidney transplantation: Inexperienced use of valsartan in this object.

primary Aldosteron: should not use Valsartan.

Mitral valve stenosis and aortic valve, hypertrophic myocardial disease: Precautions when using Valsartan.

After myocardial infarction: Caution when used and should evaluate kidney function regularly.

Heart failure: Be cautious when used and should evaluate kidney function regularly.

The ability to drive and operate machinery

Because the drug has side effects such as headache and dizziness, it must be very careful when using Valsartan for drivers and operating machinery.

Pregnancy

must not be used for pregnant women for more than 3 months. Notify the doctor if you have a plan to get pregnant or suspect pregnancy.

Breastfeeding period

Drug interaction

Need to notify your doctor if you are in use or have recently used the following drugs because of the risk of interaction:

Other medications for hypertension, especially diuretics. Aliskiren.

Storage

Store in a dry place, avoid light, temperatures below 30 ° C.

Other drugs

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