Valsartan-MV 80mg USP medicine for hypertension and heart failure (3 blisters x 10 tablets)

Dosage form Box of 3 blisters x 10 tablets
Specifications Valsartan

Ingredient

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Composition information	Content
Valsartan	80mg

Uses

indications

The drug is indicated in the following cases:

Treatment of hypertension in adults and children over 6 years old, can be used alone or in combination with other anti -blood pressure drugs. Left ventricular heart to reduce cardiovascular mortality.

In the Renin - Angiotensin - Aldosteron system, Angiotensin I is not active to be converted into angiotensin II with strong vasoconstrictor activity, causing hypertension. At the same time, stimulate the adrenal glands to excrete aldosteron. The affinity of Angiotensin II on AT1 and AT2 receptors is similar, while Valsartan's affinity for the AT1 receptor is about 20,000 times stronger than the AT2 receptor affinity. ATI receptor participates in most or all activities on the heart, kidney and TKTW. Valsartan selectively inhibits Angiotensin II attached to ATI receptor in many different tissues, including blood vessel and adrenal glands, lowering blood pressure by antagonistic effects caused by angiotensin II (vasoconstriction, increasing antosteron secretion, increased catecholamine secretion secretion in the adrenal gland and before SinAP, releasing arginin vasopressin, water -encrusting and causing water hypertension and water hyperplasia).

Comparison with AT1 receptor anti -receptor drugs, Angiotensin I transferred enzyme inhibitors into Angiotensin II are not completely because Angiotensin II can be formed through other enzymes without ACE inhibitors. Valsartan does not inhibit the breaking of Bradykinin, so it does not cause adverse reactions such as persistent cough, often occurring with angiotensin enzyme inhibitors.

Hypotension effects about 2 hours after taking Valsartan, reaching maximum after 4-6 hours and maintaining the effect for 24 hours. When the dose is repeated, the anti -hypertension effect is clearly shown after 2 weeks, reaching maximum after 4 weeks and maintained when long -term treatment.

Pharmacokinetics

absorption

Valsartan absorbs quickly after drinking. Oral bioavailability reaches about 25%. The maximum concentration of plasma is about 2-4 hours after taking the drug. The food has a disadvantage of Valsartan's absorption, reducing AUC by about 40% and reducing the maximum concentration in plasma by about 50%, but the plasma concentration after taking 8 hours is similar whether the patient is hungry or not. However, AUC decreases not to reduce clinical effects, so it is possible to take Valsartan during or outside the meal. AUC and the maximum concentration in Valsartan's plasma increases linear ratio with the dose of the recommended dose range.

Distribution

Valsartan is strongly linked to plasma proteins (about 94 - 97%), mainly linked to albumin. The distribution voltage is stable after the intravenous injection of Valsartan, so it proves that there is no important distribution Valsartan into tissues.

Metabolism

Valsartan is not significantly metabolized, only 20% of the dose found in the form of metabolites. The metabolic substance of Valsartan is Valeryl 4-Hydroxy Valsartan, which is not active in urine and feces.

Elimination

Valsartan is eliminated in many phases (t1/2alpha

In patients with heart failure: Average time to achieve the peak plasma concentration and half -life elimination of Valsartan is similar to healthy people. Valsartan's AUC and CMAX values increase linearly and almost proportional to the dose in the clinical dose range (40 - 160 mg, twice a day). The average accumulation rate is about 1.7. The apparent clearance of Valsartan after drinking about 4.5 liters/hour. Age does not affect the apparent clearance in people with heart failure.

Elderly: In some people, the plasma valsartan levels are slightly higher than young people, but not clinically significant.

Renal failure: There is no correlation between kidney function and plasma valsartan levels. Therefore, there is no need to adjust the dose for people with kidney damage (CLCR> 10 ml/min). Currently there is no experience for patients with CLCR

Hepatic failure: About 70% of the absorption dose is excreted in bile, mainly in a constant form. Valsartan is less metabolic. Auc is twice as seen in mild liver failure compared to healthy people. However, there is no correlation between the plasma concentrations of Valsartan and the severity of the liver disease. Valsartan has not been studied in severe liver failure.

Before taking Valsartan-MV 80mg USP medicine for hypertension and heart failure (3 blisters x 10 tablets)

How to use

Valsartan is used by oral. Can use valsartan during or away from meals.

Dosage

Adult dose

Hypertension: The starting dose is 80mg, 1 time/day. The drug starts to work after 2 weeks, maximum effect of 4 weeks. In case of necessity, the dose of 160mg, 1 time/day can be used. The distance to adjust the drug dose is at least 4 weeks. The maximum dose is 320mg, 1 time/day. The distance to adjust the drug dose is at least 2 weeks. The maximum daily dose is 320 mg, divided into small doses. Consider reducing the dose of valsartan for patients being treated with diuretics. Do not coordinate 3 groups of drugs: Angiotensin enzyme inhibitors, beta and valsartan blockers. Valsartan should be started early within 12 hours after myocardial infarction. In the case of hypotension with symptoms or kidney dysplasia, the dose may be reduced. Valsartan can be used with other treatments of myocardial infarction such as blood clots, acetylsalicylic acid, beta blockers, statin and diuretics. Do not recommend coordination with ACE inhibitors.

Children from 6-16 years old

The starting dose is 80mg once a day for people weighing 35kg or more. The dose must be adjusted according to the response of blood pressure. The maximum dose is clinically tested as follows:

Weight from ≥18kg to

Weight from ≥35kg to Patients with renal failure

Children: It is not recommended to use Valsartan in children with ClCR

Patients with liver failure

Be cautious when used in patients with liver disease. The dose of Valsartan drugs does not exceed 80mg in patients with mild to medium -sized liver failure without cholestasis. Contraindicated to use Valsartan for patients with severe hepatic impairment accompanied by cholestasis.

What to do when overdose? Slow heart rate can also occur due to sympathetic nerve stimulation.

If symptomic hypotension occurs, the patient should be placed in a back, low head, and intravenously 0.9%sodium chloride solution. Overdose management depends on the time of overdose of the drug, manifestation and severity of the symptoms, but the most important measure is still stabilizing hemodynamics for patients.

Hemorrhage does not eliminate Valsartan.

What to do when you forget a dose? However, if you are close to the next dose, skip the forgotten dose and follow the schedule of the day.

Side Effects

Common, ADR> 1/100

Central nervous system: dizziness, dizziness, fatigue, headache.

cardiovascular: lower blood pressure, lower posture, fainting. blood creatinine, renal dysfunction.

Immune: allergic reactions, itching, skin rash, anaphylactic reaction, angioedema, increased sensitivity to light, hair loss. taste, constipation, indigestion, flatulence, vomiting. drug use.

Warnings

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

Contraindicated

Sensitive people with Valsartan or any ingredients of the drug.

Severe liver failure, biliary cirrhosis, cholestasis.

Pregnant women (especially in the middle and last three months of pregnancy).

Patients with diabetes or renal failure (GFR

Caution when used

Risk of hypotension: Hypoglycemia is rare in patients with non -complicated hypertension. Hypotension with symptoms that often occur in patients with a decrease in the volume of circulating due to the use of high -dose dosage drugs, have a restriction of salt, blood separation, diarrhea or vomiting. In these patients, sodium and/or water rehydration should be compensated or reduced diuretics before starting treatment with Valsartan. It is necessary to closely monitor patients in the beginning of treatment. If the hypotension occurs, symptoms, the patient should be placed in a back, low head. In case of severe hypotension, it is necessary to compensate for intravenously 0.9%sodium chloride solution. Miraculous hypotension is not required to control Valsartan but should be adjusted to be cautious dose after blood pressure of the patient has stabilized.

Be cautious when starting to treat people with heart failure or clinical signs of left ventricular dysfunction after myocardial infarction due to lowering blood pressure in these patients. However, there is no need to stop the drug if the dose of the drug is in the recommended dose range. Need to closely monitor the kidney function of this patient during treatment.

The risk of hyperkalemia, especially in patients with heart failure or patients with attached renal failure. Simultaneous use of potassium diuretics, potassium supplements or other drugs are likely to increase serum potassium levels (such as heparin). Patients need to monitor serum levels periodically.

Be cautious in patients with kidneys and kidney stenosis on both sides or kidney stenosis on one side due to the unprocessed safety. The use of renin-angiotensin-aldosteron inhibitors can generally increase serum creatinine levels or increase blood urea nitrogen urea (bun) in patients with kidney stenosis. Need to closely monitor kidney function in these patients when treated with Valsartan.

Patients with renal insufficiency have a ClCr

Patients with mild to moderate liver failure without bile stasis.

Patients with primary Aldosteron due to the renin-angiotensin-aldosteron system are not activated in these patients.

Caution for patients with aortic valve stenosis or mitral valve stenosis or myocardial hypertrophy.

The drug contains less than 1mmol sodium (23mg) in a dose, which should be considered non -sodium.

The effect of the drug on driving and operating machinery

There has been no research on the impact on the ability to drive. When driving or operating machinery, it is necessary to pay attention to occasionally dizziness or fatigue.

Use drugs for women during pregnancy and lactation

pregnancy

Valsartan and drugs directly acted on the renin-angiotensin-aldosteron system when used in pregnant women in the middle 3 months and the last 3 months of pregnancy can cause damage to the fetus (impaired renal function, less amniotic fluid, skull dots) and newborn babies (kidney failure, hypotension, hyperkalemia) Therefore, contraindicated use of Valsartan for pregnant women during the three months between and the last three months of pregnancy. It is not recommended to use Valsartan in the first three months of pregnancy. When detected pregnancy, the patient is being treated with Valsartan should stop immediately and replace other medications. If you have used Valsartan for a long period of three months in the middle of pregnancy, it is necessary to have an ultrasound to check the kidney function and the fetal skull.

Babies whose mothers use Valsartan during pregnancy should be closely monitored by the risk of hypotension.

Breastfeeding period

Experimental data on mice shows Valsartan is excreted into breast milk. It is not clear whether Valsartan will be excreted in human milk. Due to the disadvantage in breastfed babies, breastfeeding should be stopped during valsartan treatment or stopped and replaced with other drugs.

Interactive drug

Interaction of drugs with other drugs and other types of interactions as follows:

Lithi: When used with Valsartan, increases the level of lithium in the blood, leading to lithium poisoning. Closely monitor patients, monitor toxicity of lithium toxicity and plasma lithium concentration.

Aliskiren: Unable to simultaneously use with Valsartan due to the risk of increased serum potassium and hypotension.

Angiotensin transfer enzyme inhibitors: It is not recommended to simultaneously use with Valsartan due to the risk of hypotension, kidney failure and increased serum potassium level. Beta -blocking anti -blood pressure drugs and calcium channel blockers: simultaneously used with Valsartan increases the effect of lowering blood pressure.

Diuretics, thiazid diuretics: Hypotension with symptoms that may occur when starting to use Valsartan in patients who are taking high doses of diuretics. Serum potassium concentration may increase, decrease or not change when coordinated depending on the patient.

Potassium diuretics, potassium supplements: It is not recommended to simultaneously use with Valsartan due to the risk of increased serum potassium level and increased serum creatinine levels in patients with heart failure.

Non -steroid anti -inflammatory drugs (NSAIDs): Be cautious when used simultaneously with valsartan due to reduced hypotension effect, increased risk of kidney failure and increased serum potassium level. Therefore, it is necessary to monitor kidney function in the stage of initial treatment and water compensation enough for patients with impaired circulating mass.

Transporter: In vitro data shows Valsartan and the substrate of OATP1B1/ OATP1B3 and MRP2, the transport channels of liver cells. The clinical involvement of this finding is not known. Simultaneous use of absorption channel inhibitors (e.g. rifampin, ciclosporin) or exhaust canal (for example, Ritonavir) may increase Valsartan levels. Simultaneous use with those drugs, it is necessary to take appropriate treatments when starting or ending treatment.

Children: In children and adolescents with high blood pressure, who are at risk of kidney complications, need to be cautious when using Valsartan and the inhibitors of the Renin Angiotensin Aldosteron inhibitors due to increased blood potassium concentration in the blood. Should closely monitor kidney function and potassium concentration.

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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