Exforge 10mg/160mg Novartis Treatment of hypertension (2 blisters x 14 tablets)

Dosage form Box of 2 blisters x 14 tablets
Specifications Valsartan, amlodipine

Ingredient

Composition information	Content
Valsartan	160mg
Amlodipine	10mg

Uses

indications

Exforge 10/160 drugs are indicated in the following cases:

Treatment of hypertension in adults that blood pressure is not fully controlled when treating single therapy with amlodipine or valsartan.

Pharmacological

Exforge combines two lower blood pressure compounds with additional mechanisms to control blood pressure in basic hypertension patients: Amlodipine belongs to the group of antagonistic drugs of calcium and valsartan belonging to Angiotensin II antagonistic drug group. The combination of these substances has the effect of lowering blood pressure, reducing blood pressure at a higher level than one of the two components.

Dynamic pharmacokinetics

After drinking, the peak concentration of plasma of Valsartan and Amlodipine is achieved in 3 and 6–8 hours respectively. Exforge's speed and absorption level are equivalent to the bioavailability of Valsartan and Amlodipine when used in the form of individual tablets.

amlodipine

absorption:

After taking with Amlodipine's own dose, Amlodipine's peaked plasma concentration is achieved after 6-12 hours. Absolute bioavailability has been calculated from 64% to 80%. Amlodipine's biology is not affected by food.

Distribution:

The distribution volume is approximately 21L/kg, about 97.5% of the drug is circulating with plasma proteins.

Metabolism:

Amlodipine is metabolized (about 90%) in the liver into non -working metabolites.

Era:

Eliminating amlodipine from plasma is two phases, with the last selling time of about 30 to 50 hours. The concentration of plasma drugs in a stable state is achieved after continuous medication for 7-8 days. 10% amlodipine initially and 60% of amlodipine metabolites are excreted in the urine.

Valsartan

absorption:

After drinking Valsartan alone, the peak of the plasma of Valsartan has been achieved after 2-4 hours. Absolutely average is 23%. Food reduces bioavailability by about 40% and the peak concentration in plasma is about 50.

Distribution:

The volume of distribution in the stable state of Valsartan after intravenous injection is about 17 liters. Valsartan binds with serum protein (94-97%), mainly serum albumin.

Metabolism:

Valsartan is not changed at a high level because only about 20% of the dose is restored in the form of metabolites. A hydroxy metabolite has been determined in low plasma (less than 10% AUC of Valsartan). This metabolite has no pharmacological activity.

Era:

Valsartan shows that the dynamics decay on exponentially (t ½α

Before taking Exforge 10mg/160mg Novartis Treatment of hypertension (2 blisters x 14 tablets)

How to use

oral medication.

Dosage

Exforge 10 mg/160 mg can be used for patients with blood pressure that are not fully controlled with amlodipine 10 mg or Valsartan 160 mg alone or with Exforge 5 mg/160 mg.

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? Use activated carbon immediately or up to two hours after taking Amlodipin has been shown to significantly reduce the absorption of Amlodipine. Significant hypotension due to Exforge overdose needs cardiovascular support, including regular monitoring of heart and respiratory function, high limbs, and pay attention to the amount of liquid and urine circulation. Vascular contraction may be helpful in recovering blood pressure, provided that there is no contraindication to use it. Calcium gluconate intravenous injection may be useful in reversing the effects of blockade of calcium channels.

Both valsartan and amlodipine are not able to be removed by dialysis.

What to do when you forget a dose? However, if close to the next dose, skip the forgotten dose and take the next dose at the time as planned. Note that it should not be used double the prescribed dose.

Side Effects

When using Exforge 10/160, you may experience unwanted effects (ADR).

Common, ADR> 1/100

Infection and toxicity: Nasomitis, influenza;

Nervous system: dizziness, headache, depression; Fatigue, edema;

Cardiovascular system: tachycardia; Heart;

When experiencing side effects of the drug, it is necessary to stop using and notify the doctor or go to the nearest medical facility for timely treatment.

Warnings

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

contraindicated

Hypersensitivity to active ingredients, with dihydropyridine derivatives, or any excipients of the drug.

three months and the last three months of pregnancy

serious hypotension.

Caution when using

has not determined the safety and effectiveness of amlodipine in hypertension.

Excessive hypotension is seen in 0.4% of non -complicated hypertension patients are treated with Exforge in controlled studies with placebo. In patients with renin-anidensin systems that have been activated (such as patients with volume reduction and/or salt that need high-dose diuretics) using angiotensin receptor blockers, may occur with symptoms. This situation should be adjusted before using Exforge or strict medical monitoring at the beginning of treatment.

Be careful when used simultaneously with potassium supplements, potassium -saving diuretic, salt replacement substitutes containing potassium or other drug products that can increase potassium concentration (heparin, etc.) and regularly monitor potassium concentration.

Be cautious when using Exforge to treat hypertension in patients with kidney stenosis on one side or both sides or narrowing one kidney because of blood urea and serum creatinine may increase

It is necessary to be especially cautious when using exforge for patients with mild to moderate liver failure or biliary obstruction.

Patients with primary hyperplation increase should not be treated with Angiotensin II antagonistic valsartan because their Renin-Anotensin system is affected by primary disease.

Should stop using Exforge immediately in angiography patients and should not be used again.

Calcium channel blockers, including amlodipine, should be used carefully for patients with congestion heart failure, as they can increase the risk of cardiovascular events and death in the future.

Special prudence is indicated in patients with significant mitral stenosis or a significant aortic stenosis.

Do not use a combination of ACE, ARB or Aliskiren inhibitors.

The ability to drive and operate machinery

There is no report

Pregnancy

should not take Angiotensin II (AIRAS) receptor receptor drug during pregnancy. Unless treatment is necessary, patients who are planning to become pregnant should be changed to a safe treatment for hypotension for safe use during pregnancy.

Breastfeeding period

Exforge is not recommended and alternative treatments with a better safety configuration, which is better established during breastfeeding will be prioritized, especially when raising infants or premature babies.

Drug interaction

Interactions related to amlodipine

Exforge is used with other antihypertensive drugs (such as alpha blockers, diuretics) and other drug products that can cause side effects to lower blood pressure (such as three -ring antidepressants, alpha blockers that treat benign prostatic hyperplasia) can increase the effect of lowering blood pressure.

Use amlodipine with beam grapefruit or grapefruit juice is not recommended by bioavailability may increase in some patients, leading to blood pressure loss effects.

Simultaneous use of CYP3A4 inhibitors: simultaneous use of amlodipine with strong or average inhibitors CYP3A4 (protease inhibitors, antifungal group Azole, macrolid such as erythromycin or clarithromycin, verapamil or diltiazem) can lead to significant increase in Amlodipine effect. Pharmacokinetic changes may be more pronounced in the elderly. Clinical monitoring and dose adjustment may be required.

Simultaneous use of CYP3A4 induction (anti -convulsions, such as carbamazepine, phenobarbital, phenytoin, fosphenytoin, primidone], rifampicin, hypericum perforatum) can give a lower concentration of amlodipine. Should be cautious when used with the drugs causing CYP3A4.

Simvastatin: The dose of 10 mg amlodipine, 80 mg Simvastatin leads to an increase in 77% of the effect of simvastatin compared to using simvastatin alone. This is recommended to limit the dosage of Simvastatin 20 mg daily in patients using amlodipine.

dantrolene: Due to the risk of hyperkalemia, it is recommended that it is not used with the same calcium channel blockers such as amlodipine, which can avoid patients who are susceptible to malignant body hyperplasia and in managing malignant body temperature.

Interactions related to Valsartan

Lithium: Increased recovery at serum and toxic lithium concentration has been reported during simultaneous use of lithium with angiotensin II conversion inhibitors or receptor antagonists, including valsartan if used, the risk of lithium poisoning may increase.

Potassium diuretic, potassium supplements, replacement salt contains potassium and other substances that can increase potassium concentration.

When used simultaneously with NSAID, acetylsalicylic acid (> 3 g/day), decreased in effectiveness of hypotension may occur. Moreover, it can lead to an increase in the risk of kidney function and increased serum potassium. Need to monitor kidney function at the beginning of treatment.

Simultaneous inhibition of RAAS with ARB, inhibition of conversion or Aliskiren:

Clinical test data has shown that the simultaneous inhibition of RAAS through the use of a combination of enzyme inhibitors, ARB or Aliskiren will increase the risk of side effects such as hypotension, hyperkalemia and renal function impairment (including acute renal failure) compared to RAAS-single use.

Storage

Leave a cool place, avoid light, temperature below 30⁰C.

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