Exforge 5mg/80mg 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	80mg
Amlodipine	5mg

Uses

Indications

Exforge 5mg/80mg drugs are indicated in cases of idiopathic hypertension treatment.

Pharmacokinus

Exforge combines two compounds to treat hypertension with a supplementary mechanism to control blood pressure in patients with idiopathic hypertension: Amlodipine belongs to Calcium and Valsartan drug groups belong to the Angiotensin II receptor drug group (Ang II). The combination of these two components has a complementary effect on the effect of treating hypertension, reducing blood pressure to a stronger level than when using each alone ingredient.

amlodipine

The amlodipine component of Exforge prevents passing through the membrane of calcium ions into the heart muscle and blood vessel smooth muscle. The mechanism of anti -hypertension effect of Amlodipine is due to the effect of direct relaxation of blood vessel smooth muscles, causing reducing the resistance of peripheral blood vessels and reducing blood pressure. The data on the experimentation shows that Amlodipine is associated with the location combined with dihydropyridine and does not have to dihydropyrine.

valsartan

Valsartan is an Angiotensin II receptor opposite substance that has a strong activity and isolated orally, selectively acting on the AT1 receptor type responsible for the known effects of Angiotensin II. The concentration of angiotensin II in plasma increases after the AT1 receptor is inhibited with Valsartan, which can stimulate the AT2 receptor not inhibited, which has a counterweight effect with the AT1 receptor.

pharmacokinetic pharmacokinetics

amlodipine

absorption

After taking orally, Amlodipine is solitary with the treatment dose, the peak concentration of amlodipine in plasma is achieved after 6-12 hours. Absolute bioavailability is calculated 64 - 80%.

Distribution

The distribution volume is about 21 liters/kg. Amlodipine passes through the placenta and is excreted about breast milk.

Biological Change

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

Elimination

Amlodipine elimination from plasma has a 2-phase form with the final selling time of about 30-50 hours, 60% of amlodipine metabolites are eliminated through urine.

Valsartan

absorption

After using the lonely oral oral Valsartan, the peak concentration of Valsartan in plasma is achieved after 2-4 hours. Absolute bioavailability is 23%.

Distribution

Valsartan's distribution volume in a stable state after a 17 -liter vein use shows that Valsartan is not widely distributed into the tissues. Valsartan is strongly connected to serum protein (97%), mainly serum albumin.

Biological Change

Valsartan is not changed to a degree because only about 20% of the dose is found in the form of metabolites.

Elimination

Valsartan is mainly discharged in a constant form (about 83% of the dose) and urine (about 13% of the dose), mainly constant drugs. Valsartan's waste sale time is 6 hours.

valsartan/amlodipine

After taking oral Exforge, Valsartan's peak concentration in plasma is achieved after 3 hours with the peak concentration of amlodipine in plasma achieved after 6-8 hours. The speed and level of Exforge absorption are equivalent to the bioavailability of Valsartan and Amlodipine when used in the form of separate tablets.

Before taking Exforge 5mg/80mg Novartis Treatment of hypertension (2 blisters x 14 tablets)

How to use

Take oral use, should use Exforge with a little water. Exforge can be used or not with food.

Dosage

Exforge dose is recommended as 1 tablet/day.

Exforge 5mg/80mg can be used in patients with blood pressure that are not fully controlled with amlodipine 5mg or Valsartan 80mg for lone.

kidney failure

Unsurprisingly adjustable dose for patients with mild to moderate renal failure, need to monitor potassium and creatinine concentrations in patients with medium renal impairment.

Hepatic failure

In patients with mild to moderate liver failure without biliary stasis, the maximum recommended dose is 80mg of valsartan. When converting patients with hypertension eligible for amlodipine or exforge, the lowest dose should be used by Amlodipine monochromatic therapy or of the corresponding amlodipine ingredient.

Elderly patients (from 65 years of age)

When transferring elderly patients with eligible hypertension to use amlodipine or exforge, the lowest dose should be used by Amlodipine monomer or of the corresponding amlodipine ingredient.

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 medication that causes vasoconstriction may be helpful in recovery of vascular tone and blood pressure, provided that it is not contraindicated.

If new to medication, may consider vomiting or gastric lavage. Using activated carbon immediately or up to 2 hours after using amlodipine has shown significantly reducing the absorption of Amlodipine. Intravenous calcium gluconate can be beneficial in reversing the effects of calcium channel closing.

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 Exforge 5mg/80mg, you may experience unwanted effects (ADR).

Common, ADR> 1/100

Infections and parasites infection: rhinitis, influenza.

Nervous system disorders: headache.

Systemic disorders and local medication: edema, hot red face, weakness.

Uncommon, 1/1000

Nervous system disorders: dizziness, drowsiness, dizziness due to posture, paresthesia.

Disorders of ears and mesmerizing: Dizziness.

Arrhythmic disorders: tachycardia, chest drum.

Vascular disorders: Hypotension.

Respiratory, chest and mediastinum disorders: cough, sore throat - larynx.

Gastrointestinal disorders: diarrhea, nausea, abdominal pain, constipation, dry mouth.

Skin and subcutaneous tissue disorders: rash, erythema.

Instructions on how to handle ADR

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

Exforge 5mg/80mg contraindications in the following cases:

Hypersensitivity to active ingredients, derivative Dihydropyridine or any excipients are listed in the excipient component.

Heavy liver failure, biliary cirrhosis or cholestasis.

Use Exforge simultaneously with Aliskiren -containing products in patients with diabetes or kidney failure (glomerular filtration speed (GFR

Pregnant women in the middle and the last 3 months of pregnancy.

Hypotension.

SHARE (including cardiac shock).

Conclusion of left ventricle.

Unstable heart failure about hemodynamics after acute myocardial infarction.

Precautions when using

Patients with hypoglycatry sodium or volume loss

In patients with activated renin-analiotensin systems being treated with angiotensin receptor blockers, hypotension may occur. Recommendation to adjust this situation before using Exforge or to be closely monitored at the beginning of treatment.

If excessive hypotension occurs when using Exforge, the patient must be in the lying position and if necessary, intravenously salted salt solution. Can continue treatment once the blood pressure has been stable.

Hyperbonia

Be careful when using simultaneously with potassium supplements, potassium diuretic, salt -containing substances containing potassium, or other drugs that can increase potassium levels and should regularly monitor potassium concentrations.

Patients with renal artery stenosis

Be careful when using Exforge to treat hypertension in patients with narrowed kidney stenosis on one side or either side, kidney artery stenosis in patients with one kidney.

Patients with renal failure

There is no data on severe cases (creatinine clearance

Avoid the use of Angiotensin receptor blockers (ARB) - including Valsartan - or Angiotensin (ACEI) with aliskiren in patients with severe renal impairment.

Patients with liver failure

Need to be careful especially when using Exforge for patients with mild to moderate liver failure or there are biliary obstruction disorders.

Tharma

Must stop Exforge immediately in angioed development patients and not reuse Exforge.

Patients with heart failure/myocardial infarction

Be careful when using calcium channel blockers including amlodipine in patients with congestion heart failure because these drugs may increase the risk of cardiovascular events and future deaths.

Patients with acute myocardial infarction

Need to be careful especially when using amlodipine for patients with aortic valve stenosis or mitral stenosis, or hypertrophic cardiomyopathy.

Cuong Aldosteron Tien Phat

Patients with primary Aldosteron should not be treated with Valsartan as Angiotensin II antagonists because their renin-angiotensin system is affected by this first disease.

Dual inhibitors of the renin-Anotensin-irtsteron system (RAAS)

It is not recommended to inhibit the double-analotensin-aldosteron (RAAS) system through the use of Angiotensin (ACE), Angiotensin (ARB) or Aliskiren receptor blockers or Aliskiren because of the risk of hypotension, hyperkalemia and kidney function impairment.

The ability to drive and operate machinery

There has been no research on impact on the ability to drive and use machinery. When driving or using machines, it should sometimes occur dizziness or fatigue.

Pregnancy

as with any other drugs directly act on the renin-angiotensin-aldosterone system (RAAS), do not use Exforge in pregnant women.

Breastfeeding period

It is unclear whether Valsartan is excreted in breast milk or not. Amlodipine has been reported to be excreted in breast milk. The impact of amlodipine on infants is unknown. Do not recommend Exforge for women who are breastfeeding.

Medicinal interaction

Other medications for hypertension: drugs that treat hypertension are often used (alpha blockers, diuretics) and other drugs that can cause adverse effects to lower blood pressure (e.g. anti -depression drugs, alpha blockers in the treatment of hyperplasia) can increase blood pressure effectively)

amlodipine

Simultaneously use many doses of Amlodipine 10mg with simvastatin 80mg, resulting in an increase of 77% in contact with simvastatin compared to when using Simvastatin alone.

Use amlodipine simultaneously with strong inhibitors or medium inhibitors CYP3A4 (Protease inhibitors, Azol antifungal drugs, macrolid drugs such as erythromycin or clarithromycin, verapamil or diltiazem) can significantly increase amlodipine levels.

Amlodipine concentration may increase when used simultaneously with grapefruit juice due to CYP3A4 inhibitors.

valsartan

Concomitance the use of Angiotensin receptor blockers (ARB), including Valsartan, with other drugs that affect the Renin-Anotensin system that is associated with increased hypotension, hyperkalemia and changes in renal function compared to monomers.

Be cautious when used simultaneously with potassium supplements, potassium -keeping diuretics, salt substitutes containing potassium or other drugs that can increase potassium levels (such as heparin, etc.) and should regularly monitor potassium levels.

When using the Angiotensin II receptor antagonist simultaneously with NSAID drugs, the reduction of the effectiveness of hypotension may occur.

Increased healing of blood and toxic lithium concentrations reported when used simultaneously lithium with enzyme inhibitors or angiotensin II receptor inhibitors including Exforge.

Use a combination of inhibitors inhibitors (such as rifampicin, cyclosporin) or transportation (such as ritonavir) may increase body contact level with Valsartan.

Storage

Do not store over 30 ° C. Keep the medicine in the original packaging to avoid moisture.

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