Valsacard 80mg Polfarmex medicine for hypertension, heart failure (4 blisters x 7 tablets)

Uncommon, 1/1000

Heavy liver failure, cirrhosis and bile stasis

Caution when using

hyperkalemia

It is recommended that Valsacard should not be used simultaneously with potassium supplements, potassium diuretic, replacement salts containing potassium, or other factors that may increase potassium level (heparin ...). Potassium concentration should be monitored in patients for appropriate treatment.

Patients with sodium loss and/or epidemic loss

In patients with sodium loss and/or severe loss of epidemic as high -dose dietary treatment, symptomic hypotension may occur after the beginning of treatment with Valsacard. Loss of sodium and/or loss of fluid should be treated before starting treatment with valsacard, such as reducing diuretics.

Patients with renal artery stenosis

In patients with 2 -sided kidney stenosis or one -sided kidney stenosis on one unique kidney, the safety of the drug has not been set.

Patients with kidney implants

There is no document about the safety of using Valsacard in kidney implant patients.

Patients with primary Aldosteron increases

Patients with primary aldosteron increase should not be treated with Valsacard due to their inactive renin-anidensin system.

Patients with aortic stenosis and hypertrophic heart muscle valve

Similar to other vasodilators, especially careful when prescribing drugs in patients with aortic stenosis or mitral valve, or congestion heart muscle disease (Hocm).

Patients with renal failure

There is no document on the safety of using drugs in patients with creatinine clearance 10 ml/min.

Patients with liver failure

Be cautious when using Valsartan in patients with mild to medium -sized liver failure.

Pregnant women

Women who are pregnant should not use Angiotensin II receptor inhibitors (AIRAS). Unless continued to treat AIRAS is necessary, patients planning to get pregnant should change other hypertension treatments safely during pregnancy. When the patient is diagnosed with pregnancy, it should stop treating with Airas immediately, and starts a replacement therapy.

Patients after myocardial infarction

Compared to treatment with corresponding therapies, using a combination of captopril and valsartan does not show any more clinical benefits, but also increases the risk of unwanted effects. Therefore, it is recommended not to use Valsartan combination with ACE inhibitors.

Be careful to monitor when starting treatment in patients after myocardial infarction.

Evaluation of patients after myocardial infarction must always include kidney function assessment.

Using Valsartan in patients after myocardial infarction often leads to somewhat reduced blood pressure, but the discontinuation of treatment due to hypotension is continuing is often unnecessary as long as the dose is in accordance with the instructions.

Patients with heart failure

The risk of unwanted effects, especially hypotension, hyperkalemia and impaired renal function (including acute renal failure) can increase when Valsartan is used in combination with a ACE inhibitors. In patients with heart failure, the combination of three drugs: ACE inhibitors, beta and valsartan blockers did not show any clinical benefits. This combination seems to increase the risk of side effects and therefore are not recommended. The combination of a ACE inhibitors, a mineralocorticoid and valsartan receptor antagonists are not recommended. These combinations must be used under professional supervision and must regularly monitor regular kidney, electrolytes and blood pressure.

Be careful to monitor when starting treatment in patients with heart failure. Evaluation of patients with heart failure must always include kidney function assessment.

Using Valsartan in heart failure patients often leads to somewhat reduced blood pressure, but the discontinuation of treatment due to hypotension is continuing is often unnecessary as long as the dose is in accordance with the instructions.

In patients with renal function depending on the activity of the renin-angiotensin-aldosteron system (for example, patients with severe congestive heart failure), the treatment of ACE inhibitors is often associated with urinary minority and/or hyperemia continued and (rare) acute renal failure and/or death. Valsartan is an Angiotensin II receptor antagonist, so it is impossible to rule out the use of Valsartan may be related to renal function decline.

Do not use ACE inhibitors and Angiotensin II receptor antagonists in patients with diabetes.

History of angioedema

Evala, including laryngeal swelling and bar, causes obstruction of the airway and/or swelling of the face, lips, throat and/or tongue that have been reported in patients treated with Valsartan; Some of the previous patients had angels with other drugs including ACE inhibitors. Valsartan should be stopped immediately in progressive angioedema patients, and should not be used again.

Double blockade drugs Renin-Anotensin-Aldosterone (RAAS)

There is evidence that the simultaneous use of ACE inhibitors, Angiotensin II or Aliskiren receptor antagonists increases the risk of hypotension, hyperkalemia and impaired renal function (including acute renal failure). Double blockade of RAAS systems through the use of ACE inhibitors, Angiotensin II or Aliskiren receptor drug inhibitors, therefore, is not recommended.

If dual blockade therapy is considered absolutely necessary, it must be conducted under professional supervision and must be closely monitored regularly with kidney function, electrolyte and blood pressure.

Do not use ACE inhibitors and Angiotensin II receptor antagonists in patients with diabetes.

Pediatric group

Renal function decline:

The use in children with creatinine clearance 30 ml/min. Kidney function and serum potassium must be closely monitored when treated with Valsartan, especially when there are other symptoms (fever, dehydration) capable of reducing kidney function.

Liver function decline:

Like in adults, Valsartan is contraindicated in patients with severe liver failure, bile cirrhosis and cholestasis. Clinical experience using Valsartan in mild liver impaired children is medium limited. The dose of Valsartan should not exceed 80 mg in these patients.

The ability to drive and operate machinery

There is no research on influence on the ability to operate machinery and trains. In some cases, patients sometimes have dizziness or fatigue.

Pregnancy

The use of Angiotensin II receptor inhibitors is not recommended in the first 3 months of pregnancy. Contraindicated Angiotensin II receptor inhibitors in the middle 3 months and the last 3 months of pregnancy.

Epidemiological evidence related to the risk of teratogenicity after using ACE inhibitors in the first 3 months of pregnancy has not been concluded; However, it is not possible to rule out a minor risk. While there is no muscle -controlled epidemiological data with angiotensin II receptor inhibitors, similar risks may occur in this drug group. Unless continued to treat AIRAS is necessary, patients planning to get pregnant should change other hypertension treatments safely during pregnancy. When the patient is diagnosed with pregnancy, it should stop treating with Airas immediately, and starts a replacement therapy.

ARIAS therapy for AIRAS in the middle and at the end of pregnancy toxicity to the fetus (impaired renal function, amniotic fluid deficiency, skull slowly) and toxicity for babies (kidney failure, hypotension, hyperkalemia).

If using AIRAS for 3 months between pregnancy, it is necessary to check the kidney and skull ultrasound.

Babies whose mothers used AIRAS must be closely monitored to lower blood pressure.

breastfeeding period

Because there is no information related to the use of valsartan while breastfeeding, Valsartan is not recommended. Alternative treatments with better safety should be applied, especially when raising babies or premature births.

Interactive drug

Dual blockade of RAAS system with ACE inhibitors, Angiotensin II or Aliskiren receptor drugs

Clinical test data shows that the dual blockade of RAAS systems through the use of ACE inhibitors, Angiotensin II or Aliskiren receptor is related to increased frequency of side effects such as lowering blood pressure, increased blood potassium and reducing kidney function (including acute renal failure) compared to using only one single Raas system.

Not used simultaneously with

lithium

Increasing lithium recovery in serum and toxicity has been reported during use simultaneously Valsartan with ACE inhibitors. Because there is no research on simultaneous use of Valsartan and Lithi, this combination is not recommended. If it is necessary to use a combination of drugs with lithium, carefully monitor the lithium concentration in serum. If a diuretic is also used, the risk of lithium poisoning will increase.

Potassium diuretics, potassium supplements, replacement salt containing potassium and other substances can increase potassium levels

If the combination of valsartan with drugs affects potassium concentration is necessary, it is necessary to monitor the potassium concentration in patients.

Precautions when used simultaneously with

Non-steroid anti-inflammatory drugs (NSAIDs), including selective inhibitors of COX-2, acetylsalicylic acid> 3 g/day, and non-selective NSAIDs

Concomitance Angiotensin II receptor antagonists with nsalds drugs can reduce the effect of lowering blood pressure. Moreover, this combination may increase the risk of kidney function and increase serum potassium. Therefore, the recommendation for monitoring of kidney function, as well as adequate water rehydration for patients at the beginning of treatment.

Transport substances

In vitro data indicates that Valsartan is the substrate of the drug transportation into the OatP1B1/OATP1B3 liver and of the drug transportation to the liver MRP2. It is unknown the clinical involvement of this finding. Simultaneously treating drugs inhibitors into the liver (rifampin, ciclosporin) or transportation to the liver (ritonavir) may increase the levels of valsartan in the body. Conduct appropriate care when starting or ending treatment with these drugs.

Other drugs

In drug interactive studies with Valsartan, no clinical interactions are clinically significant with Valsartan or any of the following substances: cimetidin, warfarin, furosemid, digoxin, atenolol, indometacin, hydrochlorothiazie, amlodipine, glibenclamie.

Pediatric group

In children and adolescents with high blood pressure, the abnormalities in the kidneys are often encountered, must be cautious when using Valsartan simultaneously with RAAS system inhibitors - drugs that can increase serum potassium levels. Must closely monitor kidney function and serum potassium concentration.