Viacoram medicine 3.5mg/2.5mg Servier Treatment of hypertension (30 tablets)

Heart failure with unstable hemodynamics after acute myocardial infarction.

Simultaneously used with Aliskiren in patients with diabetes or renal failure (glomerular filtration level

significantly narrow the kidney artery on both sides or artery stenosis in one kidney to take the remaining function.

Precautions for use

Facility on the face, limb, lips, mucosa, tongue, subject or larynx are rarely recorded in patients treated with transferred inhibitors, including Perindopril. This phenomenon may appear at any time during treatment. If this phenomenon occurs, Viacoram should be stopped immediately and takes appropriate and continuous monitoring measures until these symptoms are gone. In general, the phenomenon of local and lips swelling is usually cured without treatment, although antihistamine drugs may have the effect of reducing symptoms.

Evaluation related to laryngeal edema can be fatal. When tongue edema, subject or larynx can cause respiratory obstruction, immediately use emergency measures. This measure includes the use of Adrenalin with or not accompanied by ventilation measures. Patients should be closely monitored until the symptoms of complete retreat.

Patients with a history of angioedema are not related to the treatment of enzyme inhibitors that can increase the risk of angioedema when using viacoram.

Evaluation in the intestinal tract is rarely recorded in patients treated with enzyme inhibitors. These patients show signs of abdominal pain (with or without nausea or vomiting), in some cases without the previous edema and the C-1 esterase concentration is normal. Evaluation is diagnosed with abdominal CT scan, or ultrasound or during surgery and the regression of symptoms after stopping the medication inhibitors. The intestinal angioedema should be considered in distinguished diagnosis in patients using enzyme inhibitors with abdominal pain.

Anaphylactic reactions during the sensitivity process

Patients taking enzyme inhibitors during the treatment of sensitivity (such as the venom of the winged insect) have encountered anaphylactic reactions. Anaphylactic reactions may be avoided in these patients when temporarily suspended the transferred inhibitors but these reactions may reappear if they accidentally come back to the allergens.

leukopenia/ grain leukemia/ thrombocytopenia/ anemia

leukopenia/granulocytosis, thrombocytopenia and anemia have been recorded in patients using enzyme inhibitors. Rarely appear leukopenia in patients with normal renal function and no other complex factors. Should be especially cautious when taking viacoram for patients with collagen vascular disease, patients are treating immunosuppressive, treating with allopurinol or process, or combining these risk factors, especially if the patient has previously impaired kidney function. Some patients in these patients have severe infections, sometimes not responding to positive antibiotic treatment. If using viacoram for these patients, periodic monitoring of the number of white blood cells and patients should be instructed to notify any signs of infection (such as sore throat, fever).

Double blockade of Renin - Angiotensin - Aldosteron (RAAS)

There is evidence that the use of enzyme inhibitors simultaneously, Angiotensin II or Aliskiren receptor inhibitors increases the risk of hypotension, hyperkalemia and impaired renal function (including acute renal failure). Double blockade of RAAS systems using a combination of enzyme inhibitors, Angiotensin II or Aliskiren receptor inhibitors are therefore not recommended.

If the dual blockade therapy is certainly considered necessary, this use is only performed under the supervision of the expert and should be closely monitored regularly for kidney, electrolyte and blood pressure.

Transfer inhibitors and Angiotensin II receptor inhibitors should not be used simultaneously in patients with diabetes kidney disease.

primary Aldosteron

Patients with primary Aldosteron power syndrome are generally not responding to anti-hypertension drugs operating through inhibition of the renin-angiotensin system. Therefore, the use of this product is not recommended.

Pregnant women

Do not start using viacoram during pregnancy. Unless the continued use of Viacoram is considered necessary, the patient is planning to get pregnant, so he switched to another medication to treat hypertension, which had safe data set in pregnant women. When the patient is diagnosed with pregnancy, it should be stopped immediately with Viacoram and if possible, another alternative treatment should be applied.

Used in patients with renal failure

Contraindicated using viacoram in patients with severe renal impairment (clearing creatinine below 30ml/minute).

On patients with average renal impairment (creatinine clearance is about 30ml/minute to 60ml/minute, the starting dose of viacoram is recommended as 3.5mg/2.5mg for daily use. Regular medical monitors in these patients include monitoring of potassium and creatin levels.

In some patients with narrowed kidney stenosis on both sides or one side stenosis has been treated with enzyme inhibitors, which have recorded the phenomenon of increased blood urea and serum creatinine, often recovered after stopping treatment. This is especially likely to occur in patients with renal impairment. The risk of severe hypotension and renal failure increases if there is signs of hypertension - renal vessels. Some patients with hypertension do not show signs of previous kidney disease, which have increased blood urea and creatinine, often mild and transient, especially when concurrent Perindopril and diuretics. This is more likely to occur in patients who have impaired renal function before.

Amlodipin may be used for patients with renal impairment at normal doses. Change plasma amlodipine concentration is not related to the level of renal failure. Amlodipine cannot be removed by dialysis.

kidney transplant

Due to the lack of experience related to the use of Viacoram in patients who have just been transplanted with kidney, treated with viacoram so it is not recommended.

Aortic hypertension

There is an increase in the risk of hypotension and renal failure in patients with narrowed kidney stenosis on both sides or artery stenosis in a kidney with the remaining function when treated with enzyme inhibitors. Treatment with diuretics may be a combination agent. The impaired renal function can occur with only a small change in serum creatinine even in patients with kidney stenosis on the one side.

Use drugs in patients with impaired liver function

The enzyme inhibitors are rarely related to the syndrome that starts with cholestasis and progress to serious liver necrosis and (sometimes) death. The mechanism of this syndrome is not well known. Patients using viacoram with jaundice and increasing liver enzymes should stop using Viacoram and appropriate medical monitoring.

In patients with liver function impairment, the waste time of amlodipine is prolonged and the area under the curve (AUC) is higher.

Use drugs for elderly patients

Should be cautious when taking the starting dose and increasing the dose in elderly patients, based on kidney function.

Should monitor kidney function before increasing the dose. Therefore, medical monitoring should include monitoring of potassium and creatinin levels.

Precautions when using

Hypertension

Safety and effectiveness of amlodipine on unpaid hypertension attacks.

Use drugs in patients with heart failure

Should be careful treatment for patients with heart failure.

Be cautious when using viacoram for patients with congestion heart failure, as amlodipine can increase the risk of cardiovascular events and deaths afterwards.

Hypotension

Transfer inhibitors can cause hypotension. Symptoms of hypotension are recognized as rare in patients with no complications of hypertension and is more likely to appear in patients with reduced circulatory volume such as treatment with diuretics, salt -limiting diet, hemolysis, diarrhea or vomiting or in serious hypertension patients dependent on renin. In patients with high risk of hypotension with symptoms, it is recommended to closely monitor blood pressure, kidney function and serum potassium concentration during Viacoram's treatment.

Similar considerations are applied to patients with myocardial oral disease, excessive hypotension can lead to myocardial infarction or stroke.

If there is a hypotension, the patient should be on his back and if necessary, the intravenous solution of Sodium Clorid 9mg/ml (0.9%) should be transmitted (0.9%). Hypoglycemia is not contraindicated for the next dose, the next dose can often be used without fear when blood pressure has increased after the collection of circulating mass.

Aortic stenosis and hypertrophic cardiac/myocardial valve

Be cautious when using enamel inhibitors transferred to patients with mitral stenosis and congestion of left ventricular heart such as aortic stenosis or hypertrophic cardiomyopathy.

Race

Menurgam inhibitors increase the rate of angioedema in black skin patients more in other skin -colored patients.

Moderary inhibitors may have less blood pressure on black people than other skin -colored people, which may be due to a more common low -blooded lyin activity in the population of hypertension patients with hypertension.

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cough has been recorded when using viacoram. Cough is characterized by dry, persistent and out of treatment. Coughing caused by transferred enzyme inhibitors should be considered as part of cough distinct diagnosis.

surgery/ anesthesia

In patients undergoing major surgery or during anesthesia, using drugs that can cause hypotension, Perindopril may inhibit the formation of secondary angiotensin II formation to compensate for the release of the released Renin. Viacoram should be stopped a day before surgery. If hypotension appears and hypotension is considered to be due to this mechanism, it is necessary to adjust by increasing the volume of circulation.

Hemorrhage

Hyetics have been recorded in some patients treated with transferred inhibitors, including Perindopril. Factors that increase blood potassium include renal failure, worsening renal function, age (> 70 years old), diabetes, events that occur, especially dehydration, acute cardiomemia loss, metabolic acidosis and simultaneous use with potassium diuretics (such as Spironolacton, Eplerenon, Triamteren or Amilorid, Solo or combination), supplements of potassium or replacement salts; Or patients taking other drugs that increase serum potassium (such as heparin, other transfer inhibitors, Angiotensin II antagonists, acetylsalicylic acid ≥ 3G/day, COX-2 inhibitors and non-selective anti-inflammatory drugs, immunosuppressants such as cyclosporin or tacrolimus, trimethoprim).

Use potassium supplements, potassium diuretic or alternative salts containing special potassium in patients with impaired renal function can significantly increase serum potassium. Hyperboly hyperpass can cause serious arrhythmia, sometimes leading to death. If the simultaneous use of viacoram with any of the above drugs is really necessary, should be used carefully and regularly monitor blood potassium concentration.

Patients with diabetes

In patients with diabetes treated with oral diabetes or insulin drugs, it is advisable to strictly control blood glucose in the first month of viacoram treatment.

Potassium drugs, potassium supplements or replacement salt containing potassium

It is not recommended to combine viacoram with potassium drugs, potassium supplements or replacement salt containing potassium.

excipients

The drug contains lactose. Patients with rare genetic diseases such as galactose intolerance, lactase lactase deficiency or Glucose-Galactose should not be used.

The ability to drive and operate machinery

There are no studies conducted on the effect of Viacoram on driving and operating machinery.

Perindopril and Amlodipin may have a slightly affected on average on the ability to drive and operate machinery. If the patient has dizziness, headache, fatigue, exhaustion or nausea, the ability to react may be impaired.

Caution recommendations when using viacoram, especially when starting treatment.

Pregnancy

Based on the influence of each ingredient in this combination preparation in pregnant and lactating women: It is not recommended to use viacoram in the first three months of pregnancy. Contraindicated to use Viacoram in the middle 3 months and the last 3 months of pregnancy.

Related to Perindopril

It is not recommended to use enzyme inhibitors in the first three months of pregnancy. Contraindicated to use enzyme inhibitors in the middle and last three months of pregnancy.

Epidemiological evidence shows that there is no conclusion about the risk of fetal defects after taking enzyme inhibitors transferred in the first three months of pregnancy, but it does not rule out the possibility of slightly increasing this risk. Except for the case of continuing treatment with medication inhibitors, patients planning to become pregnant should turn to other antihypertensive drugs that are considered safe during pregnancy. When the patient is diagnosed with pregnancy, it is advisable to stop treating with enzyme inhibitors immediately and if possible, the replacement treatment should start.

The use of enzyme inhibitors in the middle and last three months of pregnancy is known to be toxic to the fetus (reducing kidney function, amniotic fluid, skull slowly) and toxicity on infants (kidney failure, hypotension, hyperkalemia).

If the patient takes the enzyme inhibitor in three months between pregnancy, it is recommended that the ultrasound should be taken to check the kidney function and the fetal skull.

Babies whose mothers use medication inhibitors, they should be closely monitored.

Related to amlodipine

The safety of amlodipine in pregnant women has not been established.

In animal studies, reproductive toxicity has been recorded in high doses. Only recommendation on pregnant women when there is no safer alternative measure and when the risk is due to the disease is greater than the mother and the fetus.

fertility

Related to Perindopril

The drug does not affect fertility.

Related to amlodipine

The biochemical change in the tip of the sperm has been recorded in some patients treated with calcium channel blockers. There are no clinical data on the ability of amlodipine to fertility. In a study on rats, the adverse effects on the fertility of the male rat.

Breastfeeding period

Related to Perindopril

Due to the lack of information related to the use of Perindopril during breastfeeding, it is not recommended to use Perindopril and should be replaced by other treatments that have been better known for safety during breastfeeding, especially when raising infants or premature babies.

Related to amlodipine

It is not known whether Amlodipin is excreted through breast milk or not. The decision to continue/stop breastfeeding or continue/stop treatment with amlodipin should be considered based on the benefits of breastfed babies and amlodipine treatment benefits on the mother.

Drug interaction

Clinical research data has shown double-anidensin-kendosteron (RAAS) system by using a combination of enzyme inhibitors, Angiotensin II or Aliskiren receptor inhibitors that are associated with higher frequency of disadvantages such as blood pressure, hyperpoints and impairment. granting) When compared to the use of drug therapy, it is impacted on the RAAS system.

Hemorrhage -causing potassium -causing drugs

Some medications or groups of treatments may increase the risk of hyperkalemia: Aliskiren, potassium salt, potassium -keeping diuretics, transferred inhibitors, Angiotensin II receptor drugs, non -steroid anti -inflammatory drugs, heparin, immunosuppressants such as cyclosporin or tacrolimus, trimethoprim and dosage forms with sulfametholoxaoloxaoloxaolxetholxetholxetholoxhetholoxa (Co-Trimoxazole). Combining viacoram with these drugs increases the risk of hyperkalemia.

Contraindicated simultaneously

Aliskiren

In patients with diabetes or impaired renal function, the risk of hyperkalemia, renal function worsen and the incidence of cardiovascular diseases and death due to cardiovascular diseases increases.

Extracent body treatment: The body's treatment leads to blood exposure to negative charged surfaces such as hemorrhage or dialysis with high -speed filter (e.g. Polyacrylonitril film) and low density lipoprotein filter with dextran sulphate are at risk of increasing hypersonic reactions. If these treatments are required, it is necessary to consider using another type of separation membrane or another anti -hypertension drug.

There is no recommendation of simultaneous use

estramutine

The risk of increasing adverse effects such as nerveema.

MTor inhibitors (such as syrolimus, Everolimus, Temsirolimus)

Treated patients in combination with MTOR inhibitors may increase the risk of angioed.

Potassium diuretics (such as triamteren, amilorid), potassium (salt forms)

Hemorrhage (severe can lead to death), especially when combined with renal failure (the plus effect of hyperkalemia). Do not combine enzyme inhibitors with hypokalemia compounds, except for hypokalemia.

Do not recommend coordinating viacoram with the above drugs. If used simultaneously, should be carefully coordinated and regularly monitor serum potassium concentration. Use Spironolacton in heart failure, see below.

lithium

Increased lithe and toxic lithium recovery has been recorded when used simultaneously with lithium with enzyme inhibitors. It is not recommended to use viacoram with lithium, but if necessary, it is necessary to closely monitor serum lithium concentration.

dantrolen (intravenous)

In animals, ventricular vibration and cardiovascular collapse lead to death has been recorded related to hyperkalemia when combining Verapamil and intravenous dantrolen. Due to the risk of hyperkalemia, it is recommended not to simultaneously use viacoram 3.5mg/2.5mg containing amlodipine, a calcium channel blocker with dantrolen in patients with the ability to increase malignant body temperature and in the treatment of malignant body temperature.

Particularly cautious when using simultaneously

anti -diabetic drugs (insulin, oral hypoglycemic drugs)

Epidemiological studies show that the use of enzyme inhibitors and anti -diabetic drugs simultaneously (insulin, oral hypoglycemic drugs) may cause a risk of hypoglycemia due to increased hypoglyc effect of the drug. This phenomenon appears more common in the first week when combining drugs and on patients with renal failure.

baclofen

Increased hypotension effect. Monitoring blood pressure and adjusting the dose of antihypertensive drugs if necessary.

Diuretics do not keep potassium

Patients are taking diuretics, especially patients who have reduced volume of circulatory or salt loss, may experience excessive reduced blood pressure after starting treatment with enzyme inhibitors. The ability to lower blood pressure can be reduced by stopping diuretics, increasing the volume of circulation or the amount of salt used before starting treatment with viacoram.

In arterial hypertension, if treated with previous diuretics, it reduces the volume of circulatory or salt loss, should stop taking diuretics before starting to use viacoram. You can then reuse diuretics without potassium.

Need to monitor kidney function (creatinine concentration) in the first few weeks of treatment with viacoram.

Potassium diuretics (Eplerenon, Spironolacton)

In case of using eplerenon or spironolacton in the dose range from 12.5mg to 50mg/day and low doses of enzyme inhibitors.

In the treatment of heart failure II - IV (classification of NYHA) with blood ratio

Before combining drugs, patients must be tested without hyperkalemia and kidney failure.

Advanted to closely monitor blood potassium and blood creatinine once a week at the beginning of the first month of the first month of treatment and monitoring monthly.

Non -steroid anti -inflammatory drugs (NSAIDs) including aspirin dose ≥ 3g/day

When concurrent use of transferred inhibitors and non-steroid anti-inflammatory drugs (such as acetylsalicylic acid at an anti-inflammatory dose, COX-2 inhibitors and non-selective non-selective steroid anti-inflammatory drugs), hypotension effects may be impaired. Simultaneous use of Viacoram and non -steroid anti -inflammatory drugs may increase the risk of worsening kidney function, including the possibility of acute renal failure and increases serum potassium levels, especially in patients with poor kidney function before. Should be cautious when combined, especially in elderly patients. Patients should be fully rehydrated and consider monitoring of kidney function after starting treatment and periodic treatment.

CYP3A4 induction drugs

There is no data on the effects of CYP3A4 induction drugs with amlodipine. Simultaneous use with CYP3A4 induction drugs (such as rifampicin, hypericum perforatum) can reduce amlodipine levels in plasma. Should be cautious when using viacoram and drugs causing CYP3A4.

CYP3A4 inhibitors

Concomitant use amlodipine with strong and medium inhibitors CYP3A4 (protease inhibitors, antifungal drugs that conduct Azol substances, macrolids such as erythromycin and clarithromycin, verapamil or diltiazem) can significantly increase amlodipine levels in circulating. Clinical manifestations corresponding to this pharmacokinetic change of the drug can be more clear in elderly patients. Therefore, clinical monitoring and adjusting the dose of viacoram.

There is an increase in the risk of hypotension in patients using clarithromycin with amlodipine. It is recommended to closely monitor patients when using simultaneously amlodipine with clarithromycin.

Precautions when using simultaneously

Antid for hypertension (such as beta blockers) and vasodilators

Timultant use of these drugs may increase the hypotension effect of Viacoram. Using the drug simultaneously with nitroglycerin and other nitrates or other vasodilators may cause more severe hypotension, so it is advisable to be carefully considered.

Gliptin (linagliptin, saxagliptin, sitagliptin, vildagliptin)

Increased risk of angioedema due to gliptin reduces the effect of dipeptidyl peptidase IV (DPP-IV) in patients using simultaneously with enzyme inhibitors.

Three -round antidepressants/antidepressants/anesthesia

Simultaneous use of viacoram with anesthesia, three -round antidepressants and anti -psychotic drugs may increase the ability to lower blood pressure.

Sympathomical drugs

Sympathetic medications can reduce the hypotension effect of Viacoram.

Corticosteroids, Tetracosactid

Reduce the effect of lowering blood pressure (due to the effect of holding water and salt of corticosteroids).

Alpha blockers (prazosin, alfuzosin, doxazosin, tamsulosin, terazosin)

Increased hypotension and increased the risk of hypotension.

Amifostin

can increase the hypotension effect of amlodipine.

Gold

Nitritoid reactions (symptoms include blushing, nausea, vomiting and hypotension) are rarely recorded in patients being treated with injected gold (sodium aurothiomalate) and simultaneous use of enzyme inhibitors including Perindopril.

Grapefruit juice

It is not recommended to use viacoram and grapefruit juice or grapefruit juice due to amlodipine bioavailability may increase above some patients leading to increased hypotension effect of the drug.