Beatil 4mg/10mg Gedeon treatment treats idiopathic hypertension, stable coronary artery disease (3 blisters x 10 tablets)

Heart failure with unstable hemodynamics after acute myocardial infarction.

Caution when using

All cautions related to each component, as listed below, is also applied to a fixed combination of Beatil dose.

Do not recommend the simultaneous use of beatil with lithium, potassium diuretic or potassium supplements, or dantrolen.

involves Perindopril

Stable coronary artery disease

If a period of angina occurs (serious or not) in the first month of using Perindopril, it is necessary to carefully assess the benefits and risks before continuing treatment.

Hemorrhage lag

Transfer inhibitors can cause hypotension. Symptomatic hypotension in patients with hypertension is not complicated and often occurs in patients with impaired fluid impaired such as taking diuretics, diets that limit salt, separation, diarrhea, vomiting, or people with heavy hypertension.

Recognized symptomatic hypotension in patients with symptoms of heart failure, accompanied by no renal function impairment. This event usually occurs in patients with a more severe heart failure with manifestations such as hypoglycry hypoglycemia, kidney failure or high -dose dosage diuretics. In patients with an increase in the risk of symptomatic hypotension, it is necessary to control the beginning of treatment and when the dose adjustment.

The same consideration should be considered for patients with ischemic heart disease or cerebrovascular disease because of excessive hypotension on these patients that can lead to myocardial infarction or stroke.

If hypotension occurs, the patient is on the back, if necessary, the intravenous sodium chloride solution may be inferior to 9 mg/ml (0.9%). If there is a fleeting hypotension, do not combat the next doses, may be used for normal drugs when blood pressure increases again after compensation.

On some patients with congestion or low blood pressure, Perindoril can make blood pressure more.

This effect has been predicted in advance and is often not the reason for the need to stop treatment. If symptomatic hypotension, the dose may be reduced or stop using Perindopril.

Aortic stenosis and hypertrophic cardiac/myocardial valve

Similar to other transferred inhibitors, Perindopril should be used carefully for patients with mitral stenosis and blood flow obstruction from the left ventricular such as aortic stenosis or hypertrophic cardiomyopathy.

Renal function impairment

In case of renal failure (Creatinine clearance

In patients with symptoms of heart failure, hypotension after starting to use transferred enzyme inhibitors can cause further impairment of kidney function. Acute renal failure, often recovery has been reported in this case.

In some patients with narrowed kidney stenosis on both sides or renal artery stenosis when only one function is treated with enzyme inhibitors, acknowledges the hyper Urea and serum creatinine, often recovered after stopping the drug. This is especially common in patients with renal failure. If the patient is at the same time increasing the kidney pressure, the risk of kidney failure and serious hypotension also increases. In these patients, it is necessary to start using the drug in low doses and carefully adjusting the dose under strict medical supervision.

Due to the use of diuretics is a risk factor for the above situation, diuretics should be stopped and monitor kidney function during the first weeks of treatment with Perindopril. Some patients with hypertension without clear signs of kidney disease have increased blood urea and serum creatinine, usually mild and transient, especially when using Perindopril simultaneously with diuretics. This event is more common in patients with renal failure.

may need to reduce the dose and/or stop diuretics and/or perindopril.

Patients with hemolysis

There have been reports on anaphylactic reactions in patients who are separated by high pine filters and simultaneously used enzyme inhibitors. In these patients, it is necessary to consider using other types of autopsy or other hypertension drugs.

kidney transplant

There is no experience in using Perindopril in new kidney transplant patients.

Hypersensitivity/eagle

Tharms in one, limbs, lips, mucosa, tongue, subjects and/or larynx are rarely reported in patients treated with enzyme inhibitors, including perindopril.

This event can occur at any time during treatment. In these cases, the Beatil should be stopped, starting appropriate control measures until the symptoms are completely controlled. In cases where the circuit is limited to the face and lips, symptoms often regress without treatment, although so antihistamine is also helpful in reducing symptoms.

Vascular fleet associated with laryngeal edema can be fatal. If the angioedema appears at the tongue, the bar or the larynx, there is a risk of airway congestion, it should be treated immediately. Treatment may include using adrenalin and/or maintain ventilation. Patients need to be closely monitored until the symptoms are completely retreated and stable maintenance.

Patients with a history of angioedema are not related to transferred inhibitors that can increase the risk of angioedema when using enamel inhibitors.

The intestinal angioedema has been reported rare in patients treated with enzyme inhibitors. These patients show signs of abdominal pain (attached or without nausea, or vomiting); In some previous cases, there is no expression of face edema and esterase level C-1 at a normal level.

Evaluation is diagnosed with abdominal CT scan, ultrasound or surgery and symptoms often retreat after stopping the enzyme inhibitors. Need to distinguish angioedema in the intestine in patients with abdominal pain when using enzyme inhibitors.

Simultaneously used with Rapamycin's mechanical inhibitors (Mtor Inhitors, for example: Sirolimus, Everolimus, Temsirolimus).

Patients are treated simultaneously with MTOR inhibitors (for example, syrolimus, Everolimus, Temsirolimus) may increase the risk of angioedema.

Anaphylactic reactions during the low density lipoprotein (LDL) liver (LDL)

Rarely experienced anaphylactic reactions in patients using enzyme inhibitors have occurred while separating the low density lipoprotein (LDL) with Dextran Sulphat. This reaction can be avoided by temporary suspension of enzyme inhibitors before each LDL separator.

Anaphylactic reactions in sensitivity

Patients who use enzyme inhibitors during anti -sensitivity treatment (for example, the venom of the membrane insect) have encountered anaphylactic reactions. Such reactions can be avoided by temporary suspension of using enamel inhibitors on these patients, but these reactions may reappear when unintentionally repeating the situation.

Hepatic failure

Rarely encountered enzyme inhibitors related to a syndrome with the original manifestation of jaundice, then progressing into a liver necrosis and sometimes led to death. The mechanism of this syndrome is not well understood. Patients who use enzyme inhibitors have given symptoms of jaundice or significantly increased liver enzymes should stop the drug and take appropriate medical monitoring measures.

Neutral leukemia/grain leukemia/thrombocytopenia/anemia

Neutral leukemia, grain leukocytes, thrombocytopenia and anemia have been reported in patients using enzyme inhibitors. Neutral leukemia rarely appears in patients with normal renal function and no associated risk factors.

It is necessary to be particularly cautious when using Perindroprilil in patients with collagen vascular disease, using immunomodic inhibitors, being treated with Allopurinol or Procainamid, or combining the above risk factors, especially when patients are impaired renal function. Severe infections, sometimes do not respond to positive antibiotics, have appeared in some patients. If Perindopril is used in these patients, it is necessary to periodically check the white blood cell formula and guide the patient to report when detecting any signs of infection (such as fever, sore throat).

Race

The enzyme inhibitors cause angelica in black skin patients with higher rate than other patients.

Similar to other enzyme inhibitors, Perindopril's hypotension effect on black skin patients may be worse than other patients, maybe because black skin groups have higher rate with hypertension with low renin activity.

ho

Astonious cough is reported when using enzyme inhibitors. The characteristics of coughs in these cases are no sputum, persistent and retreat after stopping the drug. Coughing caused by yeast inhibitors should be noted when diagnosing cough.

surgery/anesthesia

In patients undergoing surgery or during anesthesia with anesthesia, it can cause hypotension, the beatil can inhibit the formation of the secondary angiotensin II after a reflex to increase the release of re -compensation.

Need to stop treatment before surgery a day. If there is a drop in blood pressure and is considered to be due to the above mechanism, it can be treated by adding body fluid volume.

Hemorrhage

Hyetics have been recorded in some patients treated with transferred enzyme inhibitors, including Perindopril. The risk factors for promoting hyperkalemia include impaired renal function, age (> 70 years old), diabetes, events occur simultaneously, especially dehydration, acute loss of heart disease, metabolic acid infection, simultaneous use of potassium diuretics (such as spironolacton, eplerenon, triamteren or amilorid), salt supplements containing potassium or potential supplements; Or patients taking other drugs at risk of hyperkalemia (such as heparin).

The use of potassium supplements, potassium diuretics, or salt -containing salt products can lead to significant increase in serum potassium, especially in patients with impaired renal function. Hypotension causes serious arrhythmia, sometimes death. If you have to simultaneously use Perindopril with any drugs or preparations mentioned above, caution should be used and monitor serum potassium levels.

Patients with diabetes

Patients with diabetes are treated with oral diabetes or insulin drugs, should control blood sugar in the first month of treatment with enzyme inhibitors.

lithium

In general, it is not recommended to use Lithi and Perindopril at the same time.

Potassium drugs, potassium supplements and potassium products contain potassium

In general, it is not recommended to simultaneously use Perindopril with medicine that causes potassium, potassium supplements and potassium -containing salt products.

Double Renin-Anotensin-Aldosteron (RAA)

There is evidence that the use of enamel inhibitors, Angiotensin II or Aliskiren receptor blockers increases the risk of hypotension, hyperkalemia and impaired renal function (including acute renal failure). Therefore, it is not recommended to simultaneously use enzyme inhibitors, Angiotensin II receptor blockers or Aliskiren to cover the RAA system.

If it is really necessary to be treated by double blocking Raa, the treatment process should be supervised by a doctor and closely monitor blood pressure, kidney function and electrolyte of patient.

Do not use the enzyme inhibitors and Angiotensin II receptor blockers in patients with diabetic kidney disease.

Related to amlodipine

Safety and effectiveness of amlodipine in the treatment of unpretated hypertension.

Patients with heart failure

Be careful when using the drug in patients with heart failure.

In a long -term study, placebo control (Praise -2 research) in patients with heart failure III - IV NYHA, the proportion of pulmonary edema is higher in the treatment group with amlodipine compared to the placebo group. Calcium channel blockers, including amlodipine, should be used carefully in patients with congestive heart failure because these drugs may increase the risk of cardiovascular events and future mortality rates

Hepatic failure

Amlodipin's exhaust half -life time and an area under the concentration curve over time (AUC) are higher in patients with impaired liver function; There are no recommendations for the dosage for this patient. Therefore, it is necessary to start amlodipine at the lowest dose in the recommended dose range and need to be cautious when starting to use the drug and when increasing the dose. Need to adjust the dose slowly and closely monitor in patients with severe liver failure.

Elderly

Be careful when increasing the dose in elderly patients

kidney failure

Can use amlodipine on this object at the usual doses. Change plasma amlodipine concentration is not correlated with the degree of renal failure. Amlodipine cannot be separated.

The ability to drive and operate machinery

There has been no research on the impact of Beatil on the ability to drive and operate cheeks. Should be cautious when driving or operating the machine because sometimes there is hypotension, headache, nausea, dizziness or fatigue.

pregnancy

do not recommend using Beatil in the first 3 months of pregnancy. If you are planning to get pregnant or sure you are pregnant, you need to switch to replacement therapy as soon as possible.

Contraindicated Beatil 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 3 months of pregnancy. Contraindicated use of enzyme inhibitors in the middle 3 months and the last 3 months of pregnancy.

Epidemiological evidence related to the risk of teratogenicity after exposure to enzyme inhibitors transferred in the first 3 months of pregnancy has not been concluded; However, it does not exclude the possibility that the drug increases this risk. Unless forced to continue treating with enzyme inhibitors, patients who have a plan to get pregnant should turn to other alternative therapy that have been shown to be safe during pregnancy. Women have been diagnosed with pregnancy, need to stop the use of enzyme inhibitors and replacement treatment with other therapy.

Exposure to enzyme inhibitors transferred in the three months and the last 3 months of pregnancy is known to be toxic to human fetus (reduced kidney function, amniotic fluid, skull retardation) and toxicity in infants (kidney failure, low blood pressure, hyperkalemia).

In case of exposure of enzyme inhibitors transferred in 3 months between pregnancy onwards, it is recommended that the ultrasound checks for kidney and skull function.

Children with mothers who have used enamel inhibitors should be closely monitored about the risk of hypotension.

Related to amlodipine

Amlodipine safety during pregnancy has not been established.

In animal studies, observing toxicity on reproduction in high doses.

Use during pregnancy is only recommended when there is no safer replacement therapy and when the disease is greater for both mother and fetus.

The period of breastfeeding

is not recommended to use Beatil during breastfeeding. Therefore, it is necessary to consider stopping breastfeeding or stopping beatil after evaluating the level of need for treatment for the mother.

Related to Perindopril

Because there is no information related to the use of Perindopril during breastfeeding, it is not recommended to use this drug and should choose safer alternatives, especially when infant or breastfed babies.

Related to amlodipine

It is unclear whether Amlodipin will be exposed to breast milk or not.

It is necessary to consider continuing or stopping breastfeeding or continuing or stopping amlodipine treatment based on the benefits of breastfeeding for children and the benefits of amlodipine treatment for the mother.

Drug interaction

related to Perindopril

Data from clinical trials shows that the double-anidensin-aldosteron dual clutches by using a combination of enzyme inhibitors, Angiotensin II or Aliskiren receptor blockers are associated with increased frequency of adverse events such as hypotension, hyperkalemia and kidney function impairment (including acute renal inserts) compared to a single-impact drug on a raer.

racecadotril: Move inhibitors (e.g. Perindopril) is known to cause angels. This risk can be increased when used simultaneously with racecadotril (an anti -acute diarrhea).

MTOR inhibitors (for example: syrolimus, Everolimus, temsirolimus): Patients use simultaneously with MTOR inhibitors may increase the risk of angioedema.

Hemorrhage -causing medicine:

Some drugs or therapy groups may increase the appearance of hyperkalemia: Aliskiren, potassium salts, potassium diuretics, yeast inhibitors, angiotensin II receptor antagonists, nonsteroidal anti -inflammatory drugs (NSAIDs), Heparin, immunosuppressants such as Ciclosporin, Tacrolimus, Trimethoprim. The combination of these drugs increases the risk of hyperkalemia.

There is no recommendation to simultaneously

estramustine: Increased risk of adverse effects such as vasodeic edema (angioedema).

Potassium diuretic (such as triamteren, amilorid), potassium salts: hyperkalemia (can lead to death), especially in patients with impaired renal function (hyperkalemia effect).

It is not recommended to simultaneously use Perindopril with the above mentioned drugs. If you still decide to use Perindopril simultaneously with these drugs, be cautious and regularly monitor serum potassium. Regarding use with Spironolacton in heart failure, please see the section below.

Lithi: Cases of increasing serum and toxic lithium concentration when used simultaneously lithium with enzyme inhibitors have been reported. It is not recommended to simultaneously use Perindopril with lithium. If this combination is really necessary, should control serum lithium levels carefully

Cases of use simultaneously need special care

Medications for diabetes (insulin, oral hypoglycemic drugs):

Epidemiological studies suggest that the simultaneous use of enzyme inhibitors and diabetes treatment drugs (insulin, oral hypoglycemic drugs) may increase the effect of hypoglycemia and risk of hypoglycemia.

This phenomenon is more common in the first week of combining treatment and on patients with renal failure.

baclofen:

Increased hypotension effect. Need to monitor blood pressure and adjust the dose of hypertension if necessary.

Diuretics do not keep potassium:

Patients who are taking diuretics, especially those who are impaired in the volume of body fluids and/or salt loss, may occur excessive hypotension when onset of treatment with enzyme inhibitors. The risk of hypotension may be reduced by stopping diuretics, increasing fluid volume or supplementing with salt before starting treatment with Perindopril in low doses and increasing.

In arterial hypertension, if previously treated with diuretics that reduced fluid volume or salt loss, need to choose or stop diuretics before starting the medication inhibitors, in this case, it may be used to return to diuretics that do not keep potassium afterwards, or be started to inhibit the enzyme inhibitors in low doses and then increase the dose of slowly.

In congestive heart failure treated with diuretics, it is necessary to start the enzyme inhibitors in very low doses, which may also be necessary to reduce the dose of diuretics without potassium.

In all cases, renal function (creatinine concentration) must be monitored in the first few weeks of treatment with enzyme inhibitors.

Potassium diuretics (Eplerenon, Spironolacton):

With eplerenon or spironolacton dose from 12.5 mg to 50 mg daily and low -dose enzyme inhibitors:

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

Before starting to coordinate the drug, it is necessary to check the hyperkalemia and impaired renal function. Advice to closely monitor blood potassium and blood creatinine levels in the first treatment scale at a frequency once a week and periodically monthly.

Non -steroid anti -inflammatory drugs (NSAID) include aspirin with a dosage> 3 g/day:

When using simultaneous use of enzyme inhibitors with non-steroid anti-inflammatory drugs (such as acetylsalicylic acid with anti-inflammatory doses, COX-2 inhibitors and non-selective NSAID drugs) The effectiveness of hypertension treatment can decrease. Simultaneous use of enzyme inhibitors and NSAIDs can lead to an increased risk of worsening kidney function including acute renal failure and increased serum potassium, especially in patients with reduced renal function in advance.

Be careful when combining the two groups of drugs mentioned above, especially in the elderly. Patients should be rehydrated and need to monitor kidney function after starting treatment with coordination regimen as well as periodic monitoring.

Cases of use simultaneously need to take care of

Anti -blood pressure and vasodilators: Concomitance these drugs can increase the hypotension effect of Perindopril. Simultaneous use with nitroglycerin and other nitrates, or other vasodilators, can cause additional blood pressure.

Gliptin groups (linagliptin, saxagliptin, sitqgliptin, vualdaqliptin): increased the risk of angioedema in patients using simultaneously with enzyme inhibitors due to the Dipeptidyl peptidase IV (DPP-IV) inhibitors of the Glyptin.

Triple/antidepressant/antidepressants/anesthesia: Concomitance some anesthetic, three -round antidepressants and psychotic anti -psychotic drugs with enzyme inhibitors can cause additional reduction in blood pressure

Paralgesic drugs: Sympathetic drugs can reduce the effect of treating hypertension of enzyme inhibitors.

Gold: Rare nitrite reactions (symptoms include flushing, nausea, vomiting and hypotension) in patients treated with golden therapy (sodium aurothiomalate) simultaneously with enzyme inhibitors such as Peridopril.

Contact Amlodipin

The effect of other drugs on amlodipine

CYP3A4 inhibitors:

Simultaneous use of amlodipine with strong or medium CYP3A4 inhibitors (such as protease inhibitors, -Azol antifungal drugs, macrolid -like drugs such as erythromycin or clarithromycin, verapamil or diltiazem) can significantly increase contact with amlodipine, leading to increased risk of lower blood pressure. The clinical significance of these pharmacokinetic changes may be more pronounced in the elderly. Recommended monitoring of the patient's clinical status and may need to adjust the dose.

CYP3A4 induction drugs:

There is no data on the image of CYP3A4 induction drugs on Amlodipine. The simultaneous use of amlodipine with CYP3A4 induction drugs (such as Rifampicin, Hypericum Perforatum - St. John grass) can reduce plasma amlodipine levels. Be careful when using amlodipine along with CYP3A4 induction drugs.

It is recommended not to use amlodipine along with grapefruit or grapefruit juice because some patients can increase bioavailability leading to increased hypotension.

dantrolen (Translation form):

On animals, death from ventricular vibration and cardiovascular collapse has been recorded with hyperkalemia after simultaneous use of Verapamil with venous dantrolen. Due to the risk of hyperkalemia, it is recommended to avoid coordinating with calcium channel blockers such as amlodipine for patients sensitive to malignant body hyperplasia and in the treatment of malignant body hyperplasia.

Effect of amlodipine on other drugs:

The hypotension effect of amlodipine plus the hypotension effect of antihypertensive drugs.

In clinical interactive studies, Amlodipin does not change the pharmacokinetics of Atorvastatin, Digoxin, Warfarin.

tacrolimus:

There is a risk of increased blood tacrolimus concentration in the blood when used simultaneously with amlodipine, but the pharmacokinetic mechanism of this interaction has not been fully determined. To avoid the toxicity of tacrolimus, when using amlodipine for patients being treated with tacrolimus, the concentration of tacrolimus in the blood and adjust the dose of Tacrolimus do the appropriate dose.

cyclosporin:

There is no medication interaction research between cyclosporin and amlodipine on healthy volunteers or other populations except for kidney transplant patients, in patients with kidney transplantation, which has recorded an increase in the base concentration of cyclosporin (average 0% - 40%). Consider monitoring cyclosporin levels in kidney transplant patients using amlodipine, and reducing cyclosporin when needed.

simvastatin:

Soonered with 10 mg of amlodipine and 80 mg of simvastatin leads to an increase of 77% of Simvastatin exposure compared to when using Simvastatin alone. The maximum dose of simvastatin in patients taking amlodipine is 20 mg daily.

Related to Beatil

Cases of use simultaneously need special care:

baclofen: Increasing hypotension effect. Monitoring blood pressure, kidney function and adjusting anti -hypertension dose if necessary.

Cases of use simultaneously need to consider:

Anticboo -pressure drugs (such as beta blockers) and vasodilators: Concomitant use with these drugs may increase the lowering effect of Perindopril and Amlodipine. Simultaneous use with nitroglycerin, other nitrates or vasodilators, reducing blood pressure, thus should be carefully considered.

corticosteroid, tetracosactid: reduce the effect of lowering blood pressure (due to corticosteroids holding salt and water).

Alpha-Blocker (Prazosin, Alfuzosin, Doxazosin, Tamsulosin, Terazosin): Increases the effect of lowering blood pressure and increases the risk of antihypertension.

Amifostin: Increases the hypotension effect of amlodipin.

Three -round antidepressants/psychotic/anesthetic drugs: Increases the effect of lowering blood pressure and increases the risk of hypotension.