Beatil 4mg/5mg Gedeon treatment treatments for idiopathic hypertension, stable coronary artery disease (3 blisters x 10 tablets)

Dosage form Box of 3 blisters x 10 tablets
Specifications Perindopril, amlodipine
Ingredient Coronary artery disease, high blood pressure

Ingredient

Composition information	Content
Perindopril	4mg
Amlodipine	5mg

Uses

Indications

Beatil 4mg/5mg drug is indicated as alternative therapy in the treatment of idiopathic hypertension and/or stable coronary artery disease, in patients who are controlled simultaneously with Perindopril and Amlodipine at the same dose level.

Pharmacology

Perindopril

is an enzyme inhibitor in the form of angiotensin I into angiotensin II (ACE: enzyme that converts angiotensin). The enzyme shifts (or kinase) is an expeptidase that helps convert angiotensin I into angiotensin II, vasodilators and broke bradykinine vasodilation chemicals to make the hollapeptide inactive.

When inhibiting ACE will reduce angiotensin II in plasma, resulting in increasing lenin activity in plasma (due to inhibition of negative feedback of the secretion) and reducing the secretion of aldosterone. Because Ace loses the activity of Bradykinine, ACE inhibits will increase the activity of the kallikrein-kinin system in place and the whole body (and therefore also activate the prostaglandin system). It is likely that this mechanism has contributed to the effect of lowering the hypotension of ACE inhibitors and partly responsible for some side effects of Perindopril (for example, cough).

Perindopril has an active metabolic substance as Perindoprilat. Other metabolites do not inhibit the active in vitro.

amlodipine

is an inhibitor of calcium ions, belonging to the dihydropyridine group (slow channel blockage or calcium ion antagonist) and inhibitors of calcium ionic ions enter the heart and smooth muscles of blood vessels. The anti -hypertension mechanism of Amlodipine is due to the effect of directly relaxing blood vessel muscle.

pharmacokinetics

perindopril

After taking Perindopril quickly absorbed and the peak concentration reached after 1 hour. Perindopril's waste sale time in plasma is 1 hour.

Perindopril is a precursor. 27% of Perindopril dose is in the circulation in the form of an active Perindoprilat metabolite.

Foods that limit metabolism to Perindoprilat, which is to limit bioavailability, so it is necessary to take Perindopril 1 single dose of the day in the morning, drink before meals.

The distribution volume (VD) is about 0.2 liters/kg with non -cohesive perindoprilat form. Perindoprilat bonding protein accounts for 20% of plasma proteins.

Perindoprilat's elimination will decrease in the elderly and even in patients with heart failure or kidney disease. Perindoprilat's purification through the separation is 70ml/min.

Perindopril's dynamics change in cirrhosis patients: Perindopril's liver purification (Perindopril) will be half reduced in cirrhosis. However, the amount of perindoprilate is formed without decreasing and therefore no dose adjustment.

amlodipin

After drinking with treatment dose, amlodipine absorbs well, reaching the blood peak concentration after use 6-12 hours. Absolute bioavailability is 64-80%. The distribution volume (VD) is about 21 liters/kg. Born is not affected by food. In vitro research shows about 97.5% amlodipine circulation is attached to plasma proteins.

Selling time is about 35-50 hours and stable with a single dose of the day. Amlodipine metabolizes largely in the liver so that the metabolites are inactive. About 60% of the dose will be discharged through the urine, of which 10% is non -metabolized amlodipine.

Before taking Beatil 4mg/5mg Gedeon treatment treatments for idiopathic hypertension, stable coronary artery disease (3 blisters x 10 tablets)

How to use

Take oral use. Should take medicine in the morning and before meals.

Dosage

adults

Take 1 capsule/day.

Preparations in combination with fixed dose are not suitable for initial treatment.

If you need to change the dose, the dose should be adjusted for each individual ingredient using single -composition preparations.

Patients with impaired renal function and elderly

Perindopril's elimination decreases in the elderly and patients with impaired renal function. Therefore, regular monitoring of creatinine and potassium should be monitored.

Beatil can be used for patients with Creatinin Clcr ≥ 60ml/min, not suitable for patients with ClCR

Change of plasma amlodipine concentration is not related to the level of renal failure. Amlodipin cannot be separated.

Patients with liver function impairment

The level of dosage for patients with impaired liver function has not been set. Therefore, be careful when using Beatil in these patients.

Children

The drug should not be used for young and teenagers because of the efficiency and tolerance of Perindopril when used alone or in combination with Amlodipine not yet established on these objects.

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 using overdose?

What to do when you forget 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 Beatil, you may experience unwanted effects (ADR).

Common, ADR> 1/100

Neurology: Sleeping, dizziness, headache, abnormalities ...

Eye: visual disorders.

ears and mesmerizing: tinnitus.

Cardiovascular: Brushing chest drum, flushing, tachycardia, hypotension.

Respiratory: Difficulty breathing, cough.

digestive: abdominal pain, nausea, indigestion, constipation.

Skin and subcutaneous tissue: itching, rash.

Muscle muscle: Swelling of the fish eyes, cramps.

Uncommon, 1/1000

Neurological: Run, rebel, faint, paresthesia.

Cardiovascular: arrhythmia. Respiratory: Bronchospasm. digestive: dry mouth, vomiting.

Skin and subcutaneous tissue: Hair loss, bleeding, skin color change, increased sweating. genital: impotence, big breasts in men, erectile dysfunction.

Digital kidney: urination disorders, night urination, increased frequency of urination.

musculoskeletal: joint pain, muscle pain, back pain.

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

Beatil drug is contraindicated in the following cases:

Hypersensitivity to any ingredients of the drug.

Hypersensitivity to Peridopril or any other transfer inhibitors.

History of angioedema related to the previous transferred medications.

Genetic or spontaneous angioedema.

Pregnant women in the middle of the middle or the last three months of pregnancy.

SHOULD BECLOADIL with Aliskiren -containing drugs in diabetic patients or patients with renal impairment (glomerular filtration level

Serious hypotension.

Hypersensitivity to amlodipine or any drug belongs to the dihydropyridine group.

Shock, including cardiac shock.

Blood flow congestion from the left ventricle (for example: severe aorta stenosis).

Heart failure with unstable hemodynamic 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 drops:

Transfer inhibitors can cause hypotension.

Aortic stenosis and hypertrophic 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 decline:

In case of renal failure (creatinine clearance Patients with hemolysis:

There have been reports on anaphylactic reactions in patients who are separated by high diabetes filter and simultaneous use of enzyme inhibitors.

kidney transplantation:

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

Hypersensitivity/eagles:

Facility on the face, limbs, lips, mucosa, tongue, subjects and/or larynx are rarely reported in patients treated with enzyme inhibitors, including perindopril.

Hemorrhage:

Serum hyperpass has been recorded in some patients treated with enzyme inhibitors, including perindopril.

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.

Lithi:

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

Potassium drugs, potassium supplements and potassium -containing potential products:

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

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.

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.

The ability to drive and operate machinery

There is no research on the effect of Beatil on the ability to drive and operate the machine. 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.

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.

Drug interaction

involving Perindopril

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 that causes hyperkalemia: Some medications or therapy groups may increase the appearance of hyperkalemia: Aliskiren, potassium salts, potassium diuretics, enzyme inhibitors, Angiotensin II antagonist drugs, nonsteroidal anti -inflammatory drugs (NSAIDs), Heparin, immunosuppressants such as ciclosporin, tacrolimus, trimethrim. The combination of these drugs increases the risk of hyperkalemia.

It is not recommended to simultaneously use Perindopril with estramustine, potassium diuretic (such as triamteren, amilorid), potassium salts.

related to amlodipine

CYP3A4 inhibitors: simultaneous use of amlodipine with strong or medium CYP3A4 inhibitors (such as protease inhibitors, -Azol antifungal drugs, macrolid medications such as erythromycin or clarithromycin, verapamil or diltiazem) can significantly increase contact with amlodipine. 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 effects of CYP3A4 induction drugs on Amlodipin. The simultaneous use of amlodipine with CYP3A4 induction drugs (such as Rifampicin, Hypericum Perforatum - Sacred John) 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 effect.

Amlodipine's hypotension effect plus the hypotension effect of other hypotension.

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

tacrolimus: There is a risk of increased blood concentration in the blood when used simultaneously with amlodipine.

Storage

Store at temperatures below 30 ° C, in the original packaging to avoid moisture and light.

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