BETALOC ZOK Tablet

គុណភាពព្យាបាល៖

- សម្ពាធឈាមឡើង

- ចុកដើមទ្រូងបណ្តាលមកពីឈាមចូលក្នុងបេះដូងមិនគ្រប់គ្រាន់

- ខ្សោយមុខងារបេះដូងរុំារ៉ៃ

- បង្ការការស្លាប់ដោយសារជំងឺបេះដូង និងបង្ការការលាប់នៃជំងឺជាលិកាបេះដូងធ្ងន់ធ្ងរ

- ចង្វាក់បេះដូងដើរមិនទៀងទាត់

- វិបត្តិមុខងារបេះដូងដោយការញ័រដើមទ្រូង

- ការពារជំងឺឈឺក្បាលប្រកាំង។

កម្រិត និងរបៀបប្រើ៖

- ជំងឺសម្ពាធឈាមឡើងខ្ពស់៖ ប្រើ 50ម.ក្រ 1ថ្ងៃ 1ដង។ អាចបង្កើនដល់ 100ម.ក្រ ទៅ 200ម.ក្រ 1ថ្ងៃ 1ដង និង/ឬ ប្រើរួមជាមួយឱសថប្រឆាំងសម្ពាធឈាមឡើងដទៃទៀត។

- ជំងឺចុកទ្រូងដោយខ្វះឈាមផ្គត់ផ្គង់បេះដូង៖ ប្រើ 100ម.ក្រ ទៅ 200ម.ក្រ 1ថ្ងៃ 1ដង។

- ខ្សោយបេះដូងជាប្រចាំកម្រិត II (function class II)៖ ប្រើ 25ម.ក្រ 1ថ្ងៃ 1ដង សម្រាប់រយៈពេល 2 អាទិត្យដំបូង ក្រោយ 2 អាទិត្យបន្ទាប់មកអាចបង្កើនកម្រិតប្រើដល់ 50ម.ក្រ 1ថ្ងៃ 1ដង និងអាចប្រើកើនកម្រិត 2ដងទៀត រាល់ 2អាទិត្យម្តង។ ការព្យាបាលរយៈពេលយូរ កម្រិតប្រើ អាចកើនដល់ 200ម.ក្រ 1ថ្ងៃ 1ដង។

- ខ្សោយបេះដូងជាប្រចាំកម្រិត III-IV (function class III-IV): ចាប់ផ្តើមប្រើពី 12.5 ម.ក្រ 1ថ្ងៃ 1ដង ក្រោយរយៈពេល 2អាទិត្យ កម្រិតប្រើអាចបង្កើនដល់ 25ម.ក្រ 1ថ្ងៃ ដង និងបន្ទាប់ពី 2អាទិត្យក្រោយមក កម្រិតប្រើអាចបង្កើនដល់ 50ម.ក្រ 1ថ្ងៃ 1ដង។ ចំពោះអ្នកជំងឺដែល អាចប្រើកម្រិតខ្ពស់បាន អាចបង្កើនកម្រិត 2ដង រាល់ 2អាទិត្យម្តង កម្រិតអតិបរមាគឺ 200ម.ក្រក្នុង 1ថ្ងៃ។

- ចង្វាក់បេះដូងដើរមិនទៀង៖ ប្រើ 100ម.ក្រ ទៅ 200ម.ក្រ 1ថ្ងៃ 1ដង។

- ការពារជំងឺងាប់ជាលិកាបេះដូង៖ ប្រើរយៈពេលយូរ 200ម.ក្រ 1ថ្ងៃ 1ដង។

- វិបត្តិមុខងារបេះដូង និងញ័រដើមទ្រូង៖ ប្រើ 100ម.ក្រ 1ថ្ងៃ 1ដង បើចាំបាច់អាចបង្កើនដល់ 200ម.ក្រ 1ថ្ងៃ 1ដង។

- ការពារជំងឺឈឺក្បាលប្រកាំង៖ ប្រើ 100ម.ក្រ ទៅ 200ម.ក្រ 1ថ្ងៃ 1ដង។

- ជំងឺខ្សោយមុខងារតម្រងនោម ថ្លើម ចំពោះមនុស្សចាស់ និងក្មេង ត្រូវគោរពតាមវេជ្ជបញ្ជា​ ឬឱសថការី។

Hypertension: to reduce blood pressure and to reduce the risk of cardiovascular and coronary mortality (including sodden death), and morbidity.

Angina pectoris.

Stable symptomatic chronic heart failure with impaired systolic left ventricular function as an adjunct to existing heart failure therapy.

Prevention of cardiac death and reinfarction after the acute phase of myocardial infarction.

Cardiac arrhythmias especially including supraventricular tachycardia, reduction of ventricular rate in atrial fibrillation and in ventricular extra systoles.

Functional heart disorders with palpitations.

Migraine prophylaxis.

Posology and method of administration

Betaloc ZOK is intended for once daily treatment and is preferably taken in the morning. The Betaloc ZOK tablet should be swallowed with liquid. The tablets and the divided halves should not be chewed or crushed. Concomitant intake of food does not influence the bioavailability.

Dosage should be adjusted to avoid bradycardia.

Hypertension

The recommended dosage in patients with mild to moderate hypertension is 50mg Betaloc ZOK given once daily. In patients not responding to 50mg the dose could be increased to 100-200mg once daily and/or combined with other antihypertensive agents.

Angina pectoris

The recommended dosage is 100-200mg Betaloc ZOK given once daily. If needed, Betaloc ZOK can be combined with other antianginal agents.

Stable symptomatic chronic heart failure with impaired systolic left ventricular function as an adjunct to existing heart failure therapy

The patents should have a stable chronic heart failure, without acute failure for the last 6 weeks and an essentially unchanged basal therapy for the last 2 weeks.

Treatment of heart failure with beta-blockers may sometimes cause a temporary exacerbation of the symptoms picture. In some cases, it is possible to continue the therapy or reduce the dose, and in other cases it may be necessary to discontinue the treatment. Initiation of Betaloc ZOK therapy in patients with severe heart failure (NYHA Ⅳ) should only be made by physicians especially trained in treatment of heart failure.

See the package insert about the details below:

Dosage in patients with stable heart failure, function classⅡ:

Dosage in patients with stable heart failure, function class Ⅲ-Ⅳ:

Cardiac arrhythmias

The recommended dosage is 100-200mg given once daily.

Prophylactic treatment after myocardial infarction

Long-term oral treatment with metoprolol in doses of 200mg given once daily has been shown to reduce the risk of death (including sudden death), and to reduce the risk of reinfarction (also in patients with diabetes mellitus).

Functional heart disorders with palpitations

The recommended dosage is 100mg once daily. If needed, the dose can be increased to 200mg.

Migraine prophylaxis

The recommended dosage is 100-200mg once daily.

See the package insert about the details below:

Impaired renal function

Impaired hepatic function

Elderly

Children

ហាមប្រើចំពោះ៖

- អ្នកដែលស្ទះចលនាបេះដូងថតលើ និងថតក្រោម កម្រិត 2 ឬកម្រិត 3

- អ្នកជំងឺខ្សោយបេះដូងមិនទៀងទាត់ (ហើមសួត ឬសម្ពាធឈាមចុះ)

- អ្នកជំងឺកំពុងព្យាបាលវិបត្តិកន្ត្រាក់សាច់ដុំបេះដូងលោះពេល ឬកន្ត្រាក់បន្តបន្ទាប់ដូចជាបេះដូងដើរយឺត។

- អ្នកជំងឺដែលសង្ស័យមានជំងឺងាប់ជាលិកាបេះដូងធ្ងន់ធ្ងរ

- អ្នកដែលមានអាការៈធីងធោង ភ័ន្តភាំងស្មារតី ខ្សោយកម្លាំង ខ្សោយបេះដូងបណ្តាលមកពីសាច់ដុំកន្រ្តាក់ និងបេះដូងចុះខ្សោយ (Sick-sinus syndrome)

- អ្នកជំងឺងាយមានប្រតិកម្មជាមួយសារធាតុផ្សំណាមួយនៃឱសថនេះ

- ប្រតិកម្មស្ហុកដោយបេះដូងឈប់ដើរ (Cardiogenic shock)

- វិបត្តិចលនាឈាមរត់ចេញពីបេះដូង

- ឱសថនេះមិនគួរប្រើលើអ្នកដែលសង្ស័យកើតមានជំងឺងាប់ជាលិកាបេះដូងធ្ងន់ធ្ងរដោយមានចលនាបេះដូងលោតក្រោម 45 ដងក្នុង 1នាទី។

Atrioventricular block of second or third degree, patients with unstable decompensated cardiac failure (pulmonary oedema, hypoperfusion or hypotension), and patients with continuous or intermittent inotropic therapy acting through beta-receptor agonism; clinically relevant sinus bradycardia, sick-sinus syndrome (unless a permanent pacemaker is in place), cardiogenic shock, severe peripheral arterial circulatory disorder.

Metoprolol should not be given to patients with suspected acute myocardial infarction as long as the heart rate is <45 beats/min, the P-Q interval is >0.24sec or the systolic blood pressure is <100mmHg.

Betaloc ZOK is contraindicated in patients who have shown hypersensitivity to any component of the product or to other beta-blockers.

- លើប្រព័ន្ធចលនាឈាមរត់៖ កើតមានញឹកញាប់៖ ចង្វាក់បេះដូងដើរយឺត ខ្យល់គ ត្រជាក់ចុងដៃ ចុងជើង ញ័រដើមទ្រូង។ កើតមានមិនញឹកញាប់៖ ខ្សោយ បេះដូងប្រតិកម្មស្ហុកដោយបេះដូងឈប់ដើរ (Cardiogenic shock) ស្ទះចលនាបេះដូងថតលើ និងថតក្រោមកម្រិត I (AV block I) ហើមចុកទ្រូង។ កើតមានដោយកម្រ៖ វិបត្តិចម្លងអគ្គិសនីបេះដូង ចង្វាក់បេះដូង ដើរមិនទៀងទាត់។ កើតមានដោយកម្របំផុត៖ ដំបៅរលួយបណ្តាលមកពីខ្វះឈាម ចិញ្ចឹមកោសិកា

- លើប្រព័ន្ធសរសៃប្រសាទកណ្តាល៖ កើតមានយ៉ាងញឹកញាប់៖ ហេវហត់។ កើតមានញឹកញាប់៖ វិលមុខ ឈឺក្បាល។ កើតមានមិនញឹកញាប់៖ ស្ពឹកមួយចំហៀងខ្លួន រមួលសាច់ដុំ។

- លើប្រព័ន្ធសរសៃប្រសាទកណ្តាល៖ កើតមានយ៉ាងញឹកញាប់៖ ហេវហត់។ កើមានញឹកញាប់៖ វិលមុខ ឈឺក្បាល។ កើតមានមិនញឹកញាប់៖ ស្ពឹកមួយចំហៀងខ្លួន រមួលសាច់ដុំ។

- លើប្រព័ន្ធរំលាយអាហារ៖ កើតមានញឹកញាប់៖ ថង់ក្អួត ចុកពោះ រាកទល់លាមក។ កើតមានមិនញឹកញាប់៖ ក្អួត។ កើតមានដោយកម្រ៖ ស្ងួតមាត់។

- ឈាម៖ ចំនួនប្លាកែតថយចុះ។

- លើថ្លើម៖ កើតមានដោយកម្រ៖ មុខងារថ្លើមប្រែប្រួល។ កើតមានដោយកម្របំផុត៖ រលាកថ្លើម។

- លើសាច់ដុំជាប់ឆ្អឹង៖ ឈឹសន្លាក់។

- លើការបំលែងចំណីអាហារ (metabolism): ឡើងទំងន់។

- លើផ្លូវចិត្ត៖ កើតមានញឹកញាប់៖ ធ្លាក់ទឹកចិត្ត ស្មារតីចុះខ្សោយ ដេកមិនលក់ សុបិន្តអាក្រក់។ កើតមានមិនញឹកញាប់៖ មួរម៉ៅ អារម្មណ៍ជ្រួលច្របល់ បាត់បង់សមត្ថភាពផ្លូវភេទ។ កើតមានដោយកម្រ៖ ខ្សោយការចងចាំ ភ័ន្តភាំងស្មារតី រវើរវាយ។

- លើផ្លូវដង្ហើម៖ កើតមានញឹកញាប់៖ ការពិបាកដកដង្ហើម។ កើតមានមិនញឹកញាប់៖ ទងសួតរួមតូច។ កើតមានញឹកញាប់៖ ការពិបាកដងដង្ហើម។ កើតមានមិនញឹកញាប់៖ ទងសួតរួមតូច។ កើតមានដោយកម្របំផុត៖ ហ៊ឹងត្រចៀក វិបត្តិរសជាតិ។

- លើសរីរាង្គវិញ្ញាណ៖ កើតមានដោយកម្រ៖ វិបត្តិគំហើញ ស្ងួតមាត់ និង/ឬ រលាកភ្នែក ឈឺភ្នែកក្រហម។ កើតមានដោយកម្របំផុត៖ ហ៊ឺងត្រចៀក វិបត្តិរសជាតិ។

- លើស្បែក៖ កើតមានញឹកញាប់៖ កន្ទួលលើស្បែក កន្ទាលត្រអាក បែកញើស។ កើតមានមិនញឹកញាប់៖ ជ្រុះសក់។ កើតមានដោយកម្រ៖ ខ្លាចពន្លឺថ្ងៃ បែកស្រកាជជុះមាន់។

Cardiovascular system

Common: Bradycardia, postural disorders (very rarely with syncope), cold hands and feet, palpitations.

Uncommon: Transient deterioration of heart failure symptoms, cardiogenic shock in patients with acute myocardial infarction, AV-block, oedema, precordial pain.

Rare: Disturbances of cardiac conduction, cardiac arrhythmias.

Very rare: Gangrene in patients with pre-existing severe peripheral circulatory disorders.

Central nervous system

Very common: Fatigue.

Common: Dizziness, headache.

Uncommon: Paraesthesiae, muscle cramps.

Gastrointestinal

Common: Nausea, abdominal pain, diarrhoea, constipation.

Uncommon: Vomiting.

Rare: Dry mouth.

Haematologic

Very rare: Thrombocytopenia.

Hepatic

Rare: Liver function test abnormalities.

Very Rare: Hepatitis.

Musculoskeletal

Very rare: Arthralgia.

Metabolism

Uncommon: Weight gain.

Psychiatric

Uncommon: Depression, concentration impaired somnolence or insomnia, nightmares.

Rare: Nervousness, anxiety, impotence/sexual dysfunction.

Very rare: Amnesia/memory impairment, confusion, hallucinations.

Respiratory

Common: Dyspnoea on exertion.

Uncommon: Bronchospasm.

Rare: Rhinitis.

Sense organs

Rare: Disturbances of vision, dry and/or irritated eyes, conjunctivitis.

Very rare: Tinnitus, taste disturbances.

Skin

Uncommon: Rash (in the form of urticaria psoriasiform and dystrophic skin lesions), increased sweating.

Rare: Loss of hair.

Very rare: Photosensitivity reactions, aggravated psoriasis.

- ឱសថនេះប្រើជាមួយឱសថ Verapamil ឱសថ Diltiazem និងឱសថសម្រួលចង្វាក់បេះដូងក្រុម I (Class I antiarrhythmic) បណ្តាលឱ្យខ្សោយសាច់ដុំកន្ត្រាក់បេះដូង។

- ឱសថនេះប្រើជាមួយឱសថ beta blocker ដទៃទៀតបាន តែត្រូវស្ថិតនៅក្នុងការតាមដានរបស់គ្រូពេទ្យ។

See the package insert about the details below:

Drugs that act as CYP2D6 -inducing and CYP2D6 -inhibiting substances, compounds metabolised by CYP2D6 (e.g. antiarrhythmics, antihistamines, histamine-2-receptor antagonists, antidepressants, antipsychotics, COX-2-inhibitors).

Rifampicin

Alcohol, Hydralazine

Sympathetic ganglion blocking agents, other beta-blockers (e.g. eye drops), MAO inhibitor

Clonidine

Calcium antagonists of the verapamil and diltiazem type and/or antiarrhythmic agents

Antiarrhythmic agents (of the quinidine type and amiodarone)

Digitalis glycosides

Inhalation anaesthetics

Indomethacin or other prostaglandin synthetase inhibiting drugs

Adrenaline

Oral antidiabetics

ស្រ្តីមានផ្ទៃពោះ និងបំបៅកូនមិនគួរប្រើឱសថនេះទេ ប៉ុន្តែបើចាំបាច់ត្រូវតែប្រើ ត្រូវពិគ្រោះជាមួយគ្រូពេទ្យជាមុន។

As with most drugs, Betaloc ZOK should not be given during pregnancy and lactation unless its use is considered essential. In general, beta-blockers reduce placental perfusion, which has been associated with growth retardation, intrauterine death, abortion and early labour. It is therefore suggested that appropriate maternofetal monitoring be performed in pregnant women treated with metoprolol. As with all antihypertensive agents. Beta-blockers may cause side-effects, e.g. bradycardia, in the foetus and in the newborn and breast-fed infant.

The amount of metoprolol ingested via breast-milk, however, seems to be negligible as regards beta-blocking effect in the infant if the mother is treated with metoprolol in doses within the normal therapeutic range.

- ការចាក់តាមសរសៃនូវឱសថ Calcium antagonists នៅពេលកំពុងព្យាបាលជាមួយឱសថនេះ និងឱសថ beta blocker

- ឱសថនេះត្រូវប្រើតាមកម្រិតឱសថបានត្រឹមត្រូវនៅពេលប្រើជាមួយឱសថព្យាបាលជំងឺហឺត

- ឱសថនេះផ្តល់ផលរំខានដល់ការបំលែងចំណីអាហារ

- ចំពោះអ្នកជំងឺដែលឈឺចាប់បណ្តាលមកពីបេះដូងចុះខ្សោយគួរព្យាបាលការឈឺចាប់នេះសិន មុននិងអំឡុងពេលប្រើឱសថនេះ។

- ការប្រើឱសថនេះលើអ្នកដែលមានវិបត្តិស្ទះចលនាបេះដូងកម្រិតមធ្យម វិបត្តិនេះអាចកានតែធ្ងន់ធ្ងរ តែកើតឡើងដោយកម្រ

- ប្រសិនបើអ្នកជំងឺមានចង្វាក់បេះដូងដើរយឺត ត្រូវប្រើកម្រិតទាប ឬឈប់ប្រើ

- ឱសថនេះអាចបណ្តាលឱ្យមានវិបត្តិចលនាឈាមដែលចេញពីបេះដូង និងឱ្យមានសម្ពាធឈាមចុះធ្ងន់ធ្ងរ

- ស្ត្រីមានផ្ទៃពោះ និងបំបៅកូន មិនគួរប្រើឱសថនេះទេ ប៉ុន្តែបើចាំបាច់ត្រូវតែប្រើត្រូវពិគ្រោះជាមួយគ្រូពេទ្យជាមុន

- អ្នកបើកបរយានយន្ត និងបញ្ជាគ្រឿងម៉ាស៊ីន អាចមានគ្រោះថ្នាក់ពីព្រោះការប្រើឱសថនេះបណ្តាលឱ្យមានអាការៈ វិលមុខ ឬហេវហត់។

Intravenous administration of calcium antagonists of the verapamil-type should not be given to patients treated with beta-blockers.

Generally when treating patients with asthma, concomitant therapy with a beta2-agonist (tablet and/or inhalation) should be administered. The dosage of beta2-agonists may require adjustment (increase) when treatment with Betaloc ZOK is stared. The risk of Betaloc ZOK interfering with beta2-receptors is however less than with conventional tablet formulations of beta1-selective blockers.

During treatment with Betaloc ZOK, the risk of interfering with carbohydrate metabolism or masking hypoglycaemia is likely to be less than during treatment with conventional tablet formulations of beta1-selective blockers and much less than with non-selective beta-blockers.

Patients suffering from heart failure should have their decompensation treated both before and during treatment with Betaloc ZOK.

Very rarely, a pre-existing A-V conduction disorder of moderate degree may become aggravated (possibly leading to A-V block).

If the patients develop increasing bradycardia, Betaloc ZOK should be given in lower doses or gradually withdrawn.

Betaloc ZOK may aggravate the symptoms of peripheral arterial circulatory disorders mainly due to its blood pressure lowering effect.

Where Betaloc ZOK is prescribed for a patient known to be suffering from a phaeochromocytoma, an alpha-blocker should be given concomitantly.

Prior to surgery the anaesthetist should be informed that the patient is receiving Betaloc ZOK. It is not recommended to stop beta-blocker treatment in patients undergoing surgery. Acute initiation of high-dose metoprolol to patients undergoing non-cardiac surgery should be avoided, since it has been associated with bradycardia, hypotension and stroke including fatal outcome in patients with cardiovascular risk factors.

Efficacy/safety data from controlled clinical studies in severe stable symptomatic heart failure (NYHA classⅣ)are limited. Treatment of heart failure in these patients should therefore only be initiated by physicians with especial experience and training in this area.

Patients with symptomatic heart failure in association with acute myocardial infarction and unstable angina pectoris were excluded from the study on which the indication of heart failure is founded. Efficacy/safety conditions have therefore not been documented. Use in unstable, decompensated heart failure is contraindicated.

Abrupt interruption of the medication is to be avoided. Sudden withdrawal of beta-blockade is hazardous, especially in high-risk patients, and may aggravate chronic heart failure as well as increase the risk of myocardial infarction and sudden death. Any withdrawal of Betaloc ZOK should therefore, if possible, be made gradually over at least 2 weeks when the dose is reduced by half in each step, down to the final dose when a 25mg tablet is reduced to half a tablet. The final dose should be given for at least 4 days before discontinuation. If symptoms occur, a slower anaphylactic shock assumes a more severe form.

Metoprolol is a beta1-selective beta-blocker, i.e. it blocks beta1-receptors at doses much lower than those needed to block beta2-receptors.

Metoprolol has an insignificant membrane-stabilising effect and does

Metoprolol reduces or inhibits the agonistic effect on the heart of catecholamines (which are released during physical and mental stress). This means that the usual increase in heart rate, cardiac output, cardiac contractility and blood pressure, produced by the acute increase in catecholamines, is reduced by metoprolol. During high endogenous adrenaline levels metoprolol interferes much less with blood pressure control than non-selective beta-blockers.

When mandatory, Betaloc ZOK, in combination with a beta2-agonist, may be given to patients with symptoms of obstructive pulmonary disease.

When given together with a beta2-agonist, Betaloc ZOK in therapeutic doses interferes less than non-selective beta-blockers with the beta2-mediated broncho-dilation caused by the beta2-agonist.

Betaloc ZOK gives an even plasma concentration time profile and effect (beta1-blockade) over 24 hours in contrast to conventional tablet formulations of beta-selective blockers.

Due to the lack of pronounced peaks in plasma concentration, the clinical beta1-selectivity is improved with the Betaloc ZOK formulation when compared to conventional tablet formulations of beta1-selective blockers. Furthermore the potential risk for peak plasma concentration related side-effects, such as bradycardia and leg fatigue is reduced. Betaloc ZOK interferes less with insulin release and carbohydrate metabolism than do non-selective beta-blockers.

Betaloc ZOK interferes much less with the cardiovascular response to hypoglycaemia than do non-selective beta-blockers.

Short term studies have shown that Betaloc ZOK may cause a slight increase in triglycerides and a decrease in free fatty acids in the blood. In some cases, a small decrease in the high density lipoproteins (HDL) fraction has been observed, although to a lesser extent than that following non-selective beta-blockers. However, a significant reduction in total serum cholesterol levels has been demonstrated after metoprolol treatment in one study conducted over several years.

In addition, it has been shown that Betaloc ZOK therapy increases the ejection fraction and reduces the left ventricular and systolic and diastolic volumes.