Land: Malaysia
Språk: engelsk
Kilde: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
METOPROLOL TARTRATE
IDAMAN PHARMA MANUFACTURING SDN BHD
METOPROLOL TARTRATE
100 Tablets; 500 Tablets
IDAMAN PHARMA MANUFACTURING SDN BHD
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ BETATAB 100MG TABLET Metoprolol Tartrate 100mg 1 WHAT IS IN THIS LEAFLET 1. What Betatab 100mg Tablet is used for 2. How Betatab 100mg Tablet works 3. Before you use Betatab Tablet 100mg 4. How to use Betatab Tablet 100mg 5. While you are using Betatab 100mg Tablet 6. Side Effects 7. Storage and Disposal of Betatab 100mg Tablet 8. Product Description 9. Product Registration Holder and Manufacturer 10. Date of Revision WHAT BETATAB 100MG TABLET IS USED FOR Betatab Tablet 100mg is used to treat: • Hypertension: to reduce blood pressure and to reduce the risk of cardiovascular and coronary mortality (including sudden death), and morbidity. • Angina pectoris (chest pain) • Disturbances of cardiac rhythm including especially supraventricular tachycardia (irregular heartbeat or abnormal heart rhythm) • Confirmed or suspected myocardial infarction (heart attack) - prevention of cardiac death and reinfarction. • Functional heart disorders with palpitations (a fast-beating, fluttering or pounding heart). • Migraine prophylaxis (treatment for migraine) • Hyperthyroidism (overproduction of thyroid hormone by thyroid gland). HOW BETATAB 100MG TABLET WORKS Betatab 100mg Tablet slows the heartbeat, lessen the force with which the heart muscle contracts and reduce blood vessel contraction in the heart, brain, and throughout the body. BEFORE YOU USE BETATAB 100MG TABLET _-WHEN YOU MUST NOT USE IT _ Do not use Betatab 100mg Tablet and tell your doctor if you: • allergic (hypersensitive) to metoprolol, other beta-blockers (drugs to treat high blood pressure and heart failure) or any of the other ingredients contained in Betatab Tablet 100mg. • Have a heart block (the electrical signal that controls the heartbeat is partially or completely blocked) • Have severe or uncontrolled heart failure • Have a slow, regular heartbeat. • Have a sick sinus syndrome (irregular heartbeat). • Suffer from a tight, painful feeling in the chest in periods of rest (Prinz met Les hele dokumentet
IDAMAN PHARMA MANUFACTURING BETATAB 100MG TABLET DESCRIPTION A white to off white, round, biconvex tablet with scoreline on one side. COMPOSITION Each tablet contains Metoprolol Tartrate 100mg. PHARMACODYNAMICS Metoprolol tartrate is a cardio-selective beta-adrenergic blocking agent. It has a relatively greater blocking effect on beta 1 -receptors (ie those mediating adregenic stimulation of heart rate and contractility and release of free fatty acids from fat stores) than on beta 2 - receptors, which are chiefly involved in broncho and vasodilation. PHARMACOKINETICS Absorption Metoprolol is readily and completely absorbed from the gastrointestinal tract. Metoprolol is absorbed fully after oral administration. Within the therapeutic dosage range, the plasma concentrations increase in a linear manner in relation to dosage. Peak plasma levels are achieved after approx. 1.5–2 hours. Even though the plasma profile displays a broader interindividual variability, this appears to be easily reproducible on an individual basis. Due to the extensive first-pass effect, bioavailability after a single oral dose is approx. 50%. After repeated administration, the systemic availability of the dose increases to approx. 70%. After oral intake with food, the systemic availability of an oral dose increases by [SIC] approx. 30– 40%. Distribution Peak plasma concentrations occur about 1½ hours after a single oral dose. Peak plasma metoprolol concentrations at steady state with usual doses have been reported as 20-340ng/ ml. Metoprolol is widely distributed, it crosses the bloodbrain barrier, the placenta. It is slightly bound to plasma protein. Biotransformation Metoprolol is metabolised through oxidation in the liver mainly by the CYP2D6 isoenzyme. Even though three main metabolites have been identified, none of them has a clinically significant beta-blocking effect. Generally, 95% of an oral dose is found in the urine. Only 5% of the dose is excreted unmodified via the kidneys; in isolated cases, this figure can reach as high a Les hele dokumentet