Country: Malaysia
Bahasa: Inggeris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
TRIMETAZIDINE DIHYDROCHLORIDE
Gopharma Sdn. Bhd.
TRIMETAZIDINE DIHYDROCHLORIDE
20tablet Tablets; 60tablet Tablets; 100tablet Tablets
MICRO LABS LTD
CARVIDON-MR Trimetazidine Dihydrochloride Modified Release Tablets 35 mg 1 Consumer Medication Information Leaflet (RiMUP) What is in this leaflet 1. What Carvidon-MR is used for 2. How Carvidon-MR works 3. Before you use Carvidon-MR 4. How to use Carvidon-MR 5. While you are using it 6. Side effects 7. Storage and Disposal of Carvidon- MR 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision What Carvidon-MR is used for This medicine is intended for use in combination with other medicine to treat angina pectoris (chest pain caused by coronary disease). How Carvidon-MR works Trimetazidine acts by inhibiting the breakdown of fatty acids which enhances glucose oxidation. Glucose oxidation requires less oxygen consumption thus optimises the heart's energy producing function, protecting vulnerable heart muscle tissues from further oxygen- deprived damage Before you use Carvidon-MR - When you must not use it Do not take Carvidon-MR - If you are allergic to Trimetazidine or to any other ingredients of this medicine. - If you have a Parkinson disease: disease of the brain affecting movement (trembling, rigid posture, show movements and a shuffling, unbalanced walk. - If you have severe kidney problems. Pregnancy and lactation Safety of use of Carvidon-MR in pregnant and nursing mothers has not been established. As a precaution, Carvidon-MR is not to be taken during pregnancy or breastfeeding. Tell your doctor if you are pregnant, think you are pregnant or planned to get pregnant - Before you start use it - Talk to your doctor or pharmacist before taking Carvidon-MR - Taking other medicines You must inform your doctor or pharmacist if you are taking, or have recently taken any other medicines, even if it is a medicine that you can buy without a prescription. How to use Carvidon-MR - How much to use - Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. - The recommended dose is Carvidon- MR tablet is one tablet to be Baca dokumen lengkap
1 CARVIDON-MR (TRIMETAZIDINE DIHYDROCHLORIDE MODIFIED RELEASE TABLETS 35 MG) NAME AND STRENGTH OF ACTIVE INGREDIENT: Trimetazidine Dihydrochloride ….. 35 mg. PRODUCT DESCRIPTION: Light pink colored, circular, biconvex, film coated tablets, plain on both the faces. PHARMACOLOGY: _PHARMACODYNAMICS:_ _Mechanism of action_ Trimetazidine inhibits β-oxidation of fatty acids by blocking long-chain 3-ketoacyl-CoA thiolase, which enhances glucose oxidation. In an ischemic cell, energy obtained during glucose oxidation requires less oxygen consumption than in the β-oxidation process. Potentiation of glucose oxidation optimizes cellular energy processes, thereby maintaining proper energy metabolism during ischemia. Pharmacodynamic effects In patients with ischemic heart disease, Trimetazidine acts as a metabolic agent, preserving the myocardial high-energy phosphate intracellular levels. Ant ischemic effects are achieved without concomitant hemodynamic effects. _PHARMACOKINETICS:_ Orally, the maximum concentration is on average five hours after taking the tablet. About 24 hours, the plasma concentration is maintained at concentrations greater than or equal to 75% of the maximum concentration for 11 hours. The steady state is reached, no later than the 60th hour. The pharmacokinetic characteristics of trimetazidine are not influenced by meal. The apparent volume of distribution is 4.8 l/Kg, the determination of trimetazidine protein is weak: the value measured in vitro is 16%. The elimination of trimetazidine is mainly via the kidneys, mainly in the form of the unchanged product. The half-life of trimetazidine is an average of 7 hours in healthy young volunteers, and 12 hours in the elderly over 65 years. The total clearance of trimetazidine is the one that results from renal clearance majority directly related to creatinine clearance and to a lesser value, a hepatic clearance that decreases with age. A specific clinical study, conducted in an elderly population, with a dose of 2 tablets per day in two doses, as measured Baca dokumen lengkap