מדינה: סינגפור
שפה: אנגלית
מקור: HSA (Health Sciences Authority)
TRIMETAZIDINE DIHYDROCHLORIDE
SERVIER (S) PTE LTD
Pending
35MG
TABLET, FILM COATED
TRIMETAZIDINE DIHYDROCHLORIDE 35 mg
ORAL
Prescription Only
LES LABORATOIRES SERVIER INDUSTRIE
ACTIVE
2003-04-25
Vastarel MR 1/5 PACKAGE INSERT VASTAREL MR INN: Trimetazidine PRESENTATION AND COMPOSITION Boxes of 60 modified release film-coated tablets, each containing 35mg of trimetazidine dihydrochloride._ _ Excipients: calcium hydrogen phosphate, hypromellose, povidone, magnesium stearate, silica colloidal anhydrous. Coating: glycerol, macrogol, magnesium stearate, hypromellose, red iron oxide, titanium dioxide. PROPERTIES _PHARMACODYNAMIC PROPERTIES _ OTHER CARDIOVASCULAR ANTIANGINAL DRUG ATC CODE: C01EB15 (C: CARDIOVASCULAR SYSTEM) Mechanism of action By preserving energy metabolism in cells exposed to hypoxia or ischaemia, trimetazidine prevents a decrease in intracellular ATP levels, thereby ensuring the proper functioning of ionic pumps and transmembrane sodium-potassium flow whilst maintaining cellular homeostasis. Trimetazidine inhibits β-oxidation of fatty acids by blocking long-chain 3-ketoacyl-CoA thiolase, which enhances glucose oxidation. In an ischaemic 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 ischaemia. Pharmacodynamic effects In patients with ischaemic heart disease, trimetazidine acts as a metabolic agent, preserving the myocardial high-energy phosphate intracellular levels. Anti-ischemic effects are achieved without concomitant haemodynamic effects. Clinical efficacy and safety Clinical studies have demonstrated the effica קרא את המסמך השלם
Vastarel MR _ _ 1/6 PACKAGE INSERT 1. NAME OF THE MEDICINAL PRODUCT VASTAREL MR TABLET 35 mg, modified release film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Trimetazidine dihydrochloride…………………………………….35 mg_ _ Excipients q.s. for one modified release film-coated tablet. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Modified release film-coated tablet 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Trimetazidine is indicated in adults as add-on therapy for the symptomatic treatment of patients with stable angina pectoris who are inadequately controlled by or intolerant to first- line antianginal therapies. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY Oral use. The dose is one tablet of 35 mg of trimetazidine twice daily i.e. once in the morning and once in the evening during meals. The benefit of the treatment should be assessed after three months and trimetazidine should be discontinued if there is no treatment response. SPECIAL POPULATIONS _ _ _Patients with renal impairment _ In patients with moderate renal impairment (creatinine clearance [30-60] ml/min) (see sections 4.4 and 5.2), the recommended dose is 1 tablet of 35 mg in the morning during breakfast. _ _ _ _ _Elderly patients _ Elderly patients may have increased trimetazidine exposure due to age-related decrease in renal function (see section 5.2). In patients with moderate renal impairment (creatinine clearance [30-60] ml/min), the recommended dose is 1 tablet of 35 mg in the morning during breakfast._ _ Dose titration in elderly patients should be exercised with caution (see section 4.4)._ _ _ _ _Paediatric population: _ The safety and efficacy of trimetazidine in children aged below 18 years have not been established. No data are available. Vastarel MR _ _ 2/6 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Parkinson disease, parkinsonian symptoms, tremors, restless leg syndrome, and other related movement קרא את המסמך השלם