देश: सिंगापुर
भाषा: अंग्रेज़ी
स्रोत: HSA (Health Sciences Authority)
TRIMETAZIDINE
SERVIER (S) PTE LTD
C01EB15
20 mg
TABLET, FILM COATED
TRIMETAZIDINE 20 mg
ORAL
Prescription Only
LES LABORATOIRES SERVIER INDUSTRIE
ACTIVE
1988-06-08
VASTAREL film-coated tablet PACKAGE INSERT VASTAREL 20 MG Film-coated tablet INN: Trimetazidine PRESENTATION AND COMPOSITION Box of 60 film-coated tablets, each containing 20 mg of trimetazidine dihydrochloride. Excipients: q.s.f. one tablet 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 efficacy and safety of trimetazidine in the treatment of patients with chronic angina, either alone or when the benefit from other antianginal medicinal products was insufficient. In a 426-patients randomized, double blind, placebo-controlled study (TRIMPOL-II), trimetazidine (60 पूरा दस्तावेज़ पढ़ें
1 PACKAGE INSERT 1. NAME OF THE MEDICINAL PRODUCT VASTAREL, film-coated tablets 2. QUALITATIVE AND QUANTITIVE COMPOSITION Trimetazidine dihydrochloride……………………………………………….20 mg Excipients q.s. for one film-coated tablet For a full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM 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. Method of administration The dose is one tablet of 20 mg of trimetazidine three times a day 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 20 mg twice daily, i.e., one in the morning and one in the evening during meals. _ _ _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 20 mg twice daily, i.e., one in the morning and one in the evening during meals. Dose titration in elderly patients should be exercised with caution (see section 4.4). 2 _Paediatric population: _ The safety and efficacy of trimetazidine in children aged below 18 years have not been established. No data are available. 4.3 CONTRAINDICATIONS - Hypersensitivity to the active substance or to any of the excipients; - Parkinson disease, parkinsonian symptoms, tremors, restless leg syndrome, and other related movement disorders; - Severe renal impairment (creatinine clearance < 3 पूरा दस्तावेज़ पढ़ें