VASTAREL TABLET 20 mg
国家: 新加坡
语言: 英文
来源: HSA (Health Sciences Authority)
资料单张 有效成分:
TRIMETAZIDINE
可用日期:
SERVIER (S) PTE LTD
ATC代码:
C01EB15
剂量:
20 mg
药物剂型:
TABLET, FILM COATED
组成:
TRIMETAZIDINE 20 mg
给药途径:
ORAL
处方类型:
Prescription Only
厂商:
LES LABORATOIRES SERVIER INDUSTRIE
授权状态:
ACTIVE
授权日期:
1988-06-08
资料单张
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
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产品特点
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
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