Vastarel MR

Vastarel MR





Full Prescribing Info
Trimetazidine diHCl is 1-(2,3,4-trimethoxybenzyl) piperazine dihydrochloride.
Pharmacology: 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 transmembranous 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 maintaning proper energy metabolism during ischaemia.
Trimetazidine is indicated in adults as add-on therapy for the symptomatic treatment of patients with stable angina who are inadequately controlled by or intolerant to first-line antianginal therapies.
Adjuvant symptomatic treatment for vertigo and tinnitus (noises detected by the ear: whistling, buzzing, which do not correspond to any exterior sounds).
Adjuvant treatment of visual disorders of a circulatory origin.
Dosage/Direction for Use
Oral route.
Dosage: 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.
In patients with renal impairment/elderly: In patients with moderate renal impairment (creatinine clearance [30-60] ml/min), 1 tablet of 35 mg in the morning during breakfast.
Administration: 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.
Limited information is available on trimetazidine overdose. Treatment should be symptomatic.
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 <30 ml/min).
Special Precautions
This medicinal product is not a curative treatment for angina attacks, nor is it indicated as an initial treatment for unstable angina or myocardial infarction, nor in the pre-hospital phase or during the first days of hospitalization. In the event of an angina attack, the coronaropathy should be reevaluated and an adaptation of the treatment considered. Trimetazidine can cause or worsen parkinsonian symptoms (tremor, akinesia, hypertonia), which should be regularly investigated, especially in elderly patients. Falls may occur, related to gait instability or hypotension, in particular in patients taking antihypertensive treatment.
Effects on the Ability to Drive or Operate Machines: Caution because of dizziness and drowsiness have been observed.
Use In Pregnancy & Lactation
Use in Pregnancy: Avoid prescription.
Use in Lactation: It should not be used.
Adverse Reactions
Common: Dizziness, headache, abdominal pain, diarrhoea, dyspepsia, nausea, vomiting, rash, pruritus, urticarial, asthenia.
Rare: palpitations, extrasystoles, tachycardia, arterial hypotension, orthostatic hypotension that may be associated with malaise, dizziness for fall, in particular in patients taking antihypertensive treatment, flushing.
Not known: Parkinsonian symptoms (tremor, akinesia, hypertonia), gait instability, restless leg syndrome, other related movement disorders, usually reversible after treatment discontinuation, sleep disorders (insomnia, drowsiness), vertigo, constipation, AGEP (acute generalized exanthematus pustulosis), angioedema, agranulocytosis, thrombocytopenia, thrombocytopenic purpura, hepatitis.
Drug Interactions
No drug interaction has been reported.
ATC Classification
C01EB15 - trimetazidine ; Belongs to the class of other cardiac preparations.
MR tab 35 mg x 60's.
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