Each Modified-Release Tablet contains: Trimetazidine Dihydrochloride 35 mg.
Trimetazidine is a cardiovascular drug that acts as an effective anti-anginal agent by modulating cardiac energy metabolism. It is an anti-ischemic metabolic agent that improves myocardial glucose utilization through inhibition of fatty acid metabolism. By preserving the energy metabolism in cells exposed to hypoxia or ischemia, Trimetazidine prevents a decrease in intracellular adenosine triphosphate levels, thereby ensuring the proper functioning of ionic pumps and transmembranous sodium-potassium flow while maintaining cellular homeostasis. Trimetazidine also inhibits the oxidation of fatty acid in blood vessels.
Pharmacology: Pharmacodynamics: In patients with ischemic heart disease, Trimetazidine acts as a metabolic agent, preserving the myocardial high-energy phosphate intracellular levels. Anti-ischemic effects are achieved without concomitant hemodynamic effects.
Pharmacokinetics: Trimetazidine after oral administration, absorption of Trimetazidine is rapid and the plasma peak is reached in less than 2 hours. After a single oral dose of 35 mg of Trimetazidine, the peak plasma concentration is about 55 mg/mL. The apparent volume of distribution is 4.8 L/kg which suggests good tissue diffusion. Elimination of Trimetazidine is principally urinary; mean half-life is 6 hours.
Used in angina pectoris and in ischaemia of neurosensorial tissues as in Meniere's disease.
One tablet twice daily, that is 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.
Patients with renal impairment: In patients with moderate renal impairment (creatinine clearance 30-60 mL/min), the recommended dose is one 35 mg tablet in the morning during breakfast.
Elderly patients: Elderly patients may have increased trimetazidine exposure due to age-related decrease in renal function. In patients with moderate renal impairment (creatinine clearance 30-60 mL/min), the recommended dose is one tablet of 35 mg in the morning during breakfast. Dose titration in elderly patients should be exercised with caution.
Pediatric population: The safety and efficacy of Trimetazidine (Trivasc) in children aged below 18 years have not been established. No data are available.
Missed dose: Resume treatment normally. Do not take a double dose to compensate for the single dose that the patient forgot to take.
Limited information is available on trimetazidine overdose. Treatment should be symptomatic.
Trimetazidine is contraindicated to pregnant and lactating patients and to those who have allergic reactions to the drug.
This medicinal product is not a curative treatment for angina attacks, nor an initial treatment for unstable angina pectoris 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 (medicinal treatment and possibly revascularization).
This medicinal product can aggravate or cause symptoms similar to those of Parkinson's disease (tremor, difficulty in making movements, rigidity of limbs), which should be investigated and reported to the doctor, especially in elderly patients. In doubtful cases, patients should be referred to a neurologist for appropriate investigations.
The occurrence of movement disorders such as Parkinsonian symptoms, Restless leg syndrome, Tremors, Gait instability should lead to definitive withdrawal of Trimetazidine (Trivasc).
These cases have a low incidence and are usually reversible after treatment discontinuation. The majority of the patients recovered within 4 months after Trimetazidine (Trivasc MR) withdrawal. If Parkinsonian symptoms persist more than 4 months after drug discontinuation, a neurologist's opinion should be sought.
Falls may occur following a drop in blood pressure or a loss of balance, in particular in patients taking antihypertensive treatment. Caution should be exercised in patients with moderate renal impairment and elderly (>75 years old).
Driving and using machines: Trimetazidine (Trivasc) does not have hemodynamic effects in clinical studies, however cases of dizziness and drowsiness have been observed in post-marketing experience, which may affect ability to drive and use machines.
Use in Children: Trimetazidine (Trivasc) must not be administered to children aged below 18 years.
Pregnancy: There are no data from the use of Trimetazidine in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity. As a precautionary measure, it is preferable to avoid the use of Trimetazidine (Trivasc) during pregnancy.
Breastfeeding: It is unknown whether Trimetazidine/Metabolites are excreted in human milk. A risk to the newborns/infants cannot be excluded. Trimetazidine (Trivasc) should not be used during breastfeeding.
Trimetazidine cause rare cases of gastrointestinal disorders such as nausea and vomiting.
No other drug interactions have been reported.
Store at temperatures not exceeding 30°C.
C01EB15 - trimetazidine ; Belongs to the class of other cardiac preparations.
Trivasc MR tab 35 mg