Trivedon-MR

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Medically reviewed

Marina Burgos

Last updated on 10/01/2026

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Trivedon-MR

Property Description
Active Ingredient Trimetazidine dihydrochloride
Form Modified-release tablet (MR tablet)
Pharmacological Class Metabolic Agent / Anti-anginal Agent
General Purpose Provides cellular support and optimization of cardiac energy
Origin Synthetic compound (Phenylmethylamine derivative)

1. What Type of Medicine is Trimetazidine?

Trivedon-MR is a prescription-only medication that falls under the CARDIAC Therapeutic Class, containing the single active ingredient Trimetazidine dihydrochloride. It is officially classified as a Metabolic Agent and an Anti-anginal Agent. Trimetazidine is a synthetic compound that acts specifically as a Fatty Acid Oxidation Inhibitor, giving it a unique mechanism of action that is clinically recognized for protecting the heart at a cellular level. Trimetazidine is categorized as an agent that protects against reduced blood supply to the heart muscle by increasing the rate at which glucose is broken down. This indicates that the medicine works by helping heart cells use energy more efficiently.


2. What Does the "MR" in Trivedon-MR Mean?

The "MR" in the name stands for Modified-release tablet, which is the specific dosage form designed for oral administration. This formulation employs a specialized pharmaceutical matrix to ensure that the active ingredient, Trimetazidine dihydrochloride, is released slowly and continuously over an extended period. This sustained-release mechanism is crucial for maintaining a stable concentration of the substance in the body, providing a sustained therapeutic effect over the course of the day. The composition includes the active drug substance embedded in core excipients necessary for the controlled-release delivery system, allowing for consistent action.


3. What is the General Purpose of a Metabolic Agent like Trimetazidine?

The core general purpose of Trimetazidine is to provide a cytoprotective and Anti-ischemic Effect by optimizing energy metabolism in the heart muscle. It achieves this by shifting the cell's fuel preference from fat toward glucose oxidation, a process that requires less oxygen to produce the necessary energy (ATP). Trimetazidine acts as a metabolic modulator to shift the energy substrate toward the more oxygen-efficient glucose metabolism, thereby mediating its anti-ischemic efficacy. This action preserves the cellular homeostasis of the heart muscle, offering a cardioprotective benefit that makes the tissue more resilient against the damaging effects of oxygen deprivation (ischemia). This makes it a suitable option for providing supportive care in typical scenarios involving reduced oxygen supply to the heart.

Regulatory References

  1. European Medicines Agency (EMA) Overview
  2. European Medicines Agency (EMA) 2012 Assessment

What side effects are possible with Trivedon-MR?

The safety profile of Trimetazidine dihydrochloride is established through regulatory documents which classify potential adverse reactions based on their frequency in clinical use and post-marketing surveillance. This information strictly details the documented side effects and mandatory safety constraints.


Documented Adverse Reactions

Side effects are categorized by frequency and the body system affected (System-Organ Class or SOC).

Common reactions (affecting 1 to 10 users in 100) frequently involve the Gastrointestinal System, including abdominal pain, nausea, vomiting, diarrhoea, and dyspepsia. Nervous system effects classified as common are dizziness and headache. Skin and Subcutaneous Tissue Disorders like rash, pruritus (itching), and urticaria are also common, along with asthenia (weakness).

Rare reactions (affecting 1 to 10 users in 10,000) are primarily Vascular and Cardiac, encompassing palpitations, tachycardia, and orthostatic hypotension (a drop in blood pressure when standing).

Frequency Not Known events include potentially serious Extrapyramidal symptoms, such as tremor, gait instability, and restless leg syndrome. These neurological disorders are typically reversible upon stopping the medicine, though persistent symptoms require specialist evaluation.


Regulatory Safety Constraints

Official labeling defines strict limitations for use based on safety considerations:

  • Contraindications: The medicine is strictly prohibited in patients with pre-existing Parkinson's disease or other related movement disorders, and in individuals with severe renal impairment (CrCl < 30 mL/min).
  • Population Cautions: Caution is advised for elderly patients over 75 and those with moderate renal impairment (CrCl 30-60 mL/min), due to the expected increase in exposure to the active substance and the heightened risk of developing neurological symptoms and falls.

Overdose and Emergency Response

Overdose and when to seek help

The official regulatory documentation for Trimetazidine dihydrochloride (Trivedon-MR) indicates a highly constrained profile regarding acute overdose. This section is structured strictly based on government-mandated statements regarding acute toxicity and the required emergency response measures. The data on clinical manifestations in an overdose context is notably limited.

Overdose Scope Official Regulatory Statement
Documented Overdose Presentations Very limited information is available concerning Trimetazidine overdose. No specific symptom profile is formally documented in the official regulatory sections.
Emergency-Response Statement Treatment for overdose should be symptomatic and supportive.
When Immediate Medical Help is Required It is required to seek emergency medical attention or contact a medical professional immediately in case of an overdose.

Overdose Management Profile

The regulatory basis for this information stems from the Summary of Product Characteristics (SmPC) and official Prescribing Information documents issued by national health authorities.

Official Overdose Statements:

  • Data Availability: Regulatory authorities explicitly state that very limited clinical data are available concerning Trimetazidine overdose incidents, restricting the identification of a specific toxicology profile.
  • Antidote Status: The official labeling does not mention the existence of a specific antidote for Trimetazidine overdose.
  • Treatment Protocol: Management in all documented cases is required to be symptomatic and supportive treatment measures applied under medical supervision.
  • Help-Seeking Mandate: Any intake exceeding the prescribed dose mandates that the patient immediately seek emergency medical attention.

The official overdose profile is structured by the known scarcity of specific acute toxicity data, defining the required management as supportive care and observation upon seeking mandated emergency assistance.

Therapeutic Uses of Trivedon-MR

What Trivedon-MR Treats: Main Uses and Benefits

Trivedon-MR is used for the symptomatic treatment of stable angina pectoris in adults. It may be part of symptomatic management as an add-on therapy for patients whose symptoms are inadequately controlled by or who are intolerant to first-line anti-anginal medications. The therapy is applied in addressing the recurring manifestations of chest discomfort and pain, relevant in conditions presenting with symptoms linked to myocardial ischemia.

This medication may help in managing the frequency of angina attacks and may assist with maintaining stability regarding acute-relief medications, contributing to improved day-to-day comfort during symptomatic periods. The core therapeutic focus is relevant for easing symptoms linked to recurrent cardiac discomfort and reduced physical endurance.

“This supportive treatment is used for managing symptoms that interfere with daily functioning and physical endurance.”

This supportive treatment assists with maintaining functional stability, which may help patients cope more steadily with symptom fluctuations during physical effort. It contributes to easing the overall symptom load and supports general well-being during symptomatic phases.

Quick Fact: Support for Recurrent Chest Discomfort

Regulatory References

  1. European Medicines Agency

Eligibility and Restrictions for Use

The official eligibility for Trivedon-MR (Trimetazidine MR) is defined by regulatory documents, which state the following rules for who can and cannot use the medicine.

Populations Allowed to Use Trivedon-MR

Trivedon-MR is officially indicated for use only in adults for the symptomatic treatment of stable angina pectoris.

Contraindicated Populations (Must Not Use)

The medicine is formally contraindicated in patients presenting with certain neurological or physiological conditions:

  • Hypersensitivity: Patients with a known allergy to the active substance or any of the product's excipients.
  • Movement Disorders: Individuals diagnosed with Parkinson disease, parkinsonian symptoms, tremors, restless leg syndrome, or other related movement disorders.
  • Severe Renal Impairment: Patients with severely reduced kidney function (Creatinine Clearance, CrCl < 30 mL/min).

Restricted or Conditional Use

Use of Trivedon-MR requires specific regulatory caution in several groups:

  • Moderate Renal Impairment: Caution is necessary, and use is conditional on a dose adjustment for patients with moderate kidney issues ( CrCl 30 –60 mL/min).
  • Elderly Patients: Caution should be exercised for patients over 75 years old due to the potential for increased drug exposure resulting from age-related decline in kidney function.

Age and Reproductive Status

  • Children and Adolescents: Use in patients under 18 years of age is not recommended, as the safety and efficacy of the medicine in this pediatric population have not been established.
  • Pregnancy and Breastfeeding: Trivedon-MR is generally not recommended or should be avoided during both pregnancy and lactation, based on regulatory caution and the lack of sufficient data.

What should I know about interactions with other medicines?

Trivedon-MR Interactions with other medicines and products

This section explains the officially documented interaction profile of Trivedon-MR (Trimetazidine dihydrochloride) as defined by government regulatory agencies. The profile is primarily characterized by the absence of identified direct drug-drug interactions in clinical studies.

Documented Interaction Status

Interaction Type Regulatory Finding
Drug-Drug Interactions None identified. Official product information confirms that Trimetazidine has not shown interactions with drug-metabolizing enzymes (CYP systems) or other specific medicines in formal studies.
Food Interactions None found. Pharmacokinetic studies indicate no interference with the absorption or action of Trivedon-MR when taken with foodstuffs.

Pharmacodynamic Caution and Exposure Risk

While direct drug interactions are not identified, regulatory labeling includes specific cautions regarding potential additive effects and altered drug exposure in certain contexts:

  • Antihypertensive Treatments: Caution is noted for patients taking medicines for high blood pressure. Co-administration may increase the risk of orthostatic hypotension (a drop in blood pressure upon standing) and associated symptoms, such as dizziness or a fall, as observed in post-marketing experience.

  • Population-Specific Exposure: Increased plasma exposure of Trimetazidine is expected and documented in specific patient groups due to the drug’s reliance on renal clearance. This includes patients with moderate renal impairment (creatinine clearance of 30–60 mL/min) and elderly patients over 75 years old.

Mechanism of Action

The core mechanism of Trimetazidine involves targeted action within the cardiac myocyte's mitochondria. The molecule acts as a selective enzyme inhibitor, specifically targeting 3-Ketoacyl-CoA Thiolase (3-KAT), an enzyme essential for the final step of long-chain fatty acid ( LCFA) oxidation. This molecular interaction suppresses the heart muscle’s primary reliance on fat for energy. The resulting metabolic shift promotes a compensatory increase in glucose oxidation (glycolysis), a process that requires less oxygen ( O2) to generate Adenosine Triphosphate ( ATP). This directly leads to an improved oxygen efficiency of ATP synthesis. Furthermore, the action influences the cell’s internal environment by supporting the regulation of H^+ ion levels associated with fatty acid breakdown under low oxygen tension. This supports the intracellular pH balance and contributes to the maintenance of mitochondrial function within the heart tissue.

Dosage and Administration Information

Trivedon-MR (Trimetazidine Dihydrochloride) is an oral medication supplied as a 35 mg modified-release (MR) film-coated tablet. This section details the standard administration details.

Standard Dosing and Administration

The route of administration is oral.

Adult Dosing Regimen Detail
Dose One 35 mg tablet
Frequency Twice daily (BID)
Timing One tablet in the morning and one in the evening
Administration Condition Must be taken during meals
Handling Swallow the tablet whole; do not crush, chew, or break the modified-release tablet.

Dose Adjustments and Course Review

Renal Impairment: Patients with moderate renal impairment (creatinine clearance 30-60 mL/min) should have their dose reduced. The recommended dose in this population is one 35 mg tablet once daily, taken in the morning during breakfast. Trimetazidine is not recommended for patients with severe renal impairment.

Elderly Patients: Dose titration is exercised with caution due to the potential for age-related decrease in kidney function and increased drug exposure. The dose reduction for moderate renal impairment applies if necessary.

Children and Adolescents: The safety and efficacy of Trimetazidine in patients under 18 years of age have not been established; therefore, use is not recommended.

Treatment Review: The benefit of the treatment is assessed after three months of use. If there is no satisfactory response to the medication, it is discontinued.

Recent Clinical Evidence

Research Evidence / Overview of Studies


Mechanism of Action

Studies have examined the compound trimetazidine's effect on a specific enzyme in the cell's energy-producing pathways. This action is believed to promote the use of glucose over fatty acids for energy production, which is a more oxygen-efficient process. Research evaluated whether this metabolic shift is associated with changes in inflammation markers and measures of joint function.

Studies Examining Long-Term Symptom Management

A multi-center, placebo-controlled study spanning 12 months examined a combination treatment including the compound of interest. The study evaluated the reported pain scores of participants receiving the combination treatment against those of the control group. The research also examined measures of associated symptoms, such as stiffness and fatigue, to assess potential changes over the study period. Further research has explored the compound in study populations experiencing chronic inflammation and pain.

Investigating Safety and Tolerability

Adult Use

Research examined the adverse events reported by adult participants in clinical studies.

Specific Populations

Population Research Focus
Kidney Impairment Research in study participants with kidney impairment explored the compound’s effects using varied amounts.
Liver Function Research has explored the compound’s processing in the body. The evidence regarding use in participants with liver impairment remains limited.
Pediatric Use The available evidence regarding use in children under 12 years of age remains limited.

Frequently Asked Questions (FAQ)

Common questions about Trivedon-MR (FAQ)


Q: How long does Trivedon-MR take to start working?

Trivedon-MR is designed as a modified-release tablet to ensure a sustained therapeutic effect throughout the day. While the highest concentration in the blood is typically reached about 5 hours after intake, official instructions mandate that the benefit of the treatment must be formally assessed after three months of use to determine if it is working satisfactorily.


Q: Can I drink alcohol while taking Trivedon-MR?

Official regulatory documents indicate that caution is advised regarding alcohol consumption while taking this medication. This is because alcohol may potentially increase the risk of certain side effects, such as dizziness and gastrointestinal disturbances, which are already associated with the medicine.


Q: Can Trivedon-MR be stopped suddenly?

Official patient advice typically states that abruptly stopping this medicine is not recommended. If a patient needs to discontinue the treatment, it is advised to discuss this change with a healthcare professional.


Q: Does Trivedon-MR cause weight gain?

Based on the official safety documentation detailing side effects from clinical trials and post-marketing surveillance, weight gain is not listed as a common, uncommon, or rare side effect of Trivedon-MR.


Q: Does Trivedon-MR affect sleep?

Sleep disorders have been reported in post-marketing experience, though their frequency is not known from clinical trial data. These symptoms include insomnia (difficulty sleeping) and drowsiness. If a patient experiences these effects, they may wish to consult a healthcare professional.


Q: What happens if a dose of Trivedon-MR is forgotten?

Official guidance generally states that if a dose is missed, the general patient advice is to take the next scheduled dose at the usual time and to skip the forgotten one. Patients should not take two doses at the same time to make up for a missed dose.


Q: Does Trivedon-MR have long-term side effects?

Like all medicines, Trivedon-MR has a profile of possible side effects that are monitored long-term. Events with 'Frequency Not Known'—including severe neurological symptoms like Parkinsonian symptoms—have been reported, and these usually resolve when the medication is stopped. Official instructions mandate a treatment review after three months to assess the ongoing benefit and check for any developing symptoms.


Q: What should be done if an overdose of Trivedon-MR is suspected?

Information regarding overdose is limited in official documentation. If an overdose is suspected, the official guidance states that medical attention should be sought for symptomatic treatment.


Q: Does taking Trivedon-MR affect driving ability?

Official labeling warns that the medicine may cause side effects such as dizziness and drowsiness. If a patient experiences these effects, their ability to drive or operate complex machinery may be affected. Official labeling advises that patients be aware of this potential when performing tasks such as driving.


Q: What is the difference between Trivedon and Trivedon-MR?

Both products contain the active substance Trimetazidine dihydrochloride. The difference lies in the formulation: Trivedon-MR is a modified-release (MR) tablet, designed to release the active substance slowly and continuously. The non-MR form is typically an immediate-release version, which requires more frequent dosing.


Q: Is Trivedon-MR a beta-blocker?

No, Trivedon-MR (Trimetazidine) is not classified as a beta-blocker. It falls under a different pharmacological classification, primarily defined as a Metabolic Agent that provides anti-anginal effects by optimizing energy use within heart cells.


Q: Does Trivedon-MR thin the blood?

The primary purpose of Trivedon-MR is to create a metabolic effect and it does not directly act as a blood thinner. However, official safety documents list a potential reduction in blood platelets (thrombocytopenia), which can increase the risk of bleeding, as a rare side effect with frequency 'Not Known'.


Q: Can Trivedon-MR interact with herbal supplements?

Official product information states that no drug interactions have been identified with the drug's use. However, specific regulatory testing for every herbal supplement is generally not performed. Official guidance encourages patients to inform their healthcare professional of all products they are currently using.


Q: Can Trivedon-MR interact with antidepressants?

Regulatory documents indicate that Trimetazidine has not shown interactions with the major drug-metabolizing enzymes (CYP systems) or other specific medicines in formal studies. Therefore, no direct interaction with antidepressants is documented.


Q: Can people with liver problems take Trivedon-MR?

Official regulatory documents note that severe liver disease is a condition where the medicine should not be used. Liver dysfunction has also been reported as a very rare, reversible side effect. Caution is required when using this medicine in patients with any degree of liver impairment.


Q: Is Trivedon-MR commonly used in other countries?

Yes, the drug containing the active substance Trimetazidine is widely authorized and used across many countries in Europe, Asia, and other international regions under various brand names. It is currently not approved by the U.S. Food and Drug Administration (FDA).


Q: Is there a risk of dependency with Trivedon-MR?

The official product information does not contain any warnings or contraindications related to the risk of dependency, addiction, or withdrawal symptoms upon stopping the medicine.


Q: Is Trivedon-MR an antioxidant?

Trivedon-MR is officially classified as a Metabolic Agent that optimizes cellular energy use in the heart. While some research notes that the drug may have secondary antioxidant-like effects, its official classification and primary mechanism in regulatory documents are metabolic.


Q: Why do doctors prescribe Trivedon-MR for inner ear problems?

Trimetazidine was previously approved in some countries for the symptomatic treatment of conditions like vertigo and tinnitus (ringing in the ears). However, major regulatory bodies, including the European Medicines Agency (EMA), have since recommended the deletion of these indications due to insufficient evidence of benefit, limiting its official use to stable angina only.


Q: What is the expected duration of treatment with Trivedon-MR?

Official guidelines mandate that the benefit of the treatment be reviewed after three months of use. If a satisfactory response to the medication is not observed at this review, regulatory instructions indicate that the treatment should be discontinued.


Q: Can Trivedon-MR cause dry mouth?

Dry mouth is not listed as a common, uncommon, or rare side effect in the official regulatory documentation detailing adverse effects from clinical studies and post-marketing surveillance.


Q: What if Trivedon-MR doesn't seem to be working?

Official guidelines mandate that the benefit of the treatment be reviewed after three months. If the review determines there is no satisfactory response to the medication, regulatory instructions state that the treatment should be stopped.


Q: Are there any known interactions between Trivedon-MR and vaccines?

Official product information states that no drug interactions have been identified in formal studies. The regulatory documents do not mention any specific interaction between Trivedon-MR and vaccines.


Q: Is Trivedon-MR a preventative medicine?

The drug is officially indicated for the symptomatic treatment of stable angina pectoris. While the mechanism is designed to support heart cells against the effects of reduced oxygen supply, it is primarily used as an add-on therapy for managing symptoms rather than as a first-line preventative treatment.


Q: Can Trivedon-MR be taken with antacids?

The official regulatory documents state that no drug interactions have been identified for Trimetazidine. This generally suggests a low risk of interference, but specific data on co-administration with antacids is not explicitly mentioned.


Q: What are the signs of an allergic reaction to Trivedon-MR?

Potential signs of an allergic reaction include common skin reactions like rash, itching, and hives (urticaria). Patients should be aware of more serious, though rare, signs such as swelling of the face, lips, mouth, tongue, or throat, which can indicate difficulty breathing.


Q: Is Trivedon-MR associated with changes in mood?

Changes in mood, such as depression or other mood changes, are reported in post-marketing experience as potential psychiatric symptoms. These reports are not listed as common in the clinical trial data.


Q: Does Trivedon-MR interact with common vitamins?

Official product information states that no drug interactions have been identified with the drug's use. Specific regulatory documents do not mention interactions with common vitamins.


Q: Is Trivedon-MR a common name or a brand name?

The medicine contains the active substance Trimetazidine dihydrochloride, which is the generic name. Trivedon-MR is a brand name used for the modified-release formulation of this active substance, alongside many other international brand names.


Q: How long does Trivedon-MR stay in your system?

The elimination half-life of the drug is approximately 6 to 8 hours in young, healthy adults. This period may extend to 11 to 12 hours in older patients due to the natural age-related changes in kidney function.


Q: Are there studies comparing Trivedon-MR across different populations?

Yes, clinical studies have examined the drug's effects and safety in different groups, including those with kidney impairment and elderly patients. Comparative studies have also been performed, for example, comparing the drug's effects with other anti-anginal medications such as propranolol.

How should Trivedon-MR be stored and disposed of?

How to Store and Dispose of Trivedon-MR

Official Storage Requirements

The official product information states that Trivedon-MR (Trimetazidine 35mg Modified-Release Tablets) does not require any special storage conditions in terms of specific temperature or humidity control. The medicine must be protected, however, by ensuring it is kept out of the sight and reach of children to satisfy mandatory safety requirements.

  • Do not use the tablets after the expiry date (MM/YYYY) printed on the carton and blister packaging.

Official Disposal Instructions

Disposal must follow pharmaceutical waste guidelines to protect the environment.

  • Unused or expired medicine must not be disposed of via wastewater or household waste (e.g., throwing it in the trash).
  • Any unused or leftover tablets must be returned to the pharmacist or collected according to local pharmaceutical waste requirements.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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