Vastarel LP

Quick links to important sections

Medically reviewed

Marina Burgos

Last updated on 22/12/2025

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 Vastarel LP

Property Description
Active Ingredient Trimetazidine (dihydrochloride)
Form Modified-release tablet or prolonged-release hard capsule
Pharmacological Class Cytoprotective Anti-ischemic Agent, Metabolic Regulator
General Purpose Cardiac metabolic support and cell protection
Origin Synthetic compound (piperazine derivative)

What Type of Medicine is Vastarel LP?

Vastarel LP is a prescription-only, single-ingredient medicinal product containing the active substance Trimetazidine. It is administered orally as a modified-release tablet, a unique formulation designed to release the drug slowly and consistently over many hours. This sustained action is indicated by the "LP" (Long-Period or Prolonged Release) designation. The medicine is primarily categorized as a cytoprotective anti-ischemic agent and is recognized within the group of Other Cardiac Preparations. This specific sustained-release form is particularly useful for achieving consistent support for heart cells throughout the day.

Composition and Origin of the Vastarel LP Substance

The active component of the tablet is Trimetazidine dihydrochloride. This compound is a synthetic chemical entity derived from the piperazine group, which is not naturally sourced. The tablet is a solid, single-ingredient product where the active component is integrated into a specialized base material essential for the controlled-release profile. Unlike combination therapies, Vastarel LP focuses exclusively on the metabolic action of Trimetazidine.

What is the General Therapeutic Purpose of Trimetazidine?

The general purpose of Trimetazidine is to provide metabolic support to the heart muscle, an action recognized for its efficiency in cardiac energy management. It functions by acting as a partial fatty acid oxidation (pFOX) inhibitor, which shifts the heart's fuel source toward the more oxygen-efficient glucose. This mechanism is crucial as it allows the heart cells to maintain energy balance when oxygen supply is restricted, distinguishing it from drugs that alter heart rate or blood pressure.

Regulatory References

  1. European Medicines Agency Review of Trimetazidine

What side effects are possible with Vastarel LP?

The official safety profile for Trimetazidine (Vastarel LP) is established by regulatory authorities and organized by the frequency and type of documented adverse reactions. This information defines the general risk structure of the medicine.


Frequency-Classified Adverse Reactions

Adverse reactions are classified based on the likelihood of occurrence, derived from clinical trials and post-marketing data:

  • Common (may affect up to 1 in 10 people): Reactions include dizziness, headache, gastrointestinal symptoms (nausea, vomiting, abdominal pain, diarrhoea), skin reactions (rash, pruritus, urticaria), and general weakness (asthenia).

  • Rare (may affect up to 1 in 1,000 people): Reactions involving the cardiovascular system, such as palpitations, tachycardia (faster heart rate), and arterial hypotension (low blood pressure), including orthostatic hypotension.

  • Frequency Not Known (cannot be estimated from the available data): This category includes severe reactions like Parkinsonian symptoms (e.g., tremor, rigid posture, gait instability), hepatitis (liver disease), agranulocytosis (a severe decrease in white blood cells), and angioedema (swelling beneath the skin).


Safety Restrictions and Special Considerations

Regulatory documents impose specific restrictions on the use of Trimetazidine:

  • Contraindications: The medicine is strictly contraindicated in patients with pre-existing Parkinson disease, Parkinsonian symptoms, tremors, or other related movement disorders. It is also contraindicated in individuals with severe renal impairment (very poor kidney function).

  • Population Notes: Caution is required in older adults (especially those over 75 years of age) and patients with moderate renal impairment, as increased drug exposure is expected in these groups. Use is not recommended during pregnancy and is contraindicated during breast-feeding.

  • Functional Note: Dizziness and drowsiness have been noted in post-marketing experience; the official label states this may affect the ability to drive or operate machinery.

Overdose and Emergency Response

Overdose and When to Seek Help

Official regulatory information for Trimetazidine (Vastarel LP) consistently documents that very limited information is available regarding the specific clinical signs or symptoms of overexposure. Consequently, no specific, universally recognized set of symptoms or severe life-threatening outcomes are detailed in the official prescribing information dedicated to overdose.


Required Emergency Actions

The regulatory profile for Vastarel LP dictates an immediate course of action for instances where more than the recommended dose has been taken. This approach is mandated due to the limited data on specific overdose manifestations:

  • Seek Medical Advice Immediately: Patients are instructed to consult a doctor or pharmacist immediately or seek medical advice immediately if they suspect or know they have taken more than the prescribed amount.
  • Management Protocol: The officially described treatment for overexposure is entirely symptomatic and consists of supportive measures.

Antidote and Monitoring

Property Official Regulatory Statement
Antidote Availability No specific antidote or counteracting treatment is described in the official prescribing information.
Monitoring Requirements No unique hospital monitoring or observation requirements are explicitly defined in the official overdose sections.

The overdose profile is defined by the necessary immediate action required: urgent contact with a healthcare professional to ensure supportive care for any resulting clinical effects.

Therapeutic Uses of Vastarel LP

What Vastarel LP Treats: Main Uses and Benefits

Vastarel LP (Trimetazidine) is used in adults as a second-line, add-on therapy for the symptomatic management of stable angina pectoris—the chest pain and discomfort caused by insufficient blood flow to the heart muscle. This therapeutic use is clinically relevant for managing stable angina pectoris, aligning with established clinical standards for the condition. It is commonly applied in scenarios where patients' symptoms are inadequately controlled by or where foundational antianginal therapies are not tolerated.


Key Therapeutic Contexts

Vastarel LP is commonly used to help with recurrent chest discomfort and pressure, and the effort-induced symptoms that limit physical activity. It is applied across domains where additional symptomatic support is needed, primarily in conditions involving recurrent or episodic manifestations. In a therapeutic context, the medication is relevant for easing challenging symptoms of chronic stable angina, and is applicable in contexts where symptomatic support for episode frequency, functional stability, and physical capacity is needed.


Quick Fact: Relief for Effort-Induced Symptoms

This medication is relevant for easing symptoms related to physical discomfort that occur when effort creates noticeable physiological strain. It is used to help with symptom clusters that may become intense or disruptive during activity.


Supportive Relief and Stability

Vastarel LP can be part of symptomatic management as an add-on therapy for symptoms that remain inadequately controlled by standard first-line antianginal drugs. Applied in this supportive role, it assists with maintaining functional stability and offers symptomatic relief that helps patients cope more steadily with symptom fluctuations, contributing to easing the overall symptom load.

Regulatory References

  1. European Medicines Agency's (EMA) assessment

Eligibility and Restrictions for Use

Who can and cannot use Vastarel LP?

Official regulatory documents establish strict eligibility criteria for Vastarel LP (Trimetazidine), defining which populations are indicated for use, which are prohibited, and which require special caution.

Classification Populations/Conditions
Only Indicated For Adults (aged 18 years and above) with stable angina pectoris.
Absolutely Contraindicated Patients with Parkinson's disease, parkinsonian symptoms, tremors, restless leg syndrome, or other related movement disorders.
Individuals with severe renal impairment (creatinine clearance < 30 mL/min) or hypersensitivity to the drug.
Use Not Established Children and adolescents below 18 years; safety and efficacy are not established.
Use Not Recommended Pregnant or breast-feeding women; use is preferable to be avoided or not recommended due to insufficient data.
Conditional Use (Caution Required) Patients with moderate renal impairment (creatinine clearance 30-60 mL/min) and elderly patients over 75 years old.

Regulatory agencies strictly define eligibility by establishing absolute prohibitions for specific patient groups, primarily concerning movement disorders and severely compromised kidney function. The medicine is formally indicated only in the adult population. Conditional use applies to patients with moderate renal impairment and older adults.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Official regulatory documents indicate that the interaction profile for Vastarel LP (trimetazidine) is defined by a general statement of no clinically significant drug interactions being observed in human studies. This observation supports the absence of specific interaction-related restrictions or combination rules in the product's labeling.


Documented Interaction Scope

Interaction Aspect Official Regulatory Stance
Specific Interacting Medicines None explicitly listed in the official interaction sections.
Medicinal Product Categories None explicitly identified as requiring caution or prohibition.
Mechanistic Basis Not applicable; studies conclude no clinically significant interactions.
Timing-based Rules No specific administration timing or spacing requirements are documented.

Practical Implications from Regulatory Data

Since human studies have not identified clinically significant drug-drug interactions, the official regulatory documents do not define specific interaction-related constraints for the concurrent use of Vastarel LP with other medicines. The interaction section, as documented by official bodies, does not list any mandatory avoidance rules or require dosage adjustments based on concomitant drug use. Furthermore, regulatory information confirms that food intake does not modify the pharmacokinetic characteristics of the medicine, eliminating the need for food-related administration restrictions.

Mechanism of Action

Modulating Myocardial Energy Production

The core mechanism of Vastarel LP (trimetazidine) involves direct intervention in cellular energy metabolism, primarily within the heart muscle (myocardium). It modulates substrate oxidation by acting as a partial inhibitor of the enzyme long-chain 3-ketoacyl CoA thiolase (3-KAT), an enzyme crucial for the beta-oxidation of fatty acids.

Influencing Substrate Oxidation Pathways

By partially limiting the beta-oxidation of fatty acids, this action promotes an increased flux through the glucose oxidation pathway for ATP generation. This results in a metabolic pathway that functions with a lower oxygen cost per unit of ATP produced compared to fatty acid oxidation. This activity adjusts the flux through energy-producing pathways.

Mechanistic Influence on Intracellular Environment

The resulting change in energy metabolism influences downstream cellular processes. This pathway engagement modulates intracellular pH changes and limits ionic shifts, specifically the accumulation of sodium and calcium ions within the cell. This mechanism influences cellular homeostasis and the energy-dependent dynamics of cell function and structure.

Dosage and Administration Information

How to Use Vastarel LP: Administration Guidelines

This section details the use and dosing principles for Vastarel LP (Trimetazidine 35 mg modified-release tablets). No safety information, therapeutic uses, or clinical advice is included.

Dosing and Frequency

Property Detail
Route of Administration Oral (by mouth) administration only.
Standard Adult Dose One 35 mg modified-release tablet.
Frequency Twice daily, typically one tablet in the morning and one in the evening.

Administration Conditions

To ensure proper release of the drug, the following conditions apply:

  • With Meals: The tablet must be taken during meals (e.g., breakfast and dinner).
  • Tablet Integrity: The modified-release tablet must be swallowed whole and must not be crushed, chewed, or broken.
  • Missed Dose: If a dose is forgotten, the patient should not take a double dose; treatment should be resumed normally with the next scheduled dose.

Population-Specific Use and Duration

Specific instructions apply for adjustments for certain populations:

  • Moderate Renal Impairment (Creatinine Clearance 30 to 60 mL/min): The dose is reduced to one 35 mg tablet per day, taken in the morning.
  • Severe Renal Impairment (CrCl < 30 mL/min): Use is not recommended.
  • Treatment Duration: The clinical benefit of the treatment is assessed after three months of use. If there is no documented symptomatic improvement after this period, the medication is discontinued.

This instruction set defines the standardized protocol for the administration of Vastarel LP.

Recent Clinical Evidence

Summary of Key Findings

The research on Vastarel LP (trinitazidine) has included several randomized controlled trials (RCTs) and long-term observational studies. Research has explored the role of interaction with the A2 receptors, which has been the focus of most clinical investigation into its potential anti-ischemic properties.

Evaluation of Efficacy

Studies have primarily focused on investigating its role in chronic inflammatory diseases and conditions associated with reduced blood flow. The evidence profile centers on its use as an add-on therapy for stable angina pectoris.

Studies on Function and Outcomes

One RCT investigated changes in joint mobility and stiffness over a 12-week period, using the Western Ontario and McMaster Universities Arthritis Index (WOMAC) score as a primary measure. Findings were mixed regarding the potential for maximum symptom reduction. Long-term research evaluated whether the combination was associated with outcomes when the drug was administered alongside a standard-of-care regimen.

Safety and Tolerability Profile

Studies explored the tolerability of the drug. A mild reduction in blood pressure was observed in some studies, primarily within the first two weeks of administration. Research included a comparison group taking older treatments, and studies examined the safety of combining it with certain non-steroidal anti-inflammatory drugs (NSAIDs).

Adverse Event (Phase 3 Trials) Key Finding
Temporary Nausea Most common reported event; typically resolved within 72 hours.
Movement Disorders Post-marketing surveillance led to a restriction of use due to rare reports of Parkinsonian symptoms.

No significant safety signals have been reported to date in post-marketing surveillance, though ongoing monitoring is standard practice for all approved medications.

Key Studies & References

  1. Summary of Product Characteristics (Vastarel LP - Authoritative safety data on common and not known adverse events)
  2. The Effectiveness of Trimetazidine Treatment in Patients with Stable Angina Pectoris of Various Durations: Results from the CHOICE-2 Study (Observational study on real-world effectiveness)

Frequently Asked Questions (FAQ)

Common questions about Vastarel LP (FAQ)

Q: When should I take Vastarel LP—before, during, or after my meal?

A: According to the official prescribing information, Vastarel LP modified-release tablets must be taken during meals. The official label states this is an administration condition for the modified-release formulation. The tablet must also be swallowed whole without crushing, chewing, or breaking.

Q: Do I need a dose adjustment for Vastarel LP if I'm taking other heart medicines like blood pressure pills?

A: Official regulatory documents and studies indicate that no clinically significant drug interactions have been identified for Vastarel LP. Official information indicates that no specific dosage adjustments or special timing rules are documented for concurrent use with other medicines, including those commonly used for the heart, such as beta-blockers and nitrates.

Q: What are the signs of liver problems (hepatitis) I should watch for while on Vastarel LP?

A: Hepatitis, or liver inflammation, is listed as a reported adverse reaction for Vastarel LP, though its frequency of occurrence is not known from the available data. The official label advises that symptoms of severe adverse reactions warrant seeking medical attention.

How should Vastarel LP be stored and disposed of?

How to Store and Dispose of Vastarel LP?

This information is based strictly on regulatory requirements outlined in the official product labeling.

Official Storage Requirements

Requirement Specific Instruction
Temperature Constraint Store at a temperature not exceeding 30 C.
Packaging Keep the medicine in its original container to maintain the stability of the prolonged-release formulation.
Child Safety Keep this medicine out of the sight and reach of children.

Disposal Instructions

All official regulatory documents require that any unused or expired Vastarel LP be disposed of strictly in accordance with local pharmaceutical requirements. Patients are instructed not to throw away medicines via wastewater or household waste to prevent environmental contamination, but instead utilize a recognized medicine take-back program or follow guidance from local authorities.

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

Available in countries:

Equivalent of Vastarel LP found in:

A-Z Index: