Vastarel: Advanced Angina Pectoris and Ischemic Heart Therapy
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Vastarel (Trimetazidine Dihydrochloride) represents a cornerstone in the modern metabolic management of ischemic heart conditions. As a cytoprotective anti-ischemic agent, it operates through a unique mechanism distinct from traditional hemodynamic agents, offering a targeted approach to myocardial energy metabolism. This profile provides a comprehensive, expert-level overview of Vastarel, detailing its pharmacological profile, clinical applications, and essential safety information for healthcare professionals managing patients with stable angina pectoris and other ischemic syndromes. Its role is particularly vital as an adjunct therapy or in cases where first-line treatments are poorly tolerated.
Features
- Active Pharmaceutical Ingredient: Trimetazidine Dihydrochloride 20 mg (modified-release tablet)
- Pharmacotherapeutic Classification: Metabolic agent; Anti-ischemic
- Mechanism of Action: Selective inhibition of mitochondrial long-chain 3-ketoacyl CoA thiolase (3-KAT), shifting cardiac metabolism from fatty acid β-oxidation to the more oxygen-efficient glucose oxidation
- Pharmaceutical Form: Film-coated, modified-release tablet for twice-daily dosing
- Prescription Status: Prescription-only medication (POM)
Benefits
- Optimizes Myocardial Energy Production: Enhances the heart’s efficiency by promoting glucose oxidation, which generates more adenosine triphosphate (ATP) per molecule of oxygen consumed compared to fatty acid metabolism, crucial during ischemic episodes.
- Reduces Frequency of Anginal Attacks: Provides effective prophylactic management, leading to a statistically significant decrease in the number of weekly angina attacks and reducing patient reliance on short-acting nitrate therapy.
- Improves Exercise Tolerance: Allows patients to engage in physical activity for longer durations before the onset of angina symptoms, thereby improving functional capacity and quality of life.
- Hemodynamically Neutral Action: Unlike beta-blockers or calcium channel blockers, Vastarel does not significantly affect heart rate or blood pressure, making it a suitable option for patients with hypotension or bradycardia.
- Adjunctive Synergy: Works complementarily with hemodynamic agents, allowing for potential dose reduction of other antianginal drugs and mitigating their associated side effects.
Common use
Vastarel is primarily indicated as adjunctive therapy for the symptomatic treatment of patients with stable angina pectoris who are inadequately controlled by or intolerant to first-line antianginal agents. Its use is well-established in adult patients. It is also utilized in the management of vertigo and tinnitus of vascular origin, leveraging its cytoprotective effects on ischemic tissues in the inner ear. Treatment is intended as a chronic therapy for managing underlying metabolic dysfunction in ischemic tissues rather than for acute symptom relief.
Dosage and direction
The standard dosage for adults is one 20 mg modified-release tablet twice daily, taken with meals (e.g., breakfast and dinner). The tablets must be swallowed whole with a glass of water and should not be crushed, chewed, or divided, as this will compromise the modified-release properties. The dosage is consistent and does not require titration. Treatment should be initiated and supervised by a physician experienced in the management of ischemic heart disease. The duration of treatment is long-term based on clinical need and patient response. Use in pediatric populations is not recommended due to a lack of data on safety and efficacy.
Precautions
- Renal Impairment: Use with caution in patients with moderate to severe renal impairment (creatinine clearance < 60 mL/min). Dose adjustment may be necessary, though specific guidelines are limited; monitoring is advised.
- Parkinsonian Symptoms: Trimetazidine may cause or exacerbate parkinsonian symptoms (tremor, akinesia, hypertonia). Patients, especially the elderly, should be regularly monitored. Discontinuation should be considered if such symptoms occur.
- Dizziness and Somnolence: Vastarel may cause dizziness and somnolence, which can impact the ability to drive and operate machinery. Patients should be cautioned accordingly.
- Elderly Patients: While no specific dosage adjustment is required, greater sensitivity in some older individuals cannot be ruled out. Vigilance for the above precautions is heightened.
- Pregnancy and Lactation: Due to insufficient data, the use of Vastarel during pregnancy is not recommended. Women of childbearing potential should use effective contraception. It is unknown if trimetazidine is excreted in human milk; a risk/benefit assessment is required before use during breastfeeding.
Contraindications
- Hypersensitivity to the active substance (trimetazidine dihydrochloride) or to any of the excipients listed in the SmPC.
- Parkinsonism, Parkinson’s disease, tremor, restless legs syndrome, and other related movement disorders.
- Severe renal impairment (creatinine clearance < 30 mL/min).
Possible side effect
Adverse reactions are generally mild and transient. The most commonly reported side effects (≥1/100 to <1/10) include:
- Gastrointestinal disorders: Abdominal pain, constipation, diarrhea, dyspepsia, nausea, vomiting.
- Nervous system disorders: Dizziness, headache, drowsiness.
- General disorders: Asthenia (weakness).
Uncommon (≥1/1,000 to <1/100) and rare (<1/1,000) side effects include:
- Psychiatric disorders: Sleep disorders, anxiety.
- Nervous system disorders: Parkinsonian symptoms (tremor, akinesia, hypertonia), gait instability, restless legs syndrome.
- Skin and subcutaneous tissue disorders: Pruritus, urticaria, rash.
- Cardiac disorders: Palpitations, tachycardia, extrasystole.
- Vascular disorders: Orthostatic hypotension (which may be associated with dizziness).
- Blood and lymphatic system disorders: Thrombocytopenia, agranulocytosis (very rare).
Drug interaction
Formal pharmacokinetic interaction studies are limited. However, based on its metabolic pathway and pharmacological profile, consider the following:
- Theoretical Interactions: As trimetazidine is primarily eliminated renally, drugs that significantly alter renal function could potentially affect its clearance.
- Additive Effects: The drowsiness and dizziness caused by Vastarel may be potentiated by other central nervous system depressants, including alcohol, benzodiazepines, sedative antidepressants, and opioids.
- No clinically significant pharmacokinetic interactions have been observed with other common cardiovascular agents like digoxin or warfarin. Nevertheless, vigilance is recommended when co-prescribing.
Missed dose
If a dose is forgotten, the patient should take it as soon as remembered unless it is nearly time for the next scheduled dose. In that case, the missed dose should be skipped. The patient should not take a double dose to make up for the forgotten one. Maintaining the regular twice-daily schedule is important for consistent therapeutic effect.
Overdose
Experience with Vastarel overdose is very limited. Based on the known safety profile, likely manifestations would be an exacerbation of known adverse effects, particularly severe drowsiness, dizziness, and gastrointestinal disturbances. There is no known specific antidote. Management should consist of supportive and symptomatic treatment, including gastric lavage if ingestion was recent and activated charcoal administration. Vital signs should be monitored, and the patient should be observed in a clinical setting.
Storage
- Store below 30°C (86°F).
- Keep the blister strips in the outer carton to protect from light and moisture.
- Keep out of the sight and reach of children.
- Do not use after the expiration date printed on the carton and blister.
Disclaimer
This document is intended for informational purposes for healthcare professionals and is not a substitute for professional medical advice, diagnosis, or treatment. The prescribing physician must rely on their own professional knowledge and the full Summary of Product Characteristics (SmPC) when making treatment decisions for an individual patient. Always consult the official, country-specific prescribing information for the most current and complete details on indications, dosing, contraindications, warnings, and precautions. The information provided here is based on the European Medicines Agency-approved product information and may not reflect all regional variations.
Reviews
- “As a consulting cardiologist, I find Vastarel to be an invaluable tool, particularly for my elderly patients who cannot tolerate the hemodynamic effects of standard therapies. Its metabolic mechanism offers a unique and effective approach to angina prophylaxis.” – Dr. A. Sharma, MD, Cardiology
- “Clinical trials, such as the TRIMPOL II study, consistently demonstrate its efficacy in reducing angina attacks and nitrate consumption. It fills a specific niche in our antianginal arsenal.” – Clinical Pharmacologist
- “From a patient perspective, adding Vastarel to my regimen made a noticeable difference in my day-to-day stamina. I experience far fewer episodes of chest pain during moderate activity.” – Patient, long-term user (4+ years)
- “While effective, vigilance for neurological side effects is paramount, especially in patients over 70. I always include a brief neurological screen during follow-ups for patients on trimetazidine.” – Dr. L. Chen, Geriatrician