Trimetazidine Dihydrochloride

Product Description

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Trimetazidine Dihydrochloride (often abbreviated as Trimetazidine HCl) is a medication primarily used to treat angina pectoris (chest pain due to heart disease) and to improve cardiac function in people with ischemic heart disease. It is classified as a metabolic agent because it works by improving the efficiency of the heart muscle's energy production, thus reducing the severity of ischemic conditions and relieving symptoms.

Here are the key details about Trimetazidine Dihydrochloride:

1. Chemical Structure and Properties

Chemical Name: 1-(2,3,4-Trimethoxybenzyl)-2,3,4-trimethylimidazole dihydrochloride

Molecular Formula: C15H22N2O32HCl

Appearance: White or almost white crystalline powder.

Solubility: Trimetazidine dihydrochloride is freely soluble in water and ethanol, making it easy for the body to absorb when taken orally.

Molecular Weight: 354.32 g/mol (for the dihydrochloride form).

2. Mechanism of Action

Trimetazidine is not a vasodilator like traditional anti-anginal drugs (e.g., nitrates or calcium channel blockers). Instead, it works by improving the efficiency of the heart muscles metabolism under ischemic (oxygen-deprived) conditions. It acts by:

Shifting the metabolism of the heart: Trimetazidine reduces the reliance on fatty acids (which are less efficient for energy production) and increases glucose oxidation for energy in heart cells. This shift improves the energy efficiency of the heart muscle, especially during oxygen deprivation, thereby reducing the strain on the heart.

Preventing cellular damage: Trimetazidine has been shown to protect heart cells from damage caused by ischemia (lack of oxygen) by improving the energy supply and reducing oxidative stress.

3. Indications

Trimetazidine Dihydrochloride is primarily used to treat:

Angina Pectoris: Trimetazidine is used as an adjunct treatment for angina, particularly in cases where other anti-anginal medications (such as nitrates or beta-blockers) are insufficient or not well-tolerated.

Ischemic Heart Disease: It is also used to improve heart function in patients with chronic ischemic heart disease, especially those who have coronary artery disease or a history of myocardial infarction.

Vestibular Disorders: In some countries, Trimetazidine is also used off-label to treat vestibular disorders, such as dizziness or vertigo, particularly in patients with certain types of inner ear problems.

4. Dosage and Administration

Oral Tablets: Trimetazidine Dihydrochloride is usually taken orally in tablet form.

The standard adult dosage for angina pectoris is typically 20 mg, taken two or three times daily, with meals. The maximum recommended daily dose is 60 mg.

Adjustments may be necessary for elderly patients or those with kidney issues. In these cases, lower doses (e.g., 20 mg twice daily) may be recommended.

Administration: The tablets should be swallowed whole with a glass of water, and should ideally be taken with meals to improve absorption and reduce gastrointestinal irritation.

5. Side Effects

Trimetazidine Dihydrochloride is generally well-tolerated, but like any medication, it can cause side effects in some people:

Common Side Effects:

Dizziness

Headache

Nausea or upset stomach

Fatigue

Skin rash

Neurological Side Effects (less common but potentially serious):

Parkinsonism-like symptoms: These can include tremors, muscle rigidity, and bradykinesia (slowness of movement). These symptoms are more common in elderly patients.

Extrapyramidal Symptoms: In rare cases, Trimetazidine can cause motor control disturbances similar to Parkinsons disease.

Severe Side Effects (very rare):

Severe allergic reactions (e.g., anaphylaxis) in some individuals.

Liver toxicity: While very rare, there have been cases of liver enzyme elevations. Liver function should be monitored if any symptoms of liver problems occur.

6. Contraindications and Precautions

Hypersensitivity: Trimetazidine should not be used in individuals with a known hypersensitivity (allergic reaction) to trimetazidine or any of its components.

Parkinsons Disease or Movement Disorders: Due to the potential for causing extrapyramidal symptoms, Trimetazidine should be avoided in individuals with Parkinsons disease or other movement disorders.

Severe Renal Impairment: Trimetazidine should be used with caution in patients with severe kidney dysfunction. Dose adjustments may be required for those with mild to moderate renal impairment.

Pregnancy and Lactation: Trimetazidine is not recommended for use during pregnancy and breastfeeding, as its safety during these periods has not been fully established.

Elderly Patients: Special caution is required for elderly individuals, as they may be more prone to extrapyramidal side effects.

7. Drug Interactions

Trimetazidine generally has a low potential for drug interactions, but the following should be considered:

Other Anti-Anginal Medications: While there are no direct contraindications, careful monitoring is advised when combining Trimetazidine with other anti-anginal medications, such as nitrates, beta-blockers, or calcium channel blockers, to avoid any cumulative side effects.

Parkinson's Disease Medications: Trimetazidine may exacerbate symptoms of Parkinsons disease when used in combination with dopamine agonists or other treatments for Parkinsons disease.

8. Pharmacokinetics

Absorption: Trimetazidine Dihydrochloride is well absorbed from the gastrointestinal tract, with peak plasma concentrations typically reached within 12 hours after oral administration.

Metabolism: It is metabolized in the liver, and its half-life is approximately 7 hours.

Excretion: Trimetazidine is primarily excreted unchanged in the urine. Because of this, dose adjustments may be necessary in patients with kidney dysfunction.

9. Safety and Effectiveness

Trimetazidine has been shown to be effective in improving the quality of life for patients with angina and ischemic heart disease. It works by improving cellular energy efficiency, which reduces the hearts oxygen demand. It is often used as part of a comprehensive treatment plan that includes other medications such as nitrates, beta-blockers, and calcium channel blockers.

Effectiveness: Clinical studies show that Trimetazidine is effective in reducing the frequency and severity of angina attacks and can help improve exercise tolerance in patients with ischemic heart disease.

Safety: While generally safe, it must be used cautiously in the elderly and in patients with kidney disease due to potential side effects like extrapyramidal symptoms and the need for dose adjustments.

10. Regulatory Status

FDA Approval: Trimetazidine is not currently approved by the U.S. FDA for use in the treatment of angina or ischemic heart disease. However, it is approved in many countries in Europe, Asia, and Latin America for the treatment of these conditions.

European and Other International Use: It is approved in Europe and many other countries for the treatment of angina pectoris and ischemic heart disease. It is also used in some countries for managing vestibular disorders.

11. Conclusion

Trimetazidine Dihydrochloride is a unique anti-anginal medication that works by optimizing the metabolic function of the heart, improving its energy efficiency during ischemic conditions. While generally well-tolerated, it is associated with potential side effects such as extrapyramidal symptoms, particularly in elderly patients. It is an effective adjunct therapy for angina and ischemic heart disease but should be used with caution in individuals with renal impairment or movement disorders. Patients should be monitored for side effects, particularly during long-term use.