trimetazidine hydrochloride Tablets 20 mg

Dossier type
CTD
Dossier status
Ready to file
Country of origin
Vietnam
GMP approvals
WHO
Manufacturer #21499

This CTD dossier owner and manufacturer is a major player in the global market, with established production bases across multiple regions. They boast a wide range of products, including prescription medications and over-the-counter drugs, catering to diverse therapeutic areas such as respiratory health, pain management, gastrointestinal disorders, and infectious diseases. Their product portfolio encompasses various dosage forms like oral solids, injections, topical creams, and infusions, manufactured under strict GMP certifications. The company holds several patents for their innovative drug formulations, solidifying its competitive advantage in the industry.

TRIMETAZIDINE HYDROCHLORIDE

Trimetazidine is used in the long term treatment and management of angina. Angina is chest pain arising from the heart muscle when it falls short of enough oxygen for healthy functioning. The patients get a feeling of indigestion, fullness, pressure, or tightness in the chest spreading to arms or neck. In some countries, it is also used for treating tinnitus and dizziness. It works by improving the myocardial glucose utilization through inhibition of fatty acid metabolism, also known as a fatty acid oxidation inhibitor. Trimetazidine is a drug for angina pectoris sold under brand names called Vastarel. Trimetazidine was developed and marketed by Laboratoires Servier (France). Trimetazidine is not sold widely in the USA as it does not have FDA approval for sale in the United States.

Forms and Dose

Trimetazidine hydrochloride is sold as a modified, extended-release tablet. It is taken orally with meals. This medicine is for adults only. The recommended dose is, modified extended-release tablets of 20 mg to be taken three times a day or 35 mg. the treatment is reassessed after 3 months, if no improvement is observed, the medication can be continued.

The cost Trimetazidine Hydrochloride

In the USA, the wholesale cost of the 50mg of this powder costs USD100, whereas the importing price in different countries varies between USD 100 and USD 200 per kilo. In India, the 35 mg tablet costs USD0.12 cents.

How does Trimetazidine Hydrochloride work?

Trimetazidine Hydrochloride improves myocardial glucose utilization through inhibition of long-chain 3- ketoacyl CoA thiolase activity. This results in a reduction in fatty acid oxidation and stimulates glucose oxidation. High fatty acid oxidation rates are detrimental in ischemia because of inhibition of glucose oxidation leading to uncoupling of glycolysis and an increase in proton production. This has the potential to accelerate sodium and calcium overload in the heart, which leads to an exacerbation of ischemic injury and decreased cardiac efficiency during reperfusion.

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