The Ministry of Health has approved a domestic NSAID for parenteral administration of parecoxib

13.06.2023

Medicines

The Ministry of Health has approved the nonsteroidal anti-inflammatory drug Parecoxib from Promomed Rus. Currently, it is the only injectable selective COX-2 inhibitor in Russia. In 2020, Pfizer's parecoxib Dynastat drug was removed from the registry.


Promomed Rus has received a registration certificate for Parecoxib. Information about this posted in the State Register of Medicines. The drug is indicated as an analgesic for short-term reduction of postoperative pain. In the body, parecoxib is hydrolyzed to form valdecoxib, which selectively acts on the source of pain and has virtually no effect on physiological processes in tissues. Due to its selective action and lack of effect on the mucous membrane of the stomach and intestines, the frequency of ulcers and erosions of the gastrointestinal tract when using parecoxib is lower than when using non-selective NSAIDs.

The drug is available as a lyophilizate for the preparation of a solution for intravenous and intramuscular administration. According to the registry, the manufacturer is JSC Biochemist.

Parecoxib is a nonsteroidal anti–inflammatory drug (NSAID) with analgesic, antipyretic and anti-inflammatory effects.

The most serious adverse reactions listed in the instructions for medical use are: signs of myocardial infarction, thromboembolism, angioedema, etc.

Parecoxib is contraindicated under 18 years of age, as well as in lactating and pregnant women.

According to the GRLS, the drug Dynastat (INN parecoxib) from Pfizer was registered in Russia in 2009, also in injectable form. Later, in 2020, it was withdrawn from the registry due to the prolonged lack of supplies of the drug to the Russian market, according to the company. Then it became one of the medicines that have no active analogues in the State Register of Medicinal Products.

Promomed Rus has twice submitted documents for registration of parecoxib to the Ministry of Health, in 2019 and 2020.

Sources
  1. https://pharmvestnik.ru/content/news/Minzdrav-odobril-otechestvennyi-NPVP-dlya-parenteralnogo-vvedeniya-parekoksib.html

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