The government will include some warnings about nausea, vomit, frequent pulse and high blood pressure in using Precedex Inj. (compound: Dexmedetomidine Hydrochloride), a hypnotics sedative.
The Ministry of Food and Drug Safety식품의약품안전처 (MFDS) put to public notice Thursday the ministry’s approval condition changes for eight items of Dexmedetomidine Hydrochloride substance therapy, including Precedex Inj., and said it would gather opinions until June 22.
The changes say patients may suffer from nausea, vomit, frequent pulse and high blood pressure that require doctor’s involvement within 48 hours of stopping taking the drug. Also, the ministry will add the contents, which call for taking supplementary therapies when frequent pulse and high blood pressure occur after stopping its use.
Precedex Inj. is a drug used to calm down patients when doctors conduct cardiopulmonary resuscitation in intubation, or when doctors want to ease patients’ consciousness when they perform surgeries or operate lesser treatments without intubation.
Pfizer Korea한국화이자제약 is selling Precedex Inj., and other companies released its generics after the expiry of re-evaluation period in June 2016. These generics include Omnidex Inj. made by Kyongbo Pharm경보제약, Dexmedine Inj. made by Hana Pharm하나제약, Medex Inj. made by Ilsung Pharmaceuticals일성신약, Phamtomidine Inj. made by Pharmbio Korea Inc.한국팜비오, Dexmedetomidine Hydrochloride Penmix Dexmedetomidine Hydrochloride Inj. made by Penmix펜믹스, Hanlim Dextomin Inj. made by Hanlim pharmaceutical한림제약.
In April, the ministry changed the approval conditions of Precedex Inj. after it added the results of its investigation of the drug’s sales record. The results that came after selling it to 659 patients found two low blood pressure cases caused by adverse drug reactions, two slow pulse cases, and one high blood pressure whose relationship with the drug cannot be ruled out, ministry officials said.
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