Rationality and normativity of the package insert of dexamethasone injection related to medication safety / 中国药学杂志

ABSTRACT

OBJECTIVE: To evaluatethe rationality and normativity of the contents of thepackage insert of dexamethasoneinjectionrelated to medicationsafety, thus to facilitate the rational use of dexamethasoneinjection. METHODS: The contentsof dosage and administration, adverse drug reaction, and precautionsin the package insert of dexamethasoneinjectionwere reviewed, and the rationality and normativity of the contents were discussed according tothe published papers and the clinical medication practice in our hospital. RESULTS: The contents of the package insert of dexamethasone injectionwere simple, some of the expressionswereambiguousor not standard. Dexamethasone is a long-acting glucocorticoid drug, which has a great influence on human glucose metabolism, while the effect of water and sodium retention is weak. Using 5% glucose injection as the solvent of dexamethasone as stated in the package insertmay exacerbate hyperglycemia, and 0.9% sodium chloride injection should generally be used as the dilution solvent. Besides, when the stock solution is directly injected intravenously, the adverse reactionsof gastrointestinal tract and nervous system may be aggravated. Additionally, there was no precaution statement in the package insert that dexamethasonemay induce hypokalemia in a minority of patients even at single low dose. CONCLUSION: Package insertsof drugs are legal instruments and the most important evidence to guide the rational use of medications. Therefore, it is suggested that the package insert of dexamethasoneinjection should be further improved and revised, which will be of great significance in the implementation of clinical guidelines of glucocorticoids applicationand the rational use of glucocorticoids.