Discussion
nausea, cardiac arrhythmias, critically ill, ®, diarrhea, abdominal pain, confusion, epilepsy, allergy, vomiting, dizziness, hepatitis, insomnia, headache, erythema multiforme, rhinorrhagia
ADVERSE REACTIONS, CARDIAC ARRHYTHMIAS, CRITICALLY ILL, EPILEPSY, GASTROINTESTINAL BLEEDING, ALLERGY, INFLUENZA PNEUMONIA, TOXIC EPIDERMAL NECROLYSIS, INFLUENZA A, CONJUNCTIVITIS, ERYTHEMA MULTIFORME, EVENTS, HEPATITIS
Oseltamivir phosphate, an antiviral drug, which used in the treatment of influenza A and B, and early treatment with oseltamivir was associated with a significant 33% reduction in ICU mortality compared with late treatment. It may be related to enhanced survival in critically ill patients with influenza pneumonia, at the same time, it may decrease the ICU length of stay and duration of mechanical ventilation [In this study, the oseltamivir phosphate for suspension produced by Hetero Labs Limited was compared with the originator TAMIFLU® to evaluate the absorption rate and degree of absorption in healthy humans, and to investigate the human bioequivalence of the two drugs. The difference between the test product and the reference product TAMIFLU® under fasting and fed conditions in the pharmacokinetic parameters between was not significant, which was similar to the results of previous studies [This study confirmed the interchangeability of the test product and TAMIFLU® by verifying their bioequivalence, and that food intake did not affect the pharmacokinetics and bioequivalence of the two products. For patients, it is possible to achieve the same therapeutic effect by choosing a drug with a relatively good price.In terms of adverse reactions, the most common side effects of oseltamivir phosphate were nausea (incidence 10%), vomiting (2–15%), abdominal pain, diarrhea, headache, insomnia and dizziness. Other side effects included conjunctivitis, rhinorrhagia, allergy, cardiac arrhythmias, gastrointestinal bleeding, erythema multiforme, toxic epidermal necrolysis, confusion, hepatitis, epilepsy, and neuropsychiatric events, but the incidence was < 1%. Oseltamivir is generally well tolerated [The limitation of this study is as follows, the study is a bioequivalence trial in healthy Chinese subjects, the pharmacokinetic parameter data express the absorption distribution and elimination in Chinese subjects, and the bioequivalence in other races has not been evaluated yet, so it is not known whether there are differences between different races, which will be further verified in later trials.