Pharmacokinetics and safety of intravenous oseltamivir in infants and children in openlabel studies. | |||
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분류 | Pharmacokinetics | 조회 | 1527 |
발행년도 | 2015 | 등록일 | 2015-10-09 |
출처 | Int J Clin Pharmacol Ther. (바로가기) | ||
OBJECTIVE:
Critically ill children with influenza may be unable to swallow or absorb oral drugs. An intravenous (IV) formulation of the antiviral oseltamivir was evaluated in two prospective open-label studies.
METHODS:
Hospitalized children aged less than 1 year (NCT01053663) or 1 - 12 years (NCT01033734) with clinical or laboratoryconfirmed influenza, normal renal function, and who are unable to tolerate and/or absorb oral medication were enrolled. Patients received oseltamivir 2 - 3 mg/kg (age less than 1 year) or 2.5 - 3 mg/kg (max. 100 mg; age 1 - 12 years) by slow IV infusion twice daily for up to 6 days. Blood samples were taken for pharmacokinetics and nasal swabs taken to monitor viral shedding and resistance (by reverse transcriptase polymerase chain reaction (RTPCR) and culture). Adverse events (AEs) were monitored for 30 days from treatment initiation.
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