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PI-2Drug interaction studies -- study design, data analysis, and implications for dosing and labeling: Current opinion by HUANG, S; REYNOLDS, K; STRONG, J; NALLANI, S; LESKO, L; TEMPLE, R; ABRAHAM, S; ALHABET, S; BAWEJA, R; CHUNG, S is a Medicine article available to read on EtoBox.

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BACKGROUND: Lactating women undergoing operations under general anesthesia are advised to pump and discard their milk for 24 h after the procedure. We determined the kinetics of midazolam elimination in breast milk to ascertain its safety after midazolam administration. METHODS: Five lactating women were studied after providing institutionally-approved written informed consent. Patients were premedicated with midazolam, 2 mg IV, 5 min before anesthetic induction with fentanyl, 100 g IV, and propofol, 2.5 mg/kg IV. Anesthesia was maintained with potent volatile anesthetics. Milk was collected using an electric breast pump before and at 5, 7, 9, 11, and 24 h after drug administration. Blood samples were collected before and at regular intervals up to 7 h after drug administration. Plasma and milk midazolam concentrations were measured by LC-MS. Midazolam elimination in milk was modelled simultaneously with the plasma kinetics as the cumulative amount of drug in milk just as urinary elimination is modelled, albeit with a delay. RESULTS: Plasma midazolam pharmacokinetics were consistent with those reported by ourselves and others. In 24 h of milk collection, only 0.005 (Ϯ 0.005)% of th

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Author

HUANG, S; REYNOLDS, K; STRONG, J; NALLANI, S; LESKO, L; TEMPLE, R; ABRAHAM, S; ALHABET, S; BAWEJA, R; CHUNG, S

Publisher

Nature Publishing Group; Wiley (Blackwell Publishing); Wiley-Blackwell; Wiley; Springer Science and Business Media LLC; Research Square (ISSN 0009-9236)

Published

2006

Language

EN

Field

Medicine (Health Sciences)