Transfer of rofecoxib into human milk.
OBJECTIVE
To determine the milk-to-plasma (M/P) concentration ratio of rofecoxib in lactating mothers and estimate likely infant exposure.


METHODS
Rofecoxib 25 mg was given to six lactating women at weaning. Blood and milk were sampled up to 72 h post-dose for determination of rofecoxib concentrations. M/P ratios were derived from the respective area under the concentration-time curves. The infant 'dose' in milk was estimated and expressed as a percentage of the maternal dose, corrected for weight.


RESULTS
The median (range) M/P ratio and infant 'dose' were 0.25 (0.16-0.32) and 2.1% (1.8-3.2%), respectively.


CONCLUSIONS
The use of rofecoxib during breastfeeding is unlikely to pose harm to the suckling infant on the basis of low transfer into human milk.
Gardiner
Sharon J
SJ
Department of Clinical Pharmacology, Christchurch Hospital, Private Bag 4710, Christchurch, New Zealand. sharon.gardiner@cdhb.govt.nz
Begg
Evan J
EJ
Zhang
Mei
M
Hughes
Ruth C E
RC
D000328:Adult; D019540:Area Under Curve; D016861:Cyclooxygenase Inhibitors / Q000097:blood / Q000493:pharmacokinetics*; D005260:Female; D006207:Half-Life; D006801:Humans; D007774:Lactation / Q000378:metabolism*; D007783:Lactones / Q000097:blood / Q000493:pharmacokinetics*; D008657:Metabolic Clearance Rate; D008895:Milk, Human / Q000737:chemistry / Q000378:metabolism*; D013450:Sulfones / Q000097:blood / Q000493:pharmacokinetics*
D016861:Cyclooxygenase Inhibitors; D007783:Lactones; D013450:Sulfones; C116926:rofecoxib