Quantification of infant exposure to celecoxib through breast milk

Br J Clin Pharmacol. 2006 Jan;61(1):101-4. doi: 10.1111/j.1365-2125.2005.02520.x.

Abstract

Aims: To determine the milk-to-plasma (M/P) concentration ratio of celecoxib, and estimate likely infant exposure.

Methods: Blood and milk were sampled for 48 h after oral administration of celecoxib 200 mg to six lactating volunteers. The M/P ratio was derived from the area under the concentration-time curves (0-infinity) and the infant 'dose' estimated from celecoxib concentrations in milk.

Results: The median (range) M/P ratio was 0.18 (0.15-0.26). The median (range) infant 'dose' was 0.23% (0.17-0.30%) of the maternal dose, adjusted for weight.

Conclusion: The relative 'dose' of celecoxib to which infants are exposed via milk is very low, suggesting that breastfeeding during routine dosing would pose minimal risk.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Oral
  • Adult
  • Anti-Inflammatory Agents, Non-Steroidal / administration & dosage
  • Anti-Inflammatory Agents, Non-Steroidal / analysis
  • Anti-Inflammatory Agents, Non-Steroidal / pharmacokinetics
  • Area Under Curve
  • Celecoxib
  • Cyclooxygenase Inhibitors / administration & dosage
  • Cyclooxygenase Inhibitors / analysis
  • Cyclooxygenase Inhibitors / pharmacokinetics*
  • Environmental Exposure / adverse effects
  • Female
  • Humans
  • Infant
  • Lactation
  • Milk, Human / chemistry*
  • Mothers
  • Pyrazoles / administration & dosage
  • Pyrazoles / analysis
  • Pyrazoles / pharmacokinetics*
  • Sulfonamides / administration & dosage
  • Sulfonamides / analysis
  • Sulfonamides / pharmacokinetics*

Substances

  • Anti-Inflammatory Agents, Non-Steroidal
  • Cyclooxygenase Inhibitors
  • Pyrazoles
  • Sulfonamides
  • Celecoxib