Distribution and excretion of sumatriptan in human milk

R. E. WOJNAR-HORTON, L. P. HACKETT, P. YAPP, L. J. DUSCI, M. PAECH, K. F. ILETT
Br J Clin Pharmacol 1996; 41: 217-221

Abstract

  1. The excretion of a 6 mg subcutaneous dose of sumatriptan in breast milk was studied in five lactating volunteer subjects with a mean age of 27.6 years and a mean body weight of 75 kg. Drug concentrations in milk and plasma over the ensuing 8 h were measured by high-performance liquid chromatography.
  2. The mean milk:plasma ratio estimated from the areas under the milk and plasma concentration-time curves (AUC) was 4.9 (95% CI 4.1–5.7), indicating a significant transfer of sumatriptan into the milk compartment.
  3. The mean total recovery of drug in milk was estimated to be only 14.4 μg (95% CI 6.1–22.7 μg), or 0.24% of the 6 mg administered dose. On a weight-adjusted basis this corresponded to a mean infant exposure of 3.5% of the maternal dose (95% CI 0.3–6.7%).
  4. If oral bioavailability in the infant is similar to that in adults (14%), the weight-adjusted infant dose is reduced to 0.49%. Furthermore, allowance for reduced clearance in the infant predicts an infant exposure varying from 4.9% in a very premature neonate to 0.7% in a 30 week old infant.
  5. Since sumatriptan is usually administered as a single dose at infrequent intervals, the low level of excretion in breast milk suggests that continued breast feeding following its use will not pose a significant risk to the suckling infant. Even this minor exposure could be largely avoided by expressing and discarding all milk for 8 h after the dose.

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