Is ketorolac compatible with breast-feeding?

Fråga: Is ketorolac compatible with breast-feeding?

Sammanfattning: Ketorolac is excreted into breast milk at low concentrations corresponding to 0.16 to 0.40 % of the maternal weight-related dosage. However, there are no data on effects in breast-fed infants and due to the limited documentation of ketorolac cannot be recommended as a first choice of analgetic drug to a breast-feeding woman.

Svar: Ketorolac is excreted into breast milk at low concentrations (1). Ten women, two to six days postpartum, were given 10 mg of ketorolac orally four times daily for two days. Their infants were not allowed to breast-feed during the study. Plasma and milk samples were collected on the two dosing days and on the first day after dosing. The maternal plasma concentrations were within established ranges for ketorolac. Four of the women had milk concentrations of drug below the detection limit of quantification (5 ng/ml) and were excluded from analysis. In the remaining six women milk concentrations were between 5.2 to 7.9 ng/ml. Assuming a daily consumption of 400 ml to1L of breast milk, the infant´s dose was calculated to 0.16 to 0.40 % of the maternal weight-related dose (1). The low amounts of ketorolac in breast milk were considered as clinically insignficant (1). The manufacturer has no further information about ketorolac and breast-feeding.

In Sweden, ketorolac is only registered as injection for postoperative pain, but in other countries there are also oral preparations of the drug. The bioavailability for those preparations is reported to be 100% (2). The amount of ketorolac entering the systemic circulation of a breast-fed infant is expected to be very low. However, since there are no data on the effects of ketorolac in breast-fed infants it cannot be recommended to a breast-feeding woman and another choice of analgetic drugs should be considered. The half-life of ketorolac is about 5 hours and the drug is expected to be eliminated from the body after approximately 25 hours (5 half-lifes). Potential harm of infant lactation exposure to drugs should always be weighed against the need of treating the mother and advantages with breast-feeding in every single case.