Ketorolac Pregnancy and Breastfeeding Warnings

Ketorolac is also known as: Sprix, Toradol, Toradol IM, Toradol IV/IM

Ketorolac Pregnancy Warnings

Ketorolac is known to cross the placenta. In one study, 32 women received ketorolac 10 mg one time by intramuscular injection to relieve pain during labor. Ketorolac levels were obtained from maternal plasma and from the umbilical cord at the time of delivery, with sample tissues ranging from 0.5 to 6.5 hours post-dose. Ketorolac concentrations ranged from 0.017 to 0.119 mcg/mL in cord blood and from 0.223 to 0.873 mcg/mL in maternal plasma. The mean cord blood to maternal plasma concentration ratio was 0.116. In another study, 18 women were randomly assigned to receive ketorolac 10 mg or meperidine 50 mg or 100 mg one time by intramuscular injection to relieve pain during labor. An analysis of platelet aggregation in whole blood obtained from the neonates revealed a significant inhibition of arachidonic acid- and collagen-induced platelet aggregation in those infants whose mothers received ketorolac. ADP-induced aggregation was not affected. The clinical significance of this finding remains to be determined. Data on the use of ketorolac during pregnancy, other than for the management of labor pain, are lacking.

Ketorolac has been assigned to pregnancy category C by the FDA. Some animal studies have revealed evidence of teratogenicity. There are no controlled data in humans. In one study, only very small amounts of ketorolac were detected in umbilical vein samples after use in labor and delivery. Ketorolac is only recommended for use during pregnancy when benefit outweighs risk. Ketorolac use is considered contraindicated during labor and delivery since it may adversely affect fetal circulation and inhibit uterine contractions.

Ketorolac Breastfeeding Warnings

Ketorolac is excreted into breast milk in small amounts after oral dosing with 10 mg four times daily. Ketorolac is considered compatible with breast-feeding by the The American Academy of Pediatrics. However, the manufacturer recommends caution in nursing mothers because of the potential adverse effects of prostaglandin-inhibiting drugs on neonates. The excretion of ketorolac into human milk was evaluated in 10 healthy women. Following oral administration of ketorolac 10 mg four times daily for two days, ketorolac was undetectable (<5 ng/mL) in all milk samples from four patients. In the remaining patients, ketorolac milk concentrations ranged from 5.2 to 7.9 ng/mL 2 hours postdose. The milk to plasma ratio ranged from 0.015 to 0.037.

Caution is recommended. Excreted into human milk: Yes Excreted into animal milk: Unknown The effects in the nursing infant are unknown.

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