Ketorolac ophthalmic Pregnancy and Breast Feeding Warnings
Ketorolac ophthalmic is also known as: Acular, Acular LS, Acular PF
Overview
Avoid using Ketorolac Drops late in pregnancy. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Ketorolac Drops while you are pregnant. It is not known if Ketorolac Drops is found in breast milk. If you are or will be breast-feeding while you use Ketorolac Drops, check with your doctor. Discuss any possible risks to your baby.
Ketorolac ophthalmic Pregnancy Warnings
Ketorolac ophthalmic has been assigned to pregnancy category C by the FDA. Some animal studies have revealed evidence of teratogenicity with doses up to 312 times higher than the normal human dose. There are no controlled data in human pregnancy. Very small amounts of ketorolac were detected in umbilical vein samples after its intramuscular administration during labor and delivery. Ketorolac ophthalmic is only recommended for use during pregnancy when benefit outweighs risk.
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 times ranging from 0.5 to 6.5 hours post-dose. Ketorolac concentrations ranged from 0.02 to 0.12 mcg/mL in cord blood and from 0.2 to 0.9 mcg/mL in maternal plasma. The mean cord blood to maternal plasma concentration ratio was 0.12. 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 ophthalmic Lactation Warnings
There are no data on the excretion of ketorolac ophthalmic into human milk. Ketorolac is excreted into breast milk in small amounts after oral dosing with 10 mg four times daily. The American Academy of Pediatrics considers the maternal use of ketorolac to be compatible with breast-feeding. The manufacturer recommends caution when administering ketorolac ophthalmic to nursing women.
The excretion of ketorolac into human milk was evaluated in 10 healthy women. Following oral administration of ketorolac 10 mg four times daily for 2 days, ketorolac was undetectable (less than 5 ng/mL) in all milk samples from 4 patients. In the remaining patients, ketorolac milk concentrations ranged from 5.2 to 7.9 ng/mL 2 hours post-dose. The milk to maternal plasma ratio ranged from 0.02 to 0.04.
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