Animal studies of continuous infusion of 6, 12, or 24 mg/kg/day in rats (1.5, 3, or 5 mg/kg/day in rabbits) during organogenesis had not effect on embryonic development at 7 times the maximum recommended human dose (MRHD) in rats (8 times the MRHD in rabbits); maternal toxicity was seen at 12 mg/kg/day or higher in rats (6 mg/kg/day in rabbits). In a pre- and post-natal study (gestation day 6 to lactation day 21) of continuous infusion of 0.6, 2.4, and 6 mg/kg/day showed reduced litter size at 1.5 the MRHD and lower pup survival by day 4 at .6 times the MRHD. There are no controlled data in human pregnancy. The background birth defect and miscarriage risk for the indicated population is not known. In the US general population, the estimated major birth defect risk is 2 to 4% and the miscarriage risk is 15 to 20%.

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

The manufacturer makes no recommendation regarding use during pregnancy.

US FDA pregnancy category: Not assigned

Comments:
-Prolonged opioid use during pregnancy may lead to neonatal physical dependence and neonatal opioid withdrawal syndrome shortly after birth.
-Neonatal opioid withdrawal symptoms include irritability, hyperactivity and abnormal sleep pattern, high-pitched cry, tremor, vomiting, diarrhea, and failure to gain weight; onset, duration, and severity of symptoms depend on specific opioid used, duration of use, time from and dose of last maternal use, and the newborns rate of drug elimination.
-Observe newborns for neonatal opioid withdrawal syndrome and manage appropriately.
-There is no data on use in pregnant women to know this drugs risks, including the risk of fetal harm or reproductive effects.
-Opioids cross the placenta and may cause neonatal respiratory depression and psycho-physiologic effects; an opioid antagonist (e.g. naloxone) should be available for reversal of neonatal respiratory depression.
-Use is not recommended during or immediately prior to labor; other analgesic techniques are more appropriate.
-Opioid analgesics can prolong labor by temporarily reducing the strength, duration, and frequency of uterine contractions; this effect is not consistent and may be offset by cervical dilatation which tends to shorten labor.
-Monitor infants exposed during labor for excess sedation and respiratory depression.

See references

The manufacturer makes no recommendation regarding use during lactation.

Excreted into human milk: Unknown
Excreted into animal milk: Data not available

Comments:
-There is no information regarding this drug on the presence in human milk, the effects on a breastfed infant, or effects on milk production.
-Consider the developmental and health benefits of breastfeeding along with the mother's clinical need for this medication as well as any potential adverse effects from this drug or the underlying maternal condition.
-Monitor infants exposed through breastmilk for excess sedation and respiratory depression.
-Withdrawal symptoms may occur in breastfed infants when either maternal opioids or breastfeeding are stopped.

See references