Oxycodone

Drug Levels and Effects:




Summary of Use during Lactation:


Maternal use of maximum dosages of oral narcotics while breastfeeding can cause infant drowsiness. Newborn infants seem to be particularly sensitive to the effects of even small dosages of narcotic analgesics, particularly in the first week of life. However, the newborn's dosage is limited by the small volumes of colostrum in the first 2 to 3 days postpartum. Once the mother's milk comes in, it is best to limit maternal intake of oral oxycodone (and combinations) and to supplement analgesia with a nonnarcotic analgesic if necessary. A maximum oxycodone dosage of 30 mg daily is suggested. Oxycodone elimination is decreased in young infants and much inter-individual variability exists. Monitor the infant for drowsiness, adequate weight gain, and developmental milestones, especially in younger, exclusively breastfed infants. If the baby shows signs of increased sleepiness (more than usual), difficulty breastfeeding, breathing difficulties, or limpness, a physician should be contacted immediately.


Drug Levels:


Oxycodone is metabolized to the active metabolites, noroxycodone and oxymorphone. Oxycodone has an oral bioavailability of 60% to 87% in adults.[1] Oxycodone elimination is decreased in young infants and much inter-individual variability exists. Oxycodone can be dangerous when used as an analgesic in newborns.[2]

Maternal Levels.

Six breastfeeding mothers who were using 1 to 2 capsules containing a combination of 5 mg oxycodone and 500 mg acetaminophen every 4 to 7 hours for post-cesarean section pain had their milk sampled several times after successive doses. Peak oxycodone milk levels reportedly occurred 1 to 2 hours after the first dose and then at variable times after successive doses. The number of hours after a mother's last dose when oxycodone could still be measured in milk was depended on the number of doses taken. Oxycodone could be measured in milk up to 4, 12, and 36 hours after 4, 9, and 11 doses respectively. In all the mothers, measured oxycodone milk levels ranged from undetectable (<5 mcg/L) to 229 mcg/L. The authors estimated that an exclusively breastfed infant would receive a maximum 8% of the maternal weight-adjusted dosage of oxycodone, but active metabolite levels were not measured.[3]

Fifty mothers who delivered by cesarean section and received oxycodone had milk (colostrum) and serum samples measured for oxycodone at 24, 48 and 72 hours postpartum without respect to the time of the previous oxycodone dose. The most common doses received by the mothers during the previous 24 hours (including one 30 mg dose rectally immediately post surgery in some cases) were 60 mg (range 30 to 90 mg), 40 mg (range 0 to 90 mg), and 20 mg (range 0 to 50 mg), respectively. Mean colostrum concentrations at the 3 collection times were 58 mcg/L (range 7 to 130 mcg/L), 49 mcg/L (range 0 to 168 mcg/L), and 35 mcg/L (range 0 to 31 mcg/L), respectively. Little correlation was found between maternal dosage and colostrum concentrations, although colostrum levels correlated well with maternal serum levels, with a colostrum concentrations 3.2 to 3.4 higher than serum. Ten mothers had colostrum oxycodone concentrations over 100 mcg/L and 5 had detectable oxycodone in milk 37 hours after the last dose.[4]

Infant Levels.

In a study of 50 mothers taking oxycodone post-cesarean section, 45 blood samples were taken from 41 breastfed infants at 24, 48 or 72 hours postpartum. Only 1 of the samples had a detectable (>2 mcg/L) oxycodone level of 7.4 mcg/L. Because these infants were in the first 3 days postpartum, their dose was probably limited by the small volumes of colostrum they were ingesting.[4]


Effects in Breastfed Infants:


A 10-month-old, 7.7 kg infant of a prescription drug-dependant mother died of cardiac arrest after a 12- to 24-hour period of lethargy, hypersomnolence and dyspnea. The infant also had a recent history of fever. The mother had reportedly been breastfeeding the infant 3 times a day for several weeks and had taken 180 mg of oxycodone, as well as muscle relaxants, the day prior to her infant's death. A blood oxycodone level of 600 mcg/L was measured on autopsy. The medical examiner considered it unlikely that such a high level of oxycodone in the infant's blood could be due to breastfeeding exposure as reported by the mother and thus considered the death a homicide resulting from either the intentional administration of oxycodone directly to the infant or from a higher dose of oxycodone in breastmilk than that reported by the mother.[5]

In a study of 50 mothers taking oxycodone post-cesarean section, 50 neonates were evaluated for sedation over 48 hours after birth. None was severely sedated and less than 4% had sedation of 3 on a 1 (fully alert) to 5 (difficult to rouse) scale and none more sedated than 3 on the scale. Because these infants were in the first 3 days postpartum, their oxycodone dose was probably limited by the small volumes of colostrum they were ingesting.[4]

In a retrospective study, nursing mothers who were taking either oxycodone,codeineor acetaminophen for pain while breastfeeding were contacted by telephone to ascertain the degree of maternally perceived central nervous system (CNS) depression. Mothers taking oxycodone reported signs of CNS depression in 20% (28/139) of their infants, while those taking acetaminophen reported infant CNS depression in only 0.5% (1/184) of their infants. Women who reported infant sedation were taking 0.4 mg/kg daily of oxycodone, and unaffected were taking 0.15 mg/kg daily. Affected infants had more hours of daily uninterrupted sleep than unaffected infants, and 4 of the affected infants reportedly had "irregular breathing". Thirty-eight of 39 mothers reported that infant sedation ceased with maternal oxycodone discontinuation. Mothers of affected infants were also more likely to experience lethargy and other side effects than mothers of unaffected infants. Mothers who tookcodeinereported a similar rate of infant sedation (17%) compared to oxycodone, but the groups were statistically different in parity and postmenstrual age (PMA), with thecodeinegroup having a slightly higher PMA.[6]


Possible Effects on Lactation:


Oxycodone can increase serum prolactin.[7] However, the prolactin level in a mother with established lactation may not affect her ability to breastfeed.


Alternate Drugs to Consider:


Acetaminophen,Ibuprofen,Morphine


References:


1. Baselt RC. Disposition of toxic drugs and chemicals in man. 6th ed. Foster City: Biomedical Publications, 2002:787-9.
2. Pokela ML, Anttila E, Seppala T et al. Marked variation in oxycodone pharmacokinetics in infants. Paediatr Anaesth. 2005;15:560-5. PMID:15960639
3. Marx CM, Pucino F, Carlson JD et al. Oxycodone excretion in human milk in the puerperium. Drug Intell Clin Pharm. 1986;20:474. Abstract.
4. Seaton S, Reeves M, McLean S. Oxycodone as a component of multimodal analgesia for lactating mothers after Caesarean section: Relationships between maternal plasma, breast milk and neonatal plasma levels. Aust N Z J Obstet Gynaecol. 2007;47:181-5. PMID:17550483
5. Levine B, Moore KA, Aronica-Pollak P et al. Oxycodone intoxication in an infant: accidental or intentional exposure? J Forensic Sci. 2004;49:1358-60. PMID:15568714
6. Lam J, Kelly L, Ciszkowski C et al. Central nervous system depression of neonates breastfed by mothers receiving oxycodone for postpartum analgesia. J Pediatr. 2012;160:33-37.e2. PMID:21880331
7. Saarialho-Kere U, Mattila MJ, Seppala T. Psychomotor, respiratory and neuroendocrinological effects of a mu-opioid receptor agonist (oxycodone) in healthy volunteers. Pharmacol Toxicol. 1989;65:252-7. PMID:2555803



Substance Identification:




Substance Name:

Oxycodone

CAS Registry Number:

76-42-6

Drug Class:


  • Analgesics, Opioid

  • Narcotics

  • Antitussive Agents

  • Opiates


  • Administrative Information:




    LactMed Record Number:


    378


    Last Revision Date:


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