Use in specific populations
- Pregnancy: Prolonged use of opioid analgesics during pregnancy may cause neonatal opioid withdrawal syndrome. There are no available data with OxyContin in pregnant women to inform a drug-associated risk for major birth defects and miscarriage.
- Fetal/Neonatal Adverse Reactions: Prolonged use of opioid analgesics during pregnancy for medical or nonmedical purposes can result in physical dependence in the neonate and neonatal opioid withdrawal syndrome shortly after birth. Neonatal opioid withdrawal syndrome presents as irritability, hyperactivity and abnormal sleep pattern, high pitched cry, tremor, vomiting, diarrhea, and failure to gain weight. Observe newborns for symptoms of neonatal opioid withdrawal syndrome and manage accordingly
- Labor or Delivery: Opioids cross the placenta and may produce respiratory depression and psycho-physiologic effects in neonates. An opioid antagonist, such as naloxone, must be available for reversal of opioid-induced respiratory depression in the neonate. OxyContin is not recommended for use in women immediately prior to labor, when use of shorter-acting analgesics or other analgesic techniques are more appropriate. Monitor neonates exposed to opioid analgesics during labor for signs of excess sedation and respiratory depression
- Lactation: Oxycodone is present in breast milk. Because of the potential for serious adverse reactions, including excess sedation and respiratory depression in a breastfed infant, advise patients that breastfeeding is not recommended during treatment with OxyContin. Infants exposed to OxyContin through breast milk should be monitored for excess sedation and respiratory depression. Withdrawal symptoms can occur in breast-fed infants when maternal administration of an opioid analgesic is stopped, or when breast-feeding is stopped.
- Females and Males of Reproductive Potential: Chronic use of opioids may cause reduced fertility in females and males of reproductive potential. It is not known whether these effects on fertility are reversible.
- Geriatric Use: Respiratory depression is the chief risk for elderly patients treated with opioids, and has occurred after large initial doses were administered to patients who are not opioid-tolerant or when opioids were co-administered with other agents that depress respiration. The usual doses and dosing intervals may be appropriate for elderly patients. For geriatric patients who are debilitated and not opioid tolerant, start dosing patients at one-third to one-half the recommended starting dosage and titrate the dosage cautiously. Monitor closely for signs of central nervous system and respiratory depression, and monitor renal function.
- Hepatic Impairment: Due to greater plasma concentrations than those seen at equivalent doses in persons with normal hepatic function, a dosage reduction is recommended for these patients. For patients with hepatic impairment, start dosing patients at one-third to one-half the recommended starting dosage and titrate the dosage carefully. Monitor closely for signs of respiratory depression, sedation, and hypotension.
- Renal Impairment: Due to increased plasma concentrations in subjects with renal impairment (CrCl <60 mL/min), follow a conservative approach to dose initiation and adjust according to the clinical situation.