High Alert
Contraindicated in:
Use Cautiously in:
Use during pregnancy only if potential maternal benefit justifies potential fetal risk. Chronic maternal treatment with opioids during pregnancy may result in neonatal opioid withdrawal syndrome
;CV: hypotension
Endo: adrenal insufficiency
GI: diarrhea, nausea, vomiting
GU: ↓fertility
Neuro: allodynia, dizziness, headache, hyperalgesia, SEIZURES, somnolence
Resp: RESPIRATORY DEPRESSION (INCLUDING CENTRAL SLEEP APNEA AND SLEEP-RELATED HYPOXEMIA)
Misc: allodynia, HYPERSENSITIVITY REACTIONS (INCLUDING ANAPHYLAXIS AND ANGIOEDEMA), opioid-induced hyperalgesia,
physical dependence
,psychological dependence
Drug-drug:
Use with benzodiazepines or other CNS depressants, including other opioids, nonbenzodiazepine sedative/hypnotics, anxiolytics, general anesthetics, muscle relaxants, antipsychotics, and alcohol, may cause profound sedation, respiratory depression, coma, and death; reserve concurrent use for when alternative treatment options are inadequate.
Hepatic Impairment
Therapeutic Classification: analgesics (centrally acting), opioid analgesics
Pharmacologic Classification: opioid agonists
Absorption: 32% absorbed following oral administration.
Distribution: Widely distributed.
Half-Life: 4 hr.
Advise patient to notify health care provider if pregnancy is planned or suspected or if breastfeeding. Inform patient of potential for neonatal opioid withdrawal syndrome with prolonged use during pregnancy. Monitor neonate for signs and symptoms of withdrawal symptoms (irritability, hyperactivity and abnormal sleep pattern, high-pitched cry, tremor, vomiting, diarrhea, failure to gain weight); usually occur the first days after birth. Monitor infants exposed to tapentadol through breast milk for excess sedation and respiratory depression. Chronic use may ↓ fertility in women and men.
NDC Code