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Nucynta ER
tapentadol
Black Box Warnings .
Appropriate Use
should only be prescribed by healthcare professionals knowledgeable about opioid use and how to mitigate associated risks; reserve opioid analgesics for patients with inadequate tx alternatives; ER form not indicated for prn analgesic use; proper dosing and titration essential to decr. respiratory depression risk
Addiction, Abuse, and Misuse
opioid agonist Schedule II controlled substance with risk of addiction, abuse, and misuse, which can lead to overdose and death; assess each patient's risk before prescribing; regularly reassess all patients for misuse, abuse, and addiction
Respiratory Depression
serious, life-threatening, or fatal cases may occur even with recommended use, especially during tx start or after dose incr; to decr. risk, initiate and titrate dose appropriately; instruct patients to swallow ER tabs whole; crushing, dissolving, or chewing ER tabs can cause rapid release and absorption of potentially fatal tapentadol dose
Accidental Ingestion
accidental ingestion of even one dose, especially by children, can result in fatal tapentadol overdose
Avoid Alcohol
instruct patients using ER tabs not to consume alcoholic beverages or use alcohol-containing prescription or non-prescription medications; alcohol consumption during tx may result in incr. plasma levels and potentially fatal tapentadol overdose
Risks from Concomitant Use with Benzodiazepines, CNS Depressants
concomitant opioid use with benzodiazepines or other CNS depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death; reserve concomitant use for patients with inadequate alternative tx options
Neonatal Opioid Withdrawal Syndrome
advise pregnant patients with extended opioid use of risk of potentially life-threatening neonatal opioid withdrawal syndrome; ensure tx by neonatology experts available at delivery
Opioid Analgesic REMS
providers are strongly encouraged to complete risk evaluation and mitigation strategy (REMS)-compliant education program, counsel patients and/or caregivers with each Rx on serious risks, safe use, and importance of reading medication guide
Adult Dosing .
Dosage forms: ER TAB: 50 mg, 100 mg, 150 mg, 200 mg, 250 mg
Special Note
- [prescribing info]
- Info: consider prescribing opioid overdose reversal agent (e.g., naloxone, nalmefene), especially if risk of opioid overdose or accidental ingestion
pain, severe chronic
- [opioid-nontolerant patients]
- Dose: individualize dose PO q12h; Start: 50 mg PO q12h, may incr. by 50 mg PO no more than q12h q3 days; Max: 500 mg/24h; Info: use lowest effective dose, shortest effective tx duration; titrate slowly in patients 65 yo and older; do not cut/crush/chew/dissolve tab; taper dose gradually to avoid withdrawal symptoms if D/C tx in physically opioid-dependent patients; search 'opioid taper' for epocrates Opioid Tapering decision tool
- [opioid-tolerant patients]
- Dose: individualize dose PO q12h; Start: individualize start dose based on current opioid intake, see pkg insert for conversion, may incr. by 50 mg PO no more than q12h q3 days; Max: 500 mg/24h; Info: use lowest effective dose, shortest effective tx duration; consider low start dose, titrate slowly in patients 65 yo and older; do not cut/crush/chew/dissolve tab; taper dose gradually to avoid withdrawal symptoms if D/C tx in physically opioid-dependent patients; search 'opioid taper' for epocrates Opioid Tapering decision tool
neuropathic pain, severe diabetic
- [opioid-nontolerant patients]
- Dose: individualize dose PO q12h; Start: 50 mg PO q12h, may incr. by 50 mg PO no more than q12h q3 days; Max: 500 mg/24h; Info: use lowest effective dose, shortest effective tx duration; titrate slowly in patients 65 yo and older; do not cut/crush/chew/dissolve tab; taper dose gradually to avoid withdrawal symptoms if D/C tx in physically opioid-dependent patients; search 'opioid taper' for epocrates Opioid Tapering decision tool
- [opioid-tolerant patients]
- Dose: individualize dose PO q12h; Start: individualize start dose based on current opioid intake, see pkg insert for conversion, may incr. by 50 mg PO no more than q12h q3 days; Max: 500 mg/24h; Info: use lowest effective dose, shortest effective tx duration; consider low start dose, titrate slowly in patients 65 yo and older; do not cut/crush/chew/dissolve tab; taper dose gradually to avoid withdrawal symptoms if D/C tx in physically opioid-dependent patients; search 'opioid taper' for epocrates Opioid Tapering decision tool
renal dosing
- [see below]
- CrCl <30: avoid use
- HD/PD: not defined
hepatic dosing
- [see below]
- Child-Pugh Class B: start 50 mg no more frequently than q24h, max 100 mg/day; Child-Pugh Class C: avoid use
Peds Dosing .
Peds dosing is currently unavailable or not applicable for this drug.