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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 assoc. risks; reserve opioid analgesics for pts w/ inadequate tx alternatives; ER form not indicated for prn analgesic use; proper dosing and titration essential to decr. resp. depression risk
Addiction, Abuse, and Misuse
opioid agonist Schedule II controlled substance w/ risk of addiction, abuse, and misuse, which can lead to overdose and death; assess opioid abuse or addiction risk prior to prescribing; regularly reassess all pts for misuse, abuse, and addiction
Respiratory Depression
serious, life-threatening, or fatal cases may occur even w/ recommended use, esp. during tx start or after dose incr; to decr. risk, initiate and titrate dose appropriately; instruct pts 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, esp. by children, can result in fatal tapentadol overdose
Avoid Alcohol
instruct pts 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 w/ Benzodiazepines, CNS Depressants
concomitant opioid use w/ benzodiazepines or other CNS depressants, incl. alcohol, may result in profound sedation, resp. depression, coma, and death; reserve concomitant use for pts w/ inadequate alternative tx options
Neonatal Opioid Withdrawal Syndrome
extended use in pregnant pts can lead to potentially life-threatening neonatal opioid withdrawal syndrome; advise pregnant pts of risks and ensure tx by neonatology experts avail. at delivery if extended opioid use required
Opioid Analgesic REMS
providers are strongly encouraged to complete risk evaluation and mitigation strategy (REMS)-compliant education program, counsel pts and/or caregivers w/ 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 naloxone if risk of opioid overdose or accidental ingestion
pain, severe chronic
- [opioid-naive or opioid-nontolerant pts]
- Dose: individualize dose PO q12h; Start: 50 mg PO q12h, may incr. by 50 mg PO q12h q3 days; Max: 500 mg/24h; Info: use lowest effective dose, shortest effective tx duration; consider lower start dose in pts 65 yo and older; do not cut/crush/chew/dissolve tab; taper total daily dose by no more than 10-25% q2-4wk to D/C if long-term use
- [opioid-tolerant pts]
- 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 q12h q3 days; Max: 500 mg/24h; Info: use lowest effective dose, shortest effective tx duration; consider lower start dose in pts 65 yo and older; do not cut/crush/chew/dissolve tab; taper total daily dose by no more than 10-25% q2-4wk to D/C if long-term use
neuropathic pain, severe diabetic
- [opioid-naive or opioid-nontolerant pts]
- Dose: individualize dose PO q12h; Start: 50 mg PO q12h, may incr. by 50 mg PO q12h q3 days; Max: 500 mg/24h; Info: use lowest effective dose, shortest effective tx duration; consider lower start dose in pts 65 yo and older; do not cut/crush/chew/dissolve tab; taper total daily dose by no more than 10-25% q2-4wk to D/C if long-term use
- [opioid-tolerant pts]
- 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 q12h q3 days; Max: 500 mg/24h; Info: use lowest effective dose, shortest effective tx duration; consider lower start dose in pts 65 yo and older; do not cut/crush/chew/dissolve tab; taper total daily dose by no more than 10-25% q2-4wk to D/C if long-term use
renal dosing
- [see below]
- CrCl <30: avoid use
- HD/PD: not defined
hepatic dosing
- [see below]
- Child-Pugh Class B: start 50 mg q24h, max 100 mg/day; Child-Pugh Class C: avoid use
Peds Dosing .
Peds dosing is currently unavailable or not applicable for this drug.