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methadone
generic
Black Box Warnings .
Appropriate Use
should only be prescribed by healthcare professionals knowledgeable about long-acting opioid use for pain management and how to mitigate associated risks or in use of methadone for detoxification and maintenance tx of opioid addiction; reserve long-acting forms for patients with inadequate tx alternatives; not indicated for prn analgesic use; proper dosing and titration essential to decr. respiratory depression risk
Medication Error Risk
ensure accuracy when prescribing, dispensing, and administering methadone oral solution; dosing errors due to confusion between mg and mL or different concentrations can result in accidental overdose and death
Addiction, Abuse, and Misuse
opioid agonist Schedule II controlled substance with risk of addiction, abuse, and misuse, which can lead to overdose and death; reserve opioid analgesics for patients with inadequate tx alternatives; assess opioid abuse or addiction risk prior to 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; methadone peak respiratory depressant effects typically occur later and last longer than peak pharmacologic effects, especially during initial dosing period
Accidental Ingestion
accidental ingestion of even one dose, especially by children, can result in fatal methadone 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
expected and treatable outcome of methadone use during pregnancy; balance of risk vs. benefit may differ with patient's underlying condition, pain, or addiction; advise pregnant patients of risk of potentially life-threatening neonatal opioid withdrawal syndrome to allow appropriate management planning
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
QT Prolongation
life-threatening QT prolongation and serious arrhythmias including torsades de pointes have occurred; most cases involve pain tx with large multiple daily doses, but also reported with doses commonly used for opioid addiction maintenance tx; monitor closely for ECG changes in patients with QT prolongation risk factors, patients with history of cardiac conduction abnormalities, and patients taking medications affecting cardiac rhythm
CYP450 Interactions
concomitant use with CYP450 3A4, 2B6, 2C19, 2C9, or 2D6 inhibitors or D/C of concomitant CYP450 3A4, 2B6, 2C19, or 2C9 inducers may incr. methadone levels and may cause potentially fatal respiratory depression; monitor patients receiving any concomitant CYP450 inhibitor or inducer, and consider decr. dose with any changes to concomitant medications that may result in incr. methadone levels
Opioid Addiction Tx
methadone used for detoxification and maintenance of opioid dependence should be administered in accordance with tx standards cited in 42 CFR Section 8, including limitations on unsupervised administration
Adult Dosing .
Dosage forms: TAB: 5 mg, 10 mg; DISPERSE TAB: 40 mg; SOLUTION: 5 mg per 5 mL, 10 mg per 5 mL, 10 mg per mL; INJ: 10 mg per mL
Restricted Distribution in US
- [opioid use disorder tx]
- Info: dispensing tx for opioid use disorder restricted to certified opioid tx programs; exceptions such as emergency use described in 21 CFR 1306.07
Special Note
- [prescribing info]
- Info: consider prescribing opioid overdose reversal agent (e.g., naloxone, nalmefene), especially if risk of opioid overdose or accidental ingestion
opioid use disorder
- [medically supervised withdrawal, short-term tx]
- Dose: 10-30 mg PO x1, then may give 5-10 mg PO q2-4h prn on day 1, then stabilize dose x2-3 days, then taper dose by up to 20% q1-2 days until D/C; Max: 30 mg/initial dose, 40 mg on day 1; Info: not recommended per ASAM guidelines; documentation required if day 1 tx >30 mg/initial dose or >40 mg/day; adjust dose to suppress withdrawal symptoms; start 2.5-10 mg PO x1 for initial dose on day 1 in patients with low opioid tolerance; consider incr. dose or frequency in pregnant patients; may consider SC/IM/IV route temporarily if unable to take PO, see pkg insert; dispersible tab may only be split in 10 mg increments
- [maintenance tx]
- Dose: 60-120 mg PO qd; Start: 10-30 mg PO x1, then may give 5-10 mg PO q2-4h prn on day 1; Max: 30 mg/initial dose, 40 mg on day 1; Info: documentation required if day 1 tx >30 mg/initial dose or >40 mg/day; adjust dose to prevent withdrawal symptoms and block euphoric opioid effects; start 2.5-10 mg PO x1 for initial dose on day 1 in patients with low opioid tolerance; consider incr. dose or frequency in pregnant patients; may consider SC/IM/IV route temporarily if unable to take PO, see pkg insert; gradually decr. dose by up to 5-10% q1-2wk to D/C; dispersible tab may only be split in 10 mg increments
pain, moderate-severe chronic
- [parenteral route, opioid-nontolerant patients]
- Dose: individualize dose SC/IM/IV q8-12h; Start: 2.5 mg SC/IM/IV q8-12h; Info: use lowest effective dose, shortest effective tx duration; consider low start dose, titrate slowly in patients 65 yo and older; consider incr. dose or frequency in pregnant patients; full analgesic effect takes 3-5 days, peak respiratory depressant effect may occur later; 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
- [parenteral route, opioid-experienced patients]
- Dose: individualize dose SC/IM/IV q6-8h; Start: individualize start dose based on current opioid tx, see pkg insert for conversion; Info: use lowest effective dose, shortest effective tx duration; consider low start dose, titrate slowly in patients 65 yo and older; consider incr. dose or frequency in pregnant patients; full analgesic effect takes 3-5 days, peak respiratory depressant effect may occur later; 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
- [PO route, opioid-experienced patients]
- Dose: individualize dose PO q8-12h; Start: individualize start dose based on current opioid tx, see pkg insert for conversion; may incr. dose no more frequently than q3-5 days; Info: use lowest effective dose, shortest effective tx duration; consider incr. dose or frequency in pregnant patients; consider low start dose, titrate slowly in patients 65 yo and older; full analgesic effect takes 3-5 days, peak respiratory depressant effect may occur later; 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; dispersible tab may only be split in 10 mg increments
renal dosing
- [see below]
- CrCl <10: decr. usual start dose by 25-50%, titrate slowly
- HD: decr. usual start dose by 25-50%; no supplement after dialysis; PD: decr. usual start dose by 25-50%; no supplement; Info: titrate slowly
hepatic dosing
- [adjust dose amount]
- hepatic impairment: decr. usual start dose, amount not defined
Peds Dosing .
- Dosage forms: TAB: 5 mg, 10 mg; DISPERSE TAB: 40 mg; SOLUTION: 5 mg per 5 mL, 10 mg per 5 mL, 10 mg per mL; INJ: 10 mg per mL
Restricted Distribution in US
- [opioid use disorder tx]
- Info: dispensing tx for opioid use disorder restricted to certified opioid tx programs; exceptions such as emergency use described in 21 CFR 1306.07
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, moderate-severe chronic (off-label)
- [0.1 mg/kg/dose PO/SC/IM/IV q6-12h]
- Max: 10 mg/dose; Alt: start 0.1 mg/kg/dose PO/SC/IM/IV q4h x2-3 doses, then 0.1 mg/kg/dose PO/SC/IM/IV q6-12h; Info: individualize dose; use lowest effective dose, shortest effective tx duration; 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; dispersible tab may only be split in 10 mg increments
neonatal opioid withdrawal syndrome (off-label)
- [individualize dose PO qd-qid]
- Start: 0.05-0.1 mg/kg/dose PO q6h, may incr. by 0.05 mg/kg/dose until symptoms controlled; Info: taper dose by 10-20% q1-2 days to D/C; dispersible tab may only be split in 10 mg increments
renal dosing
- [see below]
- CrCl 30-50: give usual dose q6-8h; CrCl 10-29: give usual dose q8-12h; CrCl <10: give usual dose q12-24h; Info: titrate slowly
- HD: give usual dose q12-24h; no supplement after dialysis; PD: give usual dose q12-24h; no supplement; Info: titrate slowly
hepatic dosing
- [adjust dose amount]
- hepatic impairment: decr. usual start dose, amount not defined