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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 assoc. risks or in use of methadone for detoxification and maintenance tx of opioid addiction; reserve long-acting forms for pts w/ 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 w/ risk of addiction, abuse, and misuse, which can lead to overdose and death; reserve opioid analgesics for pts w/ inadequate tx alternatives; 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; methadone peak respiratory depressant effects typically occur later and last longer than peak pharmacologic effects, esp. during initial dosing period
Accidental Ingestion
accidental ingestion of even one dose, esp. by children, can result in fatal methadone 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
QT Prolongation
life-threatening QT prolongation and serious arrhythmias incl. torsades de pointes have occurred; most cases involve pain tx w/ large multiple daily doses, but also reported w/ doses commonly used for opioid addiction maintenance tx; monitor closely for ECG changes in pts w/ QT prolongation risk factors, pts w/ hx of cardiac conduction abnormalities, and pts taking medications affecting cardiac rhythm
CYP450 Interactions
concomitant use w/ 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 resp. depression; monitor pts receiving any concomitant CYP450 inhibitor or inducer, and consider decr. dose w/ 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 w/ tx standards cited in 42 CFR Section 8, incl. limitations on unsupervised administration
Adult Dosing .
Dosage forms: TAB: 5 mg, 10 mg; DISPERSE TAB: 40 mg; SOL: 5 mg per 5 mL, 10 mg per 5 mL, 10 mg per mL; INJ: 10 mg per mL
Restricted Distribution in US
- [opioid dependence tx]
- Info: dispensing tx for opioid dependence restricted to certified opioid tx programs; exceptions such as emergency use described in 21 CFR 1306.07
Special Note
- [prescribing info]
- Info: consider prescribing naloxone if risk of opioid overdose or accidental ingestion
opioid dependence
- [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 sx; start 2.5-10 mg PO x1 for initial dose on day 1 in pts w/ low opioid tolerance; consider incr. dose or frequency in pregnant pts; 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 sx and block euphoric opioid effects; start 2.5-10 mg PO x1 for initial dose on day 1 in pts w/ low opioid tolerance; consider incr. dose or frequency in pregnant pts; 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
- [PO route, opioid-naive pts]
- Dose: individualize dose PO q8-12h; Start: 2.5 mg PO q8-12h; Info: use lowest effective dose, shortest effective tx duration; incr. dose no more frequently than q3-5 days; consider incr. dose or frequency in pregnant pts; consider low start dose, titrate slowly in pts 65 yo and older; full analgesic effect takes 3-5 days, peak resp. depressant effect may occur later; taper total daily dose by no more than 10-25% q2-4wk to D/C if long-term use; dispersible tab may only be split in 10 mg increments
- [PO route, opioid-experienced pts]
- Dose: individualize dose PO q8-12h; Start: individualize start dose based on current opioid tx, see pkg insert for conversion; Info: use lowest effective dose, shortest effective tx duration; incr. dose no more frequently than q3-5 days; consider incr. dose or frequency in pregnant pts; consider low start dose, titrate slowly in pts 65 yo and older; full analgesic effect takes 3-5 days, peak resp. depressant effect may occur later; taper total daily dose by no more than 10-25% q2-4wk to D/C if long-term use; dispersible tab may only be split in 10 mg increments
- [parenteral route, opioid-naive pts]
- 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 pts 65 yo and older; consider incr. dose or frequency in pregnant pts; full analgesic effect takes 3-5 days, peak resp. depressant effect may occur later; taper dose gradually to D/C if long-term use
- [parenteral route, opioid-experienced pts]
- 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 pts 65 yo and older; consider incr. dose or frequency in pregnant pts; full analgesic effect takes 3-5 days, peak resp. depressant effect may occur later; taper dose gradually to D/C if long-term use
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; SOL: 5 mg per 5 mL, 10 mg per 5 mL, 10 mg per mL; INJ: 10 mg per mL
Restricted Distribution in US
- [opioid dependence tx]
- Info: dispensing tx for opioid dependence restricted to certified opioid tx programs; exceptions such as emergency use described in 21 CFR 1306.07
Special Note
- [prescribing info]
- Info: consider prescribing naloxone 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 D/C; 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 sx 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