Generic Name: methadone
Brand Names:
Diskets, Methadose, Dolophine, Methadone Hydrochloride
Conditions for Distribution and Use for the Treatment of Opiate Dependence
- When used for the treatment of opiate dependence in detoxification or maintenance programs, methadone should be dispensed only by programs certified by the Substance Abuse and Mental Health Services Administration (SAMHSA) and approved by the designated state authority (consult Federal Standards for regulatory exceptions). Certified treatment programs should dispense only oral methadone products as outlined in the Federal Opioid Treatment Standards (42 CFR 8.12).
- Failure to follow the requirements outlined in the regulations may result in criminal prosecution, seizure of the drug supply, revocation of the program certification, and injunction precluding operation of the program.
Serious Adverse Effects
- Death and life-threatening adverse effects (i.e., respiratory depression, cardiac arrhythmias) reported in patients receiving methadone. These events have been reported in patients initiating methadone therapy for pain and in patients transferring to methadone from other opiate therapy; death reported in patients initiating methadone therapy for opiate dependence. Interactions with other drugs (legal and illicit), respiratory and cardiac effects of methadone, or rapid dose titration may have contributed to these events. Consider pharmacokinetic and pharmacologic properties of methadone when initiating therapy, transferring patients from other opiate therapy, and during dose titration. (See Pharmacokinetics.)
- Respiratory depression is the major toxicity associated with methadone. Peak respiratory depressant effect occurs later and persists longer than peak analgesic effect, particularly during the early dosing period. These properties can contribute to inadvertent overdosage, especially during treatment initiation and dose titration. (See Respiratory Depression under Cautions.)
- Possible prolongation of the QT interval and serious cardiac arrhythmias, including torsades de pointes. Most cases have occurred in patients receiving relatively high dosages (>200 mg daily) for the treatment of chronic pain, but also reported in patients receiving lower dosages for maintenance treatment of opiate dependence. (See Cardiac Effects under Cautions.)
- For pain management, initiate only if potential benefits outweigh risks of methadone therapy.
 | M 2540 40 mg
bottle, 100 each Methadone HCl 40mg, Tablet for oral suspension, orange, speckled, rectangular-shaped, multi-segmented, orange, side 1:M 2540 |
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