Methadone Hydrochloride

METHADONE HYDROCHLORIDE

Manufacturer: Mylan Institutional LLC

Score: 143.0

Quick Summary

Methadone hydrochloride is a synthetic opioid analgesic used for the management of severe and persistent pain, as well as for detoxification and maintenance treatment of opioid addiction. It is available in 5 mg and 10 mg tablets and has a narrow therapeutic index, requiring careful dosing and monitoring to avoid adverse effects. Methadone has several important safety considerations, including the risk of addiction, abuse, and misuse, as well as potential interactions with other medications. The initial dose for pain management is typically 2.5 mg every 8 to 12 hours, with titration as needed, while the initial dose for detoxification and maintenance treatment is typically 20 to 30 mg. Special population considerations include use during pregnancy, nursing mothers, pediatric use, and geriatric use, all of which require careful evaluation and monitoring.

Key Clinical Findings and Indications

Management of severe and persistent pain
Detoxification treatment of opioid addiction
Maintenance treatment of opioid addiction

Important Safety Information

Warning

Addiction, Abuse, and Misuse: Methadone hydrochloride tablets expose patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death.

Contraindications

Significant respiratory depression
Acute or severe bronchial asthma
Known or suspected gastrointestinal obstruction
Hypersensitivity to methadone

Adverse Reactions

Respiratory depression
QT interval prolongation
Neonatal opioid withdrawal syndrome
Interactions with benzodiazepines and other CNS depressants

Dosing Recommendations

General Guidance

Titrate slowly, with dose increases no more frequent than every 3 to 5 days, and monitor for signs of opioid withdrawal or overdose.

Pain management

Adult Dose

2.5 mg every 8 to 12 hours

Pediatric Dose

Not established

Detoxification and maintenance treatment

Adult Dose

20 to 30 mg

Pediatric Dose

Not established

Special Population Considerations

Pregnancy

Methadone hydrochloride tablets may be used in pregnancy, but with caution and close monitoring
Neonatal opioid withdrawal syndrome is an expected outcome