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Methadone Hydrochloride

METHADONE HYDROCHLORIDE

Manufacturer: Hikma Pharmaceuticals USA Inc.

Score: 144.0

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

Nursing Mothers

  • Methadone is excreted in breast milk, and caution should be exercised when administering to nursing mothers

Pediatric Use

  • The safety and effectiveness of methadone hydrochloride tablets have not been established in pediatric patients

Geriatric Use

  • Elderly patients may have increased sensitivity to methadone, and dose selection should be cautious

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