Drug Notebook

FDA Alerts

    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.

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(METH a done)

What is the most important information I should know about methadone?

Taking methadone improperly will increase your risk of serious side effects or death. Even if you have used other narcotic medications, you may still have serious side effects from methadone. Follow all dosing instructions carefully.

Like other narcotic medicines, methadone can slow your breathing, even long after the pain-relieving effects of the medication wear off. Death may occur if breathing becomes too weak. Never use more methadone than your doctor has prescribed. Call your doctor if you think the medicine is not working.

Do not stop using methadone suddenly, or you could have unpleasant withdrawal symptoms. Call your doctor if you miss doses or forget to take this medication for longer than 3 days in a row. Do not drink alcohol while you are taking methadone. Dangerous side effects or death can occur when alcohol is combined with methadone. Check your food and medicine labels to be sure these products do not contain alcohol. Methadone can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

What is methadone?

Methadone is a narcotic pain reliever, similar to morphine. Methadone also reduces withdrawal symptoms in people addicted to heroin or other narcotic drugs without causing the "high" associated with the drug addiction.

Methadone is used as a pain reliever and as part of drug addiction detoxification and maintenance programs.

Methadone may also be used for purposes other than those listed in this medication guide.

What should I discuss with my healthcare provider before using methadone?

Taking methadone improperly will increase your risk of serious side effects or death. Even if you have used other narcotic medications, you may still have serious side effects from methadone. Follow all dosing instructions carefully. Methadone may be habit-forming and should be used only by the person it was prescribed for. Methadone should never be given to another person, especially someone who has a history of drug abuse or addiction. Keep the medication in a secure place where others cannot get to it. Do not use this medication if you have ever had an allergic reaction to a narcotic medicine (examples include codeine, morphine, Oxycontin, Darvocet, Percocet, Vicodin, Lortab, and many others). You should also not take methadone if you are having an asthma attack or if you have a bowel obstruction called paralytic ileus.

Before taking methadone, talk to your doctor if you have:

FDA pregnancy category C. This medication may be harmful to an unborn baby. It could also cause addiction or withdrawal symptoms in a newborn if the mother takes methadone during pregnancy. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Methadone can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Older adults and people with debilitating conditions may be more sensitive to the effects of this medication.

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