A narcotic analgesic - It is used to treat severe pain
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.
METHADONE (METH a done) is a pain reliever. It is used to treat severe pain. The medicine is also used to prevent withdrawal symptoms in people addicted to other drugs.
This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.
What should I tell my health care provider before I take this medicine?
They need to know if you have any of these conditions:
This medicine is for injection under the skin, into a muscle, or into a vein. It is usually given by a health care professional in a hospital or clinic setting.
If you get this medicine at home, you will be taught how to prepare and give this medicine. Use exactly as directed. Take your medicine at regular intervals. Do not take your medicine more often than directed.
It is important that you put your used needles and syringes in a special sharps container. Do not put them in a trash can. If you do not have a sharps container, call your pharmacist or healthcare provider to get one.
Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.
What if I miss a dose?
If you miss a dose, use it as soon as you can. If it is almost time for your next dose, use only that dose. Do not use double or extra doses.
What may interact with this medicine?
Do not take this medicine with any of the following medications:
This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.
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