WARNING: ABUSE POTENTIAL, LIFE-THREATENING RESPIRATORY DEPRESSION, LIFE-THREATENING QT PROLONGATION, ACCIDENTAL EXPOSURE, and TREATMENT FOR OPIOID ADDICTION
Methadone hydrochloride tablets contain methadone, an opioid agonist and Schedule II controlled substance with an abuse liability similar to other opioid agonists, legal or illicit.Assess each patient's risk for opioid abuse or addiction prior to prescribing methadone hydrochloride tablets. The risk for opioid abuse is increased in patients with a personal or family history of substance abuse (including drug or alcohol abuse or addiction) or mental illness (e.g., major depressive disorder). Routinely monitor all patients receiving methadone hydrochloride tablets for signs of misuse, abuse, and addiction during treatment.
Life-Threatening Respiratory Depression
Respiratory depression, including fatal cases, have been reported during initiation and conversion of patients to methadone hydrochloride tablets, and even when the drug has been used as recommended and not misused or abused.Proper dosing and titration are essential and methadone hydrochloride tablets should only be prescribed by healthcare professionals who are knowledgeable in the use of potent opioids for the management of chronic pain. Monitor for respiratory depression, especially during initiation of methadone hydrochloride tablets or following a dose increase. The peak respiratory depressant effect of methadone hydrochloride tablets occurs later, and persists longer than the peak analgesic effect, especially during the initial dosing period.
Life-Threatening QT Prolongation
QT interval prolongation and serious arrhythmia (torsades de pointes) have occurred during treatment with methadone. Most cases involve patients being treated for pain with large, multiple daily doses of methadone, although cases have been reported in patients receiving doses commonly used for maintenance treatment of opioid addiction. Closely monitor patients for changes in cardiac rhythm during initiation and titration of methadone hydrochloride tablets.
Accidental ingestion of methadone hydrochloride tablets, especially in children, can result in a fatal overdose of methadone.
Conditions For Distribution And Use Of Methadone Products For The Treatment Of Opioid Addiction
For detoxification and maintenance of opioid dependence, methadone should be administered in accordance with the treatment standards cited in 42 CFR Section 8, including limitations on unsupervised administration.