METHADOSE (methadone hydrochloride)
METHADOSE contains methadone, an opioid agonist indicated for the: detoxification treatment of opioid addiction (heroin or other morphine-like drugs). maintenance treatment of opioid addiction (heroin or other morphine-like drugs), in conjunction with appropriate social and medical services. Limitations of Use Methadone products used for the treatment of opioid addiction in detoxification or maintenance programs are subject to the conditions for distribution and use required under 21 CFR, Title...
Details
- Status
- Prescription
- First Approved
- 1973-03-14
- Routes
- ORAL
- Dosage Forms
- TABLET, FOR SUSPENSION, TABLET, CONCENTRATE
METHADOSE Approval History
What METHADOSE Treats
3 FDA approvalsOriginally approved for its first indication in 1973 . Covers 3 distinct patient populations.
- Other (3)
Other
(3 approvals)- • Approved indication (Mar 1973)
- • Approved indication (Apr 1993)
- • Approved indication (Apr 1993)
METHADOSE Boxed Warning
LIFE-THREATENING RESPIRATORY DEPRESSION, LIFE-THREATENING QT PROLONGATION, ACCIDENTAL INGESTION, ABUSE POTENTIAL, INTERACTIONS WITH DRUGS AFFECTING CYTOCHROME P450 ISOENZYMES and TREATMENT FOR OPIOID ADDICTION Life-Threatening Respiratory Depression Respiratory depression, including fatal cases, have been reported during initiation and conversion of patients to methadone, and even when the drug has been used as recommended and not misused or abused [see Warnings and Precautions ( 5.1 )]. Proper ...
WARNING: LIFE-THREATENING RESPIRATORY DEPRESSION, LIFE-THREATENING QT PROLONGATION, ACCIDENTAL INGESTION, ABUSE POTENTIAL, INTERACTIONS WITH DRUGS AFFECTING CYTOCHROME P450 ISOENZYMES and TREATMENT FOR OPIOID ADDICTION Life-Threatening Respiratory Depression Respiratory depression, including fatal cases, have been reported during initiation and conversion of patients to methadone, and even when the drug has been used as recommended and not misused or abused [see Warnings and Precautions ( 5.1 )]. Proper dosing and titration are essential and METHADOSE should only be prescribed by healthcare professionals who are knowledgeable in the use of methadone for detoxification and maintenance treatment of opioid addiction. Monitor for respiratory depression, especially during initiation of METHADOSE or following a dose increase. The peak respiratory depressant effect of methadone occurs later, and persists longer than the peak pharmacologic effect, especially during the initial dosing period. Managing Risks from Concomitant Use with Benzodiazepines or Other CNS Depressants Concomitant use with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, is a risk factor for respiratory depression and death [see Warnings and Precautions ( 5.2 )]. Reserve concomitant prescribing of benzodiazepines or other CNS depressants in patients in methadone treatment to those for whom alternatives to benzodiazepines or other CNS depressants are inadequate. Follow patients for signs and symptoms of respiratory depression and sedation. If the patient is visibly sedated, evaluate the cause of sedation and consider delaying or omitting daily methadone dosing. Life-Threatening QT Prolongation QT interval prolongation and serious arrhythmia ( torsades de pointes ) have occurred during treatment with methadone [see Warnings and Precautions ( 5.3 )]. Most cases involve patients being treated for pain with large, multiple daily doses of methadone, although cases have been
Clinical Trial Registry
10 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06962306 OPAL-Cleft | Pro00117598 | Ph 4 | recruiting | Optimizing Perioperative Analgesia to Lower Pain Following Cleft Palate Surgery |
| NCT07226076 | Pro00147447 | Ph 3 | recruiting | Methadone in TKA for Post-op Pain and Opioid Reduction |
| NCT06877858 | 857972 | Ph 1 | recruiting | MethaLoad Dose-Finding Study |
| NCT06086171 | SHS-An-4-2023 | Ph 4 | completed | Perioperative Methadone Compared to Placebo in Elderly Hip Fracture Patients |
| NCT05831345 | CHUB-Methadone | Ph 3 | recruiting | Intraoperative Methadone for the Prevention of Postoperative Pain |
| NCT04680286 METACEBO | 23956082 2020-002945-41 | Ph 3 | terminated | Intraoperative Methadone in Children Undergoing Surgery |
| NCT00930332 | SC22 CAN-NCIC-SC22, CDR0000641372 | Ph 1 | terminated | Methadone Hydrochloride as First-Line Therapy in Treating Patients With Chronic Neuropathic Cancer Pain |
| NCT02989597 MAPS results posted | 2016-6985 | Ph 4 | terminated | Intraoperative Methadone Administration for Improved Pain Control in Spinal Fusion Patients |
| NCT02531906 | I 262314 NCI-2015-01338, I 262314 | Ph 1 | completed | Gabapentin, Methadone Hydrochloride, and Oxycodone Hydrochloride in Improving Quality of Life in Patients With Stage II-IV Head and Neck Cancer During Chemoradiation |
| NCT01795495 results posted | IRB13-0036 Active | Ph 2 | completed | Methadone vs Magnesium in Spinal Fusion |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
METHADOSE FDA Label Details
Indications & Usage
FDA Label (PDF)METHADOSE contains methadone, an opioid agonist indicated for the: detoxification treatment of opioid addiction (heroin or other morphine-like drugs). maintenance treatment of opioid addiction (heroin or other morphine-like drugs), in conjunction with appropriate social and medical services. Limitations of Use Methadone products used for the treatment of opioid addiction in detoxification or maintenance programs are subject to the conditions for distribution and use required under 21 CFR, Title 42, Sec 8 [see Dosage and Administration ] . METHADOSE is an opioid agonist indicated for the: Detox...
WARNING: LIFE-THREATENING RESPIRATORY DEPRESSION, LIFE-THREATENING QT PROLONGATION, ACCIDENTAL INGESTION, ABUSE POTENTIAL, INTERACTIONS WITH DRUGS AFFECTING CYTOCHROME P450 ISOENZYMES and TREATMENT FOR OPIOID ADDICTION Life-Threatening Respiratory Depression Respiratory depression, including fatal c...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.