Methadone — Membership Pricing

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What Methadone is approved for (FDA label)

Methadone hydrochloride tablets is indicated for the: Management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids. Limitations of Use Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see WARNINGS AND PRECAUTIONS ( 5.1 )], reserve opioid analgesics, including methadone hydrochloride tablets, for use in patients for whom alternative analgesic treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.

Source: Read the full FDA label on DailyMed. Label effective date: December 31, 2025.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Boxed warning for Methadone (FDA label)

WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF METHADONE HYDROCHLORIDE TABLETS A ddiction, Abuse, and Misuse Because the use of methadone hydrochloride tablets exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death, assess each patient’s risk prior to prescribing and reassess all patients regularly for the development of these behaviors and conditions [see WARNINGS AND PRECAUTIONS ( 5.1 )]. Life-Threatening Respiratory Depression Serious, life-threatening, or fatal respiratory depression may occur with use of methadone hydrochloride tablets, especially during initiation or following a dosage increase. To reduce the risk of respiratory depression, proper dosing and titration of methadone hydrochloride tablets are essential [see WARNINGS AND PRECAUTIONS ( 5.2 )]. Accidental Ingestion Accidental ingestion of even one dose of methadone hydrochloride tablets, especially by children, can result in a fatal overdose of methadone [see Warnings and Precautions ( 5.2 )] . Risks From Concomitant Use With Benzodiazepines Or Other CNS Depressants Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death.

Source: FDA prescribing information (DailyMed). Set ID: 4a44bde6-c348-4316-b0e0-c24b407cb823. SPL document ID: b76dbddc-b042-47d7-a7a7-f64c7c5c5035. Label effective date: December 31, 2025. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Dosage forms and strengths for Methadone (FDA label)

10 mg Tablets: White, round, biconvex tablets, scored on one side and debossed with “N” above the score and “128” below the score and plain on the other side. Tablets: 10 mg. ( 3 )

Source: FDA prescribing information (DailyMed). Set ID: 4a44bde6-c348-4316-b0e0-c24b407cb823. SPL document ID: b76dbddc-b042-47d7-a7a7-f64c7c5c5035. Label effective date: December 31, 2025. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Adverse reactions for Methadone (FDA label)

The following serious adverse reactions are described, or described in greater detail, in other sections: Addiction, Abuse, and Misuse [see WARNINGS AND PRECAUTIONS ( 5.1 ) ] Life Threatening Respiratory Depression [see WARNINGS AND PRECAUTIONS ( 5.2 ) ] QT Prolongation [see WARNINGS AND PRECAUTIONS ( 5.4 ) ] Neonatal Opioid Withdrawal Syndrome [see WARNINGS AND PRECAUTIONS ( 5.5 ) ] Interactions with Benzodiazepines and other CNS Depressants [see WARNINGS AND PRECAUTIONS ( 5.3 ) ] Opioid-Induced Hyperalgesia and Allodynia [see WARNINGS AND PRECAUTIONS ( 5.8 ) ] Serotonin Syndrome [see WARNINGS AND PRECAUTIONS ( 5.9 ) ] Adrenal Insufficiency [see WARNINGS AND PRECAUTIONS ( 5.11 ) ] Severe Hypotension [see WARNINGS AND PRECAUTIONS ( 5.12 ) ] Gastrointestinal Adverse Reactions [see WARNINGS AND PRECAUTIONS ( 5.14 ) ] Seizures [see WARNINGS AND PRECAUTIONS ( 5.15 ) ] Withdrawal [see WARNINGS AND PRECAUTIONS ( 5.16 ) ] The following adverse reactions associated with the use of methadone were identified in clinical studies or postmarketing reports.

Source: FDA prescribing information (DailyMed). Set ID: 4a44bde6-c348-4316-b0e0-c24b407cb823. SPL document ID: b76dbddc-b042-47d7-a7a7-f64c7c5c5035. Label effective date: December 31, 2025. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Contraindications for Methadone (FDA label)

Methadone hydrochloride tablets are contraindicated in patients with: Significant respiratory depression [see WARNINGS AND PRECAUTIONS ( 5.2 ) ]. Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see WARNINGS AND PRECAUTIONS ( 5.10 ) ]. Known or suspected gastrointestinal obstruction, including paralytic ileus [see WARNINGS AND PRECAUTIONS ( 5.14 ) ]. Hypersensitivity (e.g., anaphylaxis) to methadone [see ADVERSE REACTIONS ( 6 ) ]. Significant respiratory depression ( 4 ) Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment ( 4 ) Known or suspected gastrointestinal obstruction, including paralytic ileus ( 4 ) Hypersensitivity to methadone ( 4 )

Source: FDA prescribing information (DailyMed). Set ID: 4a44bde6-c348-4316-b0e0-c24b407cb823. SPL document ID: b76dbddc-b042-47d7-a7a7-f64c7c5c5035. Label effective date: December 31, 2025. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Warnings and precautions for Methadone (FDA label)

Opioid Induced Hyperalgesia and Allodynia : Opioid-Induced Hyperalgesia (OIH) occurs when an opioid analgesic paradoxically causes an increase in pain, or an increase in sensitivity to pain. If OIH is suspected, carefully consider appropriately decreasing the dose of the current opioid analgesic or opioid rotation. ( 5.8) Serotonin Syndrome : Potentially life-threatening condition could result from concomitant serotonergic drug administration. Discontinue methadone hydrochloride tablets if serotonin syndrome is suspected. ( 5.9 ) Ri s k of Life-Threatening Respiratory Depression in Patients with Chronic P u l monary Disease or in Elderly, Cachectic, or Debilitated Patients : Regularly evaluate closely, particularly during initiation and titration. ( 5.10 ) A d r e na l Insufficiency : If diagnosed, treat with physiologic replacement of corticosteroids, and wean patient off of the opioid. ( 5.11 ) S e v e r e Hypotension : Regularly evaluate during dose initiation and titration.

Source: FDA prescribing information (DailyMed). Set ID: 4a44bde6-c348-4316-b0e0-c24b407cb823. SPL document ID: b76dbddc-b042-47d7-a7a7-f64c7c5c5035. Label effective date: December 31, 2025. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Drug interactions for Methadone (FDA label)

Inhibitors of CYP3A4, CYP2B6, CYP2C19, CYP2C9, or CYP2D6 Clinical Impact: Methadone undergoes hepatic N-demethylation by several cytochrome P450 (CYP) isoforms, including CYP3A4, CYP2B6, CYP2C19, CYP2C9, and CYP2D6. The concomitant use of methadone hydrochloride tablets and CYP3A4, CYP2B6, CYP2C19, CYP2C9, or CYP2D6 inhibitors can increase the plasma concentration of methadone, resulting in increased or prolonged opioid effects, and may result in a fatal overdose, particularly when an inhibitor is added after a stable dose of methadone hydrochloride tablets is achieved. These effects may be more pronounced with concomitant use of drugs that inhibit more than one of the CYP enzymes listed above. After stopping a CYP3A4, CYP2B6, CYP2C19, CYP2C9, or CYP2D6 inhibitor, as the effects of the inhibitor decline, the methadone plasma concentration can decrease [see CLINICAL PHARMACOLOGY ( 12.3 ) ], resulting in decreased opioid efficacy or withdrawal symptoms in patients physically dependent on methadone.

Source: FDA prescribing information (DailyMed). Set ID: 4a44bde6-c348-4316-b0e0-c24b407cb823. SPL document ID: b76dbddc-b042-47d7-a7a7-f64c7c5c5035. Label effective date: December 31, 2025. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.