Intended for U.S. healthcare professionals only. For corporate information, please visit Mallinckrodt.com X

Methadone HCI tablets, USP CII 10 mg

INDICATIONS AND USAGE

  • Methadone hydrochloride tablets are an opioid agonist indicated for the:
  • Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. 
    • Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with long-acting opioids, reserve methadone hydrochloride tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.
    • Methadone hydrochloride tablets are not indicated as an as-needed (prn) analgesic.
  • 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.

 

    IMPORTANT RISK INFORMATION

    WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; LIFE-THREATENING QT PROLONGATION; NEONATAL OPIOID WITHDRAWAL SYNDROME; and TREATMENT FOR OPIOID ADDICTION

    Addiction, Abuse, and Misuse 

    Methadone hydrochloride tablets expose 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 methadone hydrochloride tablets, and monitor all patients regularly for the development of these behaviors or conditions.

    Life-Threatening Respiratory Depression 

    Serious, life-threatening, or fatal respiratory depression may occur with use of methadone hydrochloride tablets. Monitor for respiratory depression, especially during initiation of methadone hydrochloride tablets or following a dose increase.

    Accidental Ingestion 

    Accidental ingestion of even one dose of methadone hydrochloride tablets, especially by children, can result in a fatal overdose of methadone. 

    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.

    Neonatal Opioid Withdrawal Syndrome 

    Prolonged use of methadone hydrochloride tablets during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.

    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.

    CONTRAINDICATIONS

    • Methadone hydrochloride tablets are contraindicated in patients with:
      • Significant respiratory depression 
      • Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment
      • Known or suspected paralytic ileus 
      • Hypersensitivity (e.g., anaphylaxis) to methadone 

      WARNINGS AND PRECAUTIONS

      • Methadone hydrochloride tablets contain methadone, a Schedule II controlled substance. As an opioid, methadone hydrochloride tablets expose users to the risks of addiction, abuse, and misuse [see Drug Abuse and Dependence (9)]. As long-acting opioids such as methadone hydrochloride tablets have pharmacological effects over an extended period of time, there is a greater risk for overdose and death.
      • While serious, life-threatening, or fatal respiratory depression can occur at any time during the use of methadone hydrochloride tablets, the risk is greatest during the initiation of therapy or following a dose increase. Methadone’s peak respiratory depressant effects typically occur later, and persist longer than its peak analgesic effects, particularly during the initial dosing period. Overestimating the methadone hydrochloride tablets dose when converting patients from another opioid product can result in fatal overdose with the first dose. Life-threatening respiratory depression is more likely to occur in elderly, cachectic, or debilitated patients. In patients with significant chronic obstructive pulmonary disease or cor pulmonale, and patients having a substantially decreased respiratory reserve, hypoxia, hypercapnia, or pre-existing respiratory depression, methadone may decrease respiratory drive to the point of apnea, particularly when initiating therapy and titrating with methadone, even at usual therapeutic doses.
      • Methadone inhibits cardiac potassium channels and prolongs the QT interval. Serious arrhythmia (torsades de pointes) has been observed during treatment with methadone.
      • Hypotension, profound sedation, coma, or respiratory depression may result if methadone hydrochloride tablets are used concomitantly with other CNS depressants (e.g., sedatives, anxiolytics, hypnotics, neuroleptics, other opioids).
      • Methadone hydrochloride tablets may cause severe hypotension including orthostatic hypotension and syncope in ambulatory patients. There is an increased risk in patients whose ability to maintain blood pressure has already been compromised by a reduced blood volume or concurrent administration of certain CNS depressant drugs (e.g. phenothiazines or general anesthetics).
      • Patients with brain tumors or increased intracranial pressure are susceptible to the intracranial effects of CO2 retention. Methadone hydrochloride tablets may reduce respiratory drive, and the resultant CO2 retention can further increase intracranial pressure. Opioids may also obscure the clinical course in a patient with a head injury.
      • Methadone hydrochloride tablets may cause spasm of the sphincter of Oddi.
      • Methadone hydrochloride tablets may aggravate convulsions in patients with convulsive disorders, and may induce or aggravate seizures in some clinical settings.
      • Use of partial agonists or mixed opioid agonists/antagonists analgesics may reduce the analgesic effect and/or may precipitate withdrawal symptoms. Do not abruptly discontinue methadone hydrochloride tablets.
      • Methadone hydrochloride tablets may impair the mental or physical abilities needed to perform potentially hazardous activities such as driving a car or operating machinery.

      ADVERSE EVENTS

      • Serious adverse reactions may include addiction, abuse, misuse, life-threatening respiratory depression, neonatal opioid withdrawal syndrome, hypotension, respiratory arrest, shock, cardiac arrest, and death.
      • The most common adverse reactions include lightheadedness, dizziness, sedation, nausea, vomiting, and sweating. 

      USE IN SPECIFIC POPULATIONS

      • Pregnancy: Prolonged use of opioid analgesics during pregnancy for medical or nonmedical purposes can result in physical dependence in the neonate and neonatal opioid withdrawal syndrome, which can be life threatening. Opioids cross the placenta and may produce respiratory depression in neonates
      • Breastfeeding: Methadone is secreted into human milk. Cases of sedation and respiratory depression in infants exposed to methadone through breast milk have been reported. Breastfed infants of mothers using methadone should be weaned gradually to prevent development of withdrawal symptoms in the infant.
      • Pediatrics: Safety and effectiveness in pediatric patients below the age of 18 years have not been established.

        Description White, rectangle shaped convex tablet
        Dosage Strength 10 mg
        Compares To Dolophine®
        Identification Code One side debossed with a score between "57" and "71", "M" in a box on the other side
        Rating AA

        Order Information

        NDC # Package Size Case Quantity
        0406-5771-01 100's 12
        0406-5771-62 100 UD ten 2x5 blister cards 24

        For additional information on Methadone HCI tablets, USP CII 10 mg, call Customer Service at 1.800.325.8888 or Medical Information at 1.800.778.7898.

        Dolophine is a registered trademark of Roxane Laboratories, Inc.