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Methadone HCl Tablets, USP CII 5 mg

INDICATION

Methadone hydrochloride tablets are an opioid agonist indicated for the:

  • management of moderate to severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time.
  • 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: ABUSE POTENTIAL, LIFE-THREATENING RESPIRATORY DEPRESSION, LIFE-THREATENING QT PROLONGATION, ACCIDENTAL EXPOSURE, and TREATMENT FOR OPIOID ADDICTION

Abuse Potential
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 Exposure
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.

CONTRAINDICATIONS

  • Methadone is contraindicated in patients with:
    • Significant respiratory depression.
    • Acute or severe bronchial asthma.
    • Known or suspected paralytic ileus.
    • Hypersensitivity to methadone.

WARNINGS AND PRECAUTIONS

  • Methadone is not indicated as an as-needed (prn) analgesic, for pain that is mild or not expected persist for an extended to period time, for acute pain, or post-operative pain.
  • Respiratory depression, which occurs more frequently in elderly or debilitated patients, is the chief hazard associated with methadone hydrochloride administration. Methadone's peak respiratory depressant effects typically occur later, and persist longer than its peak analgesic effects, particularly during the initial dosing period.
  • Patients tolerant to other opioids may be incompletely tolerant to methadone. Incomplete cross-tolerance is of particular concern for patients tolerant to other mu-opioid agonists who are being converted to treatment with methadone, thus making determination of dosing during opioid treatment conversion complex.
  • Methadone inhibits cardiac potassium channels and prolongs the QT interval. Serious arrhythmia (torsades de pointes) has been observed during treatment with methadone.
  • Avoid concurrent use of CNS depressants (such as alcohol) and methadone as this could increase the risk for respiratory depression, hypotension, and profound sedation.
  • Methadone, a mu-agonist opioid with an abuse liability similar to other opioid agonists is a Schedule II controlled substance and like other opioids used in analgesia, can be abused and are subject to criminal diversion.
  • Methadone should be used with caution in elderly and debilitated patients; patients who are known to be sensitive to central nervous system depressants, such as those with cardiovascular, pulmonary, renal, or hepatic disease; and in patients with comorbid conditions or concomitant medications which may predispose to dysrhythmia.
  • Monitor 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 for respiratory depression, particularly when initiating therapy and titrating with methadone hydrochloride tablets, as in these patients, even usual therapeutic doses of methadone hydrochloride tablets may decrease respiratory drive to the point of apnea.
  • 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).
  • 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 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 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 respiratory depression, 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

  • Women being treated with methadone for any indication who are already breastfeeding should be counseled to wean breastfeeding gradually in order to prevent the development of withdrawal symptoms in the infant. There have been rare cases of sedation and respiratory depression in infants exposed to methadone through breast milk.
  • Safety and effectiveness in pediatric patients below the age of 18 years have not been established.

Description White, rectangle shaped convex tablet
Dosage Strength 5 mg
Compares To Dolophine®
Identification Code One side debossed with a score between "57" and "55", "M" in a box on the other side
Rating AA

Order Information

NDC # Package Size Case Quantity
0406-5755-01 100's 12
0406-5755-62 100 UD ten 2x5 blister cards 24

For additional information on Methadone HCl Tablets, USP CII 5 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.