Methadose™ Dispersible Tablets, 40 mg (Methadone Hydrochloride Tablets for Oral Suspension USP), CII
This information is intended for U.S. healthcare professionals only.
INDICATIONS AND USAGE
Methadose Dispersible(methadone hydrochloride) tablets are indicated:
- For detoxification treatment of opioid addiction (heroin or other morphine-like drugs).
- For maintenance treatment of opioid addiction (heroin or other morphine-like drugs), in conjunction with appropriate social and medical services.
IMPORTANT RISK INFORMATION
WARNING: LIFE-THREATENING RESPIRATORY DEPRESSION, LIFE-THREATENING QT PROLONGATION, ACCIDENTAL EXPOSURE, ABUSE POTENTIAL 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. Proper dosing and titration are essential and methadone hydrochloride tablets for oral suspension 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 methadone hydrochloride tablets for oral suspension 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.
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 for oral suspension.
Accidental ingestion of methadone hydrochloride tablets for oral suspension, especially in children, can result in fatal overdose of methadone.
Methadone hydrochloride tablets for oral suspension contain methadone, an opioid agonist and Schedule II controlled substance with an abuse liability similar to other opioid agonists, legal or illicit. Routinely monitor all patients receiving methadone hydrochloride tablets for oral suspension for signs of misuse, abuse, and addiction during treatment.
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.
Regulatory Exceptions to the General Requirement for Certification to Provide Opioid Agonist Treatment:
- During inpatient care, when the patient was admitted for any condition other than concurrent opioid addiction (pursuant to 21 CFR 1306.07(c)), to facilitate the treatment of the primary admitting diagnosis.
- During an emergency period of no longer than 3 days while definitive care for the addiction is being sought in an appropriately licensed facility (pursuant to 21 CFR 1306.07(b)).
- Methadone hydrochloride tablets for oral suspension is contraindicated in patients with a known hypersensitivity to methadone hydrochloride or any other ingredient in methadone hydrochloride tablets for oral suspension.
- Methadone is contraindicated in any situation where opioids are contraindicated such as: patients with respiratory depression (in the absence of resuscitative equipment or in unmonitored settings), and in patients with acute bronchial asthma or hypercarbia.
- Methadone is contraindicated in any patient who has or is suspected of having a paralytic ileus.
WARNINGS AND PRECAUTIONS
- Respiratory depression is the chief hazard associated with methadone hydrochloride administration.
- Cases of QT interval prolongation and serious arrhythmia (torsades de pointes) have been observed during treatment with methadone.
- Patients tolerant to other opioids may be incompletely tolerant to methadone.
- 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.
- Patients receiving other opioid analgesics, general anesthetics, phenothiazines, other tranquilizers, sedatives, benzodiazepines, hypnotics, or other CNS depressants (including alcohol) concomitantly with methadone may experience respiratory depression, hypotension, profound sedation, or coma.
- The respiratory depressant effects of opioids and their capacity to elevate cerebrospinal-fluid pressure may be markedly exaggerated in the presence of head injury, other intracranial lesions or a pre-existing increase in intracranial pressure.
- The administration of opioids may obscure the diagnosis or clinical course of patients with acute abdominal condition.
- The administration of methadone may result in severe hypotension in patients whose ability to maintain normal blood pressure is compromised (e.g., severe volume depletion) abdominal conditions.
- Methadone should be given with caution, and the initial dose reduced, in certain patients such as the elderly and debilitated, and those with severe impairment of hepatic or renal function, hypothyroidism, Addison's disease, prostatic hypertrophy, or urethral stricture.
- Reproductive function in human males may be decreased by methadone treatment.
- Serious adverse reactions may include respiratory depression and, to a lesser degree, systemic hypotension. Respiratory arrest, shock, cardiac arrest, and death have occurred.
- 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.
||Methadone Hydrochloride tablets, USP
||Quadrisected, METHADOSE 40 on reverse side
For additional information on Methadose™ Dispersible Tablets, 40 mg (Methadone Hydrochloride Tablets for Oral Suspension USP), CII, call Customer Service at 1.800.325.8888 or Medical Information at 1.800.778.7898.