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
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DOLOPHINE 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 DOLOPHINE, and monitor all patients regularly for the development of these behaviors or conditions
[see Warnings and Precautions]
.
Life-threatening Respiratory Depression
Serious, life-threatening, or fatal respiratory depression may occur with use of DOLOPHINE. Monitor for
respiratory depression, especially during initiation of DOLOPHINE or following a dose increase [see Warnings
and Precautions].
Accidental Ingestion
Accidental ingestion of even one dose of DOLOPHINE, especially by children, can result in a fatal overdose of
methadone
[see Warnings and Precautions]
.
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
DOLOPHINE
[see Warnings and Precautions]
.
Neonatal Opioid Withdrawal Syndrome
Prolonged use of DOLOPHINE 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
[see Warnings and Precautions]
.
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
[see Indications and Usage]
.
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