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1. Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
DOSAGE AND ADMINISTRATION
Management of Pain
• To be prescribed only by healthcare providers knowledgeable in use of potent opioids for management of chronic pain.
• Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals.
• Individualize dosing based on the severity of pain, patient response, prior analgesic experience, and risk factors for addiction, abuse, and misuse.
• For opioid naïve patients, initiate DOLOPHINE Tablets treatment with 2.5 mg every 8 to 12 hours.
• To convert to DOLOPHINE Tablets from another opioid, use available conversion factors to obtain estimated dose.
• Titrate slowly with dose increases no more frequent than every 3 to 5 days.
• Do not abruptly discontinue DOLOPHINE Tablets in a physically dependent patient.
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Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
DOLOPHINE Tablets exposes users to risks of addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient’s risk before prescribing, and monitor regularly for development of these behaviors and conditions.
• Serious, life-threatening, or fatal respiratory depression may occur. The peak respiratory depressant effect of methadone occurs later, and persists longer than the peak analgesic effect.Monitor closely, especially upon initiation or following a dose increase.
• Accidental ingestion of DOLOPHINE, especially by children, can result in fatal overdose of methadone.
• QT interval prolongation and serious arrhythmia (torsades de pointes) have occurred during treatment with methadone. Closely monitor patients with risk factors for development of prolonged
QT interval, a history of cardiac conduction abnormalities, and those taking medications affecting cardiac conduction.
• Neonatal opioid withdrawal syndrome (NOWS) is an expected and treatable outcome of use of DOLOPHINE during pregnancy.
NOWS may be life-threatening if not recognized and treated in the neonate. The balance between the risks of NOWS and the benefits of maternal DOLOPHINE use may differ based on the risks associated with the mother’s underlying condition, pain, or addiction. Advise the patient of the risk of NOWS so that appropriate planning for management of the neonate can occur. Wiki
• Concomitant use with CYP3A4, 2B6, 2C19, 2C9 or 2D6 inhibitors or discontinuation of concomitantly used CYP3A4 2B6, 2C19, or 2C9 inducers can result in a fatal overdose of methadone.
• 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.