Drug Safety Warnings and Updates: January-March 2018

Shannon Thor, PharmD, MS


May 23, 2018

Editorial Collaboration

Medscape &

In This Article

Methadone hydrochloride (Dolophine Hydrochloride)

For more on this Drug Safety Labeling Change, click here.

For full prescribing information, click here.

Updated Boxed Warning

Risks From Concomitant Use With Benzodiazepines or Other CNS Depressants

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.

Reserve concomitant prescribing of DOLOPHINE Tablets and benzodiazepines or other CNS depressants for use in patients for whom alternatives to benzodiazepines or other CNS depressants are inadequate.

Limit dosages and durations to the minimum required for patients being treated for pain.

Follow patients for signs and symptoms of respiratory depression and sedation. If the patient is visibly sedated, evaluate the cause of sedation, and consider delaying or omitting the daily methadone dose.