drugs information

Dolophine Hydrochloride Black Box Warning

Market Name: Dolophine Hydrochloride

Generic Name: Methadone Hydrochloride

Dolophine (methadone hydrochloride) is indicated for treatment of opioid addiction in detoxification or maintenance programs. It is a Schedule II controlled narcotic substance with a high risk of dependence and criminal diversion.

When methadone treatment for opioid withdrawal is undertaken too rapidly, deaths caused by respiratory and cardiovascular side effects have occurred. Later in treatment, respiratory depression and arrhythmias were also observed. A black box warning was added to the prescribing information for Dolophine in November 2006.

Black Box Warning Date: November 2006

FDA Link: Dolophine Hydrochloride

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