Revised Dolophine Label Instructions

Based on reports that people starting methadone treatment have died or experienced serious side effects due to changes in heart beat or depressed respiration, the U.S. Food and Drug Administration (FDA) has issued a public health advisory warning and revised prescribing information for methadone hydrochloride. The FDA cautioned physicians to closely monitor patients receiving methadone during the start of treatment or during dose adjustments. The FDA explicitly recommends avoiding the use of 40mg dispersible methadone tablets for pain. Health professionals should inform patients to seek medical attention immediately if they experience symptoms such as dizziness, fainting, slow breathing, blurred vision, or extreme tiredness. Patients should also be told that pain relief from methadone does not last as long as the drug is in the body and what they should do if their pain is not controlled after taking the prescribed amount of methadone.