Limitations of Use

Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration [see Warnings and Precautions (5.1)], reserve DEMEROL Injection for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or opioid combination products):

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Have not been tolerated or are not expected to be tolerated,

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Have not provided adequate analgesia or are not expected to provide adequate analgesia.

DEMEROL Injection should not be used for an extended period of time unless the ‎pain remains severe enough to require an opioid analgesic and for which ‎alternative treatment options continue to be inadequate.‎

Use of DEMEROL Injection for an extended period of time may increase the risk of toxicity (e.g., seizures) from the accumulation of the meperidine metabolite, normeperidine.