Meperitab (Oral)

Ensure accuracy when prescribing, dispensing, and administering meperidine hydrochloride oral solution. Dosing errors due to confusion between mg and mL, and other meperidine hydrochloride oral solutions of different concentrations can result in accidental overdose and death. Meperidine hydrochloride has the potential for addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient's risk before prescribing, and monitor for development of these behaviors or conditions. To ensure that the benefits of opioid analgesics outweigh the risks of addiction, abuse, and misuse, the Food and Drug Administration (FDA) has required a Risk Evaluation and Mitigation Strategy (REMS) for these products. Serious, life-threatening, or fatal respiratory depression may occur. Monitor closely, especially upon initiation or following a dose increase. Accidental ingestion of meperidine hydrochloride, especially in children, can result in fatal overdose of meperidine hydrochloride. Prolonged use of meperidine hydrochloride during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available. Concomitant use or discontinuation of concomitantly used cytochrome P450 3A4 inhibitors may effect meperidine plasma concentrations and lead to fatal respiratory depression, profound sedation, opioid toxicity, and/or opioid withdrawal. Careful monitoring of patients should occur when meperidine and cytochrome P450 3A4 inhibitors are concurrently used. Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing for patients with inadequate alternative treatment options. Limit dosages and durations to the minimum required and follow patients for signs and symptoms of respiratory depression and sedation. Concomitant use of meperidine hydrochloride with MAOIs or use of MAOIs within the last 14 days is contraindicated and can lead to coma, severe respiratory depression, cyanosis, and hypotension .