meperidine hydrochloride 50 mg
1 INDICATIONS AND USAGE Meperidine hydrochloride tablets are indicated for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.1) ], reserve meperidine hydrochloride tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]: • Have not been tolerated, or are not expected to be tolerated, • Have not provided adequate analgesia, or are not expected to provide adequate analgesia. Meperidine hydrochloride tablets should not be used for treatment of chronic pain. Prolonged meperidine hydrochloride tablets use may increase the risk of toxicity (e.g. seizures) from the accumulation of the meperidine metabolite, normeperidine. Meperidine is an opioid agonist indicated for the management of pain, severe enough to require an opioid analgesic and for which alternative treatments are inadequate. ( 1 ) Limitations of Use ( 1 ) Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserve meperidine hydrochloride tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]: • Have not been tolerated, or are not expected to be tolerated, • Have not provided adequate analgesia, or are not expected to provide adequate analgesia.
epic pharma, llc
ROUND WHITE E 50
E 50 ROUND WHITE
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16 HOW SUPPLIED/STORAGE AND HANDLING
MEPERIDINE HYDROCHLORIDE Tablets USP, 50 mg are white, round biconvex tablets, debossed “Є” above bisect and “50” below bisect on one side, plain on the other side, available in bottles of 30, NDC 42806-050-30 and in bottles of 100, NDC 42806-050-01.
MEPERIDINE HYDROCHLORIDE Tablets USP, 100 mg are white, round biconvex tablets, debossed “Є51” on one side and bisected on the other side, available in bottles of 100, NDC 42806-051-01. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). Store at 20° to 25° C (68° to 77° F) [See USP Controlled Room Temperature]. Store
MEPERIDINE HYDROCHLORIDE tablets securely and dispose of properly [see Patient Counseling Information (17) ].
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