Application Nr Approved Date Route Status External Links
NDA005010 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Demerol Tablets And Oral Solution 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 ( 5.2 )] , Reserve Demerol Tablets Or Oral Solution 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. Demerol Tablets Or Oral Solution Should Not Be Used For Treatment Of Chronic Pain. Prolonged Demerol Tablet Or Oral Solution Use May Increase The Risk Of Toxicity (E.g. Seizures) From The Accumulation Of The Meperidine Metabolite, Normeperidine. Demerol Tablets And Oral Solution Are Opioid Agonists 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 Demerol Tablets And Oral Solution 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.

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Meperidine Hydrochloride MEPERIDINE HYDROCHLORIDE ZINC1681

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