Application Nr Approved Date Route Status External Links
ANDA203167 2013-10-29 Epidural RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Clonidine Hydrochloride Injection Is Indicated In Combination With Opiates For The Treatment Of Severe Pain In Cancer Patients That Is Not Adequately Relieved By Opioid Analgesics Alone. Epidural Clonidine Is More Likely To Be Effective In Patients With Neuropathic Pain Than Somatic Or Visceral Pain (see Clinical Trials ). The Safety Of This Drug Product Has Only Been Established In A Highly Selected Group Of Cancer Patients, And Only After An Adequate Trial Of Opioid Analgesia. Other Use Is Of Unproven Safety And Is Not Recommended. In A Rare Patient, The Potential Benefits May Outweigh The Known Risks (see Warnings ).

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Clonidine Hydrochloride CLONIDINE HYDROCHLORIDE ZINC896484

Comments