TREATING PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT

摘要

An extended release composition for an analgesic active pharmaceutical ingredient which may be an opioid, preferably hydrocodone as the only active ingredient. The extended release composition comprises a multiparticulate modified release composition which may be in the form of beads contained in an oral dosage form such as gelatin capsules as the primary package. The oral dosage units are supplied as part of a kit, which also includes a package insert all sold as a commercially marketed product. The primary package and package insert are contained in an optional secondary package and the package insert does not contain a warning, a dosing instruction, or a dosing table specifically directed to patients suffering from mild, moderate or severe hepatic impairment.