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 preferably comprises a extended release composition which may be in the form of beads contained in an oral dosage form such as gelatin capsules. The composition is designed to release hydrocodone in a way such that the increase in hydrocodone exposure in hepatically impaired patients is not clinically significant. The oral dosage units are supplied as part of a kit, which also includes a primary package and 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, and preferably explicitly states that dosing adjustment is not required for mild or moderate hepatic impairment

主权项

1. A kit for treating pain which requires daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate, comprising:
a plurality extended release opioid dosage units; a package holding the dosage units; written instructions for dosing a patient with the dosage units; wherein the active ingredient consists essentially only of hydrocodone formed as a pharmaceutically acceptable salt or complex of hydrocodone providing a dosage equivalent in each dosage unit selected from the group consisting of 15, 20, 30, 40 and 50 mg of hydrocodone bitartrate; wherein each dosage unit comprises an immediate release component and a sustained release component; wherein the sustained release component comprises 50% to 90% of the total hydrocodone in each dosage unit; wherein the sustained release component is formulated to release about 10% to about 30% of the hydrocodone in a first hour and releases more than about 60% and less than about 98% of the hydrocodone during a first 12 hours after placement in a USP dissolution apparatus buffered at a pH of 6.8; further wherein the written instructions state that no adjustment in starting dose is required in patients with some degree of hepatic impairment.