1. Dosage

In August 2014, the Drug Enforcement Administration published a final ruling to reschedule hydrocodone combination products from Schedule III to Schedule II due to their high potential of abuse. Beginning October 6, 2014, all hydrocodone combination products will be Schedule II. Single-entity hydrocodone products were already classified as Schedule II¹.

Hydrocodone bitartrate, as combination therapy, is FDA-approved as an opioid antitussive and analgesic used for the relief of cough and moderate to moderately severe pain^2-7. Hydrocodone bitartrate is available in fixed combinations with non-opiate drugs (e.g., acetaminophen, acetylsalicylic acid, chlorpheniramine, guaifenesin, ibuprofen, phenylephrine, and pseudoephedrine)^2,3,6,7. This drug should be given in the smallest effective dose and as infrequently as possible to minimize the development of tolerance and physical dependence. Hydrocodone bitartrate is available in the United States as a single entity, extended-release capsule (Zohydro® ER), formulated with abuse-deterrent beads ^.2,3,8. This hydrocodone product is FDA-approved for managing pain requiring daily, long-term, around-the-clock opiate therapy not responsive to other treatment options. Hydrocodone bitartrate extended-release tablets with abuse deterrent properties (Hysingla® ER) have also been FDA-approved to manage severe pain requiring chronic, around-the-clock opiate treatment unresponsive to other treatment regimens ^2,3,8,9.

The use of hydrocodone when prescribed by multiple physicians will be reviewed.

Hydrocodone/acetaminophen combination products containing greater than 325 mg of acetaminophen have been discontinued due to increased potential for liver toxicity.