Hysingla

Hysingla ER is a brand-name extended-release opioid analgesic containing hydrocodone bitartrate, approved for the management of moderate to severe chronic pain in adults. It was developed by Purdue Pharma L.P. and received U.S. FDA approval in 2014. The product is designed as a once-daily tablet and is intended for continuous, around-the-clock pain relief rather than for as-needed dosing.

Hysingla ER uses a hydrocodone bitartrate extended-release formulation with a polymer matrix that releases the active drug gradually over 24 hours. The tablets are intended to be swallowed whole and are designed to be tamper-resistant. The product is acetaminophen-free, unlike many other hydrocodone products.

It is indicated for adults with chronic pain who require daily, long-acting opioid therapy when other treatments have not provided adequate relief or are not tolerated. Because of the risk of dependence and overdose, it should be prescribed and used with caution and under close medical supervision.

Hysingla ER is a Schedule II controlled substance in the United States due to its potential for abuse and dependence. It should not be used in opioid-naive patients, and concurrent use with CNS depressants or alcohol can cause life-threatening respiratory depression. Dosing should be individualized, and patients should be monitored for signs of misuse and for adverse effects such as excessive sedation.

Common adverse effects include constipation, nausea, vomiting, dizziness, drowsiness, and headache. Serious risks include respiratory depression, profound sedation, hypotension, and death in overdose. Use during pregnancy may cause neonatal opioid withdrawal syndrome.

The product is part of the broader class of extended-release opioids and is subject to FDA labeling and risk-management requirements.