Qdolo FDA Approved


Qdolo (tramadol – Athena Bioscience) oral solution, 5mg/mL was approved on Sept. 1, 2020, by the U.S. Food and Drug Administration (FDA). A C-IV controlled substance, it is indicated for treating adults who have severe pain that requires an opioid, but that does not respond to other treatments. To be administered from an oral syringe or other precisely marked device, dosing begins at 25mg/day and increases at three-day intervals to a recommended dose of 50mg four times a day. Total daily doses should be 400mg or less, treatment should be at the lowest effective dose for the shortest and Qdolo should be tapered to a gradual endpoint – not stopped suddenly. All opioids have boxed warnings that they increase the risk of respiratory failure – especially if taken at the same time as other central nervous system (CNS) depressants such as alcohol or drugs in the benzodiazepine class. They also have risks of addiction and misuse. If used during pregnancy, opioids can cause withdrawal symptoms for newborns. Qdolo should not be used for children under the age of 12 years or for patients younger than 18 years who have had a tonsillectomy or adenoidectomy. Like all FDA-approved opioids, Qdolo has a risk evaluation and mitigation strategy (REMS) requiring prescribers, dispensers and patients to be certified for its use. It will be dispensed through open distribution in 16 ounce (473mL) bottles, but price and launch details have not yet been released. myMatrixx does not expect this new formulation of tramadol to have a significant impact on workers’ compensation. The drug will require pre-authorization where allowed. Please consult with your myMatrixx pharmacist with any questions about its use or potential relatedness to a claim.