Pharmacy Services
Hydrocodone Long-Acting Antitussives (Tussionex) - Safe Use
April 24, 2008
The FDA is advising healthcare providers on the safe use of long-acting hydrocodone antitussive (Tussionex Pennkinetic Extended-Release Suspension). Tussionex can cause life-threatening or fatal respiratory depression in children less than 6 years old and is contraindicated for use in these patients. Prescribing the product more frequently than every 12 hours or using an inaccurate measurement device can also lead to life-threatening or fatal respiratory depression in any patient. To prevent these adverse effects, ensure patients have an appropriate dose measurement device and prescribe according to the labeling.
Additional information is available at the following links:
- MedWatch Alert:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm091793.htm - Dear Healthcare Provider Letter:
http://www.fda.gov/downloads/Safety/MedWatch/SafetyInformation/ SafetyAlertsforHumanMedicalProducts/ucm128152.pdf - Drug Information Page:
http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm107208.htm - Public Health Advisory:
http://www.fda.gov/Drugs/DrugSafety/PublicHealthAdvisories/ucm051130.html - Prescribing Information:
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019111s015lbl.pdf
Updated
April 24, 2008; March 11, 2008; University of Utah, Drug Information Service. Copyright 2009, Drug Information Service, University of Utah, Salt Lake City, UT.
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