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FDA Date: 3/11/08
Tussionex (chlorpheniramine polistirex/hydrocodone polistirex) FDA Drug Safety Communication
Information for Healthcare Professionals: Long-Acting Hydrocodone-Containing Cough Product (marketed as Tussionex Pennkinetic Extended-Release Suspension)
FDA is highlighting important information about how to safely use Tussionex Pennkinetic Extended-Release Suspension, a long-acting hydrocodone-containing cough product. FDA has worked with the manufacturer of Tussionex to update important safety information in the drug label, including:
- Tussionex is contraindicated in patients less than 6 years old.
- Consult the prescribing information to determine the correct dose and dosing frequency of Tussionex.
- Prescribers should clearly state the prescribed volume in milliliters.
- Discuss with the patient the amount of Tussionex to be given and the frequency of dosing. Instruct patients not to take and parents not to administer it more frequently than every 12 hours.
This information reflects the current analysis of data available to FDA concerning this drug. FDA intends to update this communication when additional information or analyses become available.