Label Changes for:
Tussionex Pennkinetic (hydrocodone polistirex and chlorpheniramine polistirex) Extended-Release Suspension
March 2008
Changes have been made to the CONTRAINDICATIONS, WARNINGS, PRECAUTIONS and ADVERSE REACTIONS sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- March 2008
| The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary. |
| Sections Modified | Summary of Changes to Contraindications and Warnings |
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CONTRAINDICATIONS WARNINGS
PRECAUTIONS
ADVERSE REACTIONS
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CONTRAINDICATIONS The use of Tussionex Pennkinetic Extended-Release Suspension is contraindicated in children less than 6 years of age due to the risk of fatal respiratory depression. WARNINGS Pediatric Use The use of Tussionex Pennkinetic Extended-Release Suspension is contraindicated in children less than 6 years of age... In pediatric patients, as well as adults, the respiratory center is sensitive to the depressant action of narcotic cough suppressants in a dose-dependent manner. Caution should be exercised when administering Tussionex Pennkinetic Extended-Release Suspension to pediatric patients 6 years of age and older. Overdose or concomitant administration of Tussionex Pennkinetic Extended-Release Suspension with other respiratory depressants may increase the risk of respiratory depression in pediatric patients. Benefit to risk ratio should be carefully considered, especially in pediatric patients with respiratory embarrassment (e.g., croup)... |
