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U.S. Department of Health and Human Services

Safety

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Tussionex Pennkinetic (hydrocodone polistirex and chlorpheniramine polistirex) Extended-Release Suspension


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.


Summary View

 

Sections Modified Summary of Changes to Contraindications and Warnings

CONTRAINDICATIONS

WARNINGS

  • Pediatric Use

PRECAUTIONS

  • Information for Patients
    • Patients should be advised to measure Tussionex Pennkinetic Extended-Release Suspension with an accurate measuring device...
    • Shake well before using.
  • Pediatric Use

ADVERSE REACTIONS

  • General Disorders and Administration Site Conditions (added)
  • Respiratory, Thoracic and Mediastinal Disorders
    • Dryness of the pharynx, occasional tightness of the chest, and respiratory depression...
    • ...Use of Tussionex Pennkinetic Extended-Release Suspension in children less than 6 years of age has been associated with fatal respiratory depression...

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)...