Medication Guide App

Label Changes for:

Promethazine HCl, Phenylephrine HCl and Codeine Phosphate Oral Solution

November 2008

Changes have been made to the CONTRAINDICATIONS, WARNINGS and PRECAUTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- November 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. Read about the new physician labeling format.


Summary View

 

Sections Modified

Summary of Changes to Contraindications and Warnings

CONTRAINDICATIONS

WARNINGS

  • Boxed Warning (new)
  • Use in Pediatric Patients

PRECAUTIONS

  • General
    • Ultra-rapid Metabolizers of Codeine
  • Information for Patients
    • Patients should be advised to measure Promethazine HCI and Codeine Phosphate Oral Solution with an accurate measuring device...
    • ...Pediatric patients should be supervised to avoid potential harm in bike riding or in other
      hazardous activities...
    • ...Caution patients that some people have a variation in a liver enzyme and change codeine into morphine more rapidly and completely than other people...
    • ...Nursing mothers taking codeine can also have higher morphine levels in their breast milk if they are ultra-rapid metabolizers...
  • Pregnancy
    • Teratogenic Effects
      • Promethazine
  • Nursing Mothers
  • Pediatric Use
    • The combination of promethazine hydrochloride and codeine phosphate is contraindicated in pediatric patients less than 6 years of age, because the combination may cause fatal respiratory depression in this age population (see WARNINGS - Boxed Warning and Use in Pediatric Patients).

CONTRAINDICATIONS

The combination of promethazine hydrochloride and codeine phosphate is contraindicated in pediatric patients less than 6 years of age, because the combination may cause fatal respiratory depression in this age population.

WARNINGS

Boxed Warning:

The combination of promethazine hydrochloride and codeine phosphate is contraindicated in pediatric patients less than 6 years of age. Concomitant administration of promethazine products with other respiratory depressants has an association with respiratory depression, and sometimes death, in pediatric patients.

Postmarketing cases of respiratory depression, including fatalities, have been reported with use of promethazine hydrochloride in pediatric patients less than 2 years of age. A wide range of weight-based doses of promethazine hydrochloride have resulted in respiratory depression in these patients.

Use in Pediatric Patients:

The combination of promethazine hydrochloride and codeine phosphate is contraindicated in pediatric patients less than 6 years of age...

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