Noxafil (posaconazole) Oral Suspension, 40mg/mL February 2009

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- February 2009

 

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

PRECAUTIONS

• Information for Patients
  • ...advised to take each dose of NOXAFIL Oral Suspension during or immediately (i.e. within 20 minutes) following a full meal.....
• Drug Interactions
  • Table 8
    • Esomeprazole and Metoclopramide....monitor closely for breakthrough fungal infections

PATIENT PACKAGE INSERT

• How do I take Noxafil?
  • Take each dose of NOXAFIL with during or immediately (i.e. within 20 minutes) following a full meal, or with a liquid nutritional supplement if you are unable to eat a full meal. Alternatively, NOXAFIL may be taken with an acidic carbonated beverage (e.g. gingerale)