Label Changes for:

Videx EC (didanosine, USP) Delayed-Release Capsules (Enteric-Coated Beadlets)

September 2008

Changes have been made to the PRECAUTIONS and PATIENT PACKAGE INSERT sections of the safety label.

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

USE IN SPECIFIC POPULATIONS

  • Pediatric Use
    • Use of didanosine in pediatric patients from 2 weeks of age through adolescence is supported by evidence from adequate and well-controlled studies of didanosine in adult and pediatric patients [see Dosage and Administration (2), Adverse Reactions (6.1), Clinical Pharmacology (12.3), and Clinical Studies (14)]. Additional pharmacokinetic studies in pediatric patients support use of Videx EC in pediatric patients who weigh at least 20 kg.

PATIENT PACKAGE INSERT

The following language was added:

...Dispose of unused medicines through community take-back disposal programs when available or place Videx EC in an unrecognizable closed container in the household trash.

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