Label Changes for:
Videx EC (didanosine, USP) Delayed-Release Capsules (Enteric-Coated Beadlets)
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.|
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.