Valtrex (valacyclovir hydrochloride) Caplets September 2008

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

ADVERSE REACTIONS

• Clinical Trials Experience in Pediatric Patients

USE IN SPECIFIC POPULATIONS

• Pediatric Use

PATIENT COUNSELING INFORMATION

• Chickenpox
  • Patients should be advised to initiate treatment at the earliest sign or symptom of chickenpox.

PATIENT PACKAGE INSERT

• What is Valtrex?
  • Valtrex is used in children:
    • ...to treat chickenpox (for children 2 to <18 years of age).