Medication Guide App

Label Changes for:

Depakote ER (divalproex sodium) Extended Release Tablets

March 2008

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


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


Summary View

 

Sections Modified Summary of Changes to Contraindications and Warnings

WARNINGS AND PRECAUTIONS

  • Hypothermia
  • Interaction with Carbapenem Antibiotics
  • Suicidal Ideation
  • Monitoring: Drug Plasma Concentration
  • Effect on Ketone and Thyroid Function Tests
  • Effect on HIV and CMV Viruses Replication

USE IN SPECIFIC POPULATIONS

  • Pediatric Use
    • Initial Paragraph
    • Mania
    • Migraine Prophylaxis
    • Epilepsy
    • Pediatric Safety
    • Safety Studies - Mania
      • Safety Study-Controlled Mania Trial
      • Table 7
      • Safety Study - Open Label Mania Safety Data
    • Safety Study - Epilepsy (open label)
    • Safety Studies - Migraine (controlled and open label)
    • Prior Safety Experience
    • Nonclinical Development Toxicology

WARNINGS & PRECAUTIONS

Hypothermia

Hypothermia, defined as an unintentional drop in body core temperature to < 35° C (95° F), has been reported in association with valproate therapy both in conjunction with and in the absence of hyperammonemia. This adverse reaction can also occur in patients using concomitant topiramate with valproate after starting topiramate treatment or after increasing the daily dose of topiramate...

Interaction with Carbapenem Antibiotics

Carbapenem antibiotics (ertapenem, imipenem, meropenem) may reduce serum valproic acid concentrations to subtherapeutic levels, resulting in loss of seizure control. Serum valproic acid concentrations should be monitored frequently after initiating carbapenem therapy. Alternative antibacterial or anticonvulsant therapy should be considered if serum valproic acid concentrations drop significantly or seizure control deteriorates...

Suicidal Ideation

Suicidal ideation may be a manifestation of certain psychiatric disorders, and may persist until significant remission of symptoms occurs. Close supervision of high risk patients should accompany initial drug therapy.

Monitoring: Drug Plasma Concentration

Since Depakote ER may interact with concurrently administered drugs which are capable of enzyme induction, periodic plasma concentration determinations of valproate and concomitant drugs are recommended during the early course of therapy...

Effect on Ketone and Thyroid Function Tests

Valproate is partially eliminated in the urine as a keto-metabolite which may lead to a false interpretation of the urine ketone test.

There have been reports of altered thyroid function tests associated with valproate. The clinical significance of these is unknown...

Effect on HIV and CMV Viruses Replication

There are in vitro studies that suggest valproate stimulates the replication of the HIV and CMV viruses under certain experimental conditions. The clinical consequence, if any, is not known. Additionally, the relevance of these in vitro findings is uncertain for patients receiving maximally suppressive antiretroviral therapy. Nevertheless, these data should be borne in mind when interpreting the results from regular monitoring of the viral load in HIV infected patients receiving valproate or when following CMV infected patients clinically.

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