What is the age limit for Valproate (Depakine)?

From the Guidelines

Depakine (sodium valproate) does not have a specific age limit, but its use in children under 12 years old for bipolar disorder is not FDA-approved, and it should be used with caution in this age group. When considering the use of Depakine in pediatric patients, it's essential to weigh the potential benefits against the risks, particularly in younger children. According to the study by 1, lithium is the only agent with FDA approval for bipolar disorder in youths (age 12 years and older), although other mood stabilizers and antipsychotic agents are commonly used in clinical settings. Some key points to consider when prescribing Depakine to pediatric patients include:

• The lack of FDA approval for bipolar disorder in children under 12 years old
• The need for careful monitoring of side effects, such as liver function and platelet count
• The potential for Depakine to be effective in reducing symptoms of mania and mixed episodes, as seen in open-label trials and retrospective chart reviews
• The importance of individualizing the dosage based on the patient's weight, age, condition being treated, and response to therapy. It's crucial to consult the latest clinical guidelines and consider the individual patient's needs and medical history when making treatment decisions. In clinical practice, Depakine may be prescribed to patients of all ages, but it's essential to be aware of the potential risks and benefits, particularly in pediatric patients. The medication's mechanism of action, increasing levels of gamma-aminobutyric acid (GABA) in the brain, can help reduce excessive electrical activity that can cause seizures or mood instability, but this must be balanced against the potential risks, such as birth defects and developmental disorders in children exposed during pregnancy. Ultimately, the decision to prescribe Depakine to a pediatric patient should be made on a case-by-case basis, taking into account the latest evidence and clinical guidelines, as well as the individual patient's needs and medical history.

From the FDA Drug Label

Valproic acid is indicated as monotherapy and adjunctive therapy in complex partial seizures in adults and pediatric patients down to the age of 10 years, and in simple and complex absence seizures. For adults and children 10 years of age or older.

The age limit for DEPAKINE (valproate) is 10 years of age or older for complex partial seizures and simple and complex absence seizures 2.

• The drug is indicated for pediatric patients down to the age of 10 years.
• No information is provided for children under 10 years of age.

From the Research

DEPAKINE Age Limit

• The provided studies do not explicitly mention a specific age limit for the use of DEPAKINE (valproate) 3, 4, 5, 6, 7.
• However, one study mentions the use of depakine in children and adolescents with epilepsy, with ages ranging from 7 months to 19 years, indicating its safety and efficacy in this age group 6.
• Another study discusses the use of valproate in patients with bipolar disorder, but does not specify an age limit 3, 4, 7.
• A more recent study compares the risk of adverse cardiovascular events associated with antiseizure medications, including valproate, in patients older than 18 years, but does not provide information on an age limit for DEPAKINE 5.

Key Findings

• DEPAKINE has been found to be effective in the treatment of epilepsy in children and adolescents 6.
• Valproate has been shown to be effective in the treatment of acute mania and bipolar disorder, but its use may be associated with a higher risk of adverse cardiovascular events compared to other anticonvulsants 3, 4, 5, 7.