DIVALPROEX SODIUM

Electrolyte / Mineral

Brand names: Divalproex Sodium

Oral

Mechanism of Action

12.1 Mechanism of Action Divalproex sodium dissociates to the valproate ion in the gastrointestinal tract. The mechanisms by which valproate exerts its therapeutic effects have not been established. It has been suggested that its activity in epilepsy is related to increased brain concentrations of gamma-aminobutyric acid (GABA).

Indications

1 INDICATIONS AND USAGE Divalproex sodium extended-release tablets are indicated for: • Acute treatment of manic or mixed episodes associated with bipolar disorder

with or without psychotic features ( 1.1 ) • Monotherapy and adjunctive therapy of complex partial seizures and simple and complex absence seizures

with or without psychotic features. A manic episode is a distinct period of abnormally and persistently elevated

expansive

or irritable mood. Typical symptoms of mania include pressure of speech

motor hyperactivity

Contraindications

• e.g.
• sodium valproate
• or valproic acid. Reactions have included multiorgan hypersensitivity
• serious dermatologic reactions
• and angioedema [see Warnings and Precautions (5.12

FDA Warnings

5 WARNINGS AND PRECAUTIONS • Birth defects, decreased IQ, and neurodevelopmental disorders following in utero exposure: Should not be used to treat women with epilepsy or bipolar disorder who are pregnant or who plan to become pregnant or to treat a woman of childbearing potential unless other medications have failed to provide adequate symptom control or are otherwise unacceptable ( 5
5 ) • Suicidal behavior or ideation: Antiepileptic drugs, including divalproex sodium extended-release tablets, increase the risk of suicidal thoughts or behavior ( 5
11 ) • Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan hypersensitivity reactions, serious dermatologic reactions, and angioedema: Discontinue divalproex sodium extended-release tablets unless an alternate etiology is established ( 5
1 Hepatotoxicity General Information on Hepatotoxicity Hepatic failure resulting in fatalities has occurred in patients receiving valproate

Known Side Effects

11 documented side effects by frequency

Drug Not Working

>10%

Weight Gain

1-10%

Nausea

1-10%

Fatigue

1-10%

Drowsiness

1-10%

Tremor

1-10%

Falls

1-10%

Anxiety

1-10%

Vomiting

1-10%

Headache

1-10%

Depression

1-10%

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Formulations

Dosage Forms

Tablet

Route

Oral