DIVALPROEX SODIUM
Divalproex sodium extended-release tablets are a valproate medication indicated for the treatment of acute manic or mixed episodes associated with bipolar disorder. The drug is also utilized as both monotherapy and adjunctive therapy for various seizure types, including complex partial seizures and simple or complex absence seizures. Additionally, it is approved for the prophylaxis of migraine headaches. Healthcare providers are advised to continually reevaluate the long-term risks and benefits when using this medication for extended periods in the treatment of mania.
How DIVALPROEX SODIUM Works
Divalproex sodium functions by dissociating into the valproate ion within the gastrointestinal tract. While the exact therapeutic mechanisms have not been definitively established, the drug's activity in treating epilepsy is believed to be related to its effect on brain chemistry. Specifically, it is suggested that valproate works by increasing the concentrations of gamma-aminobutyric acid (GABA), which is an inhibitory neurotransmitter in the brain.
Details
- Status
- Prescription
- First Approved
- 2008-07-29
- Routes
- ORAL
- Dosage Forms
- TABLET, DELAYED RELEASE, CAPSULE, DELAYED REL PELLETS, TABLET, EXTENDED RELEASE
Companies
DIVALPROEX SODIUM Approval History
What DIVALPROEX SODIUM Treats
5 indicationsDIVALPROEX SODIUM is approved for 5 conditions since its original approval in 2008. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Acute manic or mixed episodes associated with bipolar disorder
- Complex partial seizures
- Simple and complex absence seizures
- Multiple seizure types that include absence seizures
- Prophylaxis of migraine headaches
DIVALPROEX SODIUM Boxed Warning
LIFE THREATENING ADVERSE REACTIONS Hepatotoxicity General Population: Hepatic failure resulting in fatalities has occurred in patients receiving valproate and its derivatives. These incidents usually have occurred during the first six months of treatment. Serious or fatal hepatotoxicity may be preceded by non-specific symptoms such as malaise, weakness, lethargy, facial edema, anorexia, and vomiting. In patients with epilepsy, a loss of seizure control may also occur. Patients should be monitore...
WARNING: LIFE THREATENING ADVERSE REACTIONS Hepatotoxicity General Population: Hepatic failure resulting in fatalities has occurred in patients receiving valproate and its derivatives. These incidents usually have occurred during the first six months of treatment. Serious or fatal hepatotoxicity may be preceded by non-specific symptoms such as malaise, weakness, lethargy, facial edema, anorexia, and vomiting. In patients with epilepsy, a loss of seizure control may also occur. Patients should be monitored closely for appearance of these symptoms. Serum liver tests should be performed prior to therapy and at frequent intervals thereafter, especially during the first six months [see Warnings and Precautions (5.1) ] . Children under the age of two years are at a considerably increased risk of developing fatal hepatotoxicity, especially those on multiple anticonvulsants, those with congenital metabolic disorders, those with severe seizure disorders accompanied by mental retardation, and those with organic brain disease. When divalproex sodium extended-release tablets are used in this patient group, it should be used with extreme caution and as a sole agent. The benefits of therapy should be weighed against the risks. The incidence of fatal hepatotoxicity decreases considerably in progressively older patient groups. Patients with Mitochondrial Disease: There is an increased risk of valproate-induced acute liver failure and resultant deaths in patients with hereditary neurometabolic syndromes caused by DNA mutations of the mitochondrial DNA Polymerase γ (POLG) gene (e.g., Alpers Huttenlocher Syndrome). Divalproex sodium extended-release tablets are contraindicated in patients known to have mitochondrial disorders caused by POLG mutations and children under two years of age who are clinically suspected of having a mitochondrial disorder [see Contraindications (4) ] . In patients over two years of age who are clinically suspected of having a hereditary mitochondrial disease
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Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
DIVALPROEX SODIUM FDA Label Details
ProIndications & Usage
FDA Label (PDF)Divalproex sodium extended-release tablets are indicated for: • Acute treatment of manic or mixed episodes associated with bipolar disorder, with or without psychotic features • Monotherapy and adjunctive therapy of complex partial seizures and simple and complex absence seizures; adjunctive therapy in patients with multiple seizure types that include absence seizures • Prophylaxis of migraine headaches 1.1 Mania Divalproex sodium extended-release tablets are a valproate and are indicated for the treatment of acute manic or mixed episodes associated with bipolar disorder, with or without psych...
WARNING: LIFE THREATENING ADVERSE REACTIONS Hepatotoxicity General Population: Hepatic failure resulting in fatalities has occurred in patients receiving valproate and its derivatives. These incidents usually have occurred during the first six months of treatment. Serious or fatal hepatotoxicity may...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.