Divalproex sodium indications and usage

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Divalproex sodium
DEPAKOTE® FDA Package Insert
Indications and Usage
Dosage and Administration
Dosage Forms and Strengths
Contraindications
Warnings and Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Overdosage
Description
Clinical Pharmacology
Nonclinical Toxicology
Clinical Studies
How Supplied/Storage and Handling
Patient Counseling Information
Labels and Packages
Clinical Trials on Divalproex sodium
ClinicalTrials.gov

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]

Indications And Usage

1.1 Mania

Depakote (divalproex sodium) is a valproate and is indicated for the treatment of the manic episodes associated with bipolar disorder. 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, reduced need for sleep, flight of ideas, grandiosity, poor judgment, aggressiveness, and possible hostility.

The efficacy of Depakote was established in 3-week trials with patients meeting DSM-III-R criteria for bipolar disorder who were hospitalized for acute mania [see Clinical Studies (14.1)].

The safety and effectiveness of Depakote for long-term use in mania, i.e., more than 3 weeks, has not been demonstrated in controlled clinical trials. Therefore, healthcare providers who elect to use Depakote for extended periods should continually reevaluate the long-term usefulness of the drug for the individual patient.

1.2 Epilepsy

Depakote is indicated as monotherapy and adjunctive therapy in the treatment of patients with complex partial seizures that occur either in isolation or in association with other types of seizures. Depakote is also indicated for use as sole and adjunctive therapy in the treatment of simple and complex absence seizures, and adjunctively in patients with multiple seizure types that include absence seizures.

Simple absence is defined as very brief clouding of the sensorium or loss of consciousness accompanied by certain generalized epileptic discharges without other detectable clinical signs. Complex absence is the term used when other signs are also present.

1.3 Migraine

Depakote is indicated for prophylaxis of migraine headaches. There is no evidence that Depakote is useful in the acute treatment of migraine headaches.

1.4 Important Limitations

Because of the risk to the fetus of decreased IQ, neural tube defects, and other major congenital malformations, which may occur very early in pregnancy, valproate should not be administered to a woman of childbearing potential unless the drug is essential to the management of her medical condition [see Warnings and Precautions (5.2, 5.3, 5.4), Use in Specific Populations (8.1), and Patient Counseling Information(17.3)].

Depakote is contraindicated for prophylaxis of migraine headaches in women who are pregnant.[1]

References

  1. "DEPAKOTE (DIVALPROEX SODIUM) TABLET, DELAYED RELEASE [ABBVIE INC.]".

Adapted from the FDA Package Insert.