DEPAKOTE ER (divalproex sodium extended-release tablets) is indicated for the treatment of acute manic or mixed episodes associated with bipolar disorder, with or without psychotic features.

The efficacy of DEPAKOTE ER is based in part on studies of DEPAKOTE (divalproex sodium delayed release tablets) in this indication, and was confirmed in a 3-week trial with patients meeting DSM-IV TR criteria for bipolar I disorder, manic or mixed type, who were hospitalized for acute mania.

The effectiveness of DEPAKOTE ER for long-term use in mania, i.e., more than 3 weeks, has not been systematically evaluated in controlled clinical trials. Therefore, physicians who elect to use DEPAKOTE ER for extended periods should continually reevaluate the long-term risk and benefits of the drug for the individual patient.

DEPAKOTE (divalproex sodium delayed-release tablets) 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.

The safety and effectiveness of DEPAKOTE for long-term use in Mania, i.e., more than 3 weeks, has not been systematically evaluated in controlled clinical trials. Therefore, physicians who elect to use DEPAKOTE for extended periods should continually reevaluate the long-term usefulness of the drug for the individual patient.

The Established Family of DEPAKOTE Formulations: Coverage of DEPAKOTE ER Extends Beyond Mania ^1,2,3,4

Indications/ DEPAKOTE Formulation	DEPAKOTE ER® (Divalproex Sodium Extended-Release Tablets)	DEPAKOTE® (Divalproex Sodium Delayed-Release Tablets)	DEPACON® (Valproate Sodium Injection) (When Oral Administration Not Feasible)	DEPAKOTE® Sprinkle Capsules (Divalproex Sodium Coated Particles in Capsules)
Monotherapy for complex partial seizures (in isolation or in association with other seizure types) (adults or children >10 years)
Adjunctive therapy for complex partial seizures (in isolation or in association with other seizure types) (adults or children >10 years)
Monotherapy for simple and complex absence seizures(adults or children >10 years)
Adjunctive therapy for simple and complex absence seizures (adults or children >10 years)
Adjunctive therapy for patients with multiple seizure types that include absence seizures (adults or children >10 years)
Prophylaxis of migraine headaches (adults only)
Treatment of manic episodes associated with bipolar disorder (adults only)
Treatment of acute manic or mixed episodes associated with bipolar disorder (adults only)

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DEPAKOTE® ER Full Prescribing Information	DEPAKOTE® Full Prescribing Information
DEPACON® Full Prescribing Information	DEPAKOTE® Sprinkle Capsules Full Prescribing Information