1 INDICATIONS AND USAGE
Divalproex sodium extended-release tablets, USP are an anti-epileptic drug 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; adjunctive therapy in patients with multiple seizure types that include absence seizures (
1.2
)
Prophylaxis of migraine headaches (
1.3
)
1.1 Mania
Divalproex sodium extended-release tablets, USP are valproates and are indicated for the treatment of acute manic or mixed episodes associated with bipolar disorder, 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, reduced need for sleep, flight of ideas, grandiosity, poor judgment, aggressiveness, and possible hostility. A mixed episode is characterized by the criteria for a manic episode in conjunction with those for a major depressive episode (depressed mood, loss of interest or pleasure in nearly all activities).
The efficacy of divalproex sodium extended-release tablets, USP are based in part on studies of 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
[see Clinical Studies (
14.1)]
.
The effectiveness of valproate 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 divalproex sodium extended-release tablets for extended periods should continually reevaluate the long-term risk-benefits of the drug for the individual patient.
1.2 Epilepsy
Divalproex sodium extended-release tablets, USP are indicated as monotherapy and adjunctive therapy in the treatment of adult patients and pediatric patients down to the age of 10 years with complex partial seizures that occur either in isolation or in association with other types of seizures. Divalproex sodium extended-release tablets, USP are also indicated for use as sole and adjunctive therapy in the treatment of simple and complex absence seizures in adults and children 10 years of age or older, and adjunctively in adults and children 10 years of age or older 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
Divalproex sodium extended-release tablets, USP are indicated for prophylaxis of migraine headaches. There is no evidence that divalproex sodium extended-release tablets, USP are 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)].
Divalproex sodium extended-release tablets, USP are contraindicated for prophylaxis of migraine headaches in women who are pregnant.