Depakote Delayed-Release Tablets are indicated for treatment of manic episodes associated with bipolar disorder. Depakote ER is indicated for acute treatment of manic or mixed episodes associated with bipolar disorder, with or without psychotic features
Use these resources to provide financial, management, and educational support to your patients.
The Depakote Savings Card is designed to save your eligible patients up to $100/month for branded Depakote. Nearly 7 out of 10 Depakote patients could pay the same or less than the generic with the Depakote Savings Card.1
This easy-to-use tool helps track patients’ treatment progress and provides you with actionable data to make better informed decisions and develop stronger communication with your patients.
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Support and advocacy groups can help your patients connect with other patients and families. Many organizations will also provide your patients with research, resources, and services.
Depression and Bipolar Support Alliance (DBSA)
National Institutes of Health (NIH)
National Institute of Mental Health (NIMH)
U.S. Food and Drug Administration (FDA)
National Alliance on Mental Illness (NAMI)
Available to patients with commercial prescription insurance coverage for Depakote who meet eligibility criteria. Copay assistance program is not available to patients receiving prescription reimbursement under any federal, state, or government-funded insurance programs (for example, Medicare [including Part D], Medicare Advantage, Medigap, Medicaid, TRICARE, Department of Defense, or Veterans Affairs programs) or where prohibited by law or by the patient’s health insurance provider. If at any time a patient begins receiving prescription drug coverage under any such federal, state, or government-funded healthcare program, patient will no longer be able to use the Depakote Savings Card and patient must call OPUS Health at 800.364.4767 to stop participation. Patients residing in or receiving treatment in certain states may not be eligible. Patients may not seek reimbursement for value received from the Depakote Savings Card from any third-party payers. Offer subject to change or discontinuance without notice. Restrictions, including monthly maximums, may apply. This is not health insurance. Please see full Terms and Conditions.
DEPAKOTE® ER (divalproex sodium) extended-release tablets, for oral use, is a valproate and is indicated for the treatment of acute manic or mixed episodes associated with bipolar disorder, with or without psychotic features.
DEPAKOTE® (divalproex sodium) delayed-release tablets, for oral use, 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. 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 DEPAKOTE ER is based in part on studies of DEPAKOTE 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 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 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 DEPAKOTE or DEPAKOTE ER for extended periods should continually reevaluate the long-term risk-benefits of the drug for the individual patient.
DEPAKOTE ER is 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. DEPAKOTE ER is 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.
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.
DEPAKOTE and DEPAKOTE ER are indicated for prophylaxis of migraine headaches. There is no evidence that DEPAKOTE ER or DEPAKOTE is useful in the acute treatment of migraine headaches.
Because of the risk to the fetus of decreased IQ, neurodevelopmental disorders, neural tube defects, and other major congenital malformations, which may occur very early in pregnancy, valproate should not be used to treat women with epilepsy or bipolar disorder who are pregnant or who plan to become pregnant unless other medications have failed to provide adequate symptom control or are otherwise unacceptable. Valproate should not be administered to a woman of childbearing potential unless other medications have failed to provide adequate symptom control or are otherwise unacceptable.
For prophylaxis of migraine headaches, DEPAKOTE and DEPAKOTE ER are contraindicated in women who are pregnant and in women of childbearing potential who are not using effective contraception.
Warning: Life-Threatening Adverse Reactions
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.
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 DEPAKOTE (divalproex sodium) delayed-release tablets, for oral use, or DEPAKOTE ER (divalproex sodium) extended-release tablets, for oral use, is 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). DEPAKOTE and DEPAKOTE ER are contraindicated in patients known to have mitochondrial disorders caused by POLG mutations and in children under two years of age who are clinically suspected of having a mitochondrial disorder. In patients over two years of age who are clinically suspected of having a hereditary mitochondrial disease, DEPAKOTE and DEPAKOTE ER should only be used after other anticonvulsants have failed. This older group of patients should be closely monitored during treatment with DEPAKOTE or DEPAKOTE ER for the development of acute liver injury, with regular clinical assessments and serum liver testing. POLG mutation screening should be performed in accordance with current clinical practice.
Valproate can cause major congenital malformations, particularly neural tube defects (e.g., spina bifida). In addition, valproate can cause decreased IQ scores and neurodevelopmental disorders following in utero exposure.
Valproate is therefore contraindicated for prophylaxis of migraine headaches in pregnant women and in women of childbearing potential who are not using effective contraception [see Contraindications (4)]. Valproate should not be used to treat women with epilepsy or bipolar disorder who are pregnant or who plan to become pregnant unless other medications have failed to provide adequate symptom control or are otherwise unacceptable.
Valproate should not be administered to a woman of childbearing potential unless other medications have failed to provide adequate symptom control or are otherwise unacceptable. In such situations, effective contraception should be used [see Warnings and Precautions (5.2, 5.3, 5.4)].
A Medication Guide describing the risks of valproate is available for patients [see Patient Counseling Information (17)].
Cases of life-threatening pancreatitis have been reported in both children and adults receiving valproate. Some of the cases have been described as hemorrhagic with a rapid progression from initial symptoms to death. Cases have been reported shortly after initial use as well as after several years of use. Patients and guardians should be warned that abdominal pain, nausea, vomiting, and/or anorexia can be symptoms of pancreatitis that require prompt medical evaluation. If pancreatitis is diagnosed, valproate should ordinarily be discontinued. Alternative treatment for the underlying medical condition should be initiated as clinically indicated.
Keep DEPAKOTE and all other medications where children cannot reach them.
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Warning: Life-Threatening Adverse Reactions
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