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Depakote ER (Divalproex Sodium) - Summary

 
 



BOXED WARNING

WARNING: LIFE THREATENING ADVERSE REACTIONS

Hepatotoxicity

Hepatic failure resulting in fatalities has occurred in patients receiving valproic acid and its derivatives. 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 ER 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.

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. Liver function tests should be performed prior to therapy and at frequent intervals thereafter, especially during the first six months [see Warnings and Precautions ].

Teratogenicity

Valproate can produce teratogenic effects such as neural tube defects (e.g., spina bifida). Accordingly, the use of Depakote ER in women of childbearing potential requires that the benefits of its use be weighed against the risk of injury to the fetus. This is especially important when the treatment of a spontaneously reversible condition not ordinarily associated with permanent injury or risk of death (e.g., migraine) is contemplated [see Warnings and Precautions ].

An information sheet describing the teratogenic potential of valproate is available for patients [see Patient Counseling Information ].

Pancreatitis

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 [see Warnings and Precautions ].

 

DEPAKOTE ER SUMMARY

Divalproex sodium is a stable co-ordination compound comprised of sodium valproate and valproic acid in a 1:1 molar relationship and formed during the partial neutralization of valproic acid with 0.5 equivalent of sodium hydroxide.

DEPAKOTE ER is indicated for prophylaxis of migraine headaches in adults. There is no evidence that DEPAKOTE ER is useful in the acute treatment of migraine headaches. Because valproic acid may be a hazard to the fetus, DEPAKOTE ER should be considered for women of childbearing potential only after this risk has been thoroughly discussed with the patient and weighed against the potential benefits of treatment (see WARNINGS — Usage In Pregnancy, PRECAUTIONS — Information for Patients).

DEPAKOTE ER is indicated as monotherapy and adjunctive therapy in the treatment of adults and children 10 years of age or older 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.

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.

SEE WARNINGS FOR STATEMENT REGARDING FATAL HEPATIC DYSFUNCTION.


See all Depakote ER indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Depakote ER (Divalproex)

Randomized, placebo-controlled trial of quetiapine XR and divalproex ER monotherapies in the treatment of the anxious bipolar patient. [2013]
are seldom the focus of bipolar treatment studies... CONCLUSIONS: Quetiapine XR in a dose range of 50-300 mg/day appears to reduce

Valproic acid, valproate and divalproex in the maintenance treatment of bipolar disorder. [2013]
CONCLUSIONS: Limited evidence supports the efficacy of valproate in the

Effects of divalproex on smoking cue reactivity and cessation outcomes among smokers achieving initial abstinence. [2012]
Divalproex, a GABA agonist, may be a useful agent in the treatment of tobacco dependence... These findings suggest that in-treatment cue reactivity assessment may proactively and dynamically inform ongoing treatment as well as provide a tool for screening potential medications for smoking cessation.

Co-morbid Disruptive Behavior Disorder and Aggression Predict Functional Outcomes and Differential Response to Risperidone Versus Divalproex in Pharmacotherapy for Pediatric Bipolar Disorder. [2011.12.02]
Abstract Objective: Co-morbid diagnoses, such as disruptive behavior disorders (DBDs) and high levels of aggression, are extremely common among youth with pediatric bipolar disorder (PBD) and may interfere with treatment response; however, they have rarely been examined as predictors of response to pharmacotherapy...

Aripiprazole plus divalproex for recently manic or mixed patients with bipolar I disorder: a 6-month, randomized, placebo-controlled, double-blind maintenance trial. [2011.12.02]
OBJECTIVES: The goal of this study was to investigate the safety and efficacy in preventing relapse of a mood episode in recently manic or mixed episode patients with bipolar I disorder stabilized with aripiprazole and divalproex combination... CONCLUSIONS: In this study, relapse of mood episode occurred fewer and later for aripiprazole with divalproex treatment than divalproex monotherapy, but the differences were not statistically significant. Copyright (c) 2011 John Wiley & Sons, Ltd. Copyright (c) 2011 John Wiley & Sons, Ltd.

more studies >>

Clinical Trials Related to Depakote ER (Divalproex)

Pediatric Switch Study for Children and Adolescent Patients With Epilepsy [Completed]
To assess the tolerability of switching from Depakote Sprinkle Capsules or Depakote tablets to Depakote ER tablets in the pediatric population.

Valproate in Late Life Schizophrenia [Completed]
The purpose of this research study is to analyze the effectiveness and tolerability of a medication, valproate ( Depakote and Depakote ER), in individuals age 50 years and older who have schizophrenia.

A Comparison Study of the Efficacy and Tolerability of Depakote ER and Depakote DR [Completed]
To compare the time to response, response rates, remission rates, and side effects in Bipolar Disorder inpatients treated with Depakote ER or Depakote DR for acute mania or mixed mania.

Effectiveness of Divalproex Sodium (Depakote) in Treating Disruptive Behavior Disorder and Explosive Tempers in Adolescents and Adults [Recruiting]

An Open Label, Double Blind Study Using Consecutive Intravenous Depacon With Oral Depakote ER for the Treatment of Cluster Headaches. [Completed]
The purpose of this study is to collect and evaluate information on the use of Depakote Extended Release (ER) and Depacon Intravenous (IV) in patients with cluster headaches. Patients who are currently in a cluster cycle will be treated with 2 consecutive days of IV Depacon followed by oral Depakote ER. Patients will receive a total of 1,000mg of Depacon and 1,000mg of Depakote ER each day. Patients may have a 3rd day of IV Depacon followed by oral Depakote ER if the primary investigator believes it to be beneficial. The patient is then sent home on oral Depakote ER. The dose of Depakote ER can range from 500mg to 2,000mg this dose is to be determined by the primary investigator. The patient will continue the oral Depakote ER until the end of their cluster cycle or for a maximum of 6 weeks, which ever comes first.

more trials >>

Reports of Suspected Depakote ER (Divalproex) Side Effects

Convulsion (19)Tremor (15)Alopecia (12)Drug Ineffective (10)Dizziness (10)Nausea (10)Weight Increased (9)Vomiting (9)Weight Decreased (8)Headache (8)more >>


Page last updated: 2014-11-30

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