A stable coordination compound comprised of sodium valproate and valproic acid used to treat manic episodes associated with bipolar disorder, epilepsy, and migraine headaches.
Brand names: Depakote, Depakote ER, and Depakote Sprinkles.
Dosages expressed as valproic acid equivalents
Tablet, delayed-release (Depakote)
125mg 250mg 500mg Tablet, extended-release (Depakote ER)
250mg 500mg Capsule (Depakote Sprinkles)
Indicated for treatment of manic episodes associated with bipolar disorder
Epilepsy: Complex partial seizures: Indicated as monotherapy and adjunctive therapy for complex partial seizures that occur either in isolation or in association with other types of seizures
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
Adult: 10-15 mg/kg/day orally initially; may increase by 5-10 mg/kg/week to achieve optimal clinical response; not to exceed 60 mg/kg/day
Depakote: If daily dose greater than 250 mg, give as divided dose
10-15 mg/kg/day orally initially; may increase by 5-10 mg/kg/week to achieve optimal clinical response; not to exceed 60 mg/kg/day.
Children under 10 years: Safety and efficacy not established Migraine Prophylaxis
Indicated for prophylaxis of migraine headaches.
There is no evidence of use for acute treatment of migraine.
No adjustment necessary for renal impairment.
With liver impairment lower doses are required.
Low serum albumin levels may cause an increase in unbound drug.
The drug should be swallowed hole, is not chewed or crushed.
Capsules may be opened and sprinkled on spoonful of soft food immediately before administration
Common side effects include:
Weakness/lack of energy
Loss of appetite
Loss of control of bodily movements
Rapid, involuntary eye movements
Weight loss/weight changes
Runny or stuffy nose
Changes in menstrual periods
Unusual or unpleasant taste in mouth
Suicidal thoughts or behavior
Unusual changes in mood or behavior
Acute or subacute cognitive decline and behavioral change.
Side effects include:
Hair texture and colorchange
Toxic epidermal necrolysis
Elevated testosterone level
Nail and nailbed disorders
Absent, or absent viable sperm in semen.
Has no known severe interactions with other drugs.
Serious interactions of divalproex sodium include:
Divalproex sodium has mild-moderate interactions with many different drugs.
Hepatic failure resulting in fatalities has occurred
Children younger than 2 years are at increased risk for fatal hepatotoxicity
Should not be used in women of childbearing age unless the drug is essential to the management of the medical condition.
All non-pregnant women of childbearing potential should use effective birth control if taking this drug.
May cause neural tube defects, and increases risk for lower cognitive test scores compared with those exposed in utero to other antiseizure medications.
Women taking valproate should use effective contraception.
Life-threatening pancreatitis have been reported in children and adults
Urea cycle disorders
Migraine headache prevention in women who are pregnant or plan to become pregnant
Probability of thrombocytopenia increases significantly as total trough valproate plasma concentrations increase.
Hypothermia has been reported.
In utero exposure increases risk for poor cognitive outcomes and anatomical malformations, compared with 3 other common anti-epileptic drugs-carbamazepine, lamotrigine, phenytoin.
May produce false-positive urine ketone test and alter thyroid function tests.
Reversible cerebral and cerebellar atrophy have been reported.
May be associatedwith central nervous system (CNS) depression and impair physical or mental abilities.
Somnolence in the elderly can occur.
Should not be utilized in post-traumatic seizure prophylaxis in patients with acute head trauma as studies show increased mortality.
There is positive evidence of human fetal risk, so the drug should be used during pregnancy for seizures or manic episodes associated with bipolar disorder that are unresponsive to other treatments only in emergencies when no safer drug is available.
Has teratogenic side effects of causing neural tube defects as well as for a cognitive development in children exposed to valproate in utero.
Should not be used for migraine headache prevention as safer alternatives exist.
Children born to women who take the drug during pregnancy have an increased risk for lower cognitive test scores.
Can cause neural tube defects.
Is excreted in breast milk.