Generic Name and Formulations:
Divalproex sodium 250mg, 500mg; ext-rel tabs.

Company:
AbbVie
Indications for DEPAKOTE ER:
Prophylaxis of migraine headaches.

Adult:
Swallow whole. 500mg once daily for 1 week, then 1g once daily. Elderly: reduce initial dose and titrate slowly; monitor.

Children:
Use other forms.

Contraindications:
Hepatic disease or significant hepatic dysfunction. Known mitochondrial disorders caused by mutations in mitochondrial DNA polymerase γ (POLG). Suspected POLG-related disorder in children <2yrs of age. Urea cycle disorders. Migraine prophylaxis in pregnant women.

Warnings/Precautions:
Increased risk of hepatotoxicity in patients with congenital metabolic disorders, multiple AEDs, severe seizure disorders with mental retardation, organic brain disorders, esp. in children <2yrs of age. Increased risk of major congenital malformations (eg, spina bifida) and decreased IQ scores. Discontinue if hepatic dysfunction, pancreatitis, thrombocytopenia, hyperammonemia, hypothermia, or multi-organ hypersensitivity reactions occur. History of liver disease; monitor liver function and clinical symptoms prior to therapy and at frequent intervals (esp. for 1st 6 mos). Follow-up if symptoms of hyperammonemia occur. Suicidal tendencies (monitor). Depakote ER is not bioequivalent to delayed-release tabs on mg/mg basis. Avoid abrupt cessation. Monitor platelets, bleeding time (at baseline, before surgery, and in pregnancy); reeva luate periodically. May affect HIV or CMV viral load (in vitro). Monitor motor and cognitive functions routinely. Elderly (monitor fluid and nutritional intake, and for somnolence). Pregnancy (Cat.X): apprise females of childbearing potential of risks to fetus. Nursing mothers: not recommended.

Interactions:
Monitor levels of valproate, ethosuximide, other anticonvulsants, and whenever an enzyme inducer is added or withdrawn. Potentiates carbamazepine, diazepam, ethosuximide, lamotrigine, phenobarbital, phenytoin, tolbutamide, warfarin, zidovudine, amitriptyline, nortriptyline. Potentiated by aspirin, felbamate. Levels reduced by rifampin, phenytoin, carbamazepine, phenobarbital, carbapenem antibiotics. CNS depression with alcohol, other CNS depressants. Clonazepam may induce absence status in patients with history of absence seizures. Concomitant topiramate may cause hyperammonemic encephalopathy, hypothermia. May interfere with urine ketone and thyroid tests. Others: see full labeling.

See Also:
DEPAKOTE

Pharmacological Class:
Antiepileptic.

Adverse Reactions:
Abdominal pain, accidental injury, alopecia, ambylopia/blurred vision, amnesia, anorexia, asthenia, ataxia, back pain, bronchitis, constipation, depression, diarrhea, diplopia, dizziness, dyspepsia, dyspnea, ecchymosis, emotional lability, fever, flu syndrome, headache, increased appetite, infection, insomnia, nausea, nervousness, nystagmus, peripheral edema, pharyngitis, rash, rhinitis, somnolence, abnormal thinking, thrombocytopenia, tinnitus, tremor, vomiting, weight gain, weight loss; hepatotoxicity, acute pancreatitis, hyperammonemia, hypothermia.

How Supplied:
Tabs 125mg—100; Tabs 250mg, 500mg—100, 500; ER 250mg—100; ER 500mg—100, 500
Indications for DEPAKOTE ER:
Acute manic or mixed episodes in bipolar disorder.

Adult:
Take once daily. Swallow whole. Initially 25mg/kg per day, max 60mg/kg per day. Elderly: reduce initial dose and titrate slowly; monitor.

Children:
Not recommended.

Contraindications:
Hepatic disease or significant hepatic dysfunction. Known mitochondrial disorders caused by mutations in mitochondrial DNA polymerase γ (POLG). Suspected POLG-related disorder in children <2yrs of age. Urea cycle disorders.

Warnings/Precautions:
Increased risk of hepatotoxicity in patients with congenital metabolic disorders, multiple AEDs, severe seizure disorders with mental retardation, organic brain disorders, esp. in children <2yrs of age. Increased risk of major congenital malformations (eg, spina bifida) and decreased IQ scores. Discontinue if hepatic dysfunction, pancreatitis, thrombocytopenia, hyperammonemia, hypothermia, or multi-organ hypersensitivity reactions occur. History of liver disease; monitor liver function and clinical symptoms prior to therapy and at frequent intervals (esp. for 1st 6 mos). Follow-up if symptoms of hyperammonemia occur. Suicidal tendencies (monitor). Depakote ER is not bioequivalent to delayed-release tabs on mg/mg basis. Avoid abrupt cessation. Monitor platelets, bleeding time (at baseline, before surgery, and in pregnancy); reeva luate periodically. May affect HIV or CMV viral load (in vitro). Monitor motor and cognitive functions routinely. Elderly (monitor fluid and nutritional intake, and for somnolence). Pregnancy (Cat.D): apprise females of childbearing potential of risks to fetus; avoid, if treatment necessary, use effective contraception. Nursing mothers: not recommended.

Interactions:
Monitor levels of valproate, ethosuximide, other anticonvulsants, and whenever an enzyme inducer is added or withdrawn. Potentiates carbamazepine, diazepam, ethosuximide, lamotrigine, phenobarbital, phenytoin, tolbutamide, warfarin, zidovudine, amitriptyline, nortriptyline. Potentiated by aspirin, felbamate. Levels reduced by rifampin, phenytoin, carbamazepine, phenobarbital, carbapenem antibiotics. CNS depression with alcohol, other CNS depressants. Clonazepam may induce absence status in patients with history of absence seizures. Concomitant topiramate may cause hyperammonemic encephalopathy, hypothermia. May interfere with urine ketone and thyroid tests. Others: see full labeling.

See Also:
DEPAKOTE

Pharmacological Class:
Antiepileptic.

Adverse Reactions:
Abdominal pain, accidental injury, alopecia, ambylopia/blurred vision, amnesia, anorexia, asthenia, ataxia, back pain, bronchitis, constipation, depression, diarrhea, diplopia, dizziness, dyspepsia, dyspnea, ecchymosis, emotional lability, fever, flu syndrome, headache, increased appetite, infection, insomnia, nausea, nervousness, nystagmus, peripheral edema, pharyngitis, rash, rhinitis, somnolence, abnormal thinking, thrombocytopenia, tinnitus, tremor, vomiting, weight gain, weight loss; hepatotoxicity, acute pancreatitis, hyperammonemia, hypothermia.

How Supplied:
Tabs 125mg—100; Tabs 250mg, 500mg—100, 500; ER 250mg—100; ER 500mg—100, 500
Indications for DEPAKOTE ER:
Monotherapy or adjunct in complex partial seizures; simple or complex absence seizures. Adjunct in multiple seizure types.

Adults and Children:
Take once daily. Swallow whole. <10yrs: not recommended. ≥10yrs: Absence seizures: initially 15mg/kg per day. Complex partial: initially 10–15mg/kg per day. Both: may increase weekly if needed by 5–10mg/kg per day; usual max 60mg/kg per day. Converting from other forms: see full labeling. Elderly: reduce initial dose and titrate slowly; monitor.

Contraindications:
Hepatic disease or significant hepatic dysfunction. Known mitochondrial disorders caused by mutations in mitochondrial DNA polymerase γ (POLG). Suspected POLG-related disorder in children <2yrs of age. Urea cycle disorders.

Warnings/Precautions:
Increased risk of hepatotoxicity in patients with congenital metabolic disorders, multiple AEDs, severe seizure disorders with mental retardation, organic brain disorders, esp. in children <2yrs of age. Increased risk of major congenital malformations (eg, spina bifida) and decreased IQ scores. Discontinue if hepatic dysfunction, pancreatitis, thrombocytopenia, hyperammonemia, hypothermia, or multi-organ hypersensitivity reactions occur. History of liver disease; monitor liver function and clinical symptoms prior to therapy and at frequent intervals (esp. for 1st 6 mos). Follow-up if symptoms of hyperammonemia occur. Suicidal tendencies (monitor). Depakote ER is not bioequivalent to delayed-release tabs on mg/mg basis. Avoid abrupt cessation. Monitor platelets, bleeding time (at baseline, before surgery, and in pregnancy); reeva luate periodically. May affect HIV or CMV viral load (in vitro). Monitor motor and cognitive functions routinely. Elderly (monitor fluid and nutritional intake, and for somnolence). Pregnancy (Cat.D): apprise females of childbearing potential of risks to fetus; avoid, if treatment necessary, use effective contraception. Nursing mothers: not recommended.

Interactions:
Monitor levels of valproate, ethosuximide, other anticonvulsants, and whenever an enzyme inducer is added or withdrawn. Potentiates carbamazepine, diazepam, ethosuximide, lamotrigine, phenobarbital, phenytoin, tolbutamide, warfarin, zidovudine, amitriptyline, nortriptyline. Potentiated by aspirin, felbamate. Levels reduced by rifampin, phenytoin, carbamazepine, phenobarbital, carbapenem antibiotics. CNS depression with alcohol, other CNS depressants. Clonazepam may induce absence status in patients with history of absence seizures. Concomitant topiramate may cause hyperammonemic encephalopathy, hypothermia. May interfere with urine ketone and thyroid tests. Others: see full labeling.

See Also:
DEPAKOTE

DEPAKOTE SPRINKLE

Pharmacological Class:
Antiepileptic.

Adverse Reactions:
Abdominal pain, accidental injury, alopecia, ambylopia/blurred vision, amnesia, anorexia, asthenia, ataxia, back pain, bronchitis, constipation, depression, diarrhea, diplopia, dizziness, dyspepsia, dyspnea, ecchymosis, emotional lability, fever, flu syndrome, headache, increased appetite, infection, insomnia, nausea, nervousness, nystagmus, peripheral edema, pharyngitis, rash, rhinitis, somnolence, abnormal thinking, thrombocytopenia, tinnitus, tremor, vomiting, weight gain, weight loss; hepatotoxicity, acute pancreatitis, hyperammonemia, hypothermia.

How Supplied:
Tabs 125mg—100; Tabs 250mg, 500mg—100, 500; Sprinkle caps—100; ER 250mg—100; ER 500mg—100, 500