Migraine and headache:
Indications for: DEPAKOTE ER
Prophylaxis of migraine headaches.
Adult Dosage:
Swallow whole. 500mg once daily for 1 week, then 1g once daily. Elderly: reduce initial dose and titrate slowly; monitor. Concomitant rufinamide: initiate at a low dose and titrate; see full labeling.
Children Dosage:
Use other forms.
DEPAKOTE ER 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 and women of childbearing potential not using effective contraception.
Boxed Warning:
Life-threatening adverse reactions (eg, hepatotoxicity, fetal risk, pancreatitis).
DEPAKOTE ER Warnings/Precautions:
Increased risk of hepatotoxicity in patients with congenital metabolic disorders, multiple AEDs, severe seizure disorders with mental retardation, organic brain disorders, mitochrondrial disorders, esp. in children <2yrs of age. Increased risk of major congenital malformations (eg, spina bifida), decreased IQ scores, and neurodevelopmental disorders. 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); reevaluate 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). Advise females of childbearing potential of risks to fetus. Nursing mothers: monitor infants.
See Also:
DEPAKOTE ER Classification:
Antiepileptic.
DEPAKOTE ER 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Monitor levels of valproate, ethosuximide, other anticonvulsants, and whenever an enzyme inducer is added or withdrawn.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, propofol, rufinamide. Potentiated by aspirin, felbamate. Efficacy reduced by carbamazepine, rifampin, phenytoin, phenobarbital, methotrexate, carbapenems, estrogen-containing hormonal contraceptives; monitor serum valproate concentrations. 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. Concomitant cannabidiol may increase risk of ALT/AST elevation. May interfere with urine ketone and thyroid tests. Others: see full labeling.
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, structural birth defects, acute pancreatitis, hyperammonemia, hypothermia.
Drug Elimination:
Renal. Half-life: 9–16 hours.
How Supplied:
Tabs 125mg—100; Tabs 250mg, 500mg—100, 500; ER 250mg—100; ER 500mg—100, 500
Mood disorders:
Indications for: DEPAKOTE ER
Acute manic or mixed episodes in bipolar disorder.
Limitations of Use:
Not for treating women with epilepsy or bipolar disorder during pregnancy or plan to become pregnant unless other alternatives failed to provide adequate control or are otherwise unacceptable.
Adult Dosage:
Take once daily. Swallow whole. Initially 25mg/kg per day, max 60mg/kg per day. Elderly: reduce initial dose and titrate slowly; monitor. Concomitant rufinamide: initiate at a low dose and titrate; see full labeling.
Children Dosage:
Not recommended.
DEPAKOTE ER 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.
Boxed Warning:
Life-threatening adverse reactions (eg, hepatotoxicity, fetal risk, pancreatitis).
DEPAKOTE ER Warnings/Precautions:
Increased risk of hepatotoxicity in patients with congenital metabolic disorders, multiple AEDs, severe seizure disorders with mental retardation, organic brain disorders, mitochondrial disorders, esp. in children <2yrs of age. Increased risk of major congenital malformations (eg, spina bifida), decreased IQ scores, and neurodevelopmental disorders. Discontinue if hepatic dysfunction, pancreatitis, thrombocytopenia, hyperammonemia, hypothermia, or DRESS/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 CBCs, coagulation tests (at baseline, before surgery, and in pregnancy); reevaluate 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: avoid. Advise females of childbearing potential of risks to fetus; if treatment needed, use effective contraception. Nursing mothers: monitor infants.
See Also:
DEPAKOTE ER Classification:
Antiepileptic.
DEPAKOTE ER 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, propofol, rufinamide. Potentiated by aspirin, felbamate. Efficacy reduced by carbamazepine, rifampin, phenytoin, phenobarbital, methotrexate, carbapenems, estrogen-containing hormonal contraceptives; monitor serum valproate concentrations. 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. Concomitant cannabidiol may increase risk of ALT/AST elevation. May interfere with urine ketone and thyroid tests. Others: see full labeling.
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, structural birth defects, acute pancreatitis, hyperammonemia, hypothermia.
Drug Elimination:
Renal. Half-life: 9–16 hours.
How Supplied:
Tabs 125mg—100; Tabs 250mg, 500mg—100, 500; ER 250mg—100; ER 500mg—100, 500
Seizure disorders:
Indications for: DEPAKOTE ER
Monotherapy or adjunct in complex partial seizures; simple or complex absence seizures. Adjunct in multiple seizure types.
Limitations of Use:
Not for treating women with epilepsy or bipolar disorder during pregnancy or plan to become pregnant unless other alternatives failed to provide adequate control or are otherwise unacceptable.
Adults and Children:
Take once daily. Swallow whole. <10yrs: not recommended. ≥10yrs: Complex partial: initially 10–15mg/kg per day. Absence seizures: initially 15mg/kg per day. Both: may increase weekly if needed by 5–10mg/kg per day; max 60mg/kg per day. Converting from other forms: see full labeling. Elderly: reduce initial dose and titrate slowly; monitor. Concomitant rufinamide: initiate at a low dose and titrate; see full labeling.
DEPAKOTE ER 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.
Boxed Warning:
Life-threatening adverse reactions (eg, hepatotoxicity, fetal risk, pancreatitis).
DEPAKOTE ER Warnings/Precautions:
Increased risk of hepatotoxicity in patients with congenital metabolic disorders, multiple AEDs, severe seizure disorders with mental retardation, organic brain disorders, mitochondrial disorders, esp. in children <2yrs of age. Increased risk of major congenital malformations (eg, spina bifida), decreased IQ scores, and neurodevelopmental disorders. Discontinue if hepatic dysfunction, pancreatitis, thrombocytopenia, hyperammonemia, hypothermia, or DRESS/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 CBCs, coagulation tests (at baseline, before surgery, and in pregnancy); reevaluate 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: avoid. Advise females of childbearing potential of risks to fetus; if treatment needed, use effective contraception. Nursing mothers: monitor infants.
See Also:
DEPAKOTE ER Classification:
Antiepileptic.
DEPAKOTE ER 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, propofol, rufinamide. Potentiated by aspirin, felbamate. Efficacy reduced by carbamazepine, rifampin, phenytoin, phenobarbital, methotrexate, carbapenems, estrogen-containing hormonal contraceptives; monitor serum valproate concentrations. 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. Concomitant cannabidiol may increase risk of ALT/AST elevation. May interfere with urine ketone and thyroid tests. Others: see full labeling.
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, structural birth defects, acute pancreatitis, hyperammonemia, hypothermia.
Drug Elimination:
Renal. Half-life: 9–16 hours.
How Supplied:
Tabs 125mg—100; Tabs 250mg, 500mg—100, 500; Sprinkle caps—100; ER 250mg—100; ER 500mg—100, 500
