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Depakote Er Generic Name & Formulations
Legal Class
Rx
General Description
Divalproex sodium 250mg, 500mg; ext-rel tabs.
Pharmacological Class
Antiepileptic.
See Also
How Supplied
Tabs 125mg—100; Tabs 250mg, 500mg—100, 500; ER 250mg—100; ER 500mg—100, 500
Manufacturer
Mechanism of Action
Divalproex sodium dissociates to the valproate ion in the gastrointestinal tract. The mechanisms by which valproate exerts its therapeutic effects have not been established. It has been suggested that its activity in epilepsy is related to increased brain concentrations of gamma-aminobutyric acid (GABA).
Depakote Er Indications
Indications
Prophylaxis of migraine headaches.
Depakote Er Dosage and Administration
Adult
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
Use other forms.
Depakote Er Contraindications
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.
Depakote Er Boxed Warnings
Boxed Warning
Life-threatening adverse reactions (eg, hepatotoxicity, fetal risk, pancreatitis).
Depakote Er Warnings/Precautions
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.
Depakote Er Pharmacokinetics
Elimination
Renal. Half-life: 9–16 hours.
Depakote Er Interactions
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.
Depakote Er Adverse Reactions
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.
Depakote Er Clinical Trials
See Literature
Depakote Er Note
Not Applicable
Depakote Er Patient Counseling
See Literature
Depakote Er Generic Name & Formulations
Legal Class
Rx
General Description
Divalproex sodium 250mg, 500mg; ext-rel tabs.
Pharmacological Class
Antiepileptic.
See Also
How Supplied
Tabs 125mg—100; Tabs 250mg, 500mg—100, 500; ER 250mg—100; ER 500mg—100, 500
Manufacturer
Mechanism of Action
Divalproex sodium dissociates to the valproate ion in the gastrointestinal tract. The mechanisms by which valproate exerts its therapeutic effects have not been established. It has been suggested that its activity in epilepsy is related to increased brain concentrations of gamma-aminobutyric acid (GABA).
Depakote Er Indications
Indications
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.
Depakote Er Dosage and Administration
Adult
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
Not recommended.
Depakote Er Contraindications
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.
Depakote Er Boxed Warnings
Boxed Warning
Life-threatening adverse reactions (eg, hepatotoxicity, fetal risk, pancreatitis).
Depakote Er Warnings/Precautions
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.
Depakote Er Pharmacokinetics
Elimination
Renal. Half-life: 9–16 hours.
Depakote Er Interactions
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.
Depakote Er Adverse Reactions
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.
Depakote Er Clinical Trials
See Literature
Depakote Er Note
Not Applicable
Depakote Er Patient Counseling
See Literature
Depakote Er Generic Name & Formulations
Legal Class
Rx
General Description
Divalproex sodium 250mg, 500mg; ext-rel tabs.
Pharmacological Class
Antiepileptic.
See Also
How Supplied
Tabs 125mg—100; Tabs 250mg, 500mg—100, 500; Sprinkle caps—100; ER 250mg—100; ER 500mg—100, 500
Manufacturer
Mechanism of Action
Divalproex sodium dissociates to the valproate ion in the gastrointestinal tract. The mechanisms by which valproate exerts its therapeutic effects have not been established. It has been suggested that its activity in epilepsy is related to increased brain concentrations of gamma-aminobutyric acid (GABA).
Depakote Er Indications
Indications
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.
Depakote Er Dosage and Administration
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
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.
Depakote Er Boxed Warnings
Boxed Warning
Life-threatening adverse reactions (eg, hepatotoxicity, fetal risk, pancreatitis).
Depakote Er Warnings/Precautions
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.
Depakote Er Pharmacokinetics
Elimination
Renal. Half-life: 9–16 hours.
Depakote Er Interactions
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.
Depakote Er Adverse Reactions
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.
Depakote Er Clinical Trials
See Literature
Depakote Er Note
Not Applicable
Depakote Er Patient Counseling
See Literature
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