DEPAKOTE SPRINKLE Dosage & Rx Info

Depakote Sprinkle Generic Name & Formulations

Legal Class

General Description

Divalproex sodium 125mg; coated particles in caps.

Pharmacological Class

Antiepileptic.

How Supplied

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

Manufacturer

AbbVie

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 Sprinkle 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 Sprinkle Dosage and Administration

Adults and Children

May swallow caps whole or sprinkle contents on soft food. Complex partial: <10yrs: not recommended. ≥10yrs: initially 10–15mg/kg per day. Absence seizures: initially 15mg/kg per day. Both: may increase weekly by 5–10mg/kg per day; max 60mg/kg per day; give in divided doses if total daily dose >250mg. Elderly: reduce initial dose and titrate slowly; monitor. Concomitant rufinamide: initiate at a low dose and titrate; see full labeling.

Depakote Sprinkle 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 Sprinkle Boxed Warnings

Boxed Warning

Life-threatening adverse reactions (eg, hepatotoxicity, fetal risk, pancreatitis).

Depakote Sprinkle 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 1^st 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 Sprinkle Pharmacokinetics

Metabolism

Hepatic.

Elimination

Renal. Half-life: 9–16 hours.

Depakote Sprinkle 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 Sprinkle 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 Sprinkle Clinical Trials

See Literature

Depakote Sprinkle Note

Not Applicable

Depakote Sprinkle Patient Counseling