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Valproate Sodium Generic Name & Formulations
Legal Class
Rx
General Description
Valproate sodium 100mg/mL; soln for IV infusion after dilution; preservative-free.
Pharmacological Class
Antiepileptic.
How Supplied
Contact supplier
Manufacturer
Valproate Sodium Indications
Indications
Temporary alternative to oral valproate in patients with complex partial seizures, simple and complex absence seizures, and multiple seizure types that include absence seizures.
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.
Valproate Sodium Dosage and Administration
Adults and Children
Give by IV infusion over 60mins (max 20mg/min) preferably at 6-hour intervals (doses up to 15mg/kg over 5–10mins have been used: see full labeling). <2yrs: not studied (see full labeling). Partial seizures: ≥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. Switch to oral valproate as soon as possible. Replacement therapy: switch to equivalent total daily dose of oral valproate and give at the same dosing interval; titrate according to plasma valproate levels. Elderly: reduce initial dose and titrate slowly; monitor. Concomitant rufinamide: initiate at a low dose and titrate; see full labeling.
Valproate Sodium 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.
Valproate Sodium Boxed Warnings
Boxed Warning
Life-threatening adverse reactions (eg, hepatotoxicity, fetal risk, pancreatitis).
Valproate Sodium 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 months). Avoid abrupt cessation. Evaluate for urea cycle disorders. May affect viral load in HIV or CMV infection. Monitor motor and cognitive functions routinely. Monitor CBCs, coagulation tests (esp. if used in pregnancy). Suicidal tendencies (monitor). Prophylaxis of post-traumatic seizure: not recommended. Elderly (monitor fluid and nutritional intake, and for dehydration, somnolence, tremor, other adverse reactions). Pregnancy: avoid. Advise female patients of reproductive potential of risks to fetus; if treatment needed, use effective contraception. Nursing mothers: monitor infants.
Valproate Sodium Pharmacokinetics
See Literature
Valproate Sodium Interactions
Interactions
Monitor levels of valproate, ethosuximide, other anticonvulsants, and when an enzyme inducer is added or withdrawn. Potentiates carbamazepine, diazepam, lamotrigine, phenobarbital, phenytoin, tolbutamide, warfarin, zidovudine, amitriptyline, nortriptyline, propofol, rufinamide. Potentiated by aspirin, felbamate. Efficacy reduced by rifampin, phenytoin, carbamazepine, phenobarbital, carbapenems, estrogen-containing hormonal contraceptives; monitor serum valproate concentrations. CNS depression with alcohol, other CNS depressants. Clonazepam may induce absence status in patients with absence seizures. Concomitant topiramate may cause hyperammonemic encephalopathy, hypothermia. May interfere with urine ketone and thyroid tests. Others: see full labeling.
Valproate Sodium Adverse Reactions
Adverse Reactions
Abdominal pain, alopecia, amblyopia/blurred vision, amnesia, anorexia, asthenia, ataxia, bronchitis, constipation, depression, diarrhea, diplopia, dizziness, dyspepsia, dyspnea, ecchymosis, emotional lability, fever, flu syndrome, headache, infection, insomnia, nausea, nervousness, nystagmus, peripheral edema, pharyngitis, rhinitis, somnolence, abnormal thinking, thrombocytopenia, tinnitus, tremor, vomiting, weight gain, weight loss; hepatotoxicity, structural birth defects, acute pancreatitis, hyperammonemia, hypothermia; rare: Fanconi's syndrome in children, Stevens-Johnson syndrome.
Valproate Sodium Clinical Trials
See Literature
Valproate Sodium Note
Notes
Formerly known under the brand name Depacon.
Valproate Sodium Patient Counseling
See Literature
