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Valproic Acid Syrup Generic Name & Formulations
Legal Class
Rx
General Description
Valproic acid (as sodium salt) 250mg/5mL; oral soln.
Pharmacological Class
Carboxylic acid.
See Also
How Supplied
Contact supplier.
Manufacturer
Valproic Acid Syrup 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.
Valproic Acid Syrup Dosage and Administration
Adults and Children
Swallow caps whole. Partial seizures: <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.
Valproic Acid Syrup 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.
Valproic Acid Syrup Boxed Warnings
Boxed Warning
Life-threatening adverse reactions (eg, hepatotoxicity, fetal risk, pancreatitis).
Valproic Acid Syrup 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, or DRESS/multi-organ hypersensitivity reactions occur. Consider discontinuing if hypothermia develops. History of liver disease; monitor liver function and clinical symptoms prior to therapy and at frequent intervals (esp. for 1st 6mos). 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). 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.
Valproic Acid Syrup Pharmacokinetics
See Literature
Valproic Acid Syrup Interactions
Interactions
Monitor levels of valproate, ethosuximide, other anticonvulsants, and when 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 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. Separate dosing of cholestyramine by 3hrs. May interfere with urine ketone and thyroid tests. Others: see full labeling.
Valproic Acid Syrup 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, increased appetite, infection, insomnia, nausea, nervousness, nystagmus, peripheral edema, pharyngitis, rhinitis, somnolence, abnormal thinking, thrombocytopenia, tinnitus, tremor, vomiting, weight gain, weight loss; hepatotoxicity, structural birth defects, pancreatitis, hyperammonemia, hypothermia.
Valproic Acid Syrup Clinical Trials
See Literature
Valproic Acid Syrup Note
Notes
Formerly known under the brand name Depakene.
Valproic Acid Syrup Patient Counseling
See Literature
