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Valproic Acid Syrup
Valproic Acid Syrup Generic Name & Formulations General DescriptionValproic acid (as sodium salt) 250mg/5mL; oral soln.
Pharmacological ClassCarboxylic acid.
How SuppliedContact supplier.
Mechanism of ActionValproic acid dissociates to the valproate ion in the GI 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).
Valproic Acid Syrup Indications IndicationsMonotherapy or adjunct in complex partial seizures; simple or complex absence seizures. Adjunct in multiple seizure types.
Limitations of UseNot 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 ChildrenSwallow 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 ContraindicationsHepatic 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 WarningLife-threatening adverse reactions (eg, hepatotoxicity, fetal risk, pancreatitis).
Valproic Acid Syrup Warnings/Precautions Warnings/PrecautionsIncreased 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 EliminationHalf-life: 9–16 hours.
Valproic Acid Syrup Interactions InteractionsMonitor 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 ReactionsAbdominal 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 TrialsSee Literature
Valproic Acid Syrup Note NotesFormerly known under the brand name Depakene.
Valproic Acid Syrup Patient CounselingSee Literature
Valproic Acid
Valproic Acid Generic Name & Formulations General DescriptionValproic acid 250mg; caps.
Pharmacological ClassCarboxylic acid.
How SuppliedContact supplier.
Mechanism of ActionValproic acid dissociates to the valproate ion in the GI 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).
Valproic Acid Indications IndicationsMonotherapy or adjunct in complex partial seizures; simple or complex absence seizures. Adjunct in multiple seizure types.
Limitations of UseNot 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 Dosage and Administration Adults and ChildrenSwallow 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 Contraindications ContraindicationsHepatic 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 Boxed Warnings Boxed WarningLife-threatening adverse reactions (eg, hepatotoxicity, fetal risk, pancreatitis).
Valproic Acid Warnings/Precautions Warnings/PrecautionsIncreased 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 Pharmacokinetics EliminationHalf-life: 9–16 hours.
Valproic Acid Interactions InteractionsMonitor 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 Adverse Reactions Adverse ReactionsAbdominal 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 Clinical TrialsSee Literature
Valproic Acid Note NotesFormerly known under the brand name Depakene.
Valproic Acid Patient CounselingSee Literature
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