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Author: Admin | 2025-04-28
Administration is temporarily not feasibleIV dosing: Equivalent to oral dose and frequencyAdministration: 60-minute IV infusion (no more than 20 mg/min)Drug level monitoring and dosage adjustments may be necessaryPatients should be switched to the oral formulation as soon as clinically feasible, use of the IV formulation for periods longer than 14 days has not been studiedComments:A good correlation has not been established between daily dose, serum concentrations, and therapeutic effect, however, serum levels between 50 and 100 mcg/mL is therapeutic for most patients; some patients may be controlled with higher or lower serum concentrations.Optimal clinical response is usually achieved at daily doses below 60 mg/kg/day; if satisfactory clinical response has not been achieved, plasma levels should be measured.Uses:As monotherapy and adjunctive therapy in the treatment of complex partial seizures that occur either in isolation or in association with other types of seizures; as monotherapy and adjunctive therapy in the treatment of simple and complex absence seizures; and adjunctively in multiple seizure types which include absence seizures.Simple absence is defined as very brief clouding of the sensorium or loss of consciousness accompanied by certain generalized epileptic discharges without other detectable clinical signs; complex absence is the when other signs are also present.Renal Dose AdjustmentsUse caution; no adjustment recommended, but higher than expected free fractions may be expectedLiver Dose AdjustmentsHepatic disease or significant hepatic dysfunction: ContraindicatedDose AdjustmentsElderly Patients:Starting doses should be reduced and doses should be increased more slowly and with regular monitoring for fluid and nutritional intake, dehydration, somnolence, and other adverse reactions; ultimate therapeutic dose should be achieved based on tolerability and clinical responseConcomitant use of rufinamide:For patients stabilized on rufinamide prior to initiating valproate, begin valproate at a low dose, and titrate to a clinically effective doseTherapeutic drug monitoring:Epilepsy: Therapeutic range: 50 to 100 mcg/mL, although some may be controlled with lower or higher plasma concentrationsMonitoring for total concentrations may be misleading in patients with higher free concentrations; higher than expected free fractions occur in the elderly, in patients with hyperlipidemia, and in patients with hepatic and renal diseasesMonitoring of valproate and concomitant drug concentrations should be increased whenever enzyme inducing drugs are introduced or withdrawnThrombocytopenia: The probability of thrombocytopenia increases significantly at total valproate concentrations of 110 mcg/mL (females) or 135 mcg/mL (males) or moreDrug Withdrawal/Discontinuation:Abrupt discontinuation should be avoided, especially in patients for whom this drug is prescribed to prevent major seizures because of the strong possibility of precipitating status epilepticusPrecautionsUS BOXED WARNINGS: LIFE-THREATENING ADVERSE REACTIONS:Hepatotoxicity:General Population: Hepatic failure resulting in fatalities has occurred in patients taking this drug and its derivatives. These incidents usually have occurred during the first 6 months of treatment. Serious or fatal hepatotoxicity may be preceded by non-specific symptoms such as malaise, weakness, lethargy, facial edema, anorexia, and vomiting. In patients with epilepsy, a loss of seizure control may also occur. Patients should be monitored closely for appearance of these symptoms. Serum liver tests should be performed prior to therapy and at frequent intervals thereafter, especially during the first six monthsChildren: Children younger
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