From the FDA Drug Label
The maximum recommended dosage is 60 mg/kg/day. No recommendation regarding the safety of valproate for use at doses above 60 mg/kg/day can be made
The maximum dose of valproate is 60 mg/kg/day.
- The safety of valproate at doses above 60 mg/kg/day is not recommended due to the lack of information. 1
From the Research
The maximum dose of valproate is typically 60 mg/kg/day, with a usual maximum daily dose of 3,000 mg for adults, as supported by the most recent and highest quality study 2. When determining the maximum dose of valproate, it is essential to consider the patient's clinical response and serum drug levels, with therapeutic levels generally ranging from 50-125 μg/mL 2.
Key Considerations
- Treatment usually begins at a lower dose (10-15 mg/kg/day) and is gradually increased to minimize side effects 2.
- Valproate is commonly administered in divided doses (2-3 times daily), though extended-release formulations allow for once-daily dosing 2.
- Patients with hepatic impairment require lower doses, and regular monitoring of liver function, complete blood count, and drug levels is essential 2.
- Side effects include gastrointestinal disturbances, sedation, tremor, weight gain, hair loss, and rarely, serious hepatotoxicity or pancreatitis 2.
- Valproate carries significant teratogenic risks and should be avoided in women of childbearing potential when possible 2.
Administration and Monitoring
- The medication should be taken with food to reduce gastrointestinal side effects, and abrupt discontinuation should be avoided to prevent seizure exacerbation 2.
- Regular monitoring of liver function, complete blood count, and drug levels is crucial to minimize the risk of adverse effects 2.
- The most recent study 2 provides the strongest evidence for the maximum dose of valproate, and its findings should be prioritized in clinical decision-making.