Dosing information for epilepsy
STAVZOR is indicated for monotherapy and adjunctive therapy of complex partial seizures and simple and complex absence seizures.
STAVZOR is also indicated for adjunctive therapy in patients with multiple seizure types that include absence seizures.
Dosage forms and strengths
STAVZOR is available in 125 mg, 250 mg and 500 mg dosage strengths, making it convenient to initiate and titrate.
Dosage and administration
Target serum levels for epilepsy dosing are 50-100 µg/mL.
Adjunctive therapy, initial monotherapy and conversion to monotherapy dosing
Initial dose: 10 to 15 mg/kg/day
Titration: Increase by 5 to 10 mg/kg/week to achieve optimal clinical response
Optimal clinical response: Optimal clinical response is usually achieved at daily doses below 27.2 mg/lb/day (60 mg/kg/day).
- If satisfactory clinical response has not been achieved, plasma levels should be measured to determine whether or not they are in the usually accepted therapeutic range (50 to 100 µg/mL).
Total daily doses: Total daily doses that exceed 250 mg should be given in divided doses.
Conversion to monotherapy: Please see full STAVZOR Prescribing Information
Administration
Complex Partial Seizures: Start at 10 to 15 mg/kg/day, increasing at one week intervals by 5 to 10 mg/kg/day to achieve optimal clinical response. If response is not satisfactory, check valproate plasma level.
Absence Seizures: Start at 15 mg/kg/day, increasing at one week intervals by 5 to 10 mg/kg/day until seizure control or limiting side effects.
Converting from other formulations of Depakene®
Initiate STAVZOR, as replacement therapy, at the same daily dose and dosing schedule as the patient's previous formulation.
After the patient is stabilized on STAVZOR, a dosing schedule of 2 or 3 times a day may be elected in selected patients on Depakene.
Depakene (divalproex sodium) is a registered trademark of Abbott Laboratories, North Chicago, IL.
Important Safety Information You Should Know about STAVZOR
Liver problems Your doctor should check your liver function before you start taking STAVZOR and at frequent intervals while you're on therapy. If you feel generally ill (malaise), weak, and tired, if your face is swollen and you lose your appetite, and start vomiting, call your doctor immediately.
Pregnancy: Birth defectsWomen who can become pregnant need to know that valproic acid has been associated with birth defects, in particular with spina bifida, a condition in which the baby's spinal canal fails to close. If you are planning to become pregnant, you should discuss the risks of birth defects, along with other possible treatment options, with your doctor. If you do become pregnant while taking STAVZOR, call your doctor immediately.
Read more important safety information about pregnancy.
PancreatitisSome people taking valproate have experienced a serious, life-threatening illness called pancreatitis (inflamed pancreas). If you experience stomach pain, nausea, vomiting, and/or loss of appetite, call your doctor immediately.
Common side effects reported in studies with valproate were nausea, drowsiness, vomiting, and dizziness. These are not all the side effects that may occur. You will find a complete list of side effects in the full Prescribing Information.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
Recent Information about Antiepileptic Medications including STAVZOR® (valproic acid) Delayed Release Capsules for any use
For Patients and Caregivers
All antiepileptic medicines, used for any condition, may increase suicidal thoughts or actions in some patients. Pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. Keep all follow-up visits with the healthcare provider as scheduled. Call the healthcare provider between visits as needed, especially if you have concerns about symptoms.
Watch for and call the healthcare provider right away to report if you or your family member see the appearance or worsening of symptoms of depression, any unusual changes in mood or behavior, or the appearance of suicidal thoughts, behavior, or thoughts about self-harm. Behaviors of concern should be reported immediately to the healthcare provider.
For Healthcare Professionals
All antiepileptic drugs (AEDs), including STAVZOR, increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication. Anyone considering prescribing Stavzor or any other AED must balance their risk of suicidal thoughts and behavior with the risk of untreated illness.
Patients, their caregivers, and families should be informed that AEDs increase the risk of suicidal thoughts and behavior and should be advised of the need to be alert for the emergence or worsening of the signs and symptoms of depression, any unusual changes in mood or behavior, or the emergence of suicidal thoughts, behavior or thoughts about self-harm. Behaviors of concern should be reported immediately to healthcare providers.
For medical inquiries specific to Stavzor, please call 1-800-455-8070
