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STAVZOR dosing information for bipolar mania disorder

STAVZOR is indicated for the acute treatment of manic episodes associated with bipolar disorder.

Dosage forms and strengths

STAVZOR is available in 125 mg, 250 mg and 500 mg dosage strengths, making it convenient to initiate and titrate.

three dose sizes

Dosage and administration

STAVZOR has a wide therapeutic window for achieving target serum levels (50-125 µg/mL).

The maximum recommended dosage for all indications is 60 mg/kg/day. The safety of doses above 60 mg/kg/day is not established. Divide daily dosage above 250 mg into separate doses.

Initial dose: Start at 750 mg daily, in divided doses

Titration: Increase as rapidly as possible to achieve the lowest therapeutic dose or desired plasma level

Maximum recommended dosage: The maximum recommended dosage for all indications is 27.2 mg/lb/day (60 mg/kg/day).

Examples of maximum dosage:

Weight (lbs)	100	120	140	160	180	200	220
Mg/day	2750	3250	3875	4375	5000	5500	6000

For more information, please see full STAVZOR Prescribing Information

Bipolar Symptoms Checker

Important Safety Information You Should Know about STAVZORLiver 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 defects Women 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.Pancreatitis Some 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 useFor Patients and CaregiversAll 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 ProfessionalsAll 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