How STAVZOR may help your loved one
STAVZOR has a unique advanced valproic acid formulation. Valproic acid is one of the most trusted and effective medications available to stabilize mood and treat the manic episodes of bipolar disorder. It's recommended as a first-line therapy by the American Psychiatric Association. STAVZOR is approved by the Food and Drug Administration.
Although it is not completely understood how it works in the brain, scientists believe that valproic acid regulates the balance of brain chemicals. It helps your loved one think more calmly and clearly.
How is STAVZOR different from other valproic drugs?
STAVZOR has a unique advanced soft gel formulation that can help your loved one start – and stay – on therapy. Staying on bipolar disorder medication is key to reducing the likelihood of a relapse in bipolar symptoms.
Easy-to-swallow capsules
The smaller size and soft gel formulation of STAVZOR make the capsules easy to swallow.
For many people, swallowing pills, tablets or capsules is a challenge that may prevent them from following their doctor's recommended therapy. In fact, a survey has shown that 84% of adults reported they hesitate taking medication due to pill size — and 40% had difficulty in swallowing pills.
Patients prefer smaller, easy-to-swallow unique soft gel capsules. STAVZOR soft gel capsules (500 mg dosage formulation) are up to 40% smaller than other valproic acid tablets.
Nationwide survey of adults shows:
Formulated to be gentler on the stomach
In addition, the unique advanced enteric formulation of STAVZOR soft gel capsules delivers the drug to the small intestine, not the stomach. It's formulated to reduce reflux and gastric irritation.
STAVZOR is up to 40% smaller than other valproate medications. STAVZOR is a form of valproate that comes in a small, easy-to-swallow soft gel capsule that patients prefer.
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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