What makes STAVZOR unique
STAVZOR (valproic acid) is a patented, delayed-release soft gel capsule formulation of valproate for the treatment of the manic episodes associated with bipolar disorder, as well as epilepsy and migraine headache prophylaxis.
STAVZOR small, easy-to-swallow soft gel capsules are an innovative valproate formulation formulated to help your patients start — and stay on — their therapy.
Here's what makes STAVZOR unique:
- Small, soft gel capsules are easy to swallow with enteric technology formulated to reduce reflux and gastric irritability
- Patients save money on every STAVZOR prescription
Other features of STAVZOR:
- Patients prefer clear oval soft gel capsules
- It's easy for your patients to find
STAVZOR soft gel capsules are easy to swallow
STAVZOR small size, soft gel formulation makes capsules easy to swallow.
STAVZOR soft gel capsules in the 500mg dosage form are up to 40% smaller than Depakote® or Depakote ER®* (divalproex sodium) tablets. These features make the capsules easy for patients to swallow – and obviate the need for sprinkling the contents of a capsule on food.
Enteric technology formulated to reduce reflux and gastric irritability
STAVZOR soft gel capsule is formulated for favorable GI tolerability. Enteric properties in the clear, soft gel allow the valproate to be absorbed in the small intestine rather than in the stomach, where standard formulations of valproic acid are absorbed. This may reduce the potential for reflux and gastric irritability.
The capsule shell is resistant to gastric acid, but when exposed to intestinal pH, it ruptures and releases the valproic acid. In addition, time to maximum plasma concentration occurred at 2.3 hours compared with 3.7 hours with divalproex delayed-release tablet — indicating faster absorption with overall extent of absorption being comparable and demonstrated bioequivalence.
Absorbed in the small intestine, not the stomach.
Patients prefer clear oval soft gel capsules
When asked to view various dosage forms, 71% (86% female) of consumers preferred clear oval soft gels. And a new patient survey confirms that 83% of Depakote/Depakote ER* patients would prefer soft gel capsules like STAVZOR as long as it was equal in effectiveness and side effects, chart data on file
It's easy for your patients to obtain
Noven Therapeutics is making it easy for your patients to fill their prescription.
Remind your patients there is no generic form of STAVZOR. They should receive a small, orange soft gel capsule.
*Depakote/Depakote ER (divalproex sodium) are registered trademarks 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