Stavzor® is part of the psychiatry products franchise of Noven Therapeutics, LLC.
Stavzor® is indicated for:
- the acute treatment of manic episodes associated with bipolar disorder;
- monotherapy and adjunctive therapy of complex partial seizures and simple and complex absence seizures; adjunctive therapy in patients with multiple seizure types that include absence seizures; and
- prophylaxis of migraine headaches.
Stavzor® soft gel capsules are small (up to 40% smaller than Depakote® and Depakote ER® tablets at the 500 mg dosage strength) and easy to swallow, with an advanced enteric technology designed to reduce reflux and gastric irritability. The product was approved by the FDA on July 29, 2008, and is now available in pharmacies.
Depakote® and Depakote ER® are registered trademarks of Abbott Laboratories.
For additional information, visit www.stavzor.com.
Important Safety Informatio 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 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 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
For patient, physician
and pharmacist inquiries
regarding Stavzor™,
please contact:
Kendle International,
Inc.
441 Vine Street
Suite 1200
Cincinnati, Ohio 45202
Attn: Safety Department
Ph: 800-455-8070
Copyright © 2012 Noven Pharmaceuticals, Inc. All rights reserved.