My severe episode plan
Sometimes a change in your everyday social rhythms can cause a relapse in your moods. A stressful life event also may trigger a severe episode. In some severe cases, it may be necessary for you to be hospitalized.
- Possible early warning signs of the onset of a severe manic episode include an excessive feeling of euphoria (exceedingly happy), hyperactivity, destructive or impulsive behavior, sleeplessness, irritability and anger, talking sarcastically and rapidly, telephoning friends at in the middle of the night and stopping medications.
- Depressive episode warning signs include a lasting mood of sadness and/or hopelessness, decreased energy, sleep problems and thoughts of death or suicide.
Learn more about bipolar disorder symptoms.
A family member or friend may be your caregiver at this time, and will need important information to be able to contact your doctor and provide details of your recent moods and triggers.
Fill out the following sheet and keep it near the phone. If you have any advanced directions, keep a copy with this plan. Make copies for family members or friends who will be able to provide support as your moods are stabilized and you return to wellness. If you have Advance Directives, consider keeping them with your Severe Episode Plan (PDF).
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