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Stavzor

What are migraines?

Migraines are severe, debilitating headaches. The pain of a migraine headache is often described as an intense "pulsing" or "throbbing" pain in one or several parts of the head.

Migraines can include the following symptoms:

  • Extreme sensitivity to light and sound
  • Nausea
  • Vomiting

When a migraine is about to occur, about 20% of individuals may experience flashing lights, zigzag lines or have a temporary loss of vision. This is called an "aura." Approximately 80% of individuals with migraines, however, don't experience the aura.

Who is likely to be affected?

Migraines affect approximately 28,000,000 Americans. Women are three times more likely to have migraines than men. Children as well as adults may suffer from the headaches.

  • Did you know? The term for individuals with migraines is "migraineurs."

What causes migraines?

It's not exactly known why some individuals suffer from migraine headaches. Migraines may result from changes in blood flow in the brain. Migraineurs appear to have genetically sensitive brain centers that overreact to certain triggers. This causes migraines. More recently, genes have been linked to migraines.

What may trigger migraines?

Migraines may be triggered by a combination of factors including:

  • Lack of sleep
  • Skipping meals
  • Exposure to bright light
  • Weather changes
  • Hormonal irregularities and changes in women
  • Anxiety and stress
  • Eating or drinking certain foods including chocolate, nuts, alcohol and processed foods with nitrates such as luncheon meats
  • Taking certain medications such as oral contraceptives or decongestants

How are migraines diagnosed?

If you suspect you have migraines, your doctor will take a thorough medical history. Your doctor also will perform a physical exam to determine if the headaches could be caused by other conditions such as a head injury or a sinus infection.

Your doctor also may order imaging tests of your brain. Diagnostic testing could include EEGs (electroencephalographs) and brain scans:

  • EEGs provide a record of electrical activity in the brain.
  • Other imaging methods such as CT (computerized tomography) or MRI (magnetic resonance imaging) scans may be used to search for sinus conditions or other physical conditions causing the headaches.

Be prepared to tell your doctor:

  • When your headaches occurred
  • How long they lasted
  • How severe they were
  • The area of the head where the pain usually is located
  • What symptoms occurred
  • For women, if they occurred during a menstual cycle
  • If anything seemed to trigger the headaches, such as eating chocolate or being in a bright light
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Many individuals with migraine headaches don't consult physicians. Despite the availability of effective medications, the majority of migraineurs with severe headaches aren't treated with medications.

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How are migraines treated?

Your doctor may recommend a combination of medications, lifestyle changes and complementary therapies to help stop the pain of migraines.

Medications

Migraines may be treated with drugs in two approaches: treating the symptoms of a migraine and preventing a migraine from reoccurring. Your doctor may recommend both. Over–the–counter medications also may be used to combat pain. Hormone therapy may help some women.

Valproic acid (valproate) medication has been established as effective in the preventative treatment of migraines.

STAVZOR is valproate medication that 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.

Lifestyle changes

Your doctor can help you determine what lifestyle changes may help reduce the triggers that can cause your migraines. Getting enough sleep, avoiding stressors, being physically active and avoiding certain foods are all healthy choices that you can make to help reduce the likelihood of migraine headaches.

Complementary therapies

Additional therapies may be useful in combating headaches. Your doctor can provide further information on which ones may work for you. Biofeedback, in which you're trained how to control your body's stress reaction, and psychotherapy can help you control stressors that may trigger migraines. Other stress reduction techniques include yoga and meditation.

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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