stiripentol

What is the most important information I should know about stiripentol?

A small number of people have thoughts about suicide while taking stiripentol. Stay alert to changes in your mood or symptoms. Report any new or worsening symptoms to your doctor.

What is stiripentol?

Stiripentol is used to treat seizures associated with Dravet syndrome. Dravet syndrome is a rare chronic form of epilepsy that begins in the first year of life and causes frequent or prolonged seizures.

Stiripentol is for use in adults and children at least 2 years old who also take another medicine called clobazam.

Stiripentol may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before taking stiripentol?

Tell your doctor if you have ever had:

• liver or kidney disease;
• suicidal thoughts or actions;
• depression, a mood disorder; or
• if you drink alcohol.

The powder form of this medicine may contain phenylalanine. Tell your doctor if you have phenylketonuria (PKU).

A small number of people have thoughts about suicide while taking stiripentol. Your doctor will need to check your progress at regular visits. Your family or other caregivers should also be alert to changes in your mood or symptoms.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of stiripentol on the baby.

How should I take stiripentol?

Your doctor will perform blood tests to make sure you do not have conditions that would prevent you from safely using stiripentol.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

You may need to take two different strengths of stiripentol capsules to make up your correct dose. Follow your doctor's dosing instructions very carefully.

Dissolve one packet of the powder in 3 ounces of water. Stir and drink this mixture right away. Add at least 1 ounce more water to the glass, swirl gently and drink right away.

Stiripentol doses are based on weight. Your dose needs may change if you gain or lose weight.

Stiripentol can cause nausea, vomiting, loss of appetite, and weight loss. Weigh yourself often, and tell your doctor if you begin to lose weight. Your medication doses may need to be adjusted.

Do not change your stiripentol or other seizure medication doses or dosing schedules without your doctor's advice.

Decreased appetite and weight loss may affect growth in a child. Your doctor will need to check your child's growth rate at regular intervals.

Stiripentol can increase your risk of bleeding or infection. You will need frequent medical tests.

Do not stop using stiripentol suddenly, even if you feel fine. Stopping suddenly may cause increased seizures. Follow your doctor's instructions about tapering your dose.

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking stiripentol?

What are the possible side effects of stiripentol?

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), depressed, or have thoughts about suicide or hurting yourself.

• severe drowsiness;
• significant weight loss;
• easy bruising, unusual bleeding, purple or red spots under your skin;
• low white blood cell counts --fever, mouth sores, skin sores, sore throat, cough, trouble breathing;

Common side effects may include:

• nausea, loss of appetite;
• weight loss;
• drowsiness;
• agitation;
• problems with balance or muscle movement;
• tremor, slurred speech;
• muscle weakness; or
• sleep problems (insomnia).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect stiripentol?

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Other drugs may affect stiripentol, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Where can I get more information?

Your pharmacist can provide more information about stiripentol.