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 6 months old and weighing 15 lbs (7 kg) or more who also take another medicine called clobazam.

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

Stiripentol can cause drowsiness, especially if you also drink alcohol or take other medicines that can make you sleepy. Tell your doctor about all your current medicines and any you start or stop using. Avoid driving or hazardous activity until you know how stiripentol will affect you.

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.

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.

Always take stiripentol during a meal.

Swallow the capsule whole and do not crush, chew, break, or open it.

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.

Take the capsule with a full glass of water.

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.

Store at room temperature away from moisture, heat, and light.

Do not stop using stiripentol suddenly, even if you feel fine. Seizures may increase if you stop using stiripentol suddenly. Follow your doctor's instructions about tapering your dose.

Usual Adult Dose for Dravet Syndrome:

25 mg/kg orally twice a day or 16.67 mg/kg orally 3 times a day
Maximum dose: 3000 mg/day

Comments:
-No clinical data are available to support the use of this drug as monotherapy in Dravet syndrome.
-The total daily dose is 50 mg/kg/day.

Use: For the treatment of seizures associated with Dravet syndrome in patients taking clobazam

Usual Pediatric Dose for Dravet Syndrome:

6 months to less than 1 year:
-Weight at least 7 kg: 25 mg/kg orally twice a day

1 year and older:
-Weight 7 to less than 10 kg: 25 mg/kg orally twice a day
-Weight at least 10 kg: 25 mg/kg orally twice a day or 16.67 mg/kg orally 3 times a day
Maximum dose: 3000 mg/day

Comments:
-No clinical data are available to support the use of this drug as monotherapy in Dravet syndrome.
-The total daily dose is 50 mg/kg/day.
-For patients 6 months to less than 1 year: Dosing frequency should not exceed twice a day to limit free water administration and to avoid overexposures.
-For patients 1 year and older weighing 7 to less than 10 kg: Dosing frequency should not exceed twice a day to avoid overexposures.

Use: For the treatment of seizures associated with Dravet syndrome in patients taking clobazam

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.

Tell your doctor if you are pregnant or breastfeeding.

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

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.

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

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from light, excess heat, and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

Talk to your doctor about drinking or eating a lot of caffeine-containing products such as coffee, tea, energy drinks, cola, or chocolate.

Avoid driving or hazardous activity until you know how stiripentol will affect you. Your reactions could be impaired.

Do not drink alcohol. Drinking alcohol with this medicine can cause severe drowsiness.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

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.

Stiripentol may cause serious side effects. Call your doctor at once if you have:

• severe drowsiness;

• significant weight loss;

• easy bruising, unusual bleeding, purple or red spots under your skin; or

• low white blood cell counts--fever, mouth sores, skin sores, sore throat, cough, trouble breathing.

Common side effects of stiripentol 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.

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.

Using stiripentol with other drugs that make you drowsy can worsen this effect. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.

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.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to stiripentol.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.