Stiripentol

Stiripentol is used to treat seizures that are linked to Dravet syndrome. Dravet syndrome is a rare, long-lasting type of epilepsy that starts in the first year of life and leads to frequent or long-lasting seizures.

Stiripentol can be used by adults and children who are at least 6 months old and weigh 15 lbs (7 kg) or more, as long as they are also taking another medication called clobazam.

Stiripentol may also be used for reasons not mentioned in this medication guide.

Your doctor will do blood tests to ensure you do not have any conditions that would make it unsafe for you to use stiripentol.

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

Always take stiripentol with 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 get the 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 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 start 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 regularly.

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.

Stiripentol can make you feel sleepy, especially if you drink alcohol or take other medicines that can also cause drowsiness. Inform your doctor about all the medicines you are currently taking and any that you begin or stop. Do not drive or do dangerous activities until you understand how stiripentol affects you.

A small number of people may have thoughts about suicide while using stiripentol. Be aware of any changes in your mood or symptoms. Let your doctor know about any new or worsening symptoms.

Tell your doctor if you have ever had:

• liver or kidney disease;
• suicidal thoughts or actions;
• depression or 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.

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.

Usual Adult Dose for Dravet Syndrome:

25 mg/kg orally twice a day or 16.67 mg/kg orally 3 times a dayMaximum dose: 3000 mg/dayComments:-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 day1 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 dayMaximum dose: 3000 mg/dayComments:-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

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

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

• 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.

Sometimes it is not safe to use certain medications together. Some drugs can change the 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 make this effect worse. 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.