Diacomit is a prescription medicine 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.

Diacomit 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.

There is no clinical data to support the use of Diacomit alone to treat Dravet syndrome.

Diacomit 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 this medicine will affect you.

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

Before taking this medicine

Diacomit should not be given to a child younger than 6 months of age.

To make sure Diacomit is safe for you, 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 Diacomit. 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.

Do not start or stop taking seizure medication during pregnancy without your doctor's advice. Stiripentol may harm an unborn baby, but having a seizure during pregnancy could harm both mother and baby. The benefit of preventing seizures may outweigh any risk. Tell your doctor right away if you become pregnant.

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

It may not be safe to breastfeed while using this medicine. Ask your doctor about any risk.

Use Diacomit exactly as prescribed by your health care provider. Your doctor will perform blood tests to make sure you do not have conditions that would prevent you from safely using Diacomit.

Follow all directions on your prescription label and read all medication guides or instruction sheets.

Always take this medicine 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 Diacomit 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.

Diacomit 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 Diacomit 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 Diacomit suddenly, even if you feel fine. Seizures may increase if you stop using Diacomit 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

Diacomit should not be given to a child younger than 6 months of age.

To make sure Diacomit is safe for you, 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 Diacomit. 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.

Do not start or stop taking seizure medication during pregnancy without your doctor's advice. Stiripentol may harm an unborn baby, but having a seizure during pregnancy could harm both mother and baby. The benefit of preventing seizures may outweigh any risk. Tell your doctor right away if you become pregnant.

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

It may not be safe to breastfeed while using this medicine. Ask your doctor about any risk.

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.

Avoid driving or hazardous activity until you know how this medicine 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 to Diacomit: 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.

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 Diacomit 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.

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 Diacomit 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 interact with 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.