Stiripentol

What it is used for

DIACOMIT is indicated for the treatment of seizures associated with Dravet syndrome (DS) in patients taking clobazam who are 6 months of age and older and weighing 7 kg or more. There are no clinical data to support the use of DIACOMIT as monotherapy in Dravet syndrome. DIACOMIT is indicated for the treatment of seizures associated with Dravet syndrome in patients taking clobazam who are 6 months of age and older and weighing 7 kg or more.

There are no clinical data to support the use of DIACOMIT as monotherapy in Dravet syndrome.

The most important thing to know

DIACOMIT can cause serious side effects, including: Sleepiness and drowsiness. Sleepiness and drowsiness are serious and common side effects. DIACOMIT can make you sleepy or dizzy, and slow your thinking. Your healthcare provider may decrease your dose of clobazam or other seizure medicines. Do not drive, operate heavy machinery, or do other dangerous activities until you know how DIACOMIT affects you.

Do not drink alcohol or take other medicines that may make you sleepy or dizzy while taking DIACOMIT until you talk to your healthcare provider. DIACOMIT, when taken with alcohol or medicines that cause sleepiness or dizziness, may make your sleepiness or dizziness worse. Loss of appetite and weight loss. Loss of appetite and weight loss are serious and common side effects.

DIACOMIT can cause frequent nausea and loss of appetite that can cause weight loss. Your weight should be checked frequently during DIACOMIT treatment. Children who take DIACOMIT should have their weight and growth checked often. Low white blood cell counts (neutropenia) and low platelet counts (thrombocytopenia). Low white blood cell counts may occur during treatment with DIACOMIT and may cause serious infections.

Low platelet counts may cause serious bleeding problems. Your healthcare provider should check your white blood cell count and platelet count before and during treatment. Do not stop taking DIACOMIT without first talking to your healthcare provider. Stopping a seizure medicine such as DIACOMIT should be done slowly to avoid having seizures more often, or seizures that do not stop (status epilepticus).

Like other antiepileptic drugs, DIACOMIT may cause suicidal thoughts or actions in a very small number of people (about 1 in 500). Call your healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you: thoughts about suicide or dying attempts to commit suicide new or worse depression new or worse anxiety feeling agitated or restless panic attacks trouble sleeping (insomnia) new or worse irritability acting aggressive, being angry, or violent acting on dangerous impulses an extreme increase in activity and talking (mania) other unusual changes in behavior or mood How can I watch for early symptoms of suicidal thoughts and actions?

Pay attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. Keep all follow-up visits with your healthcare provider as scheduled. Call your healthcare provider between visits as needed, especially if you are worried about symptoms. Suicidal thoughts or actions can be caused by things other than medicines.

If you have suicidal thoughts or actions, your healthcare provider may check for other causes. Call your healthcare provider right away if you have any of the above side effects while taking DIACOMIT. What is DIACOMIT? DIACOMIT is a prescription medicine used along with clobazam to treat seizures in people with Dravet syndrome who are 6 months of age and older and weighing 15 pounds (7 kg) or more.

DIACOMIT has not been shown to be able to treat seizures associated with Dravet syndrome without the use of clobazam. It is not known if DIACOMIT is safe and effective in children under 6 months of age or who weigh less than 15 pounds (7 kg). Before you take DIACOMIT, tell your healthcare provider about all of your medical conditions, including if you: have liver or kidney problems.

have phenylkentonuria (PKU). DIACOMIT for oral suspension contains aspartame. The artificial sweetener may be harmful to people with PKU. have or have had depression, mood problems, suicidal thoughts or behavior. drink alcohol. are pregnant or plan to become pregnant. It is not known if DIACOMIT may harm your unborn baby.

Tell your healthcare provider right away if you become pregnant while taking DIACOMIT. You and your healthcare provider will decide if you should take DIACOMIT while you are pregnant. Pregnancy Registry: If you become pregnant while taking DI

How to take it

Take DIACOMIT exactly as your healthcare provider tells you to take it. Your healthcare provider will tell you how much DIACOMIT to take and when to take it. Read the Instructions for Use at the end of this Medication Guide for information on the right way to use. DIACOMIT capsules should be swallowed whole with a glass of water during a meal.

Do not break or open capsules. DIACOMIT for oral suspension should be mixed in a glass of water (100 mL) and should be taken right away after mixing during a meal. To be sure there is no medicine left in the glass, add a small amount of water (25 mL) to the drinking cup and drink all of the mixture. See the complete Instructions for Use on the right way to use DIACOMIT for oral suspension.

Your healthcare provider may change your dose if needed. Do not change your dose of DIACOMIT without talking to your healthcare provider. If you miss a dose of DIACOMIT, take it as soon as you remember. If it is almost time for the next scheduled dose, skip the missed dose and take your next dose at your regular time.

Side effects, and when to stop

DIACOMIT may cause serious side effects, including: The most common side effects of DIACOMIT include: agitation loss of control of body movements (ataxia) low muscle tone or muscle weakness (hypotonia) nausea tremor trouble saying words clearly (dysarthria) trouble sleeping (insomnia) These are not all the possible side effects of DIACOMIT.

For more information, ask your healthcare provider or pharmacist. Tell your healthcare provider if you have any side effect that bothers you or that does not go away. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Who should not take it

Do not take 2 doses of DIACOMIT at the same time. If you take too much DIACOMIT, call your healthcare provider or go to the nearest hospital emergency room right away.

What to avoid

Do not drive, operate heavy machinery, or do other dangerous activities that need you to be alert until you know how DIACOMIT affects you. Do not drink alcohol or take other medicines that may make you sleepy or dizzy while taking DIACOMIT without first talking to your healthcare provider.

Storing it

Store DIACOMIT at room temperature between 68°F to 77°F (20°C to 25°C). Store in a dry place in the original package. Protect from light. Keep DIACOMIT and all medicines out of the reach of children.