Diacomit

Diacomit is a prescription medication use with other medications to treat seizures caused by Dravet syndrome, a form of epilepsy, in people 2 years or older. Diacomit belongs to a group of drugs called anticonvulsants. These work by slowing down the actions of nerve cells during a seizure and prevent the brain from spreading the seizure.

The medication comes in capsule form and also as a powder for suspension. Diacomit capsules are swallowed whole 2 or 3 times a day, with a full glass of water during a meal. Powder for suspension can be mixed in a glass of water and taken immediately after mixing during a meal. 

Common side effects of Diacomit include sleepiness and drowsiness, decreased appetite, agitation, and weight loss. Do not drive or operate heavy machinery until you know how Diacomit affects you.

Diacomit is a prescription medicine used along with clobazam to treat seizures in people 2 years or older with Dravet syndrome.

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 2 years of age. There is limited information on safety in patients 6 months and older in non-pivotal trials.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Diacomit. See the “Diacomit Precautions” section.

Common side effects of Diacomit include:

• Agitation
• Ataxia (loss of full control of body movements)
• Hypotonia (reduced muscle strength)
• Nausea
• Tremor
• Dysarthria (difficulty saying words clearly)
• Insomnia (trouble sleeping)

This is not a complete list of Diacomit side effects. Ask your doctor or pharmacist for more information. Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about any side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• Medications that are substrates of the enzyme CYP1A2 such as Lotronex (alosetron), Clozaril (clozapine), caffeine, melatonin, Remeron (mirtazapine), Zyprexa (olanzapine), theophylline, and Zanaflex (tizanidine).
• Medications that are substrates of the enzyme CYP2B6 such as Zoloft (sertraline), Methadose (methadone), Wellbutrin (bupropion), Diprivan (propofol), Ketalar (ketamine), and Viramune (nevirapine).
• Medications that are substrates of the enzyme CYP3A4 such as Alfenta (alfentanil), Parlodel (bromocriptine), Tegretol (carbamazepine), Klonopin (clonazepam), Cardizem (diltiazem), Zocor (simvastatin), and Cialis (tadalafil).
• Medications that are substrates of the enzyme CYP2C8 such as Cordarone (amiodarone), Tegretol (carbamazepine), Voltaren (diclofenac), Advil (ibuprofen), Avandia (rosiglitazone), and Prandin (repaglinide).

This is not a complete list of Diacomit drug interactions. Ask your doctor or pharmacist for more information.

Serious and clinically significant side effects have been reported with Diacomit including the following:

• 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

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.

Medications can interact with certain foods or drinks. In some cases, this may be harmful, and your doctor may advise you to avoid certain foods. In the case of Diacomit, do not drink alcohol or take other medicines that may make you sleepy or dizzy while taking without first talking to your healthcare provider.

Before taking Diacomit, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• have liver or kidney problems.

• have phenylkentonuria (PKU). Diacomit powder 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.

• are breastfeeding or plan to breastfeed.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Taking Diacomit with certain other medicines can cause side effects or affect how well Diacomit or the other medicines work. Do not start or stop other medicines without talking to your healthcare provider. Know the medicines you take. Keep a list of them and show it to your healthcare provider and pharmacist when you get a new medicine.

Tell your doctor if you are pregnant or plan to become pregnant.

In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

A pregnancy exposure registry does exist that monitors pregnancy outcomes in pregnant women exposed to anticonvulsants, such as Diacomit. Physicians are advised to recommend that pregnant patients taking Diacomit enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry. The patient themselves must call the toll-free number 1-800-233-2334, in order to be registered. For more information on the registry, you can visit the website http://www.aedpregnancyregistry.org/.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Diacomit crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medications, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Diacomit.

• 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.
• Diacomit capsules should be swallowed whole with a glass of water during a meal. Do not break or open capsules.
• Diacomit powder 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 powder 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. 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.

Take this medication exactly as prescribed by your doctor. Follow the directions in prescription label carefully.

The dose your doctor recommends may be based on the following:

• The condition being treated

• Other medical conditions you have

• other medications you are taking

• how you respond to this medication

• your weight

• your height

• your age

• your gender

The recommended dose of Diacomit (stiripentol) for the treatment of seizures associated with Dravet syndrome is 50mg/kg/day divided into 2 or 3 doses a day.

If you take too much Diacomit, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

• 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.

This page was written by Robert Moton, PharmD Candidate 2020 | UT Austin College of Pharmacy