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Diacomit

Last reviewed on RxList: 9/4/2018
Diacomit Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 9/4/2018

Diacomit (stiripentol) is an antiepileptic drug (AED) indicated for the treatment of seizures associated with Dravet syndrome in patients 2 years of age and older taking clobazam. Common side effects of Diacomit include:

The dosage of Diacomit is 50 mg/kg/day, administered by mouth in 2 or 3 divided doses. Diacomit may interact with theophylline, caffeine, sertraline, thiotepa, midazolam, triazolam, quinidine, diazepam, clopidogrel, carbamazepine, methotrexate, prazosin, glyburide, clobazam, rifampin, phenytoin, phenobarbital, and other CNS depressants, including alcohol. Tell your doctor all medications and supplements you use. Tell your doctor if you are pregnant or plan to become pregnant before taking Diacomit; it may harm a fetus. There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to AEDs, such as Diacomit, during pregnancy. It is unknown if Diacomit passes into breast milk. Consult your doctor before breastfeeding.

Our Diacomit (stiripentol) Capsules, for Oral Use And Diacomit (Stiripentol) Powder, for Oral Suspension Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

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.

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Diacomit Consumer Information

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.

Call your doctor at once if you have:

  • severe drowsiness;
  • significant weight loss;
  • easy bruising, unusual bleeding, purple or red spots under your skin;
  • low white blood cell counts--fever, mouth sores, skin sores, sore throat, cough, trouble breathing;

Common 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.

Read the entire detailed patient monograph for Diacomit (Stiripentol)

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What Is Epilepsy? Symptoms, Causes, and Treatments See Slideshow
Diacomit Professional Information

SIDE EFFECTS

The following serious or otherwise clinically significant adverse reactions are described elsewhere in the labeling:

  • Somnolence [see WARNINGS AND PRECAUTIONS]
  • Decreased Appetite and Decreased Weight [see WARNINGS AND PRECAUTIONS]
  • Neutropenia and Thrombocytopenia [see WARNINGS AND PRECAUTIONS]
  • Withdrawal Symptoms [see WARNINGS AND PRECAUTIONS]
  • Risks in Patients with Phenylketonuria [see WARNINGS AND PRECAUTIONS]
  • Suicidal Behavior and Ideation [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in clinical trials of another drug, and may not reflect the rates observed in practice.

During its development for the treatment of seizures associated with Dravet syndrome, DIACOMIT was administered to 55 healthy male volunteers and 438 patients with Dravet syndrome, including 310 patients treated for 12 months or more. The conditions and duration of exposure varied greatly, and included single-and multiple-dose clinical pharmacology studies in healthy male volunteers, 2 randomized, double-blind, placebo-controlled, 12-week studies in patients with Dravet syndrome (Study 1 and Study 2), and open-label long-term studies.

In Study 1 and Study 2, 33 patients received DIACOMIT and 31 patients received placebo for a treatment duration of 8 weeks. Adverse reactions from these trials are presented below. Approximately 53% of patients were female and the mean age was 9.2 years. All patients were taking clobazam and valproate.

There were 2 patients in whom adverse reactions led to discontinuation of DIACOMIT treatment: one patient had an adverse reaction of status epilepticus; the second patient had drowsiness, balance impaired and sialorrhea.

The most common adverse reactions, occurring in at least 10% of DIACOMIT-treated patients and more frequently than on placebo, included somnolence (67%), decreased appetite (45%), agitation (27%), ataxia (27%), weight decreased (27%), hypotonia (24%), nausea (15%), tremor (15%), dysarthria (12%), and insomnia (12%).

Table 2 lists the adverse reactions that occurred in 5% or more of DIACOMIT-treated patients and at a rate greater than in patients on placebo in the 2 randomized, double-blind, placebo-controlled, clinical trials in patients with Dravet syndrome (Study 1 and Study 2).

Table 2: Adverse Reactions in 5% or More of DIACOMIT-Treated Patients and More Frequently than on Placebo in Patients with Dravet Syndrome (Study 1 and Study 2)

Adverse Reactions Study 1 and 2- Pooled Total
DIACOMIT (50mg/kg/day)
N=33 %
Placebo
N=31 %
Gastrointestinal disorders
Nausea 15 3
Vomiting 9 0
Salivary hypersecretion 6 0
General disorders and administration site conditions
Fatigue 9 3
Pyrexia 6 3
Infections and infestations
Bronchitis 6 0
Nasopharyngitis 6 0
Investigations
Weight decreased 27 6
Weight increased 6 3
Metabolism and nutrition disorders
Decreased appetite 46 10
Nervous system disorders
Somnolence 67 23
Ataxia 27 23
Hypotonia 18 13
Tremor 15 10
Dysarthria 12 0
Psychiatric disorders
Agitation 27 16
Insomnia 12 7
Aggression 9 0

Read the entire FDA prescribing information for Diacomit (Stiripentol)

QUESTION

If you have had a seizure, it means you have epilepsy. See Answer
Related Resources for Diacomit

© Diacomit Patient Information is supplied by Cerner Multum, Inc. and Diacomit Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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