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Stiripentol oral

Updated 2 Feb 2023 | Stiripentol


Oral formulations containing stiripentol.

Drugs List

  • DIACOMIT 250mg capsules
  • DIACOMIT 250mg sachets
  • DIACOMIT 500mg capsules
  • DIACOMIT 500mg sachets
  • stiripentol 250mg capsules
  • stiripentol 250mg sachets
  • stiripentol 500mg capsules
  • stiripentol 500mg sachets
  • Therapeutic Indications


    Epilepsy (adjunctive treatment)

    Treatment, in combination with clobazam and valproate, of refractory generalized tonic-clonic seizures in patients with severe myoclonic epilepsy in infancy (SMEI, Dravet's syndrome) whose seizures are not adequately controlled with clobazam and valproate.


    Stiripentol should only be administered under the supervision of a specialist in diagnosis and management of epilepsy in infants and children.


    Children 3 years and over
    Stiripentol dose is calculated on a mg/kg body weight basis. Daily dosage may be administered in 2 or 3 divided doses.
    Initiation of adjunctive therapy with stiripentol should be undertaken over 3 days using upwards dose escalation to reach the recommended dose of 50mg/kg/day in conjunction with clobazam and valproate.

    Stiripentol dosage escalation should be gradual, starting with 20mg/kg/day for 1 week, then 30mg/kg/day for 1 week. Further dosage escalation is age dependent: Children and adolescents 12 years and older
    Receive an additional 5mg/kg/day each week until the optimum dose is reached based on clinical judgement.
    Children from 6 to less than 12 years
    Receive an additional 10mg/kg/day each week, thus achieving the recommended dose of 50mg/kg/day in four weeks.
    Children less than 6 years
    Receive an additional 20mg/kg/day in the third week, thus achieving the recommended dose of 50mg/kg/day in three weeks.

    Children under 3 years
    The clinical decision for use in children under 3 with SMEI needs to be made on an individual patient basis taking into consideration the potential clinical risks and benefits. Adjunctive therapy with stiripentol should only be started when SMEI diagnosis has been clinically confirmed. It is recommended to carefully monitor children aged 6 months to 3 years whilst on stiripentol.


    For oral administration.

    The oral powder should be mixed in a glass of water and taken immediately after mixing during a meal.

    Always take with food as stiripentol degrades rapidly in an acidic environment. Do not take with milk or dairy products, carbonated drinks, fruit juice or food and drink that contains caffeine or theophylline.


    Hepatic impairment
    History of psychosis
    Renal impairment

    Precautions and Warnings

    Children under 3 years
    Glucose-galactose malabsorption syndrome
    Hereditary fructose intolerance

    Some formulations contain aspartame - caution in phenylketonuria
    Advise ability to drive/operate machinery may be affected by side effects
    Monitor growth of children during treatment
    Treatment to be prescribed under the supervision of a specialist
    Presentations with sorbitol unsuitable in hereditary fructose intolerance
    Some formulations contain glucose
    Must be taken with food and water
    Monitor full blood count before and at 6 monthly intervals during treatment
    Monitor hepatic function before and at 6 monthly intervals during treatment
    Bioavailability differs with preparations;caution on changing formulations
    Female: Barrier or non-hormonal contraception advised during treatment

    Bioequivalence between capsules and oral suspension has not been established; clinical supervision is recommended if changing formulation.

    Pregnancy and Lactation


    Use stiripentol with caution during pregnancy.

    The manufacturer advises caution if stiripentol during pregnancy. At the time of writing there is limited published information regarding the use of stiripentol during pregnancy. Potential risks are unknown.


    Stiripentol is contraindicated during breastfeeding.

    The manufacturer does not recommend breastfeeding whilst taking stiripentol. Animal data reports significant levels of stiripentol in the breast milk, however presence in human breast milk and the effect on exposed infants are unknown.

    Side Effects

    Altered liver function tests
    Behavioural disturbances (children)
    Cutaneous allergy
    Decreased appetite
    Disturbances of gastrointestinal function
    Gamma glutamyl transferase (GGT) increased
    Hyperexcitability (children)
    Hyperkinesia (children)
    Sleep disturbances
    Weight loss


    It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

    The following number will direct the caller to the relevant local centre (0844) 892 0111

    Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( ) or if this is unavailable at the backup site ( ).

    Further Information

    Last Full Review Date: November 2019

    Reference Sources

    Summary of Product Characteristics: Diacomit 250 mg hard capsules. Alan Pharmaceuticals Ltd. Revised September 2018.
    Summary of Product Characteristics: Diacomit 500 mg hard capsules. Alan Pharmaceuticals Ltd. Revised September 2018.
    Summary of Product Characteristics: Diacomit 250 mg powder for oral suspension in sachet. Alan Pharmaceuticals Ltd. Revised September 2018.
    Summary of Product Characteristics: Diacomit 500 mg powder for oral suspension in sachet. Alan Pharmaceuticals Ltd. Revised September 2018.

    NICE Evidence Services Available at: Last accessed: 14 November 2019

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