Stiripentol oral
- Drugs List
- Therapeutic Indications
- Dosage
- Administration
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Oral formulations containing stiripentol.
Drugs List
Therapeutic Indications
Uses
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.
Dosage
Stiripentol should only be administered under the supervision of a specialist in diagnosis and management of epilepsy in infants and children.
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.
Administration
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.
Contraindications
Breastfeeding
Hepatic impairment
History of psychosis
Renal impairment
Precautions and Warnings
Children under 3 years
Glucose-galactose malabsorption syndrome
Hereditary fructose intolerance
Phenylketonuria
Pregnancy
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
Pregnancy
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.
Lactation
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
Aggression
Altered liver function tests
Anorexia
Ataxia
Behavioural disturbances (children)
Cutaneous allergy
Decreased appetite
Diplopia
Disturbances of gastrointestinal function
Dizziness
Drowsiness
Dystonia
Fatigue
Gamma glutamyl transferase (GGT) increased
Hyperexcitability (children)
Hyperkinesia (children)
Hypotonia
Insomnia
Irritability
Nausea
Neutropenia
Photosensitivity
Rash
Sleep disturbances
Thrombocytopenia
Urticaria
Vomiting
Weight loss
Overdosage
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 ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
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: www.nice.org.uk Last accessed: 14 November 2019
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
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