Stiripentol (1 brand name, 2 dosage forms, 1 route)
Available dosage forms: FOR SUSPENSION, CAPSULE.
Routes of administration: ORAL.
Brand Names
- DIACOMIT
Indications and Usage
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.
Contraindications
None.
Adverse Reactions
The following serious or otherwise clinically significant adverse reactions are described elsewhere in the labeling: Somnolence [see Warnings and Precautions (5.1)] Decreased Appetite and Decreased Weight [see Warnings and Precautions (5.2)] Neutropenia and Thrombocytopenia [see Warnings and Precautions (5.3)] Withdrawal Symptoms [see Warnings and Precautions (5.4)] Risks in Patients with Phenylketonuria [see Warnings and Precautions (5.5)] Suicidal Behavior and Ideation [see Warnings and Precautions (5.6)]
Mechanism of Action
The mechanism by which DIACOMIT exerts its anticonvulsant effect in humans is unknown. Possible mechanisms of action include direct effects mediated through the gamma-aminobutyric acid (GABA)A receptor and indirect effects involving inhibition of cytochrome P450 activity with resulting increase in blood levels of clobazam and its active metabolite.
Overdosage
There are no data concerning overdose in humans. In mice treated with high doses of stiripentol (600 to 1800 mg/kg i.p.), decreased motor activity and decreased respiration were observed. Treatment of an overdose should be supportive (symptomatic measures in intensive care units). For management of a suspected drug overdose, contact your regional Poison Control Center.