Generic Drug Therapeutic Class: Neurology-Psychiatry
active ingredients: Stiripentol
Granulate for oral suspension
Box of 50 sachets-dose
Severe myoclonic epilepsy of the infant, as defined by the international classification *, in addition to the association valproate of sodium and clobazam, when this one proves to be insufficient to control the crises:
* - age of onset before one year with clonic seizures or tonic-clonic seizures febrile or not, possibly unilateral and / or prolonged, with normal EEG, normal MRI and normal psychomotor development;
- after one year, appearance:
. Myoclonus, atypical absences, even partial seizures,
. spikes generalized waves and often photosensitivity,
. a slowdown in psychomotor development.
Dosage DIACOMIT 250 mg Granule for oral suspension Box of 50 sachets-dose
- The initial dosage is 50 mg / kg / day.
- In case of insufficient efficacy, the dosage may be increased up to 75 mg / kg / day, or even 100 mg / kg / day with a maximum of 4 g per day.
- This increase in the initial dosage will be done gradually over 3 days while the dosage of the associated anti-epileptic drugs will be reduced in parallel.
- The daily dosage will be divided into 2 or 3 doses in the middle of meals to improve digestive tolerance.
Method of administration: The contents of the sachet can be dissolved in a glass of water or mixed with milk or dairy products (yogurts, swiss petits ...).
- Hypersensitivity to any of the components of the drug.
- Psychotic antecedents like crazy puffs.
- Severe hepatic insufficiency in the absence of data.
- Treatment with cisapride, pimozide, ergotamine, dihydroergotamine, halofantrine, quinidine, bepridil, ciclosporin, tacrolimus, sirolimus and statins (simvastatin and atorvastatin) (see interactions).
NOT RECOMMENDED :
Breast-feeding: In the absence of data on passage into breast milk, breastfeeding is not recommended during treatment.
Diacomit side effects
The most common side effects are:
- neurological disorders : drowsiness, insomnia, agitation, aggressiveness, atony, hypotonia, hypertonia;
- visual disturbances (in particular diplopia) during the combination with carbamazepine;
- gastrointestinal disorders : anorexia, weight loss (especially during combination with sodium valproate), nausea, vomiting, abdominal pain;
- skin effects : rash;
- biology : increase of gamma GT (in particular during combination with carbamazepine and valproate).
These side effects are usually due to increased plasma concentrations of other antiepileptic drugs (see warnings and precautions for use and interactions) and decline when the dosage of these associated drugs is reduced.
A few cases of neutropenia have been reported, spontaneously regressing or stopping stiripentol.