natgillin/translations-raw huggingface dataset:
As stiripentol inhibited CYP2D6 in vitro at concentrations that are achieved clinically in plasma, drugs that are metabolized by this isoenzyme like: beta-blockers (propranolol, carvedilol, timolol), antidepressants (fluoxetine, paroxetine, sertraline, imipramine, clomipramine), antipsychotics (haloperidol), analgesics (codeine, dextromethorphan, tramadol) may be subject to metabolic interactions with stiripentol.
4 Ker stiripentol zavira CYP2D6 in vitro pri koncentracijah, ki so enake kliničnim koncentracijam v plazmi, imajo lahko zdravila, ki se presnavljajo preko tega izoencima (npr. zaviralci adrenergičnih receptorjev beta (propranolol, karvedilol, timolol), antidepresivi (fluoksetin, paroksetin, sertralin, imipramin, klomipramin), antipsihotiki (haloperidol), analgetiki (kodein, dekstrometorfan, tramadol)), presnovne interakcije s stiripentolom.
A dose-adjustment may be necessary for drugs metabolised by CYP2D6 and that are individually dose titrated.
Pri dajanju zdravil, ki se presnavljajo s CYP2D6 in kjer se odmerek določa posebej za vsakega bolnika, bo morda potrebno prilagoditi odmerek.
In the absence of available clinical data, caution should be taken with the following clinically relevant interactions with stiripentol:
Potencial stiripentola za interakcije z drugimi zdravili Ker ni kliničnih podatkov je potrebna previdnost pri naslednjih klinično pomembnih interakcijah s stiripentolom:
- Rye ergot alkaloids (ergotamine, dihydroergotamine)
- Alkaloidi rženega rožička (ergotamin, dihidroergotamin)
- Cisapride, halofantrine, pimozide, quinidine, bepridil
- Cisaprid, halofantrin, pimozid, kinidin, bepridil
Increased risk of cardiac arrhythmias and torsades de pointes/ wave burst arrhythmia in particular.
Povečano tveganje srčnih aritmij in zlasti pojava torsades de pointes/ aritmije s porušitvijo valov.
- Immunosuppressants (tacrolimus, cyclosporine, sirolimus)
Zdravila za zaviranje imunske odzivnosti (takrolimus, ciklosporin, sirolimus) Zvišane koncentracije zdravil za zaviranje imunske odzivnosti v krvi (zmanjšana presnova v jetrih).
Increased risk of dose-dependent adverse reactions such as rhabdomyolysis (decreased hepatic metabolism of cholesterol-lowering agent)
Povečano tveganje neželenih učinkov, ki so odvisni od odmerka, npr. rabdomioliza (zmanjšana jetrna presnova zdravil za znižanje ravni holesterola).
- Theophylline, caffeine
- Teofilin, kofein
Increased plasma levels of theophylline and caffeine may occur via inhibition of their hepatic metabolism, potentially leading to toxicity.
Zaradi zaviranja presnove v jetrih lahko pride do zvišanih plazemskih ravni teofilina in kofeina, kar lahko povzroči toksične učinke.
These combinations should be avoided.
Tem kombinacijam se je treba izogniti.
- Chlorpromazine
- Klorpromazin
Stiripentol enhances the central depressant effect of chlorpromazine.
Stiripentol poveča učinek klorpromazina na centralni živčni sistem.
- Effects on other AEDs
- Učinki na druga zdravila proti epilepsiji
Inhibition of CYP450 isoenzyme CYP2C19 and CYP3A4 may provoke pharmacokinetic interactions (inhibition of their hepatic metabolism) with phenobarbital, primidone, phenytoin, carbamazepine, clobazam (See, section 4.2), valproate (See, section 4.2), diazepam (enhanced myorelaxation), ethosuximide, and tiagabine.
Zaviranje CYP450 izoencimov CYP2C19 in CYP3A4 lahko povzroči farmakokinetične interakcije (zaviranje njihove presnove v jetrih) s fenobarbitalom, primidonom, fenitoinom, karbamazepinom, klobazamom (glejte poglavje 4. 2), valproatom (glejte poglavje 4. 2), diazepamom (povečana miorelaksacija), etosuksimidom in tiagabinom.
5
Priporočeno je klinično spremljanje plazemskih ravni drugih antikonvulzivov, če se dajejo sočasno s stiripentolom, z možnostjo prilagoditve odmerkov.
In a French compassionate use program for Diacomit, topiramate was added to Diacomit, clobazam and valproate in 41% of 230 cases.
V francoskem programu sočutne uporabe zdravila Diacomit so kombinaciji zdravila Diacomit, klobazama in valproata v 41% primerov od 230 dodali topiramat.
With regard to topiramate, it is considered that potential competition of inhibition on CYP2C19 should not occur because it probably requires plasma concentrations 5 – 15 times higher than plasma concentrations obtained with the standard recommended topiramate dose and dosage schedules.
Predvideva se, da se pri topiramatu ne pojavlja potencialno tekmovanje za zaviranje CYP2C19, ker so za to verjetno potrebne 5- 15- krat višje plazemske koncentracije od koncentracij, ki so v plazmi pri standardnem priporočenem odmerku topiramata ter načrtu odmerjanja.
4.6 Pregnancy and lactation
5 4. 6 Nosečnost in dojenje
Risk related to epilepsy and antiepileptic medicinal products in general:
Splošna tveganja, ki so povezana z epilepsijo in zdravili proti epilepsiji:
It has been shown that in the offspring of women with epilepsy, the prevalence of malformations is two to three times greater than the rate of approximately 3% in the general population.
Dokazano je, da je pogostnost malformacij pri otrocih žensk z epilepsijo dva do trikrat večja od pogostnosti približno 3% v splošni populaciji.
Although other factors, e. g. the epilepsy, can contribute, available evidence suggests that this increase, to a large extent, is caused by the treatment.
Čeprav lahko k temu prispevajo drugi dejavniki (npr. epilepsija), dokazi, ki so na voljo, kažejo, da to povečanje v veliki meri povzročijo zdravila.
Risk related to Diacomit:
Tveganja, ki so povezana z zdravilom Diacomit:
Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, foetal development, parturition or postnatal development at non-maternotoxic doses (See, section 5.3).
Študije na živalih za odmerke, ki niso toksični za brejo samico, ne kažejo neposrednih ali posrednih škodljivih vplivov na nosečnost, razvoj plodu, porod ali postnatalni razvoj.
In view of the indication, administration of Diacomit during pregnancy and in women of childbearing potential would not be expected.
(glejte poglavje 5. 3) Upoštevaje indikacije se ne pričakuje uporaba zdravila Diacomit med nosečnostjo ali pri ženskah v rodni dobi.
The clinical decision for use of Diacomit in pregnancy needs to be made on an individual patient basis taking into consideration the potential clinical benefits and risks.
Klinična odločitev za uporabo zdravila Diacomit med nosečnostjo mora biti sprejeta glede na posamezno bolnico ob upoštevanju potencialnih koristnih učinkov in tveganj.
Caution should be exercised when prescribing to pregnant women and use of efficient methods of contraception is advisable.
Priporočljiva je uporaba učinkovite kontracepcije.
During pregnancy:
Med nosečnostjo:
Effective anticonvulsant treatment with Diacomit must not be stopped during pregnancy as worsening of the disease is potentially harmful to both mother and foetus.
Učinkovitega antikonvulzivnega zdravljenja z zdravilom Diacomit med nosečnostjo ne smemo prekiniti, saj je lahko poslabšanje bolezni potencialno škodljivo tako za nosečnico kot za plod.
In case Diacomit therapy is continued during breast-feeding, the breast-fed infant should be carefully observed for potential adverse effects.
V primeru nadaljevanja zdravljenja z zdravilom Diacomit med dojenjem je treba dojenčka natančno spremljati za možne neželene učinke.
Patients with SMEI would not be expected to drive or operate machinery due to the nature of the underlying disease and the effects of long term administration of anticonvulsant drugs.
Za bolnike s SMEI se zaradi narave obstoječe bolezni in učinkov dolgoročnega dajanja antikonvulzivnih zdravil vožnja oz. upravljanje s stroji ne pričakuje.
Diacomit may cause dizziness and ataxia that may affect ability to drive and use machines and patients should not drive or use machinery whilst on Diacomit therapy.
Zdravilo Diacomit lahko povzroči omotico in ataksijo, ki lahko vplivata na sposobnost vožnje in upravljanja s stroji, zato bolniki, ki se zdravijo z zdravilom Diacomit, ne smejo voziti ali upravljati s stroji.
Adverse reactions encountered most often are as follows: very common (≥ 1/ 10), common (≥ 1/ 100, < 1/ 10), uncommon (≥ 1/ 1,000, < 1/ 100), rare (≥ 1/ 10,000, < 1/ 1,000), very rare (< 1/ 10,000, including isolated cases), frequency not known (cannot be estimated from the available data).
Pogostnost ni znana (ni je mogoče oceniti iz razpoložljivih podatkov).
6 System/ organ classes
6 Organski sistem
System Organ Class (MedDRA terminology)
Organski sistem Zelo pogosti (izrazoslovje MedDRA) Bolezni krvi in limfatičnega sistema in Anoreksija, izguba Presnovne apetita, zmanjšanje prehranske telesne mase (zlasti motnje pri kombiniranju z natrijevim valproatom)
Very
Pogosti Nevtropenija Perzistentna huda nevropenija ponavadi izzveni spontano, ko se prekine zdravljenje z zdravilom Diacomit
Common
Psihiatrične
Uncommon
Nespečnost
Blood and lymphatic system disorders
Agresivnost,
Neutropenia Persistent severe neutropenia usually resolves spontaneously when Diacomit is stopped.
razdražljivost,
Metabolism and nutrition disorders
vedenjske motnje, nasprotujoče motnje obnašanje, hiperekscitabilnost, motnje spanja
Anorexia, loss of appetite, weight loss (especially when combined with sodium valproate)
Zaspanost, ataksija, Hiperkinezija Bolezni živčevja hipotonija, distonija Očesne bolezni
Psychiatric Disorders
Diplopija
Insomnia
(če
Aggressiveness, irritability, behaviour disorders, opposing behaviour, hyperexcitability, sleep disorders
se
Nervous system disorders Eye disorders
uporabi v kombinaciji s karbamazepinom) Navzea, bruhanje Bolezni prebavil Fotosenzitivnost, Bolezni kože in podkožja
Drowsiness, ataxia, hypotonia, dystonia
izpuščaj,
Hyperkinesias
kožna
Diplopia (when used in combination with carbamazepine)
alergija, urtikarija Utrujenost Splošne težave Zvišane ravni γGT (izrazitejše Preiskave
Gastrointestinal disorders
pri
Nausea, vomiting
kombiniranju
Skin and subcutaneous tissue disorders General disorders
s
Investigations
karbamazepinom in valproatom)
Many of the above adverse reactions are often due to an increase in plasma levels of other anticonvulsant medicinal products (See, sections 4.4 and 4.5) and may regress when the dose of these medicinal products is reduced.
Veliko zgoraj navedenih neželenih učinkov je posledica zvišanih plazemskih koncentracij drugih antikonvulzivnih zdravil (glejte poglavji 4. 4 in 4. 5), ki lahko izzvenijo po znižanju odmerka teh zdravil.
Other Antiepileptics, ATC code:
Drugi antiepileptiki, Oznaka ATC:
N03AX17 In animal models, stiripentol antagonizes seizures induced by electric shock, pentetrazole and bicuculline.
N03AX17 V živalskih modelih je stiripentol antagonist napadov, ki jih sprožijo udar električnega toka, pentetrazol in bikukulin.
In rodent models, stiripentol appears to increase brain levels of gamma-aminobutyric acid (GABA) - the major inhibitory neurotransmitter in mammalian brain.
Pri podganah stiripentol zviša ravni gama- aminomaslene kisline (GABA) v možganih, ki je poglavitni inhibitorni nevrotransmiter v možganih sesalcev.
This could occur by inhibition of synaptosomal uptake of GABA and/ or inhibition of GABA transaminase.
To je lahko posledica zaviranja privzema GABA v sinapsah ali zaviranja GABA- transaminaze ali obojega.
Stiripentol potentiates the efficacy of other anticonvulsants, such as
Dokazano je tudi, da stiripentol pospeši prenos, ki ga posredujejo GABAA receptorji v nezrelem hipokampusu podgan, in poveča povprečno trajanje odprtosti (vendar ne frekvence) kloridnih kanalčkov GABAA receptorjev z mehanizmom, ki je podoben kot pri barbituratih.
7 carbamazepine, sodium valproate, phenytoin, phenobarbital and many benzodiazepines, as the result of pharmacokinetic interactions.
Stiripentol zveča učinkovitost ostalih 7 antikonvulzivov (npr. karbamazepina, natrijevega valproata, fenitoina, fenobarbitala in številnih benzodiazepinov) kot posledica farmakokinetičnih interakcij.
The second effect of stiripentol is mainly based on metabolic inhibition of several isoenzymes, in particular CYP450 3A4 and 2C19, involved in the hepatic metabolism of other anti-epileptic drugs.
Drugi učinek stiripentola temelji predvsem na presnovnem zaviranju več izoencimov, zlasti CYP450 3A4 in 2C19, ki sodelujeta pri presnovi drugih zdravil proti epilepsiji v jetrih.
A French compassionate use program included children from 6 months of age because the diagnosis of Dravet’ s syndrome may be made with confidence at that age in some patients.
V francoski program sočutne uporabe so vključili otroke starejše od 6 mesecev, ker lahko diagnozo Dravetovega sindroma pri nekaterih bolnikih z gotovostjo postavimo šele pri tej starosti.
The clinical decision for use of Diacomit in children with SMEI less than 3 years of age needs to be made on an individual patient basis taking into consideration the potential clinical benefits and risks (See, section 4.2).
(glejte poglavje 4. 2)
Responders were defined as having more than 50% reduction in the frequency of clonic (or tonic- clonic) seizures during the second month of the double-blind period compared with baseline.
Kot odziv so šteli najmanj 50 -% znižanje pogostnosti kloničnih (ali tonično- kloničnih) napadov v drugem mesecu dvojno slepega dela raziskave v primerjavi z izhodiščnim obdobjem.
15 (71%) patients were responders on stiripentol (including nine free of clonic or tonic-clonic seizures), whereas there was only one (5%) on placebo (none was seizure free; stiripentol 95% CI 52.1-90.7 vs. placebo 0-14.6).
Odziv so zabeležili pri 15 (71%) bolnikih, ki so jemali stiripentol (vključno z 9 bolniki brez kloničnih ali tonično- kloničnih napadov), in pri enem bolniku (5%), ki je jemal placebo (noben bolnik brez napadov; 95 -% IZ: stiripentol 52, 1 - 90, 7 v primerjavi s placebom 0 - 14, 6).
The 95% CI of the difference was 42.2-85.7.
95 -% IZ razlike je bil 42, 2- 85, 7.
Percentage of change from baseline was higher on stiripentol (-69%) than on placebo (+7%), p < 0.0001.
Odstotek razlike od izhodiščnega obdobja je bila višja pri stiripentolu (- 69%) kot pri placebu (+7%), p < 0, 0001.
21 patients on stiripentol had moderate side- effects (drowsiness, loss of appetite) compared with eight on placebo, but side-effects disappeared when the dose of comedication was decreased in 12 of the 21 cases (Chiron et al, Lancet, 2000).
Enaindvajset bolnikov, ki so jemali stiripentol, je imelo zmerne neželene učinke (zaspanost, izguba apetita) v primerjavi z osmimi bolniki, ki so jemali placebo, vendar so neželeni učinki izzveneli, ko so odmerke sočasno uporabljenih zdravil zmanjšali pri 12 od 21 bolnikov (Chiron et al, Lancet, 2000).
This medicinal product has been authorised under a “ conditional approval” scheme.
Zdravilo je pridobilo tako imenovano „ pogojno dovoljenje za promet “.
This means that further evidence on this medicinal product is awaited, in particular about the efficacy of stiripentol in combination with the maximum safe dose of the add-on therapy.
To pomeni, da se pričakujejo dodatni dokazi o zdravilu, zlasti o učinkovitosti stiripentola v kombinaciji z najvišjim varnim odmerkom dodatnega zdravljenja.
A study is being conducted to investigate this.
V ta namen trenutno poteka raziskava.
The European Medicines Agency (EMEA) will review new information on the product every year and this SPC will be updated as necessary.
Evropska agencija za zdravila (EMEA) bo vsako leto ponovno pregledala nove podatke o zdravilu in posodobila povzetek glavnih značilnosti zdravila, če bo potrebno.
Absorption / Bioavailability:
Absorpcija / Biološka razpoložljivost:
Stiripentol is quickly absorbed, with a time to peak plasma concentration of about 1.5 hours.
Stiripentol se hitro absorbira s časom do najvišje koncentracije v plazmi 1, 5 ure.
Stiripentol binds extensively to circulating plasma proteins (about 99%).
Stiripentol se veliki meri veže na krožeče plazemske beljakovine (približno 99%).
Plasma clearance decreases markedly at high doses; it falls from approximately 40 l/ kg/ day at the dose of 600 mg/ day to about 8 l/ kg/ day at the dose of 2400 mg.
Pri velikih odmerkih se plazemski očistek zelo zmanjša; pade iz približno 40 l/ kg/ dan pri odmerku 600 mg/ dan na približno 8 l/ kg/ dan pri odmerku 2400 mg.
The half-life of elimination was in the range of 4.5 hours to 13 hours, increasing with dose.
Razpolovna doba izločanja je bila v razponu od 4, 5 ure do 13 ur in se je podaljševala z odmerkom.
8 Metabolism:
Presnova:
Stiripentol is extensively metabolized, 13 different metabolites having been found in urine.
8 Stiripentol se obsežno presnavlja; v urinu so odkrili 13 različnih presnovkov.
Urinary metabolites of stiripentol accounted collectively for the majority (73%) of an oral acute dose whereas a further 13-24% was recovered in faeces as unchanged drug.
Presnovki stiripentola v urinu so skupaj predstavljali večino (73%) peroralnega akutnega odmerka, v blatu pa so odkrili še dodatnih 13- 24% odmerka v nespremenjeni obliki.
Relative bioavailabilty between the capsules and powder for oral suspension in sachet formulations has been studied in healthy male volunteers after a 1,000mg single oral administration.
Biološka uporabnost / Bioekvivalenca Relativna biološka uporabnost kapsul v primerjavi s praškom za peroralno suspenzijo v vrečkah je bila predmet študije pri zdravih prostovoljcih moškega spola po enkratnem peroralnem odmerku v višini 1000 mg.
The two formulations were bioequivalent in terms of AUC but not in terms of Cmax.
Obe farmacevtski obliki sta bili bioekvivalentni v smislu AUC, vendar ne tudi v smislu Cmax.
Cmax of the sachet was slightly higher (23%) compared with the capsule and did not meet the criteria for bioequivalence.
Cmax praška za peroralno suspenzijo v vrečkah je bil nekoliko višji (23%) v primerjavi s kapsulo in ni zpolnil pogojev za bioekvivalentnost.
5.3 Preclinical safety data Toxicity studies in animals (rat, monkey, mouse) have not revealed any consistent pattern of toxicity apart from liver enlargement associated with hepatocellular hypertrophy, which occurred when high doses of stiripentol were administered to both rodents and nonrodents.
To odkritje se šteje kot adaptivni proces na veliko presnovno breme jeter.
This finding is considered to be an adaptive response to a high metabolic burden on the liver.
Raziskave teratogenih učinkov pri podganah in kuncih so pokazale, da stiripentol ni teratogen.
Stiripentol was not teratogenic when tested in the rat and rabbit; in one study in the mouse, but not in several other similar studies, a low incidence of cleft palate formation was observed at a maternotoxic dose (800 mg/ kg/ day).
V eni študiji na miših so ugotovili nizko pojavnost palatoshize, ko so breje samice prejemale toksične odmerke (800 mg/ kg/ dan), vendar tega odkritja niso potrdili v več drugih podobnih študijah.
Studies in the rat on fertility and general reproductive performance and on pre- and postnatal development were uneventful except for a minor reduction in the survival of pups nursed by mothers exhibiting toxic responses to stiripentol at a dose of 800 mg/ kg/ day (See, section, 4.6).
Pri podganah študije plodnosti, splošne sposobnosti razmnoževanja ter prenatalnega in postnatalnega razvoja niso pokazale učinkov, razen manjšega zmanjšanja preživetja mladičev, ki so jih dojile samice s toksičnim odzivom na stiripentol v odmerku 800 mg/ kg/ dan.
Genotoxicity studies have not detected any mutagenic or clastogenic activity.
(glejte poglavje 4. 6) V genotoksičnih študijah niso odkrili mutagenih ali klastogenih aktivnosti.
In the mouse there was only a small increase in the incidence of hepatic adenomas and carcinomas in animals treated with 200 or 600mg/ kg/ day for 78 weeks but not in those given 60mg/ kg/ day.
Tega pojava niso opazili, če so živali prejemale 60 mg/ kg/ dan.
povidone K29/ 32 sodium starch glycolate (type A) magnesium stearate
povidon K29/ 32 natrijev karboksimetilškrob (tip A) magnezijev stearat
Capsule shell Gelatin Titanium dioxide (E171) Erythrosine (E127) Indigotine (E132)
Ovojnica kapsul Želatina Titanov dioksid (E 171) Eritrozin (E127) Indigotin (E132)
9 6.2 Incompatibilities
9 Navedba smiselno ni potrebna.
Not applicable.
6. 3 Rok uporabnosti
, Store in the original package in order to protect from light.
Shranjujte v originalni ovojnini za zagotovitev zaščite pred svetlobo.
Bottles of 30, 60 and 90 capsules in cardboard cartons.
Plastenka je vložena v kartonsko škatlo.
Each capsule contains 500 mg of stiripentol
Ena kapsula vsebuje 500 mg stiripentola.
0.32 mg sodium per capsule.
0, 32 mg natrija v vsaki kapsuli.
Size 0, white capsule
Bele kapsule velikosti 0
11
11 V ključnih študijah je bil ob uvedbi zdravila Diacomit dnevni odmerek klobazama 0, 5 mg/ kg/ dan, običajno razdeljen v odmerka dvakrat dnevno.
12 4.4 Special warnings and precautions for use
4. 4 Posebna opozorila in previdnostni ukrepi
Neutropenia may be associated with the administration of Diacomit, clobazam and valproate.
12 Z dajanjem zdravila Diacomit, klobazama in valproata je lahko povezana nevtropenija.
Caution is advised when combining stiripentol with other drugs that inhibit or induce one or more of these enzymes.
Svetujemo previdnost pri kombinaciji stiripentola z drugimi zdravili, ki zavirajo ali sprožajo enega ali več the encimov.
HIV protease inhibitors, antinistamines such as astemizole, chlorpheniramine, calcium channel blockers, statins, oral contraceptives, codeine) due to the increased risk of adverse events (see further in this section for 13 antiepileptic drugs).
Če klinične okoliščine zahtevajo kombiniranje stiripentola z zdravili, ki se presnavljajo s CYP2C19 (npr. citalopram, omeprazol) ali CYP3A4 (npr. več zaviralcev proteaze HIV, antihistaminiki, kot je astemizol, klorfeniramin, zaviralci kalcijevih kanalčkov, statini, peroralni kontraceptivi, kodein), je potrebna previdnost zaradi povečanja tveganja neželenih učinkov (za zdravila proti epilepsiji poglejte nadaljevanje poglavja).
As stiripentol inhibited CYP2D6 in vitro at concentrations that are achieved clinically in plasma, drugs that are metabolized by this isoenzyme like: beta-blockers (propranolol, carvedilol, timolol), antidepressants (fluoxetine, paroxetine, sertraline, imipramine, clomipramine), antipsychotics (haloperidol), analgesics (codeine, dextromethorphan, tramadol) may be subject to metabolic interactions with stiripentol.
13 Ker stiripentol zavira CYP2D6 in vitro pri koncentracijah, ki so enake kliničnim koncentracijam v plazmi, imajo lahko zdravila, ki se presnavljajo preko tega izoencima (npr. zaviralci adrenergičnih receptorjev beta (propranolol, karvedilol, timolol), antidepresivi (fluoksetin, paroksetin, sertralin, imipramin, klomipramin), antipsihotiki (haloperidol), analgetiki (kodein, dekstrometorfan, tramadol)), presnovne interakcije s stiripentolom.
15 System/ organ classes
Organski sistem 15 Organski sistem Zelo pogosti (izrazoslovje MedDRA) Bolezni krvi in limfatičnega sistema in Anoreksija, izguba Presnovne apetita, zmanjšanje prehranske telesne mase (zlasti motnje pri kombiniranju z natrijevim valproatom)
System Organ Class (MedDRA terminology)
Pogosti Nevtropenija Perzistentna huda nevropenija ponavadi izzveni spontano, ko se prekine zdravljenje z zdravilom Diacomit
Very
Občasni
Common
Nespečnost
Uncommon
Agresivnost,
Blood and lymphatic system disorders
razdražljivost,
Stiripentol has also been shown to enhance GABAA receptor-mediated transmission in the immature rat hippocampus and increase the mean open-duration (but not the frequency) of GABAA receptor chloride channels by a
Dokazano je tudi, da stiripentol pospeši prenos, ki ga posredujejo GABAA receptorji v nezrelem hipokampusu podgan, in poveča povprečno trajanje odprtosti (vendar ne frekvence) kloridnih kanalčkov GABAA receptorjev z mehanizmom, ki je podoben kot pri barbituratih.
Stiripentol potentiates the efficacy of other anticonvulsants, such as carbamazepine, sodium valproate, phenytoin, phenobarbital and many benzodiazepines, as the result of pharmacokinetic interactions.
Stiripentol zveča učinkovitost ostalih antikonvulzivov (npr. karbamazepina, natrijevega valproata, fenitoina, fenobarbitala in številnih 16 benzodiazepinov) kot posledica farmakokinetičnih interakcij.