Riferimento farmaci
Ganaxolone
Ganaxolone is a medicine in the class central nervous system. It is used for seizures.
- Classe del farmaco: Central Nervous System
- Indicato per: seizures
Ultimo aggiornamento Fonti: EMA SmPC
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In breve
- Classe del farmaco
- Central Nervous System
- Forme farmaceutiche comuni
- sospensione orale
- Dosaggi comuni
- 50 mg/ml
- Interazioni note
- 140 (Maggiore: 8 · Moderata: 126 · Minore: 6)
- Nomi commerciali
- 2
- Paesi e mercati
- 2
Per cosa si usa
Come agisce
Neuroactive steroid, methyl analogue of allopregnanolone, that positively and allosterically modulates GABAA receptors; anticonvulsant effect thought to result from tonic modulation of GABA-mediated inhibition. Precise mechanism in CDD seizures is unknown.
Dose abituale nell'adulto (sintesi del foglio illustrativo)
Adults: treatment initiation is not recommended; efficacy and safety not established. Treatment may be continued into adulthood in adolescents with demonstrated benefit.
Gravidanza e allattamento
- Gravidanza
- Unsafe No human data. In animals it caused fetal malformations (mice) and growth and behaviour problems (rats) at exposures below human levels, and neuronal death in the developing rat brain. EU label: not recommended in pregnancy or without contraception.
- Allattamento
- Safe Passes into milk (about 4 times plasma levels), but the infant dose is about 1% of the mother's dose; infant effects unknown. EU label: decide whether to stop breastfeeding or the drug. LactMed: amounts appear low and are not expected to harm the infant. Watch for drowsiness.
Effetti indesiderati segnalati
- Somnolence
- Pyrexia
- Sedation
- Hypersomnia
- Lethargy
- Drooling
Controindicazioni
- Hypersensitivity to the active substance or to any excipient.
Chi deve prestare attenzione
- Causes somnolence and sedation; other CNS depressants (anti-seizure drugs, opioids, antidepressants, alcohol) may potentiate this.
- Suicidal behaviour and ideation reported with antiepileptic drugs; caregivers should monitor and seek medical advice if signs emerge.
- Avoid strong CYP3A4 inducers (carbamazepine, phenobarbital, phenytoin, primidone, rifampicin, St John's Wort) as they reduce ganaxolone exposure.
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Interazioni principali (140)
- Amobarbital + Ganaxolone Major
- Apalutamide + Ganaxolone Major
- Armodafinil + Ganaxolone Major
- Carbamazepine + Ganaxolone Major
- Enzalutamide + Ganaxolone Major
- Ganaxolone + Phenytoin Major
- Ganaxolone + Rifampicin Major
- Ganaxolone + Secobarbital Major
- Alprazolam + Ganaxolone Moderate
- Amisulpride + Ganaxolone Moderate
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- Dosing by age, kidney and liver function, and further dose lines
- Renal and hepatic dose adjustments
- Paediatric dosing
- Dosing in older adults
- How to give it
- Pharmacokinetics
- Patient counselling points
- Food interactions
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Altri farmaci della stessa classe
Domande frequenti
What is Ganaxolone used for?
Ganaxolone is a medicine in the class central nervous system. It is used for Seizures.
What side effects have been reported with Ganaxolone?
Somnolence, Pyrexia, Sedation, Hypersomnia, Lethargy, Drooling.
Can Ganaxolone be taken in pregnancy or while breastfeeding?
Pregnancy: Unsafe. No human data. In animals it caused fetal malformations (mice) and growth and behaviour problems (rats) at exposures below human levels, and neuronal death in the developing rat brain. EU label: not recommended in pregnancy or without contraception. Breastfeeding: Safe. Passes into milk (about 4 times plasma levels), but the infant dose is about 1% of the mother's dose; infant effects unknown. EU label: decide whether to stop breastfeeding or the drug. LactMed: amounts appear low and are not expected to harm the infant. Watch for drowsiness.
What does Ganaxolone interact with?
MediHelp lists 140 known interactions for Ganaxolone. Major: 8 · Moderate: 126 · Minor: 6. The most serious include Amobarbital, Apalutamide, Armodafinil.
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