藥品參考
Ganaxolone
Ganaxolone is a medicine in the class central nervous system. It is used for seizures.
- 藥物類別: Central Nervous System
- 用途: seizures
最後更新 來源: EMA SmPC
僅供醫療專業人員參考。本頁為簡要摘要,並非醫療建議,亦不能取代官方仿單或臨床判斷。開立處方或調劑前請務必核實。
本頁的臨床內容僅提供英文版。
重點資訊
- 藥物類別
- Central Nervous System
- 常見劑型
- 口服懸液
- 常見規格
- 50 mg/ml
- 已知交互作用
- 140 (嚴重: 8 · 中度: 126 · 輕微: 6)
- 商品名
- 2
- 國家與市場
- 2
用途
作用方式
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.
成人常用劑量(仿單摘要)
Adults: treatment initiation is not recommended; efficacy and safety not established. Treatment may be continued into adulthood in adolescents with demonstrated benefit.
懷孕與哺乳
- 懷孕
- 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.
- 哺乳
- 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.
已通報的副作用
- Somnolence
- Pyrexia
- Sedation
- Hypersomnia
- Lethargy
- Drooling
禁忌症
- Hypersensitivity to the active substance or to any excipient.
哪些人需要特別留意
- 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.
請告知藥師或醫師您是否懷孕或哺乳、是否患有腎臟或肝臟疾病、是否有過敏,以及您正在使用的所有其他藥物或保健品。
重要交互作用 (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
Pro+ 會員專屬
解鎖完整頁面
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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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同類別的其他藥品
常見問題
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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