Formulary
Perampanel: Indications, Dosing, Side Effects and Interactions
Perampanel clinical drug profile including indications, dosing, side effects, cautions and interactions.
MedNext Academy | 5 min read
Perampanel: Indications, Dosing, Side Effects and Interactions
Perampanel clinical drug profile including indications, dosing, side effects, cautions and interactions.
Indications and dose
**Adjunctive treatment of focal seizures with or without secondary generalised seizures**
- **Child** (By Mouth): 12-17 years Initially 2 mg once daily, dose to be taken before bedtime, then increased, if tolerated, in steps of 2 mg at intervals of at least every 2 weeks, adjusted according to response; maintenance 4-8 mg once daily; maximum 12 mg per day.
- **Adult** (By Mouth): Initially 2 mg once daily, dose to be taken before bedtime, then increased, if tolerated, in steps of 2 mg at intervals of at least every 2 weeks, adjusted according to response; maintenance 4-8 mg once daily; maximum 12 mg per day.
**Adjunctive treatment of primary generalised tonic-clonic seizures**
- **Child** (By Mouth): 12-17 years Initially 2 mg once daily, dose to be taken before bedtime, then increased, if tolerated, in steps of 2 mg at intervals of at least every 2 weeks, adjusted according to response, maintenance up to 8 mg once daily; maximum 12 mg per day.
- **Adult** (By Mouth): Initially 2 mg once daily, dose to be taken before bedtime, then increased, if tolerated, in steps of 2 mg at intervals of at least every 2 weeks, adjusted according to response, maintenance up to 8 mg once daily; maximum 12 mg per day.
**Adjunctive treatment of focal seizures with or without secondary generalised seizures for perampanel**
- **Child 4-11 years (body-weight up to 20 kg)** (By mouth): Initially 1 mg once daily, dose to be taken before bedtime, then increased, if tolerated, in steps of 1 mg at intervals of at least every 2 weeks, adjusted according to response; maintenance 2-4 mg once daily, then increased, if tolerated, in steps of 0.5 mg at intervals of at least every 2 weeks, adjusted according to response; maximum 6 mg per day.
- **Child 4-11 years (body-weight 20-29 kg)** (By mouth): Initially 1 mg once daily, dose to be taken before bedtime, then increased, if tolerated, in steps of 1 mg at intervals of at least every 2 weeks, adjusted according to response; maintenance 4-6 mg once daily; maximum 8 mg per day.
- **Child 4-11 years (body-weight 30 kg and above)** (By mouth): Initially 2 mg once daily, dose to be taken before bedtime, then increased, if tolerated, in steps of 2 mg at intervals of at least every 2 weeks, adjusted according to response; maintenance 4-8 mg once daily; maximum 12 mg per day.
- **Child 12-17 years** (By mouth): Initially 2 mg once daily, dose to be taken before bedtime, then increased, if tolerated, in steps of 2 mg at intervals of at least every 2 weeks, adjusted according to response; maintenance 4-8 mg once daily; maximum 12 mg per day.
**Adjunctive treatment of primary generalised tonic-clonic seizures for perampanel**
- **Child 7-11 years (body-weight up to 20 kg)** (By mouth): Initially 1 mg once daily, dose to be taken before bedtime, then increased, if tolerated, in steps of 1 mg at intervals of at least every 2 weeks, adjusted according to response; maintenance 2-4 mg once daily, then increased, if tolerated, in steps of 0.5 mg at intervals of at least every 2 weeks, adjusted according to response; maximum 6 mg per day.
- **Child 7-11 years (body-weight 20-29 kg)** (By mouth): Initially 1 mg once daily, dose to be taken before bedtime, then increased in steps of 1 mg at intervals of at least every 2 weeks, adjusted according to response; maintenance 4-6 mg once daily; maximum 8 mg per day.
- **Child 7-11 years (body-weight 30 kg and above)** (By mouth): Initially 2 mg once daily, dose to be taken before bedtime, then increased, if tolerated, in steps of 2 mg at intervals of at least every 2 weeks, adjusted according to response; maintenance 4-8 mg once daily; maximum 12 mg per day.
- **Child 12-17 years** (By mouth): Initially 2 mg once daily, dose to be taken before bedtime, then increased, if tolerated, in steps of 2 mg at intervals of at least every 2 weeks, adjusted according to response, maintenance up to 8 mg once daily; maximum 12 mg per day.
Side effects
Common or very common Anxiety; appetite abnormal; back pain; behaviour abnormal; confusion; dizziness; drowsiness; dysarthria; fatigue; gait abnormal; irritability; movement disorders; nausea; vertigo; vision disorders; weight increased Uncommon Suicidal behaviours Frequency not known Homicidal ideation; severe cutaneous adverse reactions (SCARs)
Interactions
**Other interactions (25):**
- Perampanel Eisai is not considered a strong inducer or inhibitor of cytochrome P450 or UGT enzymes (see section 5.2).
- Hormonal contraceptives In healthy women receiving 12 mg (but not 4 or 8 mg/day) for 21 days concomitantly with a combined oral contraceptive, perampanel was shown to decrease the levonorgestrel...
- Ethinylestradiol AUC was not affected by perampanel 12 mg whereas C max was decreased by 18%.
- Therefore, the possibility of decreased efficacy of hormonal progestativecontaining contraceptives should be considered for women needing perampanel 12 mg/day and an additional reliable method...
- Interactions between perampanel and other antiepileptic medicinal products Potential interactions between perampanel and other antiepileptic drugs (AEDs) were assessed in clinical studies.
- A population PK analysis of three pooled Phase 3 studies in adolescent and adult patients with partialonset seizures evaluated the effect of perampanel (up to 12 mg once daily) on the PK of other...
Pregnancy
Important safety information For perampanel MHRA/CHM advice: Antiepileptics: risk of suicidal thoughts and behaviour (August 2008) See Epilepsy . MHRA/CHM advice: Antiepileptic drugs: updated advice on switching between different manufacturers' products (November 2017) See Epilepsy and see also Prescribing and dispensing information . MHRA/CHM advice: Antiepileptic drugs in pregnancy: updated advice following comprehensive safety review (January 2021) See Epilepsy .
Breast feeding
Avoid-present in milk in animal studies.
Hepatic impairment
Caution in mild to moderate impairment; avoid in severe impairment. M Dose adjustments Maximum 8 mg per day in mild to moderate impairment. M
Renal impairment
Avoid in moderate or severe impairment. M
Medicinal forms
Suspension,Tablet,Suspension
Clinical governance
**Author:** MedNext Clinical Team. **Clinical reviewer:** Dr Shameer Deen, MBBS, MS, MRCS. **Sources:** BNF, Indian Pharmacopoeia, CIMS India. **Correction:** Report errors at support@mednext.academy.
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