Perampanel Tablets
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The company has production licenses for tablets, capsules, granules, suppositories, powders, injections, oral solutions, dry suspensions, and eye drops.
Product Description
Approval Number:
H20244857
Indications:
Treatment of adults and children with partial-onset seizures (with or without secondary generalized seizures) in children aged 4 years and above.
Administration：
Adults, adolescents, and children 4 years of age and older
The dose of perampanel must be titrated according to the patient's individual response to optimize the balance between efficacy and tolerability.
This product should be taken orally once a day before bedtime.
Partial epilepsy seizures
Studies have shown that perampanel 4 mg/day to 12 mg/day is effective in treating epilepsy partial seizures.
The initial dose of this product in patients aged 4 years and above is 2mg/day. The dose can be increased in increments of 2 mg each time, depending on the clinical response and tolerability, with an interval of at least 1 or 2 weeks (the specific interval is considered according to the half-life of the concomitant drug described below), so that the maintenance dose can reach 4 mg/day to 8 mg/day.
Depending on the individual clinical response and tolerability at the 8 mg/day dose, the dose can be increased up to 12 mg/day. The interval between each dose is at least 1 week or 2 weeks (the specific interval is considered according to the half-life of the concomitant drug described below), and each dose is in increments of 2 mg.
If the patient does not shorten the half-life of this product with the drug used together, the interval between each titration of this product is at least 2 weeks. If the patient's concomitant use of drugs will shorten the half-life of this product, the interval should be at least 1 week.
Discontinuation of the drug
It is recommended to taper the dose to discontinue the drug to minimize the likelihood of seizure recurrence. However, due to the long half-life of perampanel and the slow decline in plasma concentrations after discontinuation of the drug, it can be discontinued immediately if necessary.
Missed dose
Single missed dose: Due to the long half-life of perampanel, patients should wait until the scheduled time to take the next dose.
If multiple doses are missed, but the duration is less than 5 half-lives (3 weeks for patients who have not taken this product for metabolism-inducing antiepileptic drugs, and 1 week for patients who have taken this product for metabolism-inducing antiepileptic drugs), re-starting treatment from the last dose level should be considered.
If the patient continues to discontinue this product for more than 5 half-lives, it is recommended to follow the recommended initial dose re-titration given above.
Older adults (65 years and older)
The perampanel clinical study did not include a sufficient number of participants aged ≥ 65 years to determine whether this population responds differently to the drug than younger participants. An analysis of the safety information of 905 elderly subjects treated with this product (double-blind study in non-epilepsy indications) showed no age-related differences in safety characteristics. Combined with the fact that there was no age-related exposure difference in this product, the results of the analysis showed that the elderly did not need to adjust the dose. Considering that drug interactions may occur in patients receiving polypharmacy, this product should be used with caution in elderly patients.
Renal impairment
Perampanel is used in patients with mild renal impairment and does not require dose adjustment. This product is not recommended for patients with moderate or severe renal impairment or those undergoing hemodialysis.
Liver impairment
Perampanel in patients with mild and moderate liver impairment should be based on clinical response and tolerability. For patients with mild or moderate liver impairment, titration can be started at a dose of 2 mg/day. Depending on patient tolerability and effectiveness, the titration dose should be increased at a dose of 2 mg every 2 weeks or longer.
For patients with mild and moderate liver damage, the dose of this product should not exceed 8mg/day.
Not recommended for patients with severe liver damage.
Pediatric population
The safety and efficacy of perampanel in children under 4 years of age with partial-onset seizures have not been established.
Administration
Oral administration once a day, at bedtime, on an empty stomach or with food. This product should be swallowed whole, never chewed, crushed or broken. Since the tablets are not notched, this product cannot be broken evenly.
Specifications:
2mg x 28 tablets, 4mg x 28 tablets
The company has production licenses for tablets, capsules, granules, suppositories, powders, injections, oral solutions, dry suspensions, and eye drops.
The main products cover cardiovascular diseases, diabetic complications, anti-tumor, calcium supplementation, digestive system, respiratory system, and orthopedics.
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