Finished product reference
Perampanel
Tablet · Oral · 8 mg
- List code
- 53537
- Pharmacologic class
- Noncompetitive AMPA Glutamate Receptor Antagonist
WARNING: SERIOUS PSYCHIATRIC AND BEHAVIORAL REACTIONS Serious or life-threatening psychiatric and behavioral adverse reactions including aggression, hostility, irritability, anger, and homicidal ideation and threats have been reported in patients taking perampanel .
What it is and how it works
Mechanism of Action Perampanel is a non-competitive antagonist of the ionotropic α-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid (AMPA) glutamate receptor on post-synaptic neurons. Glutamate is the primary excitatory neurotransmitter in the central nervous system and is implicated in a number of neurological disorders caused by neuronal over excitation. The precise mechanism by which perampanel exerts its antiepileptic effects in humans is unknown.
Mechanism class: AMPA Receptor Antagonists · UGT2B7 Inhibitors · UGT1A9 Inhibitors
Indications
Perampanel, a non-competitive AMPA glutamate receptor antagonist, is indicated for: Treatment of partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy 4 years of age and older Adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients with epilepsy 12 years of age and older Partial-Onset Seizures Perampanel oral suspension is indicated for the treatment of partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy 4 years of age and older. Primary Generalized Tonic-Clonic Seizures Perampanel oral suspension is indicated as adjunctive therapy for the treatment of primary generalized tonic-clonic seizures in patients with epilepsy 12 years of age and older.
Dosage and administration (summary)
Dosing in the absence of moderate or strong CYP3A4 inducers Starting dose: 2 mg once daily orally at bedtime ( 2.1 , 2.2 ) May increase dose based on clinical response and tolerability by increments of 2 mg once daily no more frequently than at weekly intervals ( 2.1 , 2.2 ) Recommended maintenance dose in monotherapy or adjunctive therapy for partial-onset seizures: 8 mg to 12 mg once daily at bedtime Recommended maintenance dose in adjunctive therapy for primary generalized tonic-clonic seizures: 8 mg once daily at bedtime Measure oral suspension using provided adaptor and dosing syringe Dosing in the presence of concomitant moderate or strong CYP3A4 inducers : see section Specific Populat…
Contraindications
None. None
Warnings and precautions
Suicidal Behavior and Ideation: Monitor for suicidal thoughts or behavior Neurologic Effects: Monitor for dizziness, gait disturbance, somnolence, and fatigue Patients should use caution when driving or operating machinery Falls: Monitor for falls and injuries Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/ Multi-Organ Hypersensitivity: Discontinue if no alternate etiology Withdrawal of Antiepileptic Drugs: In patients with epilepsy, there may be an increase in seizure frequency Serious Psychiatric and Behavioral Reactions In the controlled partial-onset seizure clinical trials,…
Pregnancy
Pregnancy Risk Summary There are no adequate data on the developmental risk associated with use in pregnant women. In animal studies, perampanel induced developmental toxicity in pregnant rat and rabbit at clinically relevant doses . In the U.S.
Storage and supply
Storage Do not store above 30°C (86°F). Do not freeze. Use within 90 days after the first opening of the bottle.
Source: Perampanel (Perampanel) — US FDA prescribing information, 2026-06-02, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.
Other presentations of the same active ingredient
Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.
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