Perampanel Film-Coated Tablets 12 mg (Perampanel)

Adult dose

This medicine is taken once daily at bedtime, with or without food. Swallow it whole with plenty of water; do not chew, crush, or divide it. Dose adjustment Adjust the dose by 2mg per day at intervals of at least 2 weeks. For patients receiving concomitant medications that do not decrease the half-life of perampanel, adjust the dose by 2mg per day at intervals of at least 2 weeks. For patients receiving concomitant medications that decrease the half-life of perampanel (such as phenytoin, carbamazepine, or oxcarbazepine), adjust the dose by 2mg per day at intervals of at least 1 week (see section ‘6. Interactions’). When discontinuing this medicine, reduce the dose gradually (see section ‘5. General precautions’). If a dose is missed during treatment, take the medicine as follows, depending on the length of time missed. ㆍIf 1 dose is missed: Given the long half-life of perampanel, do not take an additional dose; take the next dose at the scheduled time. ㆍIf 2 or more consecutive doses are missed, but the period is less than 5 times the half-life: Consider restarting treatment at the last administered dose. ㆍIf doses are missed consecutively for a period of 5 times the half-life or longer: Retitrate the dose starting from the initial dose. A period equal to 5 times the half-life corresponds to 3 weeks if the patient is not taking antiepileptic drugs that induce perampanel metabolism, and 1 week if the patient is taking such drugs. Patients with renal impairment No dose adjustment is required for patients with mild renal impairment. Use of this medicine is not recommended in patients with moderate or severe renal impairment or in patients receiving hemodialysis. Patients with hepatic impairment Dose adjustment is required in patients with mild or moderate hepatic impairment because the half-life is prolonged and exposure is increased. The initial dose is 2mg per day, with increases of 2mg per day at intervals of at least 2 weeks. The maximum recommended dose is 6mg per day for patients with mild hepatic impairment and 4mg per day for patients with moderate hepatic impairment; adjust the dose according to the patient's clinical response and tolerability, as for other patients. Use of this medicine is not recommended in patients with severe hepatic impairment.

Child dose

Monotherapy for partial-onset seizures: Age 4 years and older — Start at 2mg once daily. Increase to the maintenance dose of 4mg to 8mg once daily according to the patient's clinical response and tolerability; if needed, the dose may be increased to a maximum of 8mg once daily. Adjunctive therapy for partial-onset seizures: Age 4 years and older — Start at 2mg once daily. Increase to the maintenance dose of 4mg to 8mg once daily according to the patient's clinical response and tolerability; if needed, the dose may be increased to a maximum of 12mg once daily. Adjunctive therapy for primary generalized tonic-clonic seizures: Age 7 years and older — Start at 2mg once daily. Increase to the maintenance dose of 8mg once daily according to the patient's clinical response and tolerability; if needed, the dose may be increased to a maximum of 12mg once daily.

This medication is used for the treatment of epilepsy and carries a risk of suicidal ideation or behaviors during use. Therefore, patients and caregivers should consult a physician immediately for any unusual changes in mood or behavior. This medication may cause psychiatric-related abnormal behaviors, such as aggression, anger, and irritability, so any such symptoms should be reported quickly to the healthcare provider. Patients with hypersensitivity to this drug or genetic lactose intolerance should not take it. Elderly patients are at increased risk of falls and should be monitored closely, and patients with a history of substance abuse should be watched carefully for signs of misuse of this medication. There may be interactions with other drugs, especially when taking certain anti-epileptic medications, thus careful monitoring of dosages and patient condition is necessary. This medication can cause dizziness and drowsiness, so caution should be exercised while driving or operating dangerous machinery. Severe skin reactions have been reported, including serious rashes or systemic symptoms, and if any skin symptoms occur, use should be stopped immediately and a doctor consulted. Women who are pregnant or breastfeeding should exercise caution when taking this medication, and it is especially not recommended during pregnancy. This medication may reduce the effectiveness of hormonal contraceptives, so it is advisable to use additional non-hormonal contraceptive methods. Overdosage may result in decreased consciousness, coma, aggression, and other symptoms, and if overdose is suspected, a healthcare facility should be visited immediately. This medication should be swallowed whole without chewing, breaking, or splitting, and kept out of the reach of children.

Suicidal ideation, suicidal behavior, depression, aggression, hostility, irritability, anger, homicidal ideation, threats, confusion, psychotic disorders, dizziness, drowsiness, ataxia, dysarthria, balance disorder, diplopia, blurred vision, vertigo, nausea, drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), Stevens-Johnson syndrome (SJS), back pain, gait disturbance, fatigue, weight gain, falls, memory impairment, cognitive impairment, flexibility, perceptual abnormalities, head tremor, sedation, syncope, sensory loss, mental abnormalities, excessive psychomotor activity, slowed movements, cerebrovascular accident, level of consciousness decrease, attention deficit, orthostatic dizziness, stupor, encephalopathy, epilepsy, generalized tonic-clonic seizure, hypotonia, focal muscle spasms, cluster seizures, suicide attempt, acute psychosis, auditory hallucinations, altered mental state, sleep disorders, hallucinations, delirium, attention deficit hyperactivity disorder, bruxism, drug dependence, echolalia, visual hallucinations, mixed hallucinations, inappropriate affect, intermittent explosive disorder, schizophrenia, sleep seizures, fever, worsening of condition, malaise, chest discomfort, edema, heat sensation, swelling, facial swelling, sensation of cold, pain, peripheral edema, abdominal pain, diarrhea, abdominal discomfort, constipation, upper abdominal pain, oral ulcer formation, nausea, dry mouth, gastritis, excessive salivation, alopecia, urticaria, acne, cold sweat, friction urticaria, eye pain, increased tear secretion, decreased vision, eye fatigue, weight loss, elevated liver function tests, decreased platelet count, encephalitis, soft tissue infection, chronic hepatitis B, erectile dysfunction, menstrual disorders, sexual dysfunction, shortness of breath, nasal obstruction, orthostatic hypotension, peripheral cold sensation, musculoskeletal rigidity, myalgia, palpitations, oral injury, anemia, spontaneous abortion, bedridden, headache, seizures, hypersomnia, drowsiness, tremors, insomnia, vomiting, dyspepsia, rash, pruritus, muscle weakness, altered mental state, anxiety, aggressive behavior, coma, level of consciousness decrease

This medication may be sensitive to air or moisture, so it should be stored in a tightly closed container. The storage temperature should be kept at room temperature between 1 degree and 30 degrees Celsius. Proper storage will help maintain the efficacy of the medication.

Appearance

Blue, double-convex, round film-coated tablet

Package unit

28 tablets (14 tablets/blister × 2)