Perampanel Film-Coated Tablets 2 mg (Perampanel)

Adult dose

Take this medicine 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 medicines 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 medicines 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 of this medicine is missed during treatment, take it as follows, depending on the duration of the interruption. ㆍIf 1 dose is missed: In view of the long half-life of perampanel, do not take an additional dose; take the next dose at the next scheduled dosing time. ㆍIf 2 or more consecutive doses are missed, but the interruption is less than 5 times the half-life: Consider restarting treatment at the last administered dose. ㆍIf doses are missed for 5 times the half-life or longer consecutively: Retitrate the dose starting from the initial dose. A period corresponding to 5 times the half-life is 3 weeks in patients not taking antiepileptic medicines that induce perampanel metabolism, and 1 week in patients taking such medicines. Patients with renal impairment No dose adjustment is necessary 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 necessary 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, and the dose is increased by 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. As in other patients, adjust the dose according to the patient's clinical response and tolerability. Use of this medicine is not recommended in patients with severe hepatic impairment.

Child dose

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

This medication may carry a risk of suicidal thoughts or behaviors during treatment, so patients and their guardians should closely monitor any changes in mood or behavior. Additionally, psychiatric symptoms such as aggression, anger, or irritability may occur during the use of this medication, and if such symptoms arise, it is essential to consult a doctor immediately. This medication should not be administered to patients with specific genetic disorders or those with a history of allergic reactions. Special care is necessary for elderly patients due to an increased risk of falls, and patients with a history of substance abuse should be monitored more cautiously. There may be drug interactions when used in combination with other medications, so it is crucial to inform the physician of all medications currently being taken. This medication may cause side effects such as dizziness or drowsiness, requiring caution while driving or operating dangerous machinery. Serious allergic reactions, such as severe rashes or fever, may occur, and if symptoms like rash or fever are evident, the medication should be discontinued immediately, and medical personnel should be consulted. Women who are pregnant or breastfeeding must consult a doctor before taking this medication, and women of childbearing age should use reliable contraception. The safety of this medication for children and elderly patients has not been adequately confirmed, so it must be used with caution in these age groups. Overdosage may result in symptoms such as mental confusion, anxiety, and decreased consciousness, so the dosage should be strictly adhered to, and immediate medical attention should be sought if abnormal symptoms occur. This medication should not be chewed or crushed and must be swallowed whole with adequate water, and it should be stored out of reach of children.

Suicidal impulses, suicidal behavior, depression, aggression, hostility, irritability, anger, homicidal impulses, threats, state of confusion, psychotic disorders, dizziness, drowsiness, ataxia, speech disorders, balance disorders, double vision, blurred vision, vertigo, nausea, drug reaction accompanied by eosinophilia and systemic symptoms (DRESS syndrome), Stevens-Johnson syndrome (SJS), back pain, gait disturbances, fatigue, weight gain, falls, memory impairment, cognitive impairment, flexibility, perceptual disturbances, head tremors, sedation, syncope, sensory loss, mental disorders, hyperactivity of psychomotor activity, bradykinesia, cerebrovascular accidents, reduced level of consciousness, attention deficits, orthostatic dizziness, drowsy state, encephalopathy, epilepsy, generalized tonic-clonic seizures, hypotonia, clonic muscle spasms, cluster seizures, suicide attempts, acute psychosis, auditory hallucinations, changes in mental state, sleep disturbances, hallucinations, delirium, attention deficit hyperactivity disorder, bruxism, drug dependence, echolalia, visual hallucinations, mixed hallucinations, inappropriate affect, intermittent explosive disorder, restlessness, schizophrenia, sleep seizures, fever, deterioration of condition, malaise, chest discomfort, edema, warmth, swelling, facial swelling, cold sensation, pain, peripheral edema, abdominal pain, diarrhea, abdominal discomfort, constipation, epigastric pain, formation of oral ulcers, nausea, dry mouth, gastritis, excessive salivation, alopecia, urticaria, acne, cold sweats, frictional urticaria, eye pain, increased tear production, vision impairment, eye fatigue, weight loss, increased liver function tests, decreased platelet count, encephalitis, soft tissue infections, chronic hepatitis B, erectile dysfunction, menstrual disorders, sexual dysfunction, shortness of breath, nasal obstruction, orthostatic hypotension, peripheral coldness, musculoskeletal rigidity, myalgia, palpitations, oral injuries, anemia, spontaneous abortion, bedridden, headache, seizures, hypersomnia, somnolence, tremors, insomnia, vomiting, dyspepsia, rash, pruritus, muscle weakness, changes in mental state, anxiety, aggressive behavior, coma, reduced level of consciousness

This medication must be stored in a tightly sealed container to prevent exposure to air and moisture. It is crucial to maintain the storage temperature between 1 and 30 degrees Celsius to ensure the medication's effectiveness and safe use.

Appearance

Orange, double-convex, round film-coated tablet

Package unit

7 tablets / blister, 28 tablets (7 tablets / blister × 4), 28 tablets (14 tablets / blister × 2)