Pericompa Tablets 6 mg (Perampanel (Unformulated))

Adult dose

This medicine is taken once daily at bedtime, with or without food. Swallow the tablet 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 (e.g., phenytoin, carbamazepine, oxcarbazepine), adjust the dose by 2mg per day at intervals of at least 1 week (see ‘6. Drug interactions’). When discontinuing this medicine, reduce the dose gradually (see ‘5. General precautions’). If a dose is missed during treatment, take the medicine as follows, depending on the duration of the interruption. ㆍIf 1 dose is missed: In consideration of 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 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: Re-titrate the dose from the initial dose. The period corresponding to 5 times the half-life is 3 weeks for patients not taking antiepileptic drugs that induce perampanel metabolism, and 1 week for patients taking such medications. 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 with 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: 4 years of age and older — Treatment with this medicine is initiated at 2mg per day. Depending on the patient’s clinical response and tolerability, the dose is increased to the maintenance dose of 4mg to 8mg per day and, if necessary, may be increased to a maximum of 8mg per day. Adjunctive therapy, partial-onset seizures: 4 years of age and older — Treatment with this medicine is initiated at 2mg per day. Depending on the patient’s clinical response and tolerability, the dose is increased to the maintenance dose of 4mg to 8mg per day and, if necessary, may be increased to a maximum of 12mg per day. Adjunctive therapy, primary generalized tonic-clonic seizures: 7 years of age and older — Treatment with this medicine is initiated at 2mg per day. Depending on the patient’s clinical response and tolerability, the dose is increased to the maintenance dose of up to 8mg per day and, if necessary, may be increased to a maximum of 12mg per day.

This medication is used as an antiepileptic drug to control seizures in epilepsy patients. During treatment, there may be occurrences of suicidal thoughts or behaviors, the onset or worsening of depression, and abnormal changes in mood or behavior. Patients and guardians should closely monitor for these symptoms. Mental and behavioral disorders such as aggression, hostility, irritability, and anger may occur, and if such changes are observed, immediate consultation with a physician is necessary. Patients with allergies to this drug or its components, as well as those with lactose intolerance, should not take this medication. Elderly patients may be at increased risk of falls, requiring caution, and patients with a history of substance abuse should be closely monitored for signs of misuse of this medication. There may be interactions when taken with other drugs, particularly requiring dosage adjustments when used in combination with certain antiepileptic drugs under the guidance of a physician. Dizziness or drowsiness may occur during treatment, and caution should be exercised when driving or operating hazardous machinery. If severe skin rashes or systemic symptoms occur, discontinue use immediately and consult healthcare professionals. Women who are pregnant or breastfeeding should consult with a physician before using this medication. Women of childbearing age are advised to use additional non-hormonal contraception. There is no specific antidote in case of overdose, so immediate medical attention is necessary for appropriate treatment. This medication should not be chewed or crushed, and must be swallowed whole, and stored out of reach of children.

suicidal thoughts, suicidal behavior, depression, aggression, hostility, irritability, anger, homicidal thoughts, threats, dizziness, drowsiness, ataxia, dysarthria, balance disorder, double vision, 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 abnormalities, cognitive impairment, flexibility, perceptual disturbances, head tremors, sedation, fainting, sensory loss, mental disturbances, psychomotor hyperactivity, bradykinesia, cerebrovascular accident, level of consciousness decline, attention deficit, orthostatic dizziness, somnolence, encephalopathy, seizures, generalized tonic-clonic seizures, hypotonia, myoclonus, cluster seizures, suicide attempt, confusional state, 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, changes in mental state, negative thinking, psychotic disorders, restlessness, schizophrenia, sleep seizures, fever, worsening condition, malaise, chest discomfort, edema, warmth sensation, swelling, facial swelling, cold sensation, pain, peripheral edema, abdominal pain, diarrhea, abdominal discomfort, constipation, upper abdominal pain, oral ulcer formation, nausea, dry mouth, gastritis, hypersalivation, alopecia, urticaria, acne, diaphoresis, friction urticaria, eye pain, increased tear production, decreased vision, eye fatigue, weight loss, increased liver function tests, decreased platelet count, encephalitis, soft tissue infection, chronic hepatitis B, erectile dysfunction, menstrual disorders, sexual dysfunction, dyspnea, nasal obstruction, orthostatic hypotension, peripheral coldness, muscular stiffness, myalgia, palpitations, oral injury, anemia, spontaneous abortion, prolonged lying down, headache, seizures, hypersomnia, somnolence, tremors, insomnia, auditory hallucinations, weakness, strange sensations, drug adverse reactions, vomiting, dyspepsia, rashes, pruritus, muscle weakness, changes in mental state, anxiety, aggressive behavior, coma, level of consciousness decline

This medication should be stored in a tightly closed container to protect it from air and humidity, and it should be kept at room temperature, between 1 to 30 degrees Celsius.

Appearance

Pink, double-convex, round film-coated tablet

Package unit

30 tablets/box [10 tablets/PTP x 3], 30 tablets/bottle, 100 tablets/bottle