Peranel Tablet 2 mg (Perampanel (Unformulated))

Adult dose

This drug is taken once daily at bedtime, regardless of food, and should be swallowed whole with plenty of water without chewing, crushing, or splitting. Dose adjustment Adjust the dose by 2mg per day at intervals of at least 2 weeks. For patients receiving concomitant drugs 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 drugs that decrease the half-life of perampanel (such as phenytoin, carbamazepine, and oxcarbazepine), adjust the dose by 2mg per day at intervals of at least 1 week (see Section ‘6. Drug Interactions’). When discontinuing this drug, reduce the dose gradually (see Section ‘5. General Precautions’). If a dose of this drug is missed during treatment, take it as follows, depending on the duration of the interruption. ㆍIf 1 dose is missed: Considering the long half-life of perampanel, do not take an extra dose; take the next dose at the next scheduled dosing 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 for a consecutive period of 5 times the half-life or longer: Retitrate the dose starting from the initial dose. A period equivalent to 5 times the half-life is 3 weeks in patients not taking antiepileptic drugs that induce perampanel metabolism, and 1 week in patients taking such drugs. Patients with renal impairment No dose adjustment is necessary for patients with mild renal impairment. Use of this drug is not recommended in patients with moderate or severe renal impairment or in patients undergoing 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, 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 drug is not recommended in patients with severe hepatic impairment.

Child dose

Monotherapy, partial-onset seizures: Age 4 years and older — Initiate treatment at 2mg per day. The maintenance dose is 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 — Initiate treatment at 2mg per day. The maintenance dose is 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 — Initiate treatment at 2mg per day. The maintenance dose is up to 8mg per day; if necessary, the dose may be increased to a maximum of 12mg per day.

This drug is used in the treatment of epilepsy, and there may be an increased risk of suicidal thoughts or actions during its use, so patients' mood and behavioral changes should be monitored closely. Behavioral changes such as aggression, anger, and irritability may occur, and if these symptoms appear, a doctor should be consulted immediately. This medication should not be given to patients with certain genetic disorders or those who are hypersensitive to its ingredients, and people with lactose intolerance should not take it as it contains lactose. Elderly patients may have an increased risk of falls and should be monitored closely, and patients with a history of substance abuse should be closely observed for signs of abuse when using this medication. Drug interactions may occur when used in conjunction with other medications, particularly those that induce or inhibit metabolic enzymes in the liver, and should be monitored closely under a doctor's guidance. Dizziness or drowsiness may occur during use, so caution should be taken when driving or operating dangerous machinery. Severe skin reactions may occur, so if symptoms such as rash, fever, or swollen lymph nodes appear, the medication should be discontinued immediately, and a doctor should be consulted. Pregnant or nursing women should use this medication cautiously, and women of childbearing age are advised to use additional contraceptive methods as this medication may reduce the effectiveness of hormonal contraceptives. In case of overdose, there is no specific antidote, and immediate medical treatment and supportive care are necessary. This medication should be swallowed whole without chewing, breaking, or splitting. Keep this medication out of reach of children and do not use products that have passed their expiration date.

suicidal ideation, suicidal behavior, depression, aggression, hostility, irritability, anger, homicidal ideation, threats, 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 disorder, fatigue, weight gain, falls, memory impairment, cognitive impairment, rigidity, perceptual disturbance, head tremor, sedation, syncope, sensory loss, mental disturbance, psychomotor agitation, bradykinesia, cerebrovascular accident, decreased level of consciousness, attention deficit, orthostatic dizziness, stupor, encephalopathy, epilepsy, generalized tonic-clonic seizures, hypotonia, clonic spasms, cluster seizures, suicide attempt, confusional state, acute psychosis, auditory hallucinations, changes in mental state, sleep disorders, visual hallucinations, delirium, attention-deficit hyperactivity disorder, bruxism, drug dependence, echolalia, visual disturbances, mixed hallucinations, inappropriate affect, intermittent explosive disorder, changes in mental state, negative thinking, psychotic disorder, restlessness, schizophrenia, sleep seizures, fever, worsening condition, malaise, chest discomfort, edema, warmth, swelling, facial swelling, chill sensation, pain, peripheral edema, abdominal pain, diarrhea, abdominal discomfort, constipation, upper abdominal pain, oral ulcer formation, nausea, dry mouth, gastritis, excessive salivation, alopecia, urticaria, acne, sweating, friction urticaria, eye pain, increased tear secretion, reduced 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, dyspnea, nasal obstruction, orthostatic hypotension, peripheral coldness, musculoskeletal stiffness, myalgia, palpitations, oral injury, anemia, spontaneous abortion, bed bound, headache, seizure, hypersomnia, somnolence, tremor, insomnia, auditory hallucinations, asthenia, strange sensations, drug adverse reactions, vomiting, dyspepsia, rash, pruritus, muscle weakness, changes in mental state, anxiety, aggressive behavior, coma, decreased level of consciousness

This medication should be stored in a tightly closed container to prevent air and moisture from entering. It is best to maintain a storage temperature between 1 degree Celsius and 30 degrees Celsius at room temperature.

Appearance

Orange round film-coated tablet

Package unit

30 tablets/bottle, 90 tablets/bottle