Peranell Tablet 6 mg (Perampanel (Unstructured))

Adult dose

Administration: 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

1. Monotherapy 1) Partial-onset seizures: Age 4 years and older — Treatment with this drug is initiated at 2mg per day. Increase to the maintenance dose of 4mg to 8mg per day according to the patient's clinical response and tolerability; if necessary, the dose may be increased to a maximum of 8mg per day. 2. Adjunctive therapy 1) Partial-onset seizures: Age 4 years and older — Treatment with this drug is initiated at 2mg per day. Increase to the maintenance dose of 4mg to 8mg per day according to the patient's clinical response and tolerability; if necessary, the dose may be increased to a maximum of 12mg per day. 2) Primary generalized tonic-clonic seizures: Age 7 years and older — Treatment with this drug is initiated at 2mg per day. Increase to the maintenance dose of up to 8mg per day according to the patient's clinical response and tolerability; if necessary, the dose may be increased to a maximum of 12mg per day.

This medication is used for the treatment of epilepsy, and there may be an increased risk of suicidal thoughts or behavior, so careful monitoring for signs of depression or mood changes is necessary during use. Aggressive or hostile behavior may occur; if such symptoms appear, consult a doctor immediately. Patients with allergic reactions to this medication or with specific genetic disorders such as lactose intolerance should not take this medication. Elderly patients may have an increased risk of falls and require caution, and patients with a history of substance abuse should be closely monitored for signs of drug abuse. There may be interactions when taking this medication with others, especially in combination with certain anticonvulsants, thus requiring dosage adjustments and monitoring. Dizziness or drowsiness may occur, requiring caution when driving or operating machinery. Severe adverse effects such as serious skin reactions and liver function abnormalities may occur; if symptoms such as skin rash or fever appear, inform a doctor immediately. Use during pregnancy is not recommended, and for those who are breastfeeding, the decision to use should be made after consulting a doctor. In the event of overdose, since there is no specific antidote, immediate medical treatment is necessary; this medication should be swallowed whole without chewing or crushing. Keep out of reach of children and do not use expired products.

Suicidal thoughts, suicidal behavior, depression, aggression, hostility, irritability, rage, homicidal impulses, threats, dizziness, drowsiness, ataxia, dysarthria, 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 disturbances, cognitive impairment, flexibility, perceptual disturbances, head tremor, sedation, syncope, sensory loss, altered mental state, psychomotor agitation, bradykinesia, cerebrovascular accident, level of consciousness impairment, attention deficit, orthostatic dizziness, stupor, encephalopathy, epilepsy, generalized tonic-clonic seizures, hypotonia, myoclonic jerks, cluster seizures, suicide attempts, confusional state, acute psychosis, auditory hallucinations, changes in mental state, sleep disorders, visual 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, exacerbation of condition, fatigue (languor), chest discomfort, edema, heat 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, excessive salivation, alopecia, urticaria, acne, diaphoresis, friction urticaria, eye pain, increased tear secretion, vision reduction, eye fatigue, weight loss, elevated liver function tests, reduced 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, lying down, headache, seizures, hypersomnia, somnolence, tremors, insomnia, auditory hallucinations, weakness, strange sensations, adverse drug reactions, vomiting, dyspepsia, rash, pruritus, muscle weakness, changes in mental state, restlessness, aggressive behavior, coma, level of consciousness impairment

This medication should be stored in a tightly closed container to protect it from air and moisture. It is best to store it at room temperature, between 1 to 30 degrees Celsius, avoiding extremes of heat or cold.

Appearance

Pink, round film-coated tablet

Package unit

30 tablets/bottle, 90 tablets/bottle