Peranel Tablet 12 mg (Perampanel (Unrefined))

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 — 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. Adjunctive therapy, 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. Adjunctive therapy, 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 medicine may increase the risk of suicidal thoughts or behaviors, so careful observation for the appearance of depression or mood changes during treatment is necessary. Mental symptoms such as aggression, anger, and irritability may occur, and if these symptoms appear, immediate consultation with a physician is required. This medicine should not be administered to patients with certain genetic disorders, and special caution is necessary in patients with lactose intolerance. Caution is advised when administering to elderly patients due to the risk of falls, and patients with a history of substance abuse should be closely monitored for signs of abuse of this drug. This medication contains the dye Yellow No. 5, so patients with allergies to it should use it cautiously. Dizziness or drowsiness may occur during treatment, so it is advisable to avoid hazardous activities such as driving or operating machinery. This medicine can cause serious skin reactions, so if symptoms such as rash or fever appear, it should be discontinued immediately and a physician consulted. Because liver function abnormalities may occur, it is recommended to regularly undergo liver function tests. This medicine may interact with other drugs, so if other medications are being taken, it is essential to inform a doctor or pharmacist. Pregnant or nursing women should avoid taking this medicine, and women of childbearing age should use reliable contraception. In the case of overdose, as there is no specific antidote, one should visit a medical institution immediately for appropriate treatment. This medicine must be swallowed whole without dividing the tablet and should be stored out of reach of children.

Suicidal thoughts, suicidal behavior, depression, aggression, hostility, irritability, anger, homicidal thoughts, threats, dizziness, drowsiness, ataxia, dysarthria, balance disorders, 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 dysfunction, flexibility, perceptual disturbances, head tremor, sedation, fainting, sensory loss, psychiatric disorders, psychomotor agitation, slowed movement, cerebrovascular accident, reduced level of consciousness, attention deficit, orthostatic dizziness, drowsiness, encephalopathy, epilepsy, generalized tonic-clonic seizures, hypotonia, tonic spasms, cluster seizures, suicide attempts, confusional state, acute psychosis, hallucinations, changes in mental state, sleep disorders, 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, condition worsening, malaise, chest discomfort, edema, heat sensation, swelling, facial swelling, sensation of cold, pain, peripheral edema, abdominal pain, diarrhea, abdominal discomfort, constipation, epigastric pain, oral ulcer formation, nausea, dry mouth, gastritis, excessive salivation, alopecia, urticaria, acne, sweating, frictional urticaria, eye pain, increased tear production, vision impairment, 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 cold sensation, musculoskeletal rigidity, myalgia, palpitations, oral injury, anemia, spontaneous abortion, bedridden, headache, seizures, hypersomnia, somnolence, tremor, insomnia, auditory hallucinations, weakness, strange feelings, drug adverse reactions, vomiting, dyspepsia, rash, pruritus, muscle weakness, changes in mental state, anxiety, aggressive behavior, coma, reduced level of consciousness

This medicine should be stored in a tightly sealed container to avoid exposure to air or moisture, and it is recommended to keep it at room temperature between 1 to 30 degrees Celsius. By doing so, the efficacy of the medicine can be well maintained.

Appearance

Blue round film-coated tablet

Package unit

30 tablets/bottle, 90 tablets/bottle