Peranel Tablet 4 mg (Perampanel (Unformulated))

Adult dose

Take this medicine 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 section ‘6. Interactions’). When discontinuing this medicine, reduce the dose gradually (see section ‘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: Considering 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 half-lives: Consider restarting treatment at the last dose administered. ㆍIf doses are missed for 5 or more consecutive half-lives: Retitrate the dose starting from the initial dose. A period equivalent to 5 half-lives is 3 weeks for patients not taking antiepileptic drugs that induce perampanel metabolism, and 1 week for patients taking such drugs. Patients with renal impairment No dose adjustment is required 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 required 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. 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 started at 2mg per day. Increase the dose to the maintenance dose of 4mg to 8mg per day according to the patient's clinical response and tolerability; if needed, the dose 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 started at 2mg per day. Increase the dose to the maintenance dose of 4mg to 8mg per day according to the patient's clinical response and tolerability; if needed, the dose 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 started at 2mg per day. Increase the dose to the maintenance dose of 8mg per day according to the patient's clinical response and tolerability; if needed, the dose may be increased to a maximum of 12mg per day.

This medication is used for the treatment of epilepsy and may increase the risk of suicidal thoughts or behaviors during use, so changes in mood or behavior should be monitored closely. Patients taking this medication may exhibit psychological changes such as aggression, anger, or irritability; if these symptoms occur, they should consult a physician immediately. This drug should not be administered to patients with certain genetic disorders, such as lactose intolerance or galactose intolerance. Elderly patients may be at increased risk of falling, so caution is advised, and patients with a history of substance abuse should be closely monitored for the potential for misuse of this medication. Interactions may occur when taking this drug with other medications, especially those that induce or inhibit enzymes that metabolize drugs in the liver (CYP3A), and dosage adjustments should be made according to a physician's instructions. Dizziness and drowsiness are common during treatment, so caution is advised when engaging in activities requiring attention, such as driving or operating machinery. Severe allergic reactions may occur, so if symptoms such as rash, fever, or swollen lymph nodes appear, the patient should stop taking the medication immediately and inform a physician. Use of this medication during pregnancy is not recommended, and if breastfeeding, the effects on the newborn should be considered before taking this drug. Abrupt discontinuation may worsen seizures, so it is recommended to taper off the dosage gradually. In case of an overdose, there are no specific antidotes available, and supportive treatment should be administered while monitoring vital signs at a hospital. Finally, the tablets should not be chewed or crushed but should be swallowed whole with sufficient water, and kept out of reach of children.

suicidal thoughts, suicidal behavior, depression, aggression, hostility, irritability, anger, homicidal ideation, threats, dizziness, drowsiness, ataxia, speech disorders, balance disorders, diplopia, blurred vision, vertigo, nausea, drug reaction with 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 tremors, sedation, syncope, sensory loss, mental abnormalities, psychomotor agitation, bradykinesia, cerebrovascular accident, decreased level of consciousness, attention deficit, positional dizziness, stupor, encephalopathy, epilepsy, generalized tonic-clonic seizures, hypotonia, myoclonic jerks, cluster seizures, suicide attempts, confusion, acute psychosis, hallucinations, changes in mental status, sleep disorders, illusions, delirium, attention-deficit hyperactivity disorder, bruxism, drug dependence, echolalia, visual hallucinations, mixed hallucinations, inappropriate affect, intermittent explosive disorder, changes in mental status, negative thoughts, psychotic disorders, restlessness, schizophrenia, sleep seizures, fever, worsening condition, somatic symptoms, chest discomfort, swelling, warmth, edema, 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, cold sweat, friction urticaria, eye pain, increased tear secretion, decreased vision, eye fatigue, weight loss, increased liver function tests, decreased platelet count, encephalitis, soft tissue infections, chronic hepatitis B, erectile dysfunction, menstrual disorders, sexual dysfunction, dyspnea, nasal obstruction, orthostatic hypotension, peripheral coldness, musculoskeletal rigidity, myalgia, palpitations, oral injuries, anemia, spontaneous abortion, sedentary lifestyle, headache, seizures, hypersomnia, somnolence, tremors, insomnia, auditory hallucinations, asthenia, strange sensations, adverse drug reactions, vomiting, dyspepsia, rash, pruritus, muscle weakness, changes in mental status, anxiety, aggressive behavior, coma, decreased level of consciousness

This medication should be stored in a tightly closed container to protect it from air and moisture. The storage temperature should be maintained at room temperature between 1°C and 30°C. This will help preserve the effectiveness and safety of the medication.

Appearance

Red round film-coated tablet

Package unit

30 tablets/bottle, 90 tablets/bottle