Pericompa Tablet 2 mg (Perampanel (unrefined))

Adult dose

This medication is taken once daily before 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 reduce 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 reduce 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. Interactions’). When discontinuing this medication, reduce the dose gradually (see section ‘5. General precautions’). If a dose of this medication is missed during treatment, take it as follows depending on the duration of the interruption. ㆍIf 1 dose is missed: Given 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 shorter 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 medication 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 should be 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 in other patients, adjust the dose according to the patient's clinical response and tolerability. Use of this medication is not recommended in patients with severe hepatic impairment.

Child dose

Age 4 years and older, partial-onset seizures (monotherapy): Treatment with this medicine is initiated at 2mg per day. Depending on the patient's clinical response and tolerability, the dose is increased to a maintenance dose of 4mg to 8mg per day; if needed, it may be increased to a maximum of 8mg per day. Age 4 years and older, partial-onset seizures (adjunctive therapy): Treatment with this medicine is initiated at 2mg per day. Depending on the patient's clinical response and tolerability, the dose is increased to a maintenance dose of 4mg to 8mg per day; if needed, it may be increased to a maximum of 12mg per day. Age 7 years and older, primary generalized tonic-clonic seizures (adjunctive therapy): Treatment with this medicine is initiated at 2mg per day. Depending on the patient's clinical response and tolerability, the dose is increased to a maintenance dose of up to 8mg per day; if needed, it may be increased to a maximum of 12mg per day.

This medication is used for the treatment of epilepsy and carries a risk of suicidal thoughts or behaviors during use, so patients and caregivers should carefully observe for changes in mood or behavior. Additionally, psychological changes such as aggression, anger, and irritability may occur, so immediate consultation with a physician is necessary if any abnormal signs appear. Patients with allergies to this medication or certain genetic diseases such as lactose intolerance should not take it. Elderly patients should be cautious as the risk of falls may increase, and patients with a history of substance abuse should monitor the potential for abuse of this medication. There may be interactions when taken with other medications, so dosage adjustment according to a physician's instructions is required, especially when used with certain antiepileptic drugs. This medication can cause dizziness and drowsiness, so it is advisable to avoid driving or operating dangerous machinery. Rarely, serious skin reactions or liver dysfunction may occur, so immediate notification to the medical personnel is required if skin rash or systemic symptoms appear. Women who are pregnant or nursing should consult a physician before taking this medication, and reliable contraception is recommended for women of childbearing age. There is no specific antidote for overdose, so immediate medical attention is necessary, and this medication should be swallowed whole without chewing or crushing. Finally, it should be stored out of the reach of children, and expired products should not be used.

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 disturbances, fatigue, weight gain, falls, memory impairment, cognitive dysfunction, flexibility, perceptual disturbances, head tremor, sedation, syncope, sensory loss, psychiatric disorders, hyperactivity of psychomotor activity, sluggishness, cerebrovascular accident, decreased level of consciousness, attention deficit, positional vertigo, stupor, encephalopathy, epilepsy, generalized tonic-clonic seizures, hypotonia, focal muscle spasms, 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 disturbances, mixed hallucinations, inappropriate affect, intermittent explosive disorder, changes in mental state, negative thoughts, psychotic disorder, restlessness, schizophrenia, sleep attacks, fever, worsening condition, malaise (ennui), 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, cold sweat, 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, musculoskeletal rigidity, myalgia, palpitations, oral injury, anemia, spontaneous abortion, lying down excessively, headache, seizures, hypersomnia, somnolence, tremor, insomnia, auditory hallucinations, asthenia, strange sensations, adverse drug reactions, vomiting, dyspepsia, rash, pruritus, muscle weakness, changes in mental state, anxiety, aggressive behavior, coma, decreased level of consciousness

This medication may be sensitive to air or moisture, so it should be stored in a tightly sealed container. It is crucial to maintain a storage temperature between 1 degree and 30 degrees Celsius to preserve the effectiveness and safety of the medication.

Appearance

Orange, round, film-coated tablet with a biconvex shape

Package unit

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