Pikompah Suspension 0.5mg/mL (Perampanel)

Adult dose

Take this medicine once daily at bedtime. It may be taken with or without food, but preferably under the same conditions each day. Dosage adjustment Adjust the dose by 2 mg (4 mL) per day at intervals of at least 2 weeks. For patients receiving concomitant medicines that do not decrease the half-life of perampanel, adjust the dose by 2 mg (4 mL) per day at intervals of at least 2 weeks. For patients receiving concomitant medicines that decrease the half-life of perampanel (e.g., phenytoin, carbamazepine, oxcarbazepine), adjust the dose by 2 mg (4 mL) per day at intervals of at least 1 week (see Section 6. Drug 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 length of the interruption. ㆍIf 1 dose is missed: In consideration of perampanel's long half-life, 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 times the half-life: Consider restarting treatment at the last administered dose. ㆍIf treatment is interrupted for 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 medicines. Patients with renal impairment No dosage adjustment is required in 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 Dosage 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 2 mg (4 mL) once daily, with increases of 2 mg (4 mL) per day at intervals of at least 2 weeks. The maximum recommended dose is 6 mg (12 mL) once daily for patients with mild hepatic impairment and 4 mg (8 mL) once daily 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 medicine is not recommended in patients with severe hepatic impairment.

Child dose

Monotherapy 1) Partial-onset seizures: 4 years of age and older Initiate treatment with this medicine at 2 mg (4 mL) once daily. Increase the dose according to the patient's clinical response and tolerability to a maintenance dose of 4 mg (8 mL) to 8 mg (16 mL) once daily; if necessary, the dose may be increased to a maximum of 8 mg (16 mL) once daily. Adjunctive therapy 1) Partial-onset seizures: 4 years of age and older Initiate treatment with this medicine at 2 mg (4 mL) once daily. Increase the dose according to the patient's clinical response and tolerability to a maintenance dose of 4 mg (8 mL) to 8 mg (16 mL) once daily; if necessary, the dose may be increased to a maximum of 12 mg (24 mL) once daily. 2) Primary generalized tonic-clonic seizures: 7 years of age and older Initiate treatment with this medicine at 2 mg (4 mL) once daily. Increase the dose according to the patient's clinical response and tolerability to a maintenance dose of 8 mg (16 mL) once daily; if necessary, the dose may be increased to a maximum of 12 mg (24 mL) once daily.

This medication is an antiepileptic drug that may increase the risk of suicidal thoughts or behaviors, so patients should be closely monitored for changes in mood or behavior during treatment. Psychiatric symptoms such as aggression, anger, irritability, and suicidal thoughts may occur; if such changes are noted, it is important to consult healthcare professionals immediately. Patients with known allergies to this medication or any of its components should not take it. Moreover, patients with hereditary fructose intolerance should not take this medication due to the presence of sorbitol. Elderly patients may have an increased risk of falling, so special precautions are required when administering this medication to them. Patients with a history of substance abuse should be monitored for the potential for abuse of this medication, and dosage adjustments may be necessary depending on concomitant medications. Due to the inclusion of sorbitol and benzoic acid, attention should be paid to the risk of adverse effects in neonates or patients with certain conditions. During treatment, neurological side effects such as dizziness, drowsiness, and ataxia may occur; thus, it is advisable to avoid driving or operating dangerous machinery. Severe cutaneous adverse reactions, such as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) syndrome or Stevens-Johnson syndrome, may occur; if there is any skin rash or systemic symptoms, the medication should be discontinued immediately and healthcare professionals should be notified. Liver dysfunction has been reported, so patients with liver disease should have their liver function tested regularly. This medication may interact with other antiepileptic drugs and hormonal contraceptives; thus, it is crucial to inform healthcare professionals of any current medications during treatment. Pregnant or breastfeeding women should consult a doctor before taking this medication, and it is advisable to avoid taking it if not necessary. In cases of overdose, symptoms such as decreased consciousness or coma may occur; therefore, strict adherence to the prescribed dosage is essential, and immediate medical attention is required in the event of an overdose.

Suicidal thoughts, suicidal behavior, depression, aggression, hostility, irritability, anger, homicidal thoughts, threats, confusion, psychotic disorders, 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 disturbances, cognitive impairment, yield, perceptual disturbances, head tremor, sedation, fainting, sensory loss, mental disorders, psychomotor agitation, bradykinesia, cerebrovascular accidents, decreased level of consciousness, attention disorders, orthostatic dizziness, confusion, encephalopathy, epilepsy, generalized tonic-clonic seizures, hypotonia, clonic muscle spasms, cluster seizures, suicide attempts, 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, schizophrenia, sleep seizures, fever, worsening condition, malaise, chest discomfort, edema, warmth, swelling, facial swelling, cold sensation, pain, peripheral swelling, abdominal pain, diarrhea, abdominal discomfort, constipation, upper abdominal pain, oral ulcer formation, nausea, dry mouth, gastritis, excessive salivation, alopecia, urticaria, acne, cold sweats, friction urticaria, ocular pain, increased tear production, visual impairment, eye fatigue, weight loss, increased liver function tests, decreased platelet count, encephalitis, soft tissue infections, chronic hepatitis B, erectile dysfunction, menstrual disorders, sexual dysfunction, difficulty breathing, nasal obstruction, orthostatic hypotension, peripheral coldness, musculoskeletal rigidity, myalgia, palpitations, oral injuries, anemia, spontaneous abortion, bed-bound, headache, seizures, hypersomnia, drowsiness, tremors, insomnia, 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 protect it from air and moisture. It is important to maintain the storage temperature at room temperature between 1°C and 30°C.

Appearance

A white to off-white suspension in a plastic container

Package unit

340 milliliters per bottle