Levphil Tablet 1000 mg (Levetiracetam)

Adult dose

Film-coated tablets and oral solution are administered orally and may be taken with or without food. Take with plenty of water. The daily dose should be divided into 2 equal doses and administered twice daily. Levetiracetam treatment may be initiated intravenously or orally. When switching from oral to intravenous administration or vice versa, the change may be made directly without dose titration; the total daily dose and frequency of administration should remain the same. Monotherapy and adjunctive therapy for partial-onset seizures — Adults (18 years of age and older) and adolescents weighing 50kg or more (12~17 years): Start this drug at 500mg twice daily. However, based on the physician's assessment of potential adverse reactions relative to seizure reduction, the initial dose may be lowered to 250mg twice daily and increased to 500mg twice daily after 2 weeks. Depending on clinical response and tolerability, the dose may be increased or decreased every 2 to 4 weeks by 500mg per day [250mg per dose, twice daily] or 1000mg per day [500mg per dose, twice daily]. The maximum recommended dose is 3000mg per day [1500mg per dose, twice daily]. Adjunctive therapy for myoclonic seizures in pediatric patients (12 years of age and older): Start this drug at 500mg twice daily. However, based on the physician's assessment of potential adverse reactions relative to seizure reduction, the initial dose may be lowered to 250mg twice daily and increased to 500mg twice daily after 2 weeks. Depending on clinical response and tolerability, the dose may be increased or decreased every 2 weeks by 500mg per day [250mg per dose, twice daily] or 1000mg per day [500mg per dose, twice daily]. The maximum recommended dose is 3000mg per day [1500mg per dose, twice daily]. Efficacy has not been studied at doses below 3,000mg per day. Adjunctive therapy for primary generalized tonic-clonic seizures (12 years of age and older) — Adults (18 years of age and older) and adolescents weighing 50kg or more (12-17 years): Start this drug at 1,000mg per day [500mg per dose, twice daily]. However, based on the physician's assessment of potential adverse reactions relative to seizure reduction, the initial dose may be lowered to 250mg twice daily and increased to 500mg twice daily after 2 weeks. Depending on clinical response and tolerability, the dose may be increased or decreased every 2 weeks by 500mg per day [250mg per dose, twice daily] or 1000mg per day [500mg per dose, twice daily]. The maximum recommended dose is 3000mg per day [1500mg per dose, twice daily]. Efficacy has not been adequately studied at doses below 3,000mg per day. Patients with renal impairment: Since levetiracetam clearance is related to renal function, administer an individualized dose according to the patient's renal function. See the table below for dose adjustment in adults. Dose adjustment for adult patients with renal impairment — Normal (≥ 80): 500-1,500mg per dose, twice daily (12-hour interval) Dose adjustment for adult patients with renal impairment — Mild (50-79): 500-1,000mg per dose, twice daily (12-hour interval) Dose adjustment for adult patients with renal impairment — Moderate (30-49): 250-750mg per dose, twice daily (12-hour interval) Dose adjustment for adult patients with renal impairment — Severe (< 30): 250-500mg per dose, twice daily (12-hour interval) Dose adjustment for adult patients with renal impairment — End-stage renal disease patients on dialysis(1)(-): 500-1,000mg per dose, once daily(2) (1) An initial loading dose of 750mg is recommended on the first day of administration. (2) An additional dose of 250-500mg is recommended after dialysis. No dose adjustment is necessary in patients with mild to moderate hepatic impairment. In patients with severe hepatic impairment, creatinine clearance may underestimate renal impairment. Therefore, if creatinine clearance is below 60mL/min/1.73m2, a 50% reduction in the daily maintenance dose is recommended. Elderly patients (65 years of age and older): Dose adjustment is recommended in elderly patients with impaired renal function.

Child dose

Monotherapy and adjunctive therapy for partial-onset seizures (4 years of age and older) Children 4~11 years of age and adolescents 12~17 years of age weighing less than 50kg: Start with an initial dose of 10mg/kg per dose twice daily. Depending on clinical response and tolerability, the dose may be increased up to 60mg/kg per day [30mg/kg per dose, twice daily]. Dose changes should not exceed an increase or decrease of 20mg/kg per day [10mg/kg per dose, twice daily] every 2 weeks. Use the lowest effective dose. The maximum recommended dose is 3000mg per day. Children weighing 20kg or less: It is recommended to initiate treatment with the 100mg/ml oral solution. Children weighing 20~40kg: Start at 500mg per day [250mg per dose, twice daily], increasing by 500mg per day every 2 weeks to a maximum of 1500mg per day [750mg per dose, twice daily]. Children weighing more than 40kg: Start at 1000mg per day [500mg per dose, twice daily], increasing by 1000mg per day every 2 weeks to a maximum of 3000mg per day [1500mg per dose, twice daily]. Children weighing 50kg or more: The dose is the same as the adult dose. Adjunctive therapy for myoclonic seizures in pediatric patients (12 years of age and older): Start this drug at 500mg twice daily. However, based on the physician's assessment of potential adverse reactions relative to seizure reduction, the initial dose may be lowered to 250mg twice daily and increased to 500mg twice daily after 2 weeks. Depending on clinical response and tolerability, the dose may be increased or decreased every 2 weeks by 500mg per day [250mg per dose, twice daily] or 1000mg per day [500mg per dose, twice daily]. The maximum recommended dose is 3000mg per day [1500mg per dose, twice daily]. Efficacy has not been studied at doses below 3,000mg per day. Adjunctive therapy for primary generalized tonic-clonic seizures (12 years of age and older) — Adolescents 12-17 years of age weighing less than 50kg: Start this drug at 20mg/kg per day [10mg/kg per dose, twice daily]. Increase the dose by 20mg/kg per day [10mg/kg per dose, twice daily] every 2 weeks up to the recommended daily dose of 60mg/kg [30mg/kg per dose, twice daily]. Efficacy has not been adequately studied at doses below 60mg/kg per day. Use the following formulas for infants, children, and adolescents. ks= 0.45 (infants under 1 year of age) ks= 0.55 (children under 13 years of age and female adolescents) ks= 0.7 (male adolescents) Dose adjustment for pediatric patients and adolescents weighing less than 50kg with renal impairment — Normal (≥ 80): 10-30mg/kg (0.10-0.30 ml/kg) twice daily Dose adjustment for pediatric patients and adolescents weighing less than 50kg with renal impairment — Mild (50-79): 10-20mg/kg (0.10-0.20 ml/kg) twice daily Dose adjustment for pediatric patients and adolescents weighing less than 50kg with renal impairment — Moderate (30-49): 5-15mg/kg (0.05-0.15ml/kg) twice daily Dose adjustment for pediatric patients and adolescents weighing less than 50kg with renal impairment — Severe (< 30): 5-10 mg/kg (0.05-0.10ml/kg) twice daily Dose adjustment for pediatric patients and adolescents weighing less than 50kg with renal impairment — End-stage renal disease patients on dialysis(--): 10-20mg/kg (0.10-0.20 ml/kg) once daily(1)(2) (1) A loading dose of 15 mg/kg (0.15ml/kg) is recommended on the first day of administration. (2) An additional dose of 5-10 mg/kg (0.05-0.10ml/kg) is recommended after dialysis. Infants under 1 month of age: Oral formulations are not recommended because of insufficient safety and efficacy data. Children 4 years of age or younger: Tablet administration is not applicable; the oral solution should be administered to infants 1 month of age and older. Children under 16 years of age: Injection is not recommended because its safety and efficacy have not been established.

This drug is used for the treatment of epilepsy, and there may be an increased risk of suicidal thoughts or behavior, so patients should immediately consult their doctor if they experience symptoms of depression, mood changes, or behavioral abnormalities during treatment. This drug may frequently cause central nervous system-related side effects such as drowsiness, fatigue, coordination disorders, and behavioral abnormalities, especially during the first 4 weeks of treatment. When discontinuing the medication, the dosage should be gradually reduced to prevent the exacerbation of seizures, and abrupt cessation should be avoided. Patients with allergies to this drug or similar medications should not take it, and dosage adjustments may be necessary for patients with impaired renal function. Additionally, this drug can cause side effects such as decreased blood cell count, behavior changes, aggression, worsening of seizures, and cardiac electrical signal abnormalities (QT interval prolongation), so regular testing may be necessary. During treatment, if suicidal thoughts, depressive symptoms, or abnormal behaviors occur, patients should promptly inform healthcare providers and carefully monitor for drug-related side effects. This drug generally has low drug interactions when taken with other antiepileptic drugs, oral contraceptives, warfarin, or digoxin, however caution is advised when used concurrently with methotrexate. The use of this drug during pregnancy may affect the fetus, so it should be taken under a doctor's careful judgment, and during breastfeeding, the drug may be transmitted through breast milk, necessitating discussion with a doctor about discontinuing breastfeeding. Safety and efficacy have not been established for children, especially infants under 1 month old, and liquid formulations should be used instead of tablets for children under 4 years old. Elderly patients may have a higher risk of side effects due to impaired renal function, so careful dosage decisions are necessary. This drug may cause drowsiness or decreased concentration, so caution should be taken when driving or operating machinery, especially at the start of treatment or when increasing the dose. In case of overdose, symptoms such as drowsiness, aggression, decreased consciousness, and respiratory depression may occur, necessitating immediate emergency treatment. Finally, this drug should be kept out of reach of children, and it is safer not to transfer it into other containers.

• suicidal impulses
• suicidal behavior
• depression
• drowsiness
• fatigue
• cooperative movement disorder
• behavioral abnormalities
• weakness
• behavioral disorders
• aggression

This medication may be sensitive to air or moisture, so it should be stored in a sealed container. It is best to keep the storage temperature between 1 and 30 degrees Celsius at room temperature to safely preserve the drug's efficacy.

Appearance

White oval film-coated tablets

Package unit

30 tablets/bottle