Medication info
Q-PAM Tablet 250 mg (Levetiracetam)

Q-PAM Tablet 250 mg (Levetiracetam)

Prescription medicationTabletOral
Ingredient · strength
Levetiracetam›250mg / 1 tablet
Manufacturer / importer
Myeongin Pharmaceutical Co., Ltd.
Appearance
Blue oval film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 201208483 · Approved 2012.11.20 · Insurance code 651903790

Summary

Main use
Treatment of partial-onset seizures, myoclonic seizures, and primary generalized tonic-clonic seizures
Who takes it
Adults · Children
Adult dose
Levetiracetam film-coated tablets and oral solution are administered orally and may be taken with or without food. Take with sufficient water. The daily dose should be divided into 2 equal doses. Monotherapy and adjunctive treatment of partial-onset seizures (adults and adolescents weighing 50kg or more): Start with 500mg per dose twice daily; the dose may be increased by up to 1000mg per day every 2 to 4 weeks, to a maximum of 3000mg per day. Adjunctive treatment of myoclonic seizures in pediatric patients (12 years and older): Start with 500mg per dose twice daily; increase by 1000mg per day every 2 weeks, to a maximum of 3000mg per day. Adjunctive treatment of primary generalized tonic-clonic seizures (adults and adolescents weighing 50kg or more): Start with 500mg per dose twice daily (total 1000mg); increase by 1000mg per day every 2 weeks, to a maximum of 3000mg per day. In patients with renal impairment, adjust the dose according to creatinine clearance. For patients on dialysis, an initial loading dose of 750mg and an additional 250-500mg after dialysis are recommended. In patients with severe hepatic impairment, reduce the daily maintenance dose by 50% if creatinine clearance is less than 60mL/min. Dose adjustment according to declining renal function is recommended in older adults (65 years and older).
Child dose
Children aged 4 years and older and adolescents weighing less than 50kg (12~17 years): Start with 10mg/kg per dose twice daily and increase by 20mg/kg per day every 2 weeks, up to a maximum of 60mg/kg per day (maximum 3000mg per day). For children weighing 20kg or less, starting with the 100mg/ml oral solution is recommended. Children weighing 20~40kg: Start with 250mg per dose twice daily (total 500mg); the dose may be increased by 500mg per day every 2 weeks, up to a maximum of 1500mg per day. Children weighing more than 40kg: Start with 500mg per dose twice daily (total 1000mg); the dose may be increased by 1000mg per day every 2 weeks, up to a maximum of 3000mg per day. Adjunctive treatment of primary generalized tonic-clonic seizures (adolescents aged 12~17 years weighing less than 50kg): Start with 10mg/kg per dose twice daily; increase by 20mg/kg per day every 2 weeks, up to a maximum of 60mg/kg per day. In children and adolescents weighing less than 50kg with renal impairment, adjust the dose according to creatinine clearance. For patients on dialysis, an initial loading dose of 15mg/kg and an additional 5-10mg/kg after dialysis are recommended. Use is not recommended in infants younger than 1 month. Children 4 years and younger should receive the oral solution instead of tablets. Injectable formulations are not recommended for children under 16 years of age.

Ingredients

Manufacturer
Myeongin Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of partial-onset seizures, myoclonic seizures, and primary generalized tonic-clonic seizures

  • Secondary generalized seizures
  • partial seizures
  • myoclonic seizures
  • primary generalized tonic-clonic seizures
View approved original text

This medication is used in the treatment of epilepsy. It is used as monotherapy for treatment of partial seizures or secondary generalized seizures in patients aged 4 years and older who are newly diagnosed with epilepsy. Additionally, it can be used as an adjunct therapy for patients aged 4 years and older with secondary generalized seizures and partial seizures when existing medications are difficult to control. It is also used in patients aged 12 years and older with myoclonic epilepsy and idiopathic generalized epilepsy for treatment of tonic-clonic seizures. For patients who have difficulty with oral administration, it can be given as an injection. This effectively improves various forms of epileptic seizures.

How to take

Adult dose

Levetiracetam film-coated tablets and oral solution are administered orally and may be taken with or without food. Take with sufficient water. The daily dose should be divided into 2 equal doses. Monotherapy and adjunctive treatment of partial-onset seizures (adults and adolescents weighing 50kg or more): Start with 500mg per dose twice daily; the dose may be increased by up to 1000mg per day every 2 to 4 weeks, to a maximum of 3000mg per day. Adjunctive treatment of myoclonic seizures in pediatric patients (12 years and older): Start with 500mg per dose twice daily; increase by 1000mg per day every 2 weeks, to a maximum of 3000mg per day. Adjunctive treatment of primary generalized tonic-clonic seizures (adults and adolescents weighing 50kg or more): Start with 500mg per dose twice daily (total 1000mg); increase by 1000mg per day every 2 weeks, to a maximum of 3000mg per day. In patients with renal impairment, adjust the dose according to creatinine clearance. For patients on dialysis, an initial loading dose of 750mg and an additional 250-500mg after dialysis are recommended. In patients with severe hepatic impairment, reduce the daily maintenance dose by 50% if creatinine clearance is less than 60mL/min. Dose adjustment according to declining renal function is recommended in older adults (65 years and older).

Child dose

Children aged 4 years and older and adolescents weighing less than 50kg (12~17 years): Start with 10mg/kg per dose twice daily and increase by 20mg/kg per day every 2 weeks, up to a maximum of 60mg/kg per day (maximum 3000mg per day). For children weighing 20kg or less, starting with the 100mg/ml oral solution is recommended. Children weighing 20~40kg: Start with 250mg per dose twice daily (total 500mg); the dose may be increased by 500mg per day every 2 weeks, up to a maximum of 1500mg per day. Children weighing more than 40kg: Start with 500mg per dose twice daily (total 1000mg); the dose may be increased by 1000mg per day every 2 weeks, up to a maximum of 3000mg per day. Adjunctive treatment of primary generalized tonic-clonic seizures (adolescents aged 12~17 years weighing less than 50kg): Start with 10mg/kg per dose twice daily; increase by 20mg/kg per day every 2 weeks, up to a maximum of 60mg/kg per day. In children and adolescents weighing less than 50kg with renal impairment, adjust the dose according to creatinine clearance. For patients on dialysis, an initial loading dose of 15mg/kg and an additional 5-10mg/kg after dialysis are recommended. Use is not recommended in infants younger than 1 month. Children 4 years and younger should receive the oral solution instead of tablets. Injectable formulations are not recommended for children under 16 years of age.

Precautions

This medication is used for the treatment of epilepsy, and while taking it, there may be an increased risk of suicidal thoughts or behaviors. Patients and caregivers should immediately inform healthcare providers of any mood changes, depressive symptoms, or unusual behavior. This medication can affect the central nervous system, potentially causing drowsiness, fatigue, coordination issues, and behavioral abnormalities, especially in the first 4 weeks of administration. Abrupt discontinuation of the medication can worsen seizures; therefore, the dosage should be gradually reduced according to the physician's instructions. Patients with hypersensitivity to the active ingredient or any of the components should not take this medication. Patients with suicidal thoughts or depressive symptoms should take this medication cautiously and consult a physician, and dosage adjustment may be necessary for those with impaired kidney or liver function. This medication can cause hematological adverse reactions, such as decreased blood cell counts. Patients experiencing fatigue, fever, or symptoms of infection should have blood tests done. Psychiatric symptoms such as aggression, irritability, and mood changes may occur, and if these symptoms worsen, dosage adjustment or discontinuation of the medication should be considered. Particularly at the beginning of treatment or with dosage increases, seizures could potentially worsen, so patients should consult a doctor immediately if they experience unusual symptoms. Patients with cardiac disease or prolonged QT interval on ECG should use this medication cautiously. Women who are pregnant or planning to become pregnant should consult healthcare providers before taking this medication, and breastfeeding women should consider discontinuing breastfeeding or the medication since this drug may pass into breast milk and affect the infant. Children should be administered in liquid form rather than tablets, and the safety for infants under 1 month has not been established. Elderly patients may have decreased kidney function, so dosage should be adjusted carefully. This medication can cause drowsiness or decreased concentration when driving or operating machinery, so caution is advised. In cases of overdose, symptoms may include drowsiness, agitation, aggression, and decreased consciousness, and because there is no specific antidote, immediate medical attention is necessary. This medication has minimal interactions with other antiepileptic drugs or oral contraceptives; however, caution is advised when used in conjunction with methotrexate due to the risk of elevated blood concentrations. If any symptoms such as rashes, fever, or lymphadenopathy occur, the patient should immediately stop taking the medication and consult a healthcare provider. Long-term use of this medication may have unclear effects on growth, learning, and endocrine function; therefore, regular monitoring is necessary.

Side effects

  • suicidal impulse
  • suicidal behavior
  • depression
  • abnormal changes in mood and behavior
  • drowsiness
  • fatigue
  • coordination disorders
  • behavioral abnormalities
  • weakness
  • aggression
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  • restlessness
  • anger
  • anxiety
  • emotional blunting
  • depersonalization
  • emotional instability
  • hostility
  • irritability
  • psychotic symptoms
  • hallucinations
  • psychosis
  • suicide attempt
  • suicidal ideation
  • delusional behavior
  • headache
  • dizziness
  • tremors
  • balance disorders
  • amnesia
  • coordination incapability
  • ataxia
  • attention disorder
  • memory impairment
  • hyperactivity
  • insomnia
  • nervousness
  • personality disorder
  • abnormal thoughts
  • abdominal pain
  • diarrhea
  • dyspepsia
  • nausea
  • vomiting
  • loss of appetite
  • weight gain
  • vertigo
  • diplopia
  • blurred vision
  • myalgia
  • injury
  • nasopharyngitis
  • infection
  • cough
  • rash
  • eczema
  • itching
  • thrombocytopenia
  • choreoathetosis
  • dyskinesia
  • sensory disturbances
  • hypersomnia
  • gait disturbances
  • seizure exacerbation
  • psychotic disorders
  • abnormal behavior
  • confusional state
  • panic attacks
  • anger
  • delirium
  • obsessive-compulsive disorder
  • pancreatitis
  • liver failure
  • hepatitis
  • abnormal liver function tests
  • weight loss
  • hyponatremia
  • toxic epidermal necrolysis
  • Stevens-Johnson syndrome
  • erythema multiforme
  • hair loss
  • muscle weakness
  • pancytopenia
  • agranulocytosis
  • leukopenia
  • neutropenia
  • eosinophilia
  • drug response
  • hypersensitivity reaction
  • angioedema
  • anaphylaxis
  • acute kidney injury
  • encephalopathy
  • neuroleptic malignant syndrome
  • QT prolongation
  • rhabdomyolysis
  • elevated serum CPK
  • obsessive-compulsive disorder
  • restlessness
  • aggressiveness
  • psychomotor hyperactivity
  • sleep disorders
  • loss of appetite
  • palpitations
  • aphasia
  • movement disorders
  • impulsive behavior
  • psychomotor retardation
  • edema
  • cheilitis
  • abdominal distension
  • hypersalivation
  • urticaria
  • sepsis
  • musculoskeletal rigidity
  • neck pain
  • pollakiuria
  • dyspnea
  • decreased consciousness
  • respiratory depression
  • coma

Not everyone experiences these, and they can vary from person to person.

Storage

This medication should be stored in a tightly closed container to protect it from air and moisture. It is important to maintain room temperature between 1 degree and 30 degrees Celsius.

Appearance and packaging

Appearance

Blue oval film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.