Medication info

Pfizer Levetiracetam Injection

Prescription medicationInjectionsOralExpired
Ingredient · strength
Levetiracetam›500mg / 1 vial
Manufacturer / importer
Pfizer Pharmaceuticals Korea Limited
Appearance
A clear, colorless liquid in a clear, colorless vial for injection.
Packaging
5mL X 10 vials
Approval status
Expired

MFDS item code 201902112 · Notified 2019.04.08

This product's status changed to Expired on 2024.04.08. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment of epilepsy as monotherapy (partial seizures) or adjunctive therapy (myoclonic seizures, etc.)
Who takes it
Adults · Children
Adult dose
Levetiracetam treatment may be initiated by intravenous or oral administration. The total daily dose and frequency of administration should remain the same. The injectable formulation is administered intravenously only and infused over 15 minutes using 100mL of diluent. For monotherapy, adults and adolescents aged 16 years or older should start with 250mg twice daily and increase to 500mg twice daily after 2 weeks. The dose may be increased by 500mg per day every 2 weeks, up to a maximum of 3000mg per day. For adjunctive therapy, adults and adolescents with partial-onset seizures should start with 500mg twice daily. The dose may be increased or decreased by 1000mg per day every 2 to 4 weeks, up to a maximum of 3000mg per day. For primary generalized tonic-clonic seizures, adults and adolescents should start with 500mg twice daily. The dose should be increased by 1000mg per day every 2 weeks, up to a maximum of 3000mg per day. For patients with renal impairment, adjust the dose according to creatinine clearance: normal (≧80), 500-1500mg twice daily; mild (50-79), 500-1000mg twice daily; moderate (30-49), 250-750mg twice daily; severe (<30), 250-500mg twice daily; end-stage renal disease patients on dialysis, 500-1000mg once daily. The film-coated tablets and oral solution are administered orally and should be taken with plenty of water, with or without food. Divide the daily dose into 2 equal doses.
Child dose
For adjunctive therapy in pediatric patients aged 16 years or older (myoclonic seizures), start with 500mg twice daily. Increase the dose by 1000mg per day every 2 weeks up to the recommended daily dose of 3000mg. Efficacy has not been studied at doses below 3000mg per day. The injectable formulation is not recommended for children under 16 years of age. Tablet administration is not applicable to children 4 years of age or younger, and the oral solution should be administered to infants aged 1 month or older. Oral formulations are not recommended for infants under 1 month of age. For pediatric patients with renal impairment and adolescents weighing less than 50kg, dose adjustment depends on creatinine clearance: normal (≧80), 10-30mg/kg twice daily; mild (50-79), 10-20mg/kg twice daily; moderate (30-49), 5-15mg/kg twice daily; severe (<30), 5-10mg/kg twice daily; end-stage renal disease patients on dialysis, 10-20mg/kg once daily.

Ingredients

Importer
Pfizer Pharmaceuticals Korea Limited

Efficacy & effects

Treatment of epilepsy as monotherapy (partial seizures) or adjunctive therapy (myoclonic seizures, etc.)

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

Levetiracetam injection is used for patients who are unable to take medication orally, primarily utilized for the treatment of epilepsy. This medication is used to treat partial seizures and secondary generalized seizures in patients aged 16 years and older who have recently been diagnosed with epilepsy. It is also used as an adjunctive therapy for seizures that are difficult to control with existing first-line antiepileptic drugs. It is effective in treating myoclonic seizures in children with myoclonic epilepsy and generalized tonic-clonic seizures in patients with idiopathic generalized epilepsy. In summary, levetiracetam injection is used for the treatment of various types of epilepsy seizures.

How to take

Adult dose

Levetiracetam treatment may be initiated by intravenous or oral administration. The total daily dose and frequency of administration should remain the same. The injectable formulation is administered intravenously only and infused over 15 minutes using 100mL of diluent. For monotherapy, adults and adolescents aged 16 years or older should start with 250mg twice daily and increase to 500mg twice daily after 2 weeks. The dose may be increased by 500mg per day every 2 weeks, up to a maximum of 3000mg per day. For adjunctive therapy, adults and adolescents with partial-onset seizures should start with 500mg twice daily. The dose may be increased or decreased by 1000mg per day every 2 to 4 weeks, up to a maximum of 3000mg per day. For primary generalized tonic-clonic seizures, adults and adolescents should start with 500mg twice daily. The dose should be increased by 1000mg per day every 2 weeks, up to a maximum of 3000mg per day. For patients with renal impairment, adjust the dose according to creatinine clearance: normal (≧80), 500-1500mg twice daily; mild (50-79), 500-1000mg twice daily; moderate (30-49), 250-750mg twice daily; severe (<30), 250-500mg twice daily; end-stage renal disease patients on dialysis, 500-1000mg once daily. The film-coated tablets and oral solution are administered orally and should be taken with plenty of water, with or without food. Divide the daily dose into 2 equal doses.

Child dose

For adjunctive therapy in pediatric patients aged 16 years or older (myoclonic seizures), start with 500mg twice daily. Increase the dose by 1000mg per day every 2 weeks up to the recommended daily dose of 3000mg. Efficacy has not been studied at doses below 3000mg per day. The injectable formulation is not recommended for children under 16 years of age. Tablet administration is not applicable to children 4 years of age or younger, and the oral solution should be administered to infants aged 1 month or older. Oral formulations are not recommended for infants under 1 month of age. For pediatric patients with renal impairment and adolescents weighing less than 50kg, dose adjustment depends on creatinine clearance: normal (≧80), 10-30mg/kg twice daily; mild (50-79), 10-20mg/kg twice daily; moderate (30-49), 5-15mg/kg twice daily; severe (<30), 5-10mg/kg twice daily; end-stage renal disease patients on dialysis, 10-20mg/kg once daily.

Precautions

This medication is used for the treatment of epilepsy, and there is a risk of suicidal thoughts or behaviors while taking it, so patients and caregivers should immediately inform a doctor if such symptoms arise. Additionally, this medication may cause neurological and psychiatric adverse reactions such as drowsiness, fatigue, coordination disorders, and behavioral changes, so caution is advised. Sudden discontinuation of this medication may result in increased seizure frequency; therefore, the dosage should be gradually reduced according to the physician's instructions. Patients allergic to this medication or similar drugs should not take it. Patients with depression or suicidal thoughts should consult with their doctor before taking this medication, and dosage adjustments may be necessary for patients with impaired kidney function. Regular blood tests to monitor white blood cell counts and other parameters are recommended. Drowsiness or decreased concentration may occur during treatment, so caution is needed when driving or operating hazardous machinery. It is advisable to avoid using this medication during pregnancy, and those breastfeeding should consult a doctor to decide whether to continue taking it since the medication may be passed through breast milk. For children, this medication should be administered in liquid form from the age of 1 month, and tablets are not recommended for children under 4 years old. Symptoms of overdose may include drowsiness or coma, and immediate medical attention should be sought. This medication does not have significant drug interactions with other antiepileptic medications or oral contraceptives; however, caution should be exercised regarding changes in blood concentration when used in combination with methotrexate. If any unusual behavior or mood changes occur during treatment, immediate consultation with healthcare professionals is essential, and regular check-ups are important for safe treatment.

Side effects

  • suicidal ideation
  • suicidal behavior
  • depression
  • abnormal changes in mood and behavior
  • drowsiness
  • fatigue
  • coordination impairment
  • behavioral abnormalities
  • asthenia
  • psychotic symptoms
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  • hallucinations
  • aggression
  • restlessness
  • anger
  • anxiety
  • emotional numbness
  • depersonalization
  • emotional instability
  • hostility
  • agitation
  • insomnia
  • hypersensitivity
  • personality disorder
  • abnormal thoughts
  • appetite loss
  • weight gain
  • dizziness
  • double vision
  • blurred vision
  • myalgia
  • injury
  • infection
  • nasopharyngitis
  • cough
  • rash
  • eczema
  • itching
  • thrombocytopenia
  • chorea
  • dyskinesia
  • paresthesia
  • hypersomnia
  • encephalopathy
  • suicide attempt
  • suicidal thoughts
  • psychotic disorder
  • unusual behavior
  • confusion
  • panic attacks
  • anger
  • pancreatitis
  • liver failure
  • hepatitis
  • abnormal liver function tests
  • weight loss
  • hyponatremia
  • toxic epidermal necrolysis
  • Stevens-Johnson syndrome
  • erythema multiforme
  • hair loss
  • muscle weakness
  • rhabdomyolysis
  • increased serum CPK
  • pancytopenia
  • agranulocytosis
  • leukopenia
  • neutropenia
  • eosinophilia
  • angioedema
  • anaphylaxis
  • acute kidney injury
  • hypotension
  • memory loss
  • ataxia
  • seizures
  • dizziness
  • headache
  • hyperactivity
  • tremor
  • balance disorder
  • attention deficit
  • memory impairment
  • abdominal pain
  • diarrhea
  • indigestion
  • nausea
  • vomiting
  • headache
  • injury
  • pneumonia
  • increased serum sodium
  • pneumonia exacerbation
  • upper respiratory infection
  • increased BUN
  • leukocytosis
  • worsening condition
  • hyperthermia
  • pyuria
  • constipation
  • palpitations
  • aphasia
  • movement disorders
  • impulsive behavior
  • psychomotor retardation
  • edema
  • cheilitis
  • abdominal bloating
  • gastrointestinal disorders
  • sialorrhea
  • urticaria
  • sepsis
  • musculoskeletal rigidity
  • neck pain
  • urinary frequency disorder
  • respiratory distress
  • agitation
  • depression
  • emotional instability
  • hostility
  • hypersensitivity
  • emotional instability
  • hyperactivity
  • neurosis
  • personality disorder
  • behavior similar to psychosis
  • delusional behavior
  • auditory hallucinations
  • suicidal thoughts
  • exacerbation of schizophrenia
  • mental and non-mental adverse reactions
  • excitability
  • abnormal behavior
  • excitement
  • aggression
  • behavioral disorder
  • anger
  • apathy
  • mood changes
  • mood lability
  • rejection syndrome
  • suicidal thoughts
  • sad emotions
  • psychotic depression
  • 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 sealed container to prevent contact with air and kept at a cool temperature below 25 degrees Celsius. This helps maintain the effectiveness of the medication and prevents degradation.

Appearance and packaging

Appearance

A clear, colorless liquid in a clear, colorless vial for injection.

Package unit

5mL X 10 vials

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.

Questions about this medicine

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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.