Indication

Levetiracetam is indicated as an adjunctive therapy for-
? Partial Onset Seizures
? Myoclonic Seizures in Patients with Juvenile Myoclonic Epilepsy
? Primary Generalized Tonic-Clonic Seizures


Dosage & Administration

Treatment should be initiated with a daily dose of 1000 mg/day, given as twice-daily dosing (500 mg twice daily). Additional dosing increments may be given (1000 mg/day additional every 2 weeks) to a maximum recommended daily dose of 3000 mg.

Use in Pediatric Patients

Age/weight

Initial dose (Daily)

Incremental dose (Daily)

1 Month To < 6 Months

7 mg/kg twice daily

21 mg/kg twice daily

6 Months To < 4 Years

10 mg/kg twice daily

25 mg/kg twice daily

4 Years To < 16 Years

10 mg/kg twice daily

30 mg/kg twice daily

Adolescent with 20 - 40 kg body weight

250 mg twice daily

750 mg twice daily

 

*The daily dose should be increased every 2 weeks.

Levetira Oral Solution: Weight-Based Dosing Calculation for Pediatric Patients:

 

 Total daily dose (ml/day)                =

Daily dose (mg/kg/day) x patient weight (kg)

 

100 mg/ml

 

 

 

 

Adult Patients with Impaired Renal Function

Levetiracetam dosing must be individualized according to the patient's renal function status. Recommended doses and adjustment for dose for adults are shown in the following table-

Dosing Adjustment Regimen for Adult Patients with Impaired Renal

Function

 

Group

 

Creatinine Clearance

(ml/min.)

 

Dosage (mg)

Frequency

Normal

 

>80

 

500 to 1500

Every 12 h

Mild

 

50 - 80

500 to 1000

Every 12 h

Moderate

 

30 - 50

250 to 750

Every 12 h

Severe

 

< 30

250 to 500

Every 12 h

Patients Using Dialysis

 

 

500 to 1000

Every 24 h*

 

*Following dialysis, a 250 to 500 mg supplemental dose is

recommended.

Use in Pregnancy and Lactation

Pregnancy: Pregnancy category C.

Lactation: No data on the use of Levetiracetam in breast-feeding women

are available. Data from animals indicate that Levetiracetam is secreted

into milk. Therefore, Levetiracetam is contraindicated during

breast-feeding.


Precautions

Severe allergic reactions, abnormal thoughts, dark urine, decreased coordination, extreme dizziness, drowsiness, tiredness, or weakness, fever, chills, persistent sore throat, hallucinations, memory loss, mouth sores, muscle or neck pain, new or worsening mental problem, mood or behavior changes, new or worsening seizures, pain, suicidal thoughts or attempts, unusual bruising or bleeding, vision changes, yellowing of the skin or eyes.


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