LEVECETAM Film-coated tablet Ref.[50751] Active ingredients: Levetiracetam

The film coated tablets must be taken orally, swallowed with liquid and may be taken with or without food. The daily dose is administered in two equally divided doses.

Monotherapy

The recommended starting dose is 250 mg twice daily which should be increased to an initial therapeutic dose of 500 mg twice daily after two weeks. The dose can be further increased by 250 mg twice daily every two weeks depending upon the clinical response. The maximum dose is 1,500 mg twice daily.

Add-on therapy

Adults (>18 years of age) and adolescents (aged 12 to 17 years of age) weighing 50 kg or more

As adjunctive therapy, the therapeutic dose is 500 mg twice daily. This dose can be started on the first day of treatment.

Depending upon the clinical response and tolerance, the daily dose can be increased up to 1,500 mg twice daily. Dose changes can be made in 500 mg twice daily increments or decrements every two to four weeks.

When satisfactory control of seizures has been attained, monotherapy with levetiracetam may be envisaged by progressively decreasing and withdrawing the concomitant antiepileptic medication.

Elderly (65 years and older)

Adjustment of the dose is recommended in the elderly with compromised renal function (see Patients with renal impairment, below).

Children (aged 4 to 11 years of age) and adolescents (aged 12 to 17 years of age) weighing less than 50 kg

The initial therapeutic dose is 10 mg/kg twice daily. (See Table 1.)

Depending on the clinical response and tolerance, the daily dose can be increased up to 60 mg/kg daily (in two 30 mg/kg doses). Dose changes can be made in 10 mg/kg twice daily dose increments or decrements every two weeks.

The dosage in children 50 kg or greater is the same as in adults.

The doctor should prescribe the most appropriate pharmaceutical form and strength according to weight and dose. Please refer to Table 1.

Table 1. Recommended dosing in children aged 4 years and older:

¹ Children 20 kg or less should preferably start the treatment with levetiracetam 100 mg/mL oral solution
² Dosage in children and adolescents 50 kg or more is the same as in adults

Infants and children less than 4 years of age

There are insufficient data to recommend the use of levetiracetam in children under 4 years of age.

Patients with renal impairment

The levetiracetam daily dose must be individualised according to renal function. Refer to Table and adjust the dose as indicated. Please refer to table 2.

To use this dosing table, an estimate of the patient’s creatinine clearance (ClCr) in mL/minute is needed. The ClCr in mL/minute may be estimated from serum creatinine (micromole/L) determination using the following formula. Please refer to equation 1.

CL_cr = [140 – age (years)] x weight (kg) / 0.8136 x serum creatinine (micromol/L)

The Cl_Cr is adjusted for body surface area (BSA) as follows. Please refer to Equation 2.

CL_cr (mL/min/1.73 m²) = CL_cr (mL/min) x 1.73 / BSA subject (m²)

Table 2. Dosage schedule based on renal function:

¹ A 750 mg loading dose is recommended on the first day of treatment with levetiracetam.
² Following dialysis, a 250 to 500 mg supplemental dose is recommended.

For children with renal impairment, levetiracetam dose needs to be adjusted based on the renal function as levetiracetam clearance is related to renal function. This recommendation is based on a study in renally impaired patients.

Patients with hepatic impairment

No dose adjustment is needed in patients with mild and moderate hepatic impairment.

In patients with severe hepatic impairment, the creatinine clearance may underestimate the renal insufficiency. Therefore a 50% reduction of the daily maintenance dose is recommended when the creatinine clearance is <70 mL/min.

The highest known dose of levetiracetam received in the clinical development program was 6,000 mg/day. Other than drowsiness, there were no adverse events in the few known cases of overdose in clinical trials. Cases of somnolence, agitation, aggression, depressed level of consciousness, respiratory depression and coma were observed with levetiracetam overdoses in postmarketing use.

Treatment. There is no specific antidote for levetiracetam. Treatment for an overdose will be symptomatic and may include haemodialysis. The dialyser extraction efficiency is 60% for levetiracetam and 74% for the major metabolite (ucb L057).

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

Store below 30 deg. C.

Levecetam 250, 500, 1000 tablets come in 3 different strengths in packs of 60 tablets packed in PVC/PVDC/Al of blister pack.

In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.