Neurocet XR 500Tablet (Extended Release)

Generic

Levetiracetam

Indications

Adults and adolescents from the age of 16 with newly diagnosed epilepsy should take levetiracetam as a monotherapy for partial-onset seizures with or without secondary generalization. Adults, adolescents, children, and newborns with epilepsy from the age of one month are prescribed levetiracetam as an additional therapy for partial-onset seizures with or without secondary generalization.

in the treatment of myoclonic seizures in adults and adolescents with Juvenile Myoclonic Epilepsy starting at the age of 12.

in the treatment of primary generalized tonic-clonic seizures in adults and adolescents with idiopathic generalised epilepsy starting at the age of 12 years.

Dosage & Administration

Adults and adolescents from 16 years of age: 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 1500 mg twice daily.

Adults (≥18 years) and adolescents (12 to 17 years) weighing 50 kg or more: The initial therapeutic dose is 500 mg twice daily. This dose can be started on the first day of treatment. Depending upon the clinical response and tolerability, the daily dose can be increased up to 1,500 mg twice daily. Dose changes can be made in 500 mg twice daily increases or decrease every two to four weeks.

Pediatric population: The tablet formulation is not adapted for use in infants and children under the age of 6 years. Oral solution is the preferred formulation for use in this population. In addition, the available dose strengths of the tablets are not appropriate for initial treatment in children weighing less than 25 kg, for patients unable to swallow tablets or for the administration of doses below 250 mg. In all of the above cases, oral solution should be used.

Monotherapy: The safety and efficacy of levetiracetam in children and adolescents below 16 years as monotherapy treatment have not been established.

Add-on therapy: Oral solution is the preferred formulation for use in infants and children under the age of 6 years. For children 6 years and above, oral solution should be used for doses under 250 mg, for doses not in multiples of 250 mg when dosing recommendation is not achievable by taking multiple tablets and for patients unable to swallow tablets. The lowest effective dose should be used. The starting dose for a child or adolescent of 25 kg should be 250 mg twice daily with a maximum dose of 750 mg twice daily. Dosing for children 50 kg or greater is the same as in adults.

Add-on therapy: For infants aged from 1 month to less than 6 months: The oral solution is the formulation to use in infants.

Interaction

Pre-marketing data from adult clinical studies show that levetiracetam had no effect on the serum concentrations of existing antiepileptic medicinal products (phenytoin, carbamazepine, valproic acid, phenobarbital, lamotrigine, gabapentin, and primidone), and that these antiepileptic medicinal products had no effect on the pharmacokinetics of lev.

Probenecid, a renal tubular secretion inhibiting drug, has been demonstrated to impede renal clearance of the principal metabolite but not of levetiracetam (500 mg four times day). Nonetheless, this metabolite's concentration remains modest.

Methotrexate: It has been reported that taking levetiracetam and methotrexate together reduces methotrexate clearance, resulting in higher/longer blood methotrexate concentrations that are potentially hazardous. The levels of methotrexate and levetiracetam in the blood should be closely monitored in patients who are taking both medications at the same time.

When the osmotic laxative macrogol is administered concurrently with oral levetiracetam, there have been rare instances of diminished levetiracetam efficacy. As a result, one hour before and one hour after taking levetiracetam, macrogol should not be taken orally.

Contraindications

Hypersensitivity to the active ingredient or other pyrrolidone derivatives, as well as any excipients.

Side Effects

The following are the most common adverse responses (incidence 5% higher than placebo):

Somnolence, asthenia, illness, and dizziness in adults

Patients under the age of 18: weariness, irritability, aggressiveness, nasal congestion, and decreased appetite

Pregnancy & Lactation

Levetiracetam should not be used during pregnancy or by women of reproductive potential who are not utilizing contraception unless it is clinically essential. Human breast milk contains levetiracetam. As a result, nursing is not advised. If levetiracetam medication is required while breastfeeding, the treatment's value and risk should be evaluated against the importance of breastfeeding. In animal trials, there was no effect on fertility. There are no clinical data available, and the risk to humans is unclear.

Precautions & Warnings

Renal impairment: Patients with renal impairment may require dose adjustments when using levetiracetam. Assessment of renal function is required before dose selection in patients with substantially compromised hepatic function.

Acute renal injury: Levetiracetam use has been linked to a very small number of cases of acute kidney injury, with onset times ranging from a few days to several months.

Blood cell counts: Levetiracetam administration has been linked to rare cases of decreased blood cell counts (neutropenia, agranulocytosis, leucopenia, thrombocytopenia, and pancytopenia), usually at the start of treatment. It is recommended that you have a complete blood cell count.

Suicide, suicide attempts, and suicidal ideation and behavior have all been observed in anti-epileptic drug patients (including levetiracetam). A meta-analysis of anti-epileptic drug randomized placebo-controlled studies found a modest increase in the incidence of suicide thoughts and behavior. The mechanism underlying this risk is unknown. As a result, patients should be closely monitored for signs of depression and/or suicidal ideation and behavior, with appropriate therapy explored. Patients (and their caretakers) should be encouraged to seek medical help if they show signs of sadness or suicidal ideation or behavior.

Therapeutic Class

Anti-epileptic medications taken in addition.

Storage Conditions

Store at a cool temperature (not exceeding 25°C) and dry place, protected from light.

Pharmaceutical Name

Incepta Pharmaceuticals Ltd.