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TRELEMA is a brand name for Lacosamide. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Trelema is indicated as monotherapy in the treatment of partial-onset seizures with or without secondary generalisation in adults, adolescents and children from 2 years of age with epilepsy. Trelema is indicated as adjunctive therapy • in the treatment of partial-onset seizures with or without secondary generalisation…
Verbatim from this product's MHRA label. Tap a section to expand.
Posology The physician should prescribe the most appropriate formulation and strength according to weight and dose. The recommended posology for adults, adolescents and children from 2 years of age is summarised in the following table.
Lacosamide must be taken twice a day, approximately 12 hours apart. If a dose is missed, the patient should be instructed to take the missed dose immediately, and then to take the next dose of lacosamide at the regularly scheduled time.
If the patient notices the missed dose within 6 hours of the next one, he/she should be instructed to wait to take the next dose of lacosamide at the regularly scheduled time. Patients should not take a double dose. Adolescents and children weighing 50 kg or more, and adults Starting dose Titration (incremental steps) Maximum recommended dose Monotherapy: 50 mg twice a day (100 mg/day) or 100 mg twice a day (200 mg/day) Adjunctive therapy: 50 mg twice a day (100 mg/day) 50 mg twice a day (100 mg/day) at weekly intervals Monotherapy: up to 300 mg twice a day (600 mg/day) Adjunctive therapy: up to 200 mg twice a day (400 mg/day) Alternate initial dosage* (If applicable): 200 mg single loading dose followed by 100 mg twice a day (200 mg/day) *A loading dose may be initiated in patients in situations when the physician determines that rapid attainment of lacosamide steady state plasma concentration and therapeutic effect is warranted.
8). Administration of a loading dose has not been studied in acute conditions such as status epilepticus. Children from 2 years of age and adolescents weighing less than 50 kg Starting dose Titration (incremental steps) Maximum recommended dose Monotherapy: - up to 6 mg/kg twice a day (12 mg/kg/day) in patients ≥ 10 kg to < 40 kg - up to 5 mg/kg twice a day (10 mg/kg/day) in patients ≥ 40 kg to < 50 kg Monotherapy and Adjunctive therapy: 1 mg/kg twice a day (2 mg/kg/day) 1 mg/kg twice a day (2 mg/kg/day) at weekly intervals Adjunctive therapy: - up to 6 mg/kg twice a day (12 mg/kg/day) in patients ≥ 10 kg to < 20 kg - up to 5 mg/kg twice a day (10 mg/kg/day) in patients ≥ 20 kg to < 30 kg - up to 4 mg/kg twice a day (8 mg/kg/day) in patients ≥ 30 kg to < 50 kg Adolescents and children weighing 50 kg or more, and adults Monotherapy (in the treatment of partial-onset seizures) The recommended starting dose is 50 mg twice a day (100 mg/day) which should be increased to an initial therapeutic dose of 100 mg twice a day (200 mg/day) after one week.
Suicidal ideation and behaviour Suicidal ideation and behaviour have been reported in patients treated with anti- epileptic medicinal products in several indications. A meta-analysis of randomised placebo controlled clinical studies of anti-epileptic medicinal products has also shown a small increased risk of suicidal ideation and behaviour.
The mechanism of this risk is not known and the available data do not exclude the possibility of an increased risk for lacosamide. Therefore, patients should be monitored for signs of suicidal ideation and behaviours and appropriate treatment should be considered.
8). Cardiac rhythm and conduction Dose-related prolongations in PR interval with lacosamide have been observed in clinical studies. g. 5), as well as in elderly patients. In these patients it should be considered to perform an ECG before a lacosamide dose increase above 400 mg/day and after lacosamide is titrated to steady- state.
In the placebo-controlled clinical studies of lacosamide in epilepsy patients, atrial fibrillation or flutter were not reported; however, both have been reported in open- label epilepsy trials and in post-marketing experience. In post-marketing experience, AV block (including second degree or higher AV block) has been reported.
In patients with proarrhythmic conditions, ventricular tachyarrhythmia has been reported. In rare cases, these events have led to asystole, cardiac arrest and death in patients with underlying proarrhythmic conditions. g. slow, rapid or irregular pulse, palpitations, shortness of breath, feeling lightheaded, fainting).
Patients should be counselled to seek immediate medical advice if these symptoms occur. Dizziness Treatment with lacosamide has been associated with dizziness which could increase the occurrence of accidental injury or falls. 8). Potential for new onset or worsening of myoclonic seizures New onset or worsening of myoclonic seizures has been reported in both adult and paediatric patients with PGTCS, in particular during titration.
1. - Known second- or third-degree atrioventricular (AV) block.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Lacosamide can also be initiated at the dose of 100 mg twice a day (200 mg/day) based on the physician's assessment of required seizure reduction versus potential side effects. Depending on response and tolerability, the maintenance dose can be further increased at weekly intervals by 50 mg twice a day (100 mg/day), up to a maximum recommended daily dose of 300 mg twice a day (600 mg/day).
In patients having reached a dose greater than 200 mg twice a day (400 mg/day) and who need an additional antiepileptic medicinal product, the posology that is recommended for adjunctive therapy below should be followed. Adjunctive therapy (in the treatment of partial-onset seizures or in the treatment of primarygeneralised tonic-clonic seizures) The recommended starting dose is 50 mg twice a day (100 mg/day) which should be increased to an initial therapeutic dose of 100 mg twice a day (200 mg/day) after one week.
Depending on response and tolerability, the maintenance dose can be further increased at weekly intervals by 50 mg twice a day (100 mg/day), up to a maximum recommended daily dose of 200 mg twice a day (400 mg/day). Children from 2 years of age and adolescents weighing less than 50 kg The dose is determined based on body weight.
It is therefore recommended to initiate treatment with the syrup and switch to tablets, if desired. When prescribing the syrup, the dose should be expressed in volume (ml) rather than weight (mg). Monotherapy (in the treatment of partial-onset seizures) The recommended starting dose is 1 mg/kg twice a day (2 mg/kg/day) which should be increased to an initial therapeutic dose of 2 mg/kg twice a day (4 mg/kg/day) after one week.
Depending on response and tolerability, the maintenance dose can be further increased by 1 mg/kg twice a day (2 mg/kg/day) every week. The dose should be gradually increased until the optimum response is obtained. The lowest effective dose should be used.
In children weighing from 10 kg to less than 40 kg, a maximum dose of up to 6 mg/kg twice a day (12 mg/kg/day) is recommended. In children weighing from 40 to under 50 kg, a maximum dose of 5 mg/kg twice a day (10 mg/kg/day) is recommended.
The tables below provide examples of volumes of syrup per intake depending on prescribed dose and body weight. The precise volume of syrup is to be calculated according to the exact body weight of the child. The calculated volume should be rounded to the nearest measuring device graduated increment.
If the calculated volume is equidistant between two graduated increments, the larger graduated increment should be used (see Method of administration). 5 ml (75 mg) 9 ml (90 […]
In patients with more than one seizure type, the observed benefit of control for one seizure type should be weighed against any observed worsening in another seizure type. Potential for electro-clinical worsening in specific paediatric epilepsy syndromes The safety and efficacy of lacosamide in paediatric patients with epilepsy syndromes in which focal and generalised seizures may coexist have not been determined.
Excipients This medicinal product contains methyl hydroxybenzoate (E 218), which may cause allergic reactions (possibly delayed). This medicinal product contains 187 mg sorbitol (E 420) in each ml. Patients with hereditary fructose intolerance (HFI) should not take/be given this medicinal product.
Sorbitol may cause gastrointestinal discomfort and mild laxative effect. 93 mg propylene glycol (E 1520) in each ml. 35 mg sodium per ml, which is 81 mg sodium per 60 ml (the maximum recommended daily dose), equivalent to 4% of the WHO recommended maximum daily intake of 2 g sodium for an adult.