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PMS-LACOSAMIDE is a brand name for Lacosamide, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE........................................................................... 3 CONTRAINDICATIONS ................................................................................................ 4 WARNINGS AND PRECAUTIONS .............................................................................. 4…
Verbatim from this product's HC label. Tap a section to expand.
General Considerations pms-LACOSAMIDE (lacosamide) may be taken with or without food. Film-coated tablets The film-coated tablets are taken orally twice a day. For further directions for use, see the DOSAGE AND ADMINISTRATION, Recommended Dose and Dosage Adjustment section of the product monograph.
Recommended Dose and Dosage Adjustment Monotherapy The recommended starting dose is 100 mg twice a day (200 mg/day), with or without food. Depending on patient response and tolerability, the dose can be further increased at weekly intervals by 50 mg twice a day (100 mg/day), to a maximum recommended maintenance daily dose of 300 mg twice a day (600 mg/day).
In the monotherapy trial, the majority of patients who completed the Evaluation Phase of the study and remained seizure free received pms-LACOSAMIDE 200 or 400 mg/day (see CLINICAL TRIALS). In patients having reached pms-LACOSAMIDE ≥ 400mg/day and who need an additional antiepileptic drug, the dosing that is recommended for adjunctive therapy below should be followed.
Maximum recommended daily dose for adjunctive therapy is 400 mg/day. Adjunctive Therapy The recommended starting dose for pms-LACOSAMIDE is 50 mg twice a day, with or without food, which should be increased to an initial therapeutic dose of 100 mg twice a day after one week.
Depending on patient response and tolerability, the maintenance dose can be further increased by 50 mg twice a day every week, to a maximum recommended daily dose of 400 mg (200 mg twice a day). Doses above 400 mg/day do not confer additional benefit, are associated with more severe and substantially higher frequency of adverse reactions and are not recommended (see OVERDOSAGE, Non-acute Overdose in Humans).
, taper the daily dose by 200 mg/week). Patients with Renal Impairment No dose adjustment is necessary in patients with mild or moderate renal impairment (creatinine clearance (CLCR) > 30 mL/min). A maximum dose of 300 mg/day is recommended for patients with severe renal impairment (CLCR ≤ 30 mL/min) and in patients with end-stage renal disease.
In all patients with any degree of renal impairment, the dose titration should be performed with Product Monograph pms-LACOSAMIDE Page 20 of 38 caution (see ACTION AND CLINICAL PHARMACOLOGY, Special Populations and Conditions, Renal Impairment).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Following a 4-hour hemodialysis treatment, AUC of lacosamide was reduced by approximately 50%. Thus, dosage supplementation of up to 50% following hemodialysis may be considered. Treatment of patients with end-stage renal disease should be made with caution as there is limited clinical experience in subjects (n = 8) and no experience in patients, and there is accumulation of a metabolite (with no known pharmacological activity).
Patients with Hepatic Impairment The dose titration should be performed with caution in patients with mild to moderate hepatic impairment. A maximum dose of 300 mg/day is recommended for patients with mild or moderate hepatic impairment.
The pharmacokinetics of lacosamide have not been evaluated in severe hepatic impairment. pms-LACOSAMIDE is not recommended in patients with severe hepatic impairment (see ACTION AND CLINICAL PHARMACOLOGY, Special Populations and Conditions, Hepatic Impairment).
Geriatrics (≥ 65 years of age) Clinical experience with lacosamide in elderly patients with epilepsy is limited. Although no dose reduction is necessary in elderly patients, caution should be exercised during dose titration and age-associated decreased renal clearance with an increase in AUC levels should be considered in elderly patients (see ACTION AND CLINICAL PHARMACOLOGY, Special Populations and Conditions, Geriatrics).
Pediatrics (< 18 years of age) The safety and effectiveness of lacosamide in pediatric patients < 18 years has not been established, and therefore its use in this patient population is not indicated (see INDICATIONS AND CLINICAL USE; and WARNINGS AND PRECAUTIONS, Special Populations, Pediatrics).
Missed Dose If the patient misses a dose by a few hours, they should be instructed to take pms-LACOSAMIDE as soon as they remember. If it is close to their next dose, they should be instructed to take their medication at the next regular time.
Patients should not take two doses at the same time. OVERDOSAGE Signs, Symptoms, and Laboratory Findings of Acute Overdose in Humans Lowest known lethal dose: estimated 7g (age 56, male) (see below). Product Monograph pms-LACOSAMIDE Page 21 of 38 The types of adverse events experienced by patients exposed to acute lacosamide overdose during pre-marketing clinical trials were mostly similar to those observed in patients administered therapeutic doses of lacosamide.
Following doses above 400 mg/day up to 800 mg/day, the more commonly reported adverse events were related to the central nervous system (dizziness, headache, fatigue) and the gastrointestinal system (nausea and vomiting). There has been a single case of intentional overdose in a clinical trial by a patient who self-administered 12,000 mg lacosamide along with large doses of zonisamide, topiramate, and gabapentin.
The patient was initially comatose, had second degree AV block, seizures, and was hospitalized. An EEG revealed epileptic waveforms. The patient recovered 2 days later. From the 9 cases in pre-marketing clinical studies exposed to an acute lacosamide overdose > 800 mg, none resulted in death.
Decreased visual acuity was reported in one case from a clinical trial of lacosamide overdose at 1,050 mg within a single day. The event was considered non-serious and resolved the following day. In post-marketing experience, events reported following acute single overdoses ranging between 800 mg and 12,000 mg were dizziness, nausea, vision abnormalities, seizures (generalized tonic-clonic seizures, status epilepticus), cardiac conduction […]