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ZDS-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: ZDS-Lacosamide is indicated as: • Monotherapy in the management of partial-onset seizures in adult (>18 years of age) patients with epilepsy. All patients who participated in the monotherapy trial were newly or recently diagnosed with epilepsy (see 14 CLINICAL TRIALS). • Adjunctive therapy in the management of…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations ZDS-Lacosamide may be taken with or without food. 2 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).
2 Study Results, Monotherapy). In patients having reached ZDS-Lacosamide ≥ 400mg/day and who need an additional Page 5 of 43 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 ZDS-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
). Patients should be informed that if visual disturbances occur, they should notify their physician promptly. If visual disturbance persists, further assessment, including dose reduction and possible discontinuation of ZDS-Lacosamide, should be considered.
More frequent assessments should be considered for patients with known vision-related issues or those who are already routinely monitored for ocular conditions. Psychiatric Suicidal Ideation and Behaviour Suicidal ideation and behaviour have been reported in patients treated with antiepileptic agents in several indications.
All patients treated with antiepileptic drugs, irrespective of indication, should be monitored for signs of suicidal ideation and behaviour and appropriate treatment should be considered. Patients (and caregivers of patients) should be advised to seek medical advice should signs of suicidal ideation or behaviour emerge.
An FDA meta-analysis of randomized placebo controlled trials, in which antiepileptic drugs were used for various indications, has shown a small increased risk of suicidal ideation and behaviour in patients treated with these drugs.
The mechanism of this risk is not known. There were 43892 patients treated in the placebo controlled clinical trials that were included in the meta-analysis. Approximately 75% of patients in these clinical trials were treated for indications other than epilepsy and, for the majority of non-epilepsy indications the treatment (antiepileptic drug or placebo) was administered as monotherapy.
, patients in both treatment arms were being treated with one or more antiepileptic drug). 24% for patients on placebo) is based largely on patients that received monotherapy treatment (antiepileptic drug or placebo) for non-epilepsy indications.
The study design does not allow an estimation of the risk of suicidal ideation and behaviour for patients with epilepsy that are taking antiepileptic drugs, due both to this population being the minority in the study, and the drug-placebo comparison in this population being confounded by the presence of adjunct antiepileptic drug treatment in both arms.
1 Pregnant Women ............................................................................................ 2 Breast-feeding ................................................................................................. 14 8 ADVERSE REACTIONS ..................................................................................................
22 9 DRUG INTERACTIONS .................................................................................................. 7 Drug-Laboratory Test Interactions ………………………………………………………………………27 10 CLINICAL PHARMACOLOGY .........................................................................................
29 11 STORAGE, STABILITY AND DISPOSAL ................................................................................ 32 12 SPECIAL HANDLING INSTRUCTIONS .............................................................................
32 PART II: SCIENTIFIC INFORMATION ......................................................................................... 33 Page 3 of 43 13 PHARMACEUTICAL INFORMATION ..............................................................................
33 14 CLINICAL TRIALS .......................................................................................................... 34 Monotherapy………………………………………………………………………………………………………………. 34 Adjunctive Therapy…………………………………………………………………………………….................................
40 15 MICROBIOLOGY .......................................................................................................... 41 16 NON-CLINICAL TOXICOLOGY ........................................................................................
42 PATIENT MEDICATION INFORMATION .................................................................................... 43 Page 4 of 43 PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS ZDS-Lacosamide is indicated as: • Monotherapy in the management of partial-onset seizures in adult (>18 years of age) patients with epilepsy.
• Patients who are hypersensitive to ZDS-Lacosamide or to any of the excipients. For a complete listing, see the 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING section of the product monograph. • Patients with a history of, or presence of, second- or third-degree atrioventricular (AV) block.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Lacosamide in Canada.
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4 Drug-Drug Interactions, Oral Contraceptives). • Fertility No adverse effects on male or female fertility or reproduction were observed in rats at doses producing plasma exposures (AUC) up to approximately 2 times the plasma AUC in humans at the maximum recommended human dose (MRHD) of 400 mg/day.
Syncope In the short-term controlled adjunctive therapy trials of lacosamide in epilepsy patients with no significant system illnesses, there was no increase in syncope compared to placebo. 0% of patients who were treated with lacosamide reported an adverse reaction of syncope or loss of consciousness, compared to 0% of placebo-treated patients with diabetic neuropathy.
Most of the cases of syncope were observed in patients receiving doses above 400 mg/day. The cause of syncope was not determined in most cases. However, several were associated with either changes in orthostatic blood pressure, atrial flutter/fibrillation (and associated tachycardia), or bradycardia.
2 Clinical Trial Adverse Reactions, Syncope). 1 Pregnant Women There are no clinical studies with lacosamide in pregnant women. Studies in pregnant rats revealed that lacosamide and/or its metabolites readily crossed the placental barrier.
Data in rats and rabbits did not indicate teratogenic effects but embryo toxicity was observed at maternal toxic doses (see 5 OVERDOSAGE, Non-acute Overdose in Humans; 16 NON-CLINICAL TOXICOLOGY, Reproductive and Developmental Toxicology).
There are post-marketing reports of lacosamide crossing the placental barrier in humans. Since the potential risk for humans is not established, lacosamide should not be used during pregnancy unless the benefit to the mother clearly outweighs the potential risk to the foetus.
If women decide to become pregnant while taking ZDS-Lacosamide, the use of this product should be carefully re-evaluated.
Pregnancy Registry:
Physicians are advised to recommend that pregnant patients taking ZDS- Lacosamide enroll in the North American Antiepileptic Drug Pregnancy Registry. This can be done by calling the toll free number 1-888-233-2334, and must be done by patients themselves.
2 Breast-feeding Lacosamide is excreted in human breast milk. 83 have been reported. A decision should be made whether to discontinue nursing or to discontinue lacosamide, taking into account the benefits of the drug to the mother and any potential adverse effects of lacosamide on the breastfed infant.
2 Recommended Dose and Dose Adjustment, Pediatrics). 4 […]
All patients who participated in the monotherapy trial were newly or recently diagnosed with epilepsy (see 14 CLINICAL TRIALS). • Adjunctive therapy in the management of partial-onset seizures in adult patients with epilepsy who are not satisfactorily controlled with conventional therapy.
3 Pediatrics). 2 Geriatrics Geriatrics (> 65 years of age): The clinical experience with lacosamide in elderly patients with epilepsy is limited. 3 Pharmacokinetics, Special Populations and Conditions, Geriatrics). 2 CONTRAINDICATIONS • Patients who are hypersensitive to ZDS-Lacosamide or to any of the excipients.
For a complete listing, see the 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING section of the product monograph. • Patients with a history of, or presence of, second- or third-degree atrioventricular (AV) block. 1 Dosing Considerations ZDS-Lacosamide may be taken with or without food.
2 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).
2 Study Results, Monotherapy). In patients having reached […]