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TEVA-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: TEVA-LACOSAMIDE (lacosamide tablets) 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…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations TEVA-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 TEVA-LACOSAMIDE ≥400 mg / 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 TEVA-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 TEVA-LACOSAMIDE, should be considered.
More frequent PrTEVA-LACOSAMIDE Product Monograph Page 13 of 51 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.
2 Recommended Dose and Dosage Adjustment, Discontinuation). Carcinogenesis and Mutagenesis See 16 NON-CLINICAL TOXICOLOGY, Carcinogenesis and Mutagenesis for discussion on animal data. Cardiovascular Cardiac Rhythm and Conduction Abnormalities • PR Interval Prolongation In post-marketing experience, atrioventricular (AV) block (including second degree or higher AV block) has been reported.
In patients with proarrhythmic conditions, ventricular tachyarrhythmia has been rarely 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), and told to seek immediate medical advice if these symptoms occur.
PrTEVA-LACOSAMIDE Product Monograph Page 10 of 51 In patients who develop serious cardiac arrhythmia, TEVA-LACOSAMIDE should be discontinued and a thorough clinical benefit/risk assessment should be performed before possibly restarting therapy.
g. g. 2 Drug Interactions Overview). In such patients, obtaining an ECG before beginning TEVA-LACOSAMIDE, and after TEVA-LACOSAMIDE is titrated to steady-state, is recommended. g. 2 Drug Interactions Overview). In these patients it should be considered to perform an ECG before a TEVA-LACOSAMIDE dose increase above 400 mg/day and after TEVA-LACOSAMIDE is titrated to steady state.
2 Pharmacodynamics, Cardiac Electrophysiology). Patients with significant electrocardiographic (ECG) abnormalities were systematically excluded from these trials. 3ms for the placebo group. 3ms for the placebo group. 2ms in the placebo group.
2 Clinical Trial Adverse Reactions, Cardiac). • Atrial Fibrillation and Atrial Flutter TEVA-LACOSAMIDE administration may predispose to atrial arrhythmias (atrial fibrillation or flutter), especially in patients with diabetic neuropathy and/or cardiovascular disease.
• Patients who are hypersensitive to TEVA-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.
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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.
4 Drug-Drug Interactions, Oral Contraceptives). PrTEVA-LACOSAMIDE Product Monograph Page 14 of 51 • 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 Trail 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 embryotoxicity was observed at maternal toxic doses (see 5 OVERDOSAGE, Non-acute Overdose in Humans; 16 NON-CLINICAL TOXICOLOGY, Reproductive and Developmental Toxicology).
There are postmarketing reports of lacosamide crossing the placental barrier in humans. Since the potential risk for humans is not established, TEVA-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 TEVA-LACOSAMIDE, the use of this product should be carefully re-evaluated.
Pregnancy Registry:
Physicians are advised to recommend that pregnant patients taking TEVA- LACOSAMIDE enroll in the North American Antiepileptic Drug (NAAED) 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 in significant quantities. 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.
3 Pediatrics Pediatrics (< 18 years of age): TEVA-LACOSAMIDE is not indicated for use in pediatrics (< 18 years of age) as there […]
g. palpitations, rapid or irregular pulse, shortness of breath) and told to contact their physician should any of these symptoms occur. PrTEVA-LACOSAMIDE Product Monograph Page 11 of 51 Atrial fibrillation and flutter have been reported in open-label epilepsy trials and in post- marketing experience.
No cases occurred in the short-term investigational trials of lacosamide in epilepsy patients. 6% of patients treated with lacosamide experienced an adverse reaction of atrial fibrillation or atrial flutter, compared to 0% of placebo-treated patients.
Driving and Operating Machinery Patients should be advised not to drive a car or to operate other complex machinery or perform hazardous tasks until they are familiar with the effects of TEVA-LACOSAMIDE on their ability to perform such activities (see 7 WARNINGS AND PRECAUTIONS, Neurologic).
Hepatic/Biliary/Pancreatic Rare post-marketing reports of severe liver injury, including acute liver failure, have been reported in patients treated with lacosamide. Some of the cases were considered clinically significant and possibly or probably related to lacosamide therapy.
, pruritus, dark urine, jaundice, right upper quadrant tenderness, or unexplained "flu-like" symptoms). 5 Post-Market Adverse Drug Reactions, Hepatic/Biliary/Pancreatic). Immune Hypersensitivity Multiorgan hypersensitivity reactions (including Drug Reaction with Eosinophilia and Systemic Symptoms, or DRESS), Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN) […]