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LAMICTAL is a brand name for Lamotrigine, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Adults ( 18 years of age) LAMICTAL (lamotrigine) is indicated: • as adjunctive therapy for the management of epilepsy not satisfactorily controlled by conventional therapy; • for use as monotherapy following withdrawal of concomitant antiepileptic drugs; • as adjunctive therapy for the management of the seizures…
Verbatim from this product's HC label. Tap a section to expand.
2 Recommended Dose and Dosage Adjustment 03/2025 7 WARNINGS AND PRECAUTIONS, General 03/2025 7 WARNINGS AND PRECAUTIONS, Skin, Asian Ancestry and Allelic variation in HLA-B 03/2025 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed.
RECENT MAJOR LABEL CHANGES .......................................................................................... 2 TABLE OF CONTENTS ............................................................................................................
2 1 INDICATIONS ............................................................................................................. 1 Pediatrics................................................................................................................
2 Geriatrics ................................................................................................................ 4 2 CONTRAINDICATIONS ................................................................................................
4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ........................................................... 4 4 DOSAGE AND ADMINISTRATION................................................................................ 1 Dosing Considerations ...........................................................................................
2 Recommended Dose and Dosage Adjustment ...................................................... 4 Administration ..................................................................................................... 5 Missed Dose .........................................................................................................
12 5 OVERDOSAGE.......................................................................................................... 12
). Eosinophilia is often present. This disorder is variable in its expression and other organ systems not noted here may be involved. The syndrome shows a wide spectrum of clinical severity and may rarely lead to disseminated intravascular coagulation (DIC) and multi-organ failure.
, fever, lymphadenopathy) may be present even though a rash is not evident. If such signs or symptoms are present, the patient should be evaluated immediately. LAMICTAL should be discontinued if an alternative etiology for the signs or symptoms cannot be established.
, fever, lymphadenopathy) may herald a serious medical event and that the patient should report any such occurrence to a physician immediately. • Asian Ancestry and Allelic variation in HLA-B Some meta-analyses have shown that human leukocyte antigen (HLA)-B*1502 allele in individuals of Asian (primarily Han Chinese and Thai†) origin is associated with the risk of developing SJS/TEN when treated with lamotrigine.
If patients are known to be carrying this genetic variant, the benefits of treatment with lamotrigine should be carefully weighed against the risk of developing SJS/TEN. Should signs and symptoms suggest a severe skin reaction such as SJS or TEN, lamotrigine should be withdrawn at once, under clinical supervision.
Many HLA-B*1502-positive Asian patients treated with LAMICTAL will not develop SJS/TEN, and these reactions can still occur infrequently in HLA-B*1502-negative patients of any ethnicity. The role of other possible factors in the development of, and morbidity from, SJS/TEN, such as antiepileptic drug (AED) dose, compliance, concomitant medications, co-morbidities, and the level of dermatologic monitoring have not been studied.
In addition, it should be kept in mind that the majority of LAMICTAL-treated patients who will experience SJS/TEN have this reaction within the first few months of treatment. † The following rates provide a rough estimate of the prevalence of HLA-B*1502 in various populations.
, General 03/2025 7 WARNINGS AND PRECAUTIONS, Skin, Asian Ancestry and Allelic variation in HLA-B 03/2025 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES ..........................................................................................
2 TABLE OF CONTENTS ............................................................................................................ 2 1 INDICATIONS .............................................................................................................
1 Pediatrics................................................................................................................ 2 Geriatrics ................................................................................................................
4 2 CONTRAINDICATIONS ................................................................................................ 4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ........................................................... 4 4 DOSAGE AND ADMINISTRATION................................................................................
1 Dosing Considerations ........................................................................................... 2 Recommended Dose and Dosage Adjustment ...................................................... 4 Administration .....................................................................................................
5 Missed Dose ......................................................................................................... 12 5 OVERDOSAGE..........................................................................................................
12 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING .............................. 13 7 WARNINGS AND PRECAUTIONS ............................................................................... 1 Special Populations ..............................................................................................
Patients who are hypersensitive to this drug or to any ingredient in the formulation or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING, Composition).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Lamotrigine in Canada.
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Greater than 15% of the population is reported positive in Hong Kong, Thailand, Malaysia, and parts of the Philippines, compared to about 10% in Taiwan and 4% in North China. South Asians, including Indians, appear to have intermediate prevalence of HLA-B*1502, averaging 2 to 4%, but this may be higher in some groups.
HLA-B*1502 is present in <1% of the population in Japan and Korea. , Caucasians, African-Americans, Hispanics, and Native Americans). The estimated prevalence rates have limitations due to the wide variability in rates that exist within ethnic groups, the difficulties in ascertaining ethnic ancestry and the likelihood of mixed ancestry.
• Photosensitivity There have also been reports of photosensitivity reactions associated with lamotrigine use. If lamotrigine-associated photosensitivity is suspected in a patient showing signs of photosensitivity (such as an exaggerated sunburn), treatment discontinuation should be considered.
g. use of protective clothing and sunscreens). • Skin-related events Serious rashes requiring hospitalisation, including rare reports of fatalities, have occurred with lamotrigine (see 3 SERIOUS WARNINGS AND PRECAUTIONS BOX). The risk of serious skin rashes is higher in children than in adults.
In adult controlled studies of adjunctive lamotrigine therapy, the incidence of rash (usually maculopapular and/or erythematous) in patients receiving LAMICTAL was 10% compared with 5% in placebo patients. The rash usually occurred within the first eight weeks of therapy and resolved during continued administration of LAMICTAL.
8% of all patients in all studies. The rate of rash- LAMICTAL, lamotrigine Page 20 of 53 related withdrawal in clinical studies was higher with more rapid initial titration dosing, and in patients receiving concomitant valproic acid (VPA), particularly in the absence of AEDs that induce lamotrigine glucuronidation.
See Table 7 and Table 8; see also 4 DOSAGE AND ADMINISTRATION. 0% VPA = Valproic Acid 1 AEDs that induce lamotrigine glucuronidation include carbamazepine, phenobarbital, phenytoin, and primidone 2 AEDs that neither inhibit nor induce lamotrigine glucuronidation include clonazepam, clobazam, ethosuximide, methsuximide, vigabatrin, and gabapentin LAMICTAL, lamotrigine Page 21 of 53 Table 8 - Effect of the Initial Daily Dose1 of LAMICTAL in the Presence of Concomitant AEDs, on the Incidence of Rash Leading to Withdrawal of Treatment in Adult Add-On Clinical Trials AED Group AEDs that induce lamotrigine glucuronidation2 AEDs that induce lamotrigine glucuronidation 2 + VPA VPA ± AEDs that neither inhibit nor induce lamotrigine glucuronidation3 LAMICTAL Average Daily Dose (mg) Total Patient Number Percentage of Patients Withdrawn Total Patient Number Percentage of Patients Withdrawn Total Patient Number […]
1 Pregnant Women ............................................................................................. 2 Breast-feeding .................................................................................................. 4 Geriatrics ..........................................................................................................
23 8 ADVERSE REACTIONS............................................................................................... 1 Adverse Reaction Overview ................................................................................. 2 Clinical Trial Adverse Reactions ...........................................................................
3 Less Common Clinical Trial Adverse Reactions .................................................... 5 Post-Market Adverse Reactions........................................................................... 29 9 DRUG INTERACTIONS ..............................................................................................
2 Drug Interactions Overview ................................................................................. 3 Drug-Behavioural Interactions ............................................................................. 4 Drug-Drug Interactions ........................................................................................
6 Drug-Herb Interactions ........................................................................................ 7 Drug-Laboratory Test Interactions....................................................................... 36 10 CLINICAL PHARMACOLOGY ......................................................................................
1 Mechanism of Action ........................................................................................... 2 Pharmacodynamics .............................................................................................. 3 Pharmacokinetics .................................................................................................
37 11 STORAGE, STABILITY AND DISPOSAL ........................................................................ 40 12 SPECIAL HANDLING INSTRUCTIONS.......................................................................... 40 PART II: SCIENTIFIC INFORMATION .....................................................................................
41 13 PHARMACEUTICAL INFORMATION .......................................................................... 41 14 CLINICAL TRIALS ......................................................................................................
2 Study Results ........................................................................................................ 41 15 MICROBIOLOGY ......................................................................................................
42 16 NON-CLINICAL TOXICOLOGY .................................................................................... 42 PATIENT MEDICATION INFORMATION ................................................................................ 46 LAMICTAL, lamotrigine Page 4 of 53 PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS Adults ( 18 years of age) LAMICTAL (lamotrigine) is indicated: • as adjunctive therapy for the management of epilepsy not satisfactorily controlled by conventional therapy; • for use as monotherapy following withdrawal of concomitant antiepileptic drugs; • as adjunctive therapy for the management of the seizures associated with Lennox-Gastaut syndrome.
1 Pediatrics Pediatrics (<18 years of age) LAMICTAL (lamotrigine) is indicated as adjunctive therapy for the management of the seizures associated with Lennox-Gastaut syndrome. LAMICTAL is not recommended in children weighing less than 9 kg (see 4 DOSAGE AND […]