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AURO-LAMOTRIGINE is a brand name for Lamotrigine, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Verbatim from this product's HC label. Tap a section to expand.
) and treatment should only be initiated in children weighing 42 kg and above (see 4 DOSAGE AND ADMINISTRATION, Pediatric Dosing with Lamotrigine for Patients Receiving Medications that Induce Lamotrigine Glucuronidation, without Valproic-Acid).
Safety and efficacy in patients below the age of 16 years, other than those with Lennox-Gastaut Syndrome, have not been established. 2 Geriatrics Geriatrics (> 65 years of age): No dosage adjustment is required in patients over 65 years of age.
2 Contraindications Patients who are hypersensitive to this drug or to any ingredient in the formulation or component of the container. For a complete listing, see
). 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. Auro-Lamotrigine 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 Should signs and symptoms suggest a severe skin reaction such as SJS or TEN, lamotrigine should be withdrawn at once, under clinical supervision.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 lamotrigine 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 lamotrigine-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.
). Restarting Auro-Lamotrigine Therapy It is recommended that Auro-Lamotrigine not be restarted in patients who discontinued due to rash associated with prior treatment with Auro-Lamotrigine, unless the potential benefits clearly outweigh the risks.
If the decision is made to restart a patient who has discontinued Auro-Lamotrigine for any reason, the need to restart with the initial dosing recommendations should be assessed. The greater the interval of time since the previous dose, the greater consideration should be given to restarting with the initial dosing recommendations.
If a patient has discontinued Auro-Lamotrigine for a period of more than 5 half-lives, it is recommended that initial dosing recommendations and guidelines be followed. Auro-lamotrigine Product Monograph Page 6 of 56 The half-life of Auro-Lamotrigine is affected by other concomitant medications (see 10 CLINICAL PHARMACOLOGY).
Withdrawal of Concomitant AEDs in Adults Concomitant AEDs may be decreased over a 5-week period, by approximately 20% of the original dose every week. However, a slower taper may be used if clinically indicated. During this period, the dose of Auro-Lamotrigine administered will be dependent upon the effect of the drug being withdrawn on the pharmacokinetics of lamotrigine, together with the overall clinical response of the patient.
, phenytoin, phenobarbital, primidone, and carbamazepine) will result in an approximate doubling of the t½ of lamotrigine. Under these conditions, it may be necessary to reduce the dose of Auro-Lamotrigine. , valproic acid) will result in a decrease in the t½ of lamotrigine and may require an increase in the dose of Auro-Lamotrigine.
2 Recommended Dose and Dosage Adjustment Auro-Lamotrigine should be added to the patient's current antiepileptic therapy. Valproic acid more than doubles the elimination half-life of lamotrigine and reduces the plasma clearance by 50%; conversely, drugs that induce lamotrigine glucuronidation such as carbamazepine, phenytoin, phenobarbital, and primidone reduce the elimination half-life of lamotrigine by 50% and double the plasma clearance (see 10 CLINICAL PHARMACOLOGY).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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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.
Auro-lamotrigine Product Monograph Page 20 of 56 • 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 lamotrigine 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 lamotrigine.
8% of all patients in all studies. The rate of rash- 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 Auro-lamotrigine Product Monograph Page 21 of 56 Table 8 - Effect of the Initial Daily Dose1 of lamotrigine 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 Lamotrigine Average Daily Dose (mg) Total Patient Number Percentage of Patients Withdrawn Total Patient Number Percentage of Patients […]
These clinically important interactions require dosage schedules of lamotrigine as summarized in Table 1 through Table 3. Lamotrigine does not alter plasma concentrations of concomitantly administered AEDs that induce lamotrigine glucuronidation and therefore they do not usually require dose adjustment to maintain therapeutic plasma concentrations.
For patients receiving Auro-Lamotrigine in combination with other AEDs, an evaluation of all AEDs in the regimen should be considered if a change in seizure control or an appearance or worsening of adverse experiences is observed. e.
rash) require a more rapid withdrawal (see 7 WARNINGS AND PRECAUTIONS). The relationship of plasma concentration to clinical response has not been established for lamotrigine. Dosing of Auro-Lamotrigine should be based on therapeutic response.
In controlled clinical studies, doses of lamotrigine that were efficacious generally produced steady-state trough plasma lamotrigine concentrations of 1 to 4 mcg/mL in patients receiving one or more concomitant AEDs. Doses of lamotrigine producing this plasma concentration range were well tolerated.
As with any antiepileptic drug, the oral dose of Auro-Lamotrigine should be adjusted to the needs of the individual patient, taking into consideration the concomitant AED therapy the patient is receiving. Adults and Children Over 12 Years of Age For patients taking AEDs whose pharmacokinetic interactions with lamotrigine are currently unknown, follow the titration schedule for concomitant VPA (regardless of any concomitant mediation).
Auro-lamotrigine Product Monograph Page 7 of 56 Table 1 - Escalation regimen for lamotrigine in Patients over 12 Years of Age Patients Taking Medications that induce lamotrigine glucuronidation1 Patients Taking Medications that neither induce nor inhibit lamotrigine glucuronidation2with valproate3 without valproate3 Weeks 1 and 2 25 mg once a day 50 mg once a day 25 mg once a day Weeks 3 and 4 25 mg twice a day 50 mg twice a day 25 mg twice a day Weeks 5 onwards to maintenance Increase by 25-50 mg every 1 to 2 weeks Increase by 100 mg every 1 to 2 weeks Increase by 25-50 mg every 1 to 2 weeks Usual Maintenance Dose 50-100 mg twice a day 150-250 mg twice a day 50-100 mg twice a day 1Medications that induce lamotrigine glucuronidation include carbamazepine, phenobarbital, phenytoin, primidone, rifampin, lopinavir/ritonavir and atazanavir/ritonavir 2Medications that neither inhibit nor induce lamotrigine glucuronidation include olanzapine, oxcarbazepine, felbamate, gabapentin, levetiracetam, pregabalin, topiramate and zonisamide 3Valproic acid is an inhibitor of lamotrigine glucuronidation For patients taking valproic acid regardless of any concomitant medication, a more cautious titration schedule is available than that detailed in Table 1.
During weeks 1 and 2, a dose of 25 mg every other day may be given instead of 25 mg once daily dose. During weeks 3 and 4, a dose of 25 mg once a day may be given instead of the 25 mg twice daily dose (total daily dose of 50 mg). There have been no controlled studies to establish the effectiveness or optimal dosing regimen of add- on lamotrigine therapy in patients receiving only AEDs that neither inhibit nor induce lamotrigine glucuronidation or valproic acid.
5 mg daily […]