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Se recomienda que no se vuelva a iniciar lamictal dispersable en pacientes que lo discontinuaron por causa de exantema asociado con el tratamiento previo con lamictal dispersable a menos que el beneficio potencial claramente supere el riesgo.

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LAMICTAL has been administered to 6,694 individuals for whom complete adverse reaction data was captured during all clinical trialsonly some of which were placebo controlledDuring these trialsall adverse reactions were recorded by the clinical investigators using terminology of their own choosingTo provide a meaningful estimate of the proportion of individuals having adverse reactionssimilar types of adverse reactions were grouped into a smaller number of standardized categories using modified COSTART dictionary terminologyThe frequencies presented represent the proportion of the 6,694 individuals exposed to LAMICTAL who experienced an event of the type cited on at least 1 occasion while receiving LAMICTALAll reported adverse reactions are included except those already listed in the previous tables or elsewhere in the labelingthose too general to be informativeand those not reasonably associated with the use of the drug.

The goal of maintenance treatment with LAMICTAL is to delay the time to occurrence of mood episodesdepressionmaniahypomaniamixed episodesin patients treated for acute mood episodes with standard therapyThe target dose of LAMICTAL is 200 mg/day100 mg/day in patients taking valproatewhich decreases the apparent clearance of lamotrigineand 400 mg/day in patients not taking valproate and taking either carbamazepinephenytoinphenobarbitalprimidoneor other drugs such as rifampin and the protease inhibitor lopinavir/ritonavir that increase the apparent clearance of lamotrigineIn the clinical trialsdoses up to 400 mg/day as monotherapy were evaluatedhoweverno additional benefit was seen at 400 mg/day compared with 200 mg/daysee Clinical StudiesAccordinglydoses above 200 mg/day are not recommendedTreatment with LAMICTAL is introducedbased on concurrent medicationsaccording to the regimen outlined in Table 5If other psychotropic medications are withdrawn following stabilizationthe dose of LAMICTAL should be adjustedFor patients discontinuing valproatethe dose of LAMICTAL should be doubled over a 2-week period in equal weekly incrementssee Table 6For patients discontinuing carbamazepinephenytoinphenobarbitalprimidoneor other drugs such as rifampin and the protease inhibitors lopinavir/ritonavir and atazanavir/ritonavir that induce lamotrigine glucuronidationthe dose of LAMICTAL should remain constant for the first week and then should be decreased by half over a 2-week period in equal weekly decrementssee Table 6The dose of LAMICTAL may then be further adjusted to the target dose200 mgas clinically indicated.

Lamotrigine is rapidly and completely absorbed after oral administration with negligible first-passmetabolismabsolute bioavailabilityis 98Thebioavailabilityisnotaffected by foodPeak plasma concentrations occur anywhere from 1.4 to 4.8 hours following drug administrationThelamotriginechewable/dispersibletablets werefound to beequivalentwhether administered as dispersed in waterchewed and swallowedor swallowed wholeto the lamotrigine compressed tablets in terms of rate and extent of absorptionIn terms of rate and extent of absorptionlamotrigine orally disintegrating tabletswhether disintegrated in the mouth or swallowed whole with waterwere equivalent to the lamotrigine compressed tablets swallowed with water.

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