What is mechanism of action?

mechanism of action is Organic Cation Transporter 2 Inhibitors [MoA] or Dihydrofolate Reductase Inhibitors [MoA]

Lamotrigine

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Lamotrigine Prescribing Information

Lamotrigine can cause serious rashes requiring hospitalization and discontinuation of treatment. The incidence of these rashes, which have included Stevens-Johnson syndrome, is approximately 0.3% to 0.8% in pediatric patients (aged 2 to 17 years )and 0.08% to 0.03% in adults receiving lamotrigine tablets. One rash-related death was reported in a prospectively followed cohort of 1,983 pediatric patients (aged 2 to 16 years) with epilepsy taking lamotrigine tablets as adjunctive therapy.

In worldwide postmarketing experience, rare cases of toxic epidermal necrolysis and/or rash-related death have been reported in adult and pediatric patients, but their numbers are too few to permit a precise estimate of the rate.

Other than age, there are as yet no factors identified that are known to predict the risk of occurrence or the severity of rash caused by

lamotrigine tablets

. There are suggestions, yet to be proven, that the risk of rash may also be increased by (1) coadministration of

lamotrigine tablets

with valproate (includes valproic acid and divalproex sodium), (2) exceeding

the recommended initial dose of lamotrigine tablets, or (3) exceeding the recommended dose escalation for lamotrigine tablet. However, cases have occurred in the absence of these factors.

Nearly all cases of life-threatening rashes caused by lamotrigine tablets have occurred within 2 to 8 weeks of treatment initiation. However, isolated cases have occurred after prolonged treatment (e.g., 6 months). Accordingly, duration of therapy cannot be relied upon as means to predict the potential risk heralded by the first appearance of a rash.

Although benign rashes are also caused by

lamotrigine tablets, it is not possible to predict reliably which rashes will prove to be serious or life threatening. Accordingly, lamotrigine tablets should ordinarily be discontinued at the first sign of rash, unless the rash is clearly not drug related. Discontinuation of treatment may not prevent a rash from becoming life threatening or permanently disabling or disfiguring

[see Warnings and Precautions (5.1)].

Boxed Warning                                                                      5/2015

Indications and Usage, Bipolar Disorder (1.2)                       5/2015

Warnings and Precautions, Serious Skin Rashes (5.1)          5/2015

Warnings and Precautions, Laboratory Tests (5.13)              3/2015

Lamotrigine is indicated for:

Epilepsy - adjunctive therapy in patients aged 2 years and older:

partial-onset seizures.
primary generalized tonic-clonic seizures.
generalized seizures of Lennox-Gastaut syndrome.(1.1)

Epilepsy - monotherapy in patients aged 16 years and older:

Conversion to monotherapy in patients with partial-onset seizures who are receiving treatment with carbamazepine, phenytoin, phenobarbital, primidone, or valproate as the single AED. (1.1)

Bipolar disorder :

Maintenance treatment of bipolar I disorder to delay the time to occurrence of mood episodes in patients treated for acute mood episodes with standard therapy. (1.2)

Limitations of Use: Treatment of acute manic or mixed episodes is not recommended. Effectiveness of lamotrigine tablets in the acute treatment of mood episodes has not been established

•Dosing is based on concomitant medications, indication, and patient age. (2.1, 2.2, 2.3, 2.4)

•To avoid an increased risk of rash, the recommended initial dose and subsequent dose escalations should not be exceeded. (2.1)

•Do not restart lamotrigine tablets in patients who discontinued due to rash unless the potential benefits clearly outweigh the risks. (2.1, 5.1)

•Adjustments to maintenance doses will be necessary in most patients starting or stopping estrogen-containing oral contraceptives. (2.1, 5.7)

•Discontinuation: Taper over a period of at least 2 weeks (approximately 50% dose reduction per week). (2.1, 5.8)

Epilepsy:

•Adjunctive therapy - See Table 1 for patients > older than 12 years and Tables 2 and 3 for patients aged 2 to 12 years. (2.2)

•Conversion to monotherapy - See Table 4. (2.3)

Bipolar disorder:

See Tables 5 and 6. (2.4)

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