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Efficacy & Stability

FACT: Only LAMICTAL is proven for long-term therapy, up to 18 months, to help maintain stability against depressive episodes

LAMICTAL increased median days to intervention for depressive episodes, as reported in a combined analysis of two 18-month, placebo-controlled trials of adult patients with bipolar I disorder (secondary endpoint)⁴

Use beyond 18 months should be periodically reevaluated

Median Days to Intervention for Depression: Combined Analysis^3,4*

*	Intervention is defined as the addition of pharmacotherapy (eg, antipsychotics, antidepressants) or electroconvulsive therapy for a bipolar mood episode or one that was emerging.
†	An estimated 57% of patients taking LAMICTAL did not meet criteria for intervention to depression within the 18-month study period (532 days).³ Actual median days not calculable. Information beyond study length is unknown. Some patients considered intervention-free for depressive episodes could have had intervention for manic episodes.

LAMICTAL significantly delayed time to intervention for a mood episode or one that was emerging (P<0.001, combined analysis; P=0.029 in patients who were currently or recently depressed; and P=0.02 in patients who were currently or recently manic [primary endpoint])^1,2,4

FACT: LAMICTAL helps keep patients from destabilizing, especially for depression— as proven in two 18-month studies

At 18 months, an estimated 57% of patients taking LAMICTAL remained intervention-free for a depressive episode versus 41% taking placebo³

Percentage of Patients Remaining Intervention-Free for a Depressive Episode: Combined Analysis^3,4

‡	Additional limitations were present (eg, open-label phase, premature discontinuation of lithium arm).

More about the Tolerability Profile of LAMICTAL

Important Safety Information

Serious rashes requiring hospitalization and discontinuation of treatment have been reported with LAMICTAL, some of which have included Stevens-Johnson syndrome.

—In clinical trials of bipolar and other mood disorders, the incidence of these rashes was 0.08% (0.8/1000) in adult patients receiving LAMICTAL as initial monotherapy and 0.13% (1.3/1000) in adult patients receiving LAMICTAL as adjunctive therapy.

—The incidence of these rashes was approximately 0.3% (3/1000) in adult patients on adjunctive therapy for epilepsy. For further safety information on the increased risk of serious rash in pediatric patients with epilepsy, please see full Prescribing Information.
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.
Hypersensitivity reactions, some fatal or life-threatening, have occurred in association with the use of LAMICTAL. It is important to note that early manifestations of hypersensitivity (eg, 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, and LAMICTAL should be discontinued if an alternative etiology cannot be established.
Prior to initiation of treatment with LAMICTAL, the patient should be instructed that a rash or other signs or symptoms of hypersensitivity (eg, fever, lymphadenopathy) may herald a serious medical event and that the patient should report any such occurrence to a physician immediately.
To avoid an increased risk of rash, the recommended initial dose and subsequent dose escalations of LAMICTAL should not be exceeded (see Box Warning in Prescribing Information).
LAMICTAL should ordinarily be discontinued at the first sign of rash, unless the rash is clearly not drug-related.

LAMICTAL is indicated for the maintenance treatment of bipolar I disorder to delay the time to occurrence of mood episodes (depression, mania, hypomania, mixed episodes) in adult patients treated for acute mood episodes with standard therapy. The effectiveness of LAMICTAL in the acute treatment of mood episodes has not been established.

Patient Information Leaflet for LAMICTAL® (lamotrigine)

Complete Prescribing Information for LAMICTAL

Complete Prescribing Information is provided in Adobe's Portable Document Format (PDF). To view these documents, you will need Adobe Acrobat Reader. If you do not have it and you are unable to or do not wish to download Acrobat Reader, but still wish to receive complete Prescribing Information, please click here .