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Tolerability Profile

FACT: LAMICTAL was studied in the largest prospectively defined, placebo-controlled data set in maintenance therapy for bipolar disorder^3,4

Study Design: Combined Maintenance Studies M and D⁴

Two large, randomized, placebo-controlled clinical studies of similar design enrolled patients who were either currently or recently manic/hypomanic or currently or recently depressed, according to DSM-IV criteria ^1,2,4

Favorable tolerability profile proven in two 18-month trials

LAMICTAL is associated with a favorable tolerability profile. The most common (≥5% and numerically more frequent than placebo) side effects associated with LAMICTAL in the randomized phase of these studies were: nausea (14%), insomnia (10%), somnolence (9%), back pain (8%), fatigue (8%), rhinitis (7%), non-serious rash (7%), abdominal pain (6%), dry mouth (6%), constipation (5%), vomiting (5%), exacerbation of cough (5%), pharyngitis (5%).¹⁰

For information on serious rash, please see Important Safety Information below.

Adverse events that occurred in ≥5% and were numerically more common in patients during the dose-escalation phase of these trials, when patients may have been receiving concomitant psychotropic medications, compared to the monotherapy phase were: headache (25%), rash (11%), dizziness (10%), diarrhea (8%), dream abnormality (6%), and pruritus (6%).¹⁰

More about Initiation & Dosing

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 .

Tolerability Profile

FACT: LAMICTAL was studied in the largest prospectively defined, placebo-controlled data set in maintenance therapy for bipolar disorder3,4

FACT: LAMICTAL was studied in the largest prospectively defined, placebo-controlled data set in maintenance therapy for bipolar disorder^3,4