Lamictal Information:

The US Food and Drug Administration (FDA) has approved LAMICTAL (LAMOTRIGINE) for the maintenance treatment of adults with bipolar I disorder to delay the time to occurrence of mood episodes (depression, mania, hypomania, mixed episodes) in patients treated for acute mood episodes with standard therapy. Additionally, the FDA has noted that findings for LAMICTAL (LAMOTRIGINE) were more robust in bipolar depression-one of the most significant medical needs in the treatment of this devastating illness. The effectiveness of LAMICTAL (LAMOTRIGINE) in the acute treatment of mood episodes has not been established. LAMICTAL (LAMOTRIGINE) is the first FDA-approved therapy since lithium for the long-term maintenance of bipolar I disorder.

LAMICTAL (LAMOTRIGINE) now offers long-term stability across the spectrum of mood episodes associated with bipolar I disorder, with more robust findings in depression. As you know, depressive episodes can be a significant clinical challenge;
1 a recent study found that time spent depressed exceeds time spent manic by a factor of three.
2 What's more, LAMICTAL (LAMOTRIGINE) is long-term therapy that is convenient for you and your patients. LAMICTAL (LAMOTRIGINE) requires no blood monitoring and offers dosing that's easy for your patients. Initiate as maintenance therapy with LAMICTAL (LAMOTRIGINE) at any phase of the illness in patients treated for acute episodes with standard therapy.

Lamictal Side Effects:

Serious rashes requiring hospitalization and discontinuation of treatment have been a few of the LAMICTAL side effects reported. The incidence of these LAMICTAL side effects, which have included Stevens-Johnson syndrome, is approximately 0.8% (8/1000) in pediatric patients (age <16 years) receiving LAMICTAL as adjunctive therapy for epilepsy and 0.3% (3/1000) in adults on adjunctive therapy for epilepsy. In a prospectively followed cohort of 1983 pediatric patients with epilepsy taking adjunctive LAMICTAL, there was LAMICTAL side effects which resulted in 1 rash-related death. • In worldwide postmarketing experience, rare cases of LAMICTAL side effects like toxic epidermal necrolysis and/or rash-related death have been reported, but their numbers are too few to permit a precise estimate of the rate. • Hypersensitivity reactions, some fatal or life-threatening, have been a few of the LAMICTAL side effects reported. 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. 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 serious LAMICTAL side effects and that the patient should report any such occurrence to a physician immediately. • Because of LAMICTAL side effects like increased risk of rash, the recommended initial dose and subsequent dose escalations of LAMICTAL should not be exceeded. LAMICTAL should ordinarily be discontinued at the first sign of rash, unless the rash is clearly not drug-related.