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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.
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