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FDA Approves Lamictal(R) ODT(TM) Orally Disintegrating Tablets
Date:5/11/2009

episodes with other medicine. It is not known if Lamictal ODT is safe or effective in children or teenagers under the age of 18 with mood disorders such as bipolar disorder or depression. Lamictal ODT is also used together with other medicines to treat certain types of seizures (partial seizures, primary generalized tonic-clonic seizures, generalized seizures of Lennox-Gastaut syndrome) in people two years or older or alone when changing from other medicines used to treat partial seizures in people 16 years or older. It is not known if Lamictal ODT is safe or effective when used alone as the first treatment of seizures in adults.

Lamictal ODT will be available in 25 mg, 50 mg, 100 mg, and 200 mg strengths and is expected to be available in pharmacies in early July. For patients switching from Lamictal Tablets to the ODT formulation, the recommended dose of Lamictal ODT matches the dose of Lamictal Tablets. For patients new to Lamictal, Patient Titration Kits containing five weeks of treatment will be available. Lamictal ODT will also be available in four Maintenance Packs, one Pack for each dose strength. These Packs each contain 30 tablets and are designed to help make it easy for patients to keep up with their daily dose.

Safety Information

Prescription Lamictal ODT Tablets are not for everyone. Lamictal ODT is another form of Lamictal. Lamictal may cause a serious skin rash that may cause the patient to be hospitalized or to stop Lamictal; it may rarely cause death. There is no way to tell if a mild rash will develop into a more serious reaction. These serious skin reactions are more likely to happen when the patient begins taking Lamictal, within the first two to eight weeks of treatment. But it can happen in people who have taken Lamictal for any period of time. Children between two to 16 ye
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SOURCE GlaxoSmithKline
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