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FDA Approves Lamictal(R)XR(TM); An Extended-Release Once-Daily, New Generation Treatment for Epilepsy
Date:6/1/2009

3.

Patients with partial seizures currently taking immediate-release Lamictal twice-daily can be converted directly to once-a-day Lamictal XR using the same total daily dose. Lamictal XR will be available in pharmacies this summer.

Patented GlaxoSmithKline Extended-Release Technology

Lamictal XR Extended-Release Tablets are enteric-coated and contain a modified release formulation in the center of the tablet. There is a specially designed opening in the enteric coating on both sides of the tablet that utilizes a new technology called DiffCORE(TM), discovered and developed by GlaxoSmithKline. This allows a controlled release of the medicine in the acidic environment of the stomach, leading to a gradual release of lamotrigine into the bloodstream.

Safety Information

Prescription Lamictal XR (lamotrigine) Extended-Release Tablets are not for everyone. Lamictal XR may cause a serious skin rash that may cause the patient to be hospitalized or to stop Lamictal XR; 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 XR, within the first two to eight weeks of treatment. But it can happen in people who have taken Lamictal XR for any period of time. Children between two to 16 years of age have a higher chance of getting this serious skin reaction while taking lamotrigine. Lamictal XR is not approved for use in children less than 13 years old.

The risk of getting a rash is higher if taking Lamictal XR while taking valproate (Depakene(R) (valproic acid) or Depakote(R) (divalproex sodium), taking a higher starting dose of Lamictal XR than a healthcare provider prescribed or increasing the dose of Lamictal XR faster than p
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SOURCE GlaxoSmithKline
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