What is Lamictal?

LAMOTRIGINE (marketed as Lamictal by GlaxoSmithKline) is used in the treatment of epilepsy and bipolar disorder, and is also called an anticonvulsant.

Lamictal, is manufactured in scored tablets: 25-mg (white), 100-mg (peach), 150-mg (cream), and 200-mg (blue) and in chewable dispersible tablets that are supplied for oral administration and contain 2 mg (white), 5 mg (white), or 25 mg (white) of lamotrigine. Each Lamictal Tablet contains inactive ingredients: lactose; magnesium stearate; microcrystalline cellulose; povidone; sodium starch glycolate; ferric oxide, yellow (150-mg tablet only). And also LAMICTAL Chewable Dispersible Tablets contains inactive ingredients: blackcurrant flavor, calcium carbonate, low-substituted hydroxypropylcellulose, magnesium aluminum silicate, magnesium stearate, povidone, saccharin sodium, and sodium starch glycolate. Lamotrigine is also available in un-scored tablet form.

Lamictal is indicated as adjunctive therapy for partial seizures, the generalized seizures of Lennox-Gastaut syndrome, and primary generalized tonic-clonic seizures in adults and pediatric patients who are at least 2 years old. Lamotrigine also acts as a mood stabilizer. Lamotrigine has also been successful in controlling rapid cycling and mixed bipolar states. Lamictal is prescribed for the maintenance treatment of Bipolar Disorder to delay the time to appereance of mood episodes (mania, depression, hypomania, mixed episodes) in patients treated for acute mood episodes with standard therapy.

Lamotrigen may also be used for purposes other than those listed here.

Approval history

In December 1994 Lamictal Anticonvulsant was approved by U.S. Food and Drug Administration for use as adjunctive treatment for partial seizures in adult patients (16 and older).

In 1998, August FDA granted Lamictal as treatment of Lennox-Gastaut syndrome in pediatric(over 2 years) and adult patients, new dosage form: chewable dispersible tablets.

In December 1998 it was approved as monotherapy for treatment of partial seizures in adult patients.

In the winter of 2003 FDA approved Lamictal for use as adjunctive therapy for partial seizures in pediatric patients over 2 years of age.

In 2003, summer, it was granted by FDA for the maintenance treatment of adults with Bipolar I Disorder to delay the time to appearance of mood episodes (depression, hypomania, mania, mixed episodes) in patients treated for severe mood episodes with standard therapy.

In January 2004, U.S. Food and Drug Administration approved it for use as monotherapy for treatment of partial seizures in adult patients when converting from the anti-epileptic drug valproate.

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