Compare To: Lamictal?
LAMICTAL
(lamotrigine) Tablets
LAMICTAL
(lamotrigine) Chewable Dispersible Tablets
LAMICTAL ODT
(lamotrigine) Orally Disintegrating Tablets
DESCRIPTION
LAMICTAL (lamotrigine), an AED of the phenyltriazine class, is chemically unrelated to existing AEDs. Its chemical name is 3,5-diamino-6-(2,3-dichlorophenyl)-as-triazine, its molecular formula is C9H7N5Cl2, and its molecular weight is 256.09. Lamotrigine is a white to pale cream-colored powder and has a pKa of 5.7. Lamotrigine is very slightly soluble in water (0.17 mg/mL at 25?C) and slightly soluble in 0.1 M HCl (4.1 mg/mL at 25?C).
LAMICTAL Tablets are supplied for oral administration as 25 mg (white), 100 mg (peach), 150 mg (cream), and 200 mg (blue) tablets. Each tablet contains the labeled amount of lamotrigine and the following inactive ingredients: lactose magnesium stearate microcrystalline cellulose povidone sodium starch glycolate FD&C Yellow No. 6 Lake (100 mg tablet only) ferric oxide, yellow (150 mg tablet only) and FD&C Blue No. 2 Lake (200 mg tablet only).
LAMICTAL Chewable Dispersible Tablets are supplied for oral administration. The tablets contain 2 mg (white), 5 mg (white), or 25 mg (white) of lamotrigine and the following inactive ingredients: blackcurrant flavor, calcium carbonate, low-substituted hydroxypropylcellulose, magnesium aluminum silicate, magnesium stearate, povidone, saccharin sodium, and sodium starch glycolate.
LAMICTAL ODT Orally Disintegrating Tablets are supplied for oral administration. The tablets contain 25 mg (white to off-white), 50 mg (white to off-white), 100 mg (white to off-white), or 200 mg (white to off-white) of lamotrigine and the following inactive ingredients: artificial cherry flavor, crospovidone, ethylcellulose, magnesium stearate, mannitol, polyethylene, and sucralose.
LAMICTAL ODT Orally Disintegrating Tablets are formulated using technologies (Microcaps?* and AdvaTab?*) designed to mask the bitter taste of lamotrigine and achieve a rapid dissolution profile. Tablet characteristics including flavor, mouth-feel, after-taste, and ease of use were rated as favorable in a study of 108 healthy volunteers.
INDICATIONS
Epilepsy
Adjunctive Therapy: LAMICTAL is indicated as adjunctive therapy for the following seizure types in patients ≥ 2 years of age:
* partial seizures
* primary generalized tonic-clonic seizures
* generalized seizures of Lennox-Gastaut syndrome
Monotherapy: LAMICTAL is indicated for conversion to monotherapy in adults ( ≥ 16 years of age) with partial seizures who are receiving treatment with carbamazepine, phenytoin, phenobarbital, primidone, or valproate as the single antiepileptic drug (AED).
Safety and effectiveness of LAMICTAL have not been established (1) as initial monotherapy (2) for conversion to monotherapy from AEDs other than carbamazepine, phenytoin, phenobarbital, primidone, or valproate or (3) for simultaneous conversion to monotherapy from 2 or more concomitant AEDs.
Bipolar Disorder
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 adults ( ≥ 18 years of age) treated for acute mood episodes with standard therapy. The effectiveness of LAMICTAL in the acute treatment of mood episodes has not been established.
The effectiveness of LAMICTAL as maintenance treatment was established in 2 placebo-controlled trials in patients with Bipolar I Disorder as defined by DSM-IV [see Clinical Studies]. The physician who elects to prescribe LAMICTAL for periods extending beyond 16 weeks should periodically re-evaluate the long-term usefulness of the drug for the individual patient.
SIDE EFFECTS
The following adverse reactions are described in more detail in the WARNINGS AND PRECAUTIONS section of the label:
* Serious skin rashes [see WARNINGS AND PRECAUTIONS]
* Hypersensitivity reactions [see WARNINGS AND PRECAUTIONS]
* Acute multiorgan failure [see WARNINGS AND PRECAUTIONS]
* Blood dyscrasias [see WARNINGS AND PRECAUTIONS]
* Suicidal behavior and ideation [see WARNINGS AND PRECAUTIONS]
* Withdrawal seizures [see WARNINGS AND PRECAUTIONS]
* Status epilepticus [see WARNINGS AND PRECAUTIONS]
* Sudden unexplained death in epilepsy [see WARNINGS AND PRECAUTIONS]
Clinical Trials
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice.
LAMICTAL has been evaluated for safety in patients with epilepsy and in patients with Bipolar I Disorder. Adverse reactions reported for each of these patient populations are provided below. Excluded are adverse reactions considered too general to be infor
