6 Lake (100-mg tablet only); ferric oxide, yellow (150-mg tablet only); and FD&C Blue No. The lowest effect dose for preand post-natal developmental toxicity in rats is less than the human dose of 400 mg/day on a mg/mWhen administered to pregnant rats, lamotrigine decreased fetal folate concentrations at doses greater than or equal to 5 mg/kg/day, which is less than the human dose of 400 mg/day on a mg/mLamotrigine is present in milk from lactating women taking LAMICTAL (see The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for LAMICTAL and any potential adverse effects on the breastfed infant from LAMICTAL or from the underlying maternal condition.Human milk-fed infants should be closely monitored for adverse events resulting from lamotrigine. of 750 mg/day.The most common adverse The tablet will disintegrate rapidly, can be swallowed with or without water, and can be taken with or without food.25-mg, white, scored, shield-shaped tablets debossed with “LAMICTAL” and “25.”100-mg, peach, scored, shield-shaped tablets debossed with “LAMICTAL” and “100.”150-mg, cream, scored, shield-shaped tablets debossed with “LAMICTAL” and “150.”200-mg, blue, scored, shield-shaped tablets debossed with “LAMICTAL” and “200.”2-mg, white to off-white, round tablets debossed with “LTG” over “2.”5-mg, white to off-white, caplet-shaped tablets debossed with “GX CL2.”25-mg, white, super elliptical-shaped tablets debossed with “GX CL5.”50-mg, white to off-white, round, flat-faced, radius-edged tablets debossed with “LMT” on one side and “50” on the other side.100-mg, white to off-white, round, flat-faced, radius-edged tablets debossed with “LAMICTAL” on one side and “100” on the other side.200-mg, white to off-white, round, flat-faced, radius-edged tablets debossed with “LAMICTAL” on one side and “200” on the other side.25-mg, white, scored, shield-shaped tablets debossed with “LAMICTAL” and “25”, bottles of 100 (Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature] in a dry place.100-mg, peach, scored, shield-shaped tablets debossed with “LAMICTAL” and “100”, bottles of 100 (150-mg, cream, scored, shield-shaped tablets debossed with “LAMICTAL” and “150”, bottles of 60 (200-mg, blue, scored, shield-shaped tablets debossed with “LAMICTAL” and “200”, bottles of 60 (Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature] in a dry place and protect from light.25-mg, white, scored, shield-shaped tablets debossed with “LAMICTAL” and “25”, blister pack of 35 tablets (Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature] in a dry place.25-mg, white, scored, shield-shaped tablets debossed with “LAMICTAL” and “25” and 100 mg, peach, scored, shield-shaped tablets debossed with “LAMICTAL” and “100”, blister pack of 98 tablets (84/25-mg tablets and 14/100-mg tablets) (Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature] in a dry place and protect from light.25-mg, white, scored, shield-shaped tablets debossed with “LAMICTAL” and “25” and 100 mg, peach, scored, shield-shaped tablets debossed with “LAMICTAL” and “100”, blister pack of 49 tablets (42/25-mg tablets and 7/100-mg tablets) (Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature] in a dry place and protect from light.2-mg, white to off-white, round tablets debossed with “LTG” over “2”, bottles of 30 (5-mg, white to off-white, caplet-shaped tablets debossed with “GX CL2”, bottles of 100 (25-mg, white, super elliptical-shaped tablets debossed with “GX CL5”, bottles of 100 (Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature] in a dry place.25-mg, white to off-white, round, flat-faced, radius-edged tablets debossed with “LMT” on one side and “25” on the other, Maintenance Packs of 30 (50-mg, white to off-white, round, flat-faced, radius-edged tablets debossed with “LMT” on one side and “50” on the other, Maintenance Packs of 30 (100-mg, white to off-white, round, flat-faced, radius-edged tablets debossed with “LAMICTAL” on one side and “100” on the other, Maintenance Packs of 30 (200-mg, white to off-white, round, flat-faced, radius-edged tablets debossed with “LAMICTAL” on one side and “200” on the other, Maintenance Packs of 30 (Store between 20°C and 25°C (68°F and 77°F); with excursions permitted between 15°C and 30°C (59°F and 86°F).25-mg, white to off-white, round, flat-faced, radius-edged tablets debossed with “LMT” on one side and “25” on the other, and 50 mg, white to off-white, round, flat-faced, radius-edged tablets debossed with “LMT” on one side and “50” on the other, blister pack of 28 tablets (21/25-mg tablets and 7/50-mg tablets) (Store between 20°C and 25°C (68°F and 77°F); with excursions permitted between 15°C and 30°C (59°F and 86°F).50-mg, white to off-white, round, flat-faced, radius-edged tablets debossed with “LMT” on one side and “50” on the other, and 100 mg, white to off-white, round, flat-faced, radius-edged tablets debossed with “LAMICTAL” on one side and “100” on the other, blister pack of 56 tablets (42/50-mg tablets and 14/100-mg tablets) (Store between 20°C and 25°C (68°F and 77°F); with excursions permitted between 15°C and 30°C (59°F and 86°F).25-mg, white to off-white, round, flat-faced, radius-edged tablets debossed with “LMT” on one side and “25” on the other, 50 mg, white to off-white, round, flat-faced, radius-edged tablets debossed with “LMT” on one side and “50” on the other, and 100 mg, white to off-white, round, flat-faced, radius-edged tablets debossed with “LAMICTAL” on one side and “100” on the other, blister pack of 35 (14/25-mg tablets, 14/50-mg tablets, and 7/100-mg tablets) (Store between 20°C and 25°C (68°F and 77°F); with excursions permitted between 15°C and 30°C (59°F and 86°F).If the product is dispensed in a blister pack, the patient should be advised to examine the blister pack before use and not use if blisters are torn, broken, or missing.Distributed by: GlaxoSmithKline, Research Triangle Park, NC 27709.

The only adverse reaction for which the reports on LAMICTAL were >10% headache, infection, Adverse reactions that occurred with a frequency of Lennox-Gastaut syndrome who received LAMICTAL up to 15 mg/kg/day or a maximum In patients already taking maintenance doses of LAMICTAL and not taking glucuronidation inducers, the dose of LAMICTAL may need to be increased if atazanavir/ritonavir is added or decreased if atazanavir/ritonavir is discontinued [see Experience in patients with hepatic impairment is limited. The greater the interval of time since the previous dose, the greater consideration should be given to restarting with the initial dosing recommendations. 2 Lake (200-mg tablet only).LAMICTAL chewable dispersible tablets are supplied for oral administration.

Medication errors may also occur between the different formulations of LAMICTAL. This reduction in lamotrigine plasma concentrations is not expected to be clinically meaningful.The AUC and Cmax of oxcarbazepine and its active 10-monohydroxy oxcarbazepine metabolite were not significantly different following the addition of oxcarbazepine (600 mg twice daily) to lamotrigine (200 mg once daily) in healthy male volunteers (n = 13) compared with healthy male volunteers receiving oxcarbazepine alone (n = 13).In the same trial, the AUC and Cmax of lamotrigine were similar following the addition of oxcarbazepine (600 mg twice daily) to lamotrigine in healthy male volunteers compared with those receiving lamotrigine alone. It may take several weeks to months to achieve an individualized maintenance dose. This metabolite causes dose-dependent prolongation of the PR interval, widening of the The pharmacokinetics of lamotrigine have been studied in subjects with epilepsy, healthy young and elderly volunteers, and volunteers with chronic renal failure. It has been reported that ethinylestradiol, not progestogens, increased the clearance of lamotrigine up to 2-fold, and the progestin-only pills had no effect on lamotrigine plasma levels. In patients discontinuing carbamazepine, phenytoin, phenobarbital, primidone, or other drugs such as rifampin and the If other drugs are subsequently introduced, the dose of LAMICTAL may need to be adjusted.