Lamotrigine is contraindicated in patients who have demonstrated hypersensitivity (e.g., rash, angioedema, acute urticaria, extensive pruritus, mucosal ulceration) to the drug or its ingredients [see Boxed Warning , Warnings and Precautions (5.1 , 5.3) ] .
Lamotrigine can cause serious rashes requiring hospitalization and discontinuation of treatment. The incidence of these rashes, which have included Stevens-Johnson syndrome, is approximately 0.3% to 0.8% in pediatric patients (aged 2 to 17 years) and 0.08% to 0.3% in adults receiving lamotrigine. One rash-related death was reported in a prospectively followed cohort of 1,983 pediatric patients (aged 2 to 16 years) with epilepsy taking lamotrigine as adjunctive therapy. In worldwide postmarketing experience, rare cases of toxic epidermal necrolysis and/or rash-related death have been reported in adult and pediatric patients, but their numbers are too few to permit a precise estimate of the rate. In addition to age, factors that may increase the risk of occurrence or the severity of rash caused by lamotrigine include (1) coadministration of lamotrigine with valproate (includes valproic acid and divalproex sodium), (2) exceeding the recommended initial dose of lamotrigine, (3) exceeding the recommended dose escalation for lamotrigine, or (4) the presence of the HLA-B*1502 allele. However, cases have occurred in the absence of these factors. Nearly all cases of life-threatening rashes caused by lamotrigine have occurred within 2 to 8 weeks of treatment initiation. However, isolated cases have occurred after prolonged treatment (e.g., 6 months). Accordingly, duration of therapy cannot be relied upon as means to predict the potential risk heralded by the first appearance of a rash. Although benign rashes are also caused by lamotrigine, it is not possible to predict reliably which rashes will prove to be serious or life threatening. Accordingly, lamotrigine should ordinarily be discontinued at the first sign of rash, unless the rash is clearly not drug related. Discontinuation of treatment may not prevent a rash from becoming life threatening or permanently disabling or disfiguring [see Warnings and Precautions (5.1) ].
Lamotrigine is contraindicated in patients who have demonstrated hypersensitivity (e.g., rash, angioedema, acute urticaria, extensive pruritus, mucosal ulceration) to the drug or its ingredients [see Boxed Warning , Warnings and Precautions (5.1 , 5.3) ] .
Lamotrigine Tablets USP, 25 mg: Round, white, scored tablets. One side engraved with "TARO". Other side scored and engraved with "LMT" above the score and "25" below the score. Bottles of 30 NDC 51672-4130-6 Bottles of 60 NDC 51672-4130-4 Bottles of 100 NDC 51672-4130-1 Bottles of 1000 NDC 51672-4130-3 Unit dose packages of 100 NDC 51672-4130-0
Lamotrigine can cause serious rashes requiring hospitalization and discontinuation of treatment. The incidence of these rashes, which have included Stevens-Johnson syndrome, is approximately 0.3% to 0.8% in pediatric patients (aged 2 to 17 years) and 0.08% to 0.3% in adults receiving lamotrigine. One rash-related death was reported in a prospectively followed cohort of 1,983 pediatric patients (aged 2 to 16 years) with epilepsy taking lamotrigine as adjunctive therapy. In worldwide postmarketing experience, rare cases of toxic epidermal necrolysis and/or rash-related death have been reported in adult and pediatric patients, but their numbers are too few to permit a precise estimate of the rate. In addition to age, factors that may increase the risk of occurrence or the severity of rash caused by lamotrigine include (1) coadministration of lamotrigine with valproate (includes valproic acid and divalproex sodium), (2) exceeding the recommended initial dose of lamotrigine, (3) exceeding the recommended dose escalation for lamotrigine, or (4) the presence of the HLA-B*1502 allele. However, cases have occurred in the absence of these factors. Nearly all cases of life-threatening rashes caused by lamotrigine have occurred within 2 to 8 weeks of treatment initiation. However, isolated cases have occurred after prolonged treatment (e.g., 6 months). Accordingly, duration of therapy cannot be relied upon as means to predict the potential risk heralded by the first appearance of a rash. Although benign rashes are also caused by lamotrigine, it is not possible to predict reliably which rashes will prove to be serious or life threatening. Accordingly, lamotrigine should ordinarily be discontinued at the first sign of rash, unless the rash is clearly not drug related. Discontinuation of treatment may not prevent a rash from becoming life threatening or permanently disabling or disfiguring [see Warnings and Precautions (5.1) ].
Lamotrigine is contraindicated in patients who have demonstrated hypersensitivity (e.g., rash, angioedema, acute urticaria, extensive pruritus, mucosal ulceration) to the drug or its ingredients [see Boxed Warning , Warnings and Precautions (5.1 , 5.3) ] .
The following serious adverse reactions are described in more detail in the Warnings and Precautions section of the labeling: Serious Skin Rashes [see Warnings and Precautions (5.1) ] Hemophagocytic Lymphohistiocytosis [see Warnings and Precautions (5.2) ] Multiorgan Hypersensitivity Reactions and Organ Failure [see Warnings and Precautions (5.3) ] Cardiac Rhythm and Conduction Abnormalities [see Warnings and Precautions (5.4) ] Blood Dyscrasias [see Warnings and Precautions (5.5) ] Suicidal Behavior and Ideation [see Warnings and Precautions (5.6) ] Aseptic Meningitis [see Warnings and Precautions (5.7) ] Withdrawal Seizures [see Warnings and Precautions (5.10) ] Status Epilepticus [see Warnings and Precautions (5.11) ]
Significant drug interactions with lamotrigine are summarized in this section. Uridine 5´-diphospho-glucuronyl transferases (UGT) have been identified as the enzymes responsible for metabolism of lamotrigine. Drugs that induce or inhibit glucuronidation may, therefore, affect the apparent clearance of lamotrigine. Strong or moderate inducers of the cytochrome P450 3A4 (CYP3A4) enzyme, which are also known to induce UGT, may also enhance the metabolism of lamotrigine. Those drugs that have been demonstrated to have a clinically significant impact on lamotrigine metabolism are outlined in Table 13. Specific dosing guidance for these drugs is provided in the Dosage and Administration section and, for women taking estrogen-containing products, including oral contaceptives, in the Warnings and Precautions section [see Dosage and Administration (2.1) , Warnings and Precautions (5.9)] . Additional details of these drug interaction studies are provided in the Clinical Pharmacology section [see Clinical Pharmacology (12.3) ] . Table 13. Established and Other Potentially Significant Drug Interactions Concomitant Drug Effect on Concentration of Lamotrigine or Concomitant Drug Clinical Comment ↓ = Decreased (induces lamotrigine glucuronidation). ↑ = Increased (inhibits lamotrigine glucuronidation). ? = Conflicting data. Estrogen-containing oral contraceptive preparations containing 30 mcg ethinylestradiol and 150 mcg levonorgestrel ↓ lamotrigine Decreased lamotrigine concentrations approximately 50%. ↓ levonorgestrel Decrease in levonorgestrel component by 19%. Carbamazepine and carbamazepine epoxide ↓ lamotrigine Addition of carbamazepine decreases lamotrigine concentration approximately 40%. ? carbamazepine epoxide May increase carbamazepine epoxide levels. Lopinavir/ritonavir ↓ lamotrigine Decreased lamotrigine concentration approximately 50%. Atazanavir/ritonavir ↓ lamotrigine Decreased lamotrigine AUC approximately 32%. Phenobarbital/primidone ↓ lamotrigine Decreased lamotrigine concentration approximately 40%. Phenytoin ↓ lamotrigine Decreased lamotrigine concentration approximately 40%. Rifampin ↓ lamotrigine Decreased lamotrigine AUC approximately 40%. Valproate ↑ lamotrigine Increased lamotrigine concentrations slightly more than 2-fold. ? valproate There are conflicting study results regarding effect of lamotrigine on valproate concentrations: 1) a mean 25% decrease in valproate concentrations in healthy volunteers, 2) no change in valproate concentrations in controlled clinical trials in patients with epilepsy.
Lamotrigine, an AED of the phenyltriazine class, is chemically unrelated to existing AEDs. Lamotrigine's chemical name is 3,5-diamino-6-(2,3-dichlorophenyl)- as -triazine, its molecular formula is C 9 H 7 N 5 Cl 2 , and its molecular weight is 256.09. Lamotrigine is a white to pale cream-colored powder and has a pK a 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). The structural formula is: Lamotrigine Tablets USP are supplied for oral administration as 25 mg (white), 100 mg (light peach), 150 mg (cream), and 200 mg (light blue) tablets. Each tablet contains the labeled amount of lamotrigine and the following inactive ingredients: croscarmellose sodium, crospovidone, FD&C Blue #2 Aluminum Lake (200 mg strength only), FD&C Yellow No. 6 Lake (100 mg strength only), lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and yellow iron oxide (150 mg strength only). Meets USP Dissolution Test 3.
Lamotrigine Tablets USP, 25 mg: Round, white, scored tablets. One side engraved with "TARO". Other side scored and engraved with "LMT" above the score and "25" below the score. Bottles of 30 NDC 51672-4130-6 Bottles of 60 NDC 51672-4130-4 Bottles of 100 NDC 51672-4130-1 Bottles of 1000 NDC 51672-4130-3 Unit dose packages of 100 NDC 51672-4130-0
Advise the patient to read the FDA-approved patient labeling (Medication Guide).
Mfd. by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 2624761 Dist. by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512 Revised: November 2025 5200692-1125-20 All trademarks are the property of their respective owners.
Mfd. by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 2624761 Dist. by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512 Revised: November 2025 5200692-1125-20
Official SPL XML cached by FDA.report · DailyMed PDF
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 15 | 2023-05-09 | full-release | 2026-05-31 20:49:24 |
| Folder | File | Date |
|---|---|---|
| prescription | 44812d3c-0fc0-67dd-e063-6394a90a9d70.xml | 2025-12-10 |
| prescription | Lamo tabs med guid pg2.jpg | 2025-12-10 |
| prescription | lamo tabs med guide pg 4.jpg | 2025-12-10 |
| prescription | lamo tabs med guide pg.3.5.jpg | 2025-12-10 |
| prescription | Lamo tabs med guide pg1.jpg | 2025-12-10 |
| prescription | lamo tabs med guide pg3.jpg | 2025-12-10 |
| prescription | 43f4053d-95eb-9da6-e063-6394a90a67b7.xml | 2025-11-20 |
| prescription | lamotrigine tablets 100mg 100 tablets.jpg | 2025-11-20 |
| prescription | lamotrigine tablets 150mg 60 tablets.jpg | 2025-11-20 |
| prescription | lamotrigine tablets 200mg 60 tablets.jpg | 2025-11-20 |
| prescription | lamotrigine tablets 25mg 100 tablets.jpg | 2025-11-20 |
| prescription | medication guide_Page_1.jpg | 2025-11-20 |
| prescription | medication guide_Page_2.jpg | 2025-11-20 |
| prescription | medication guide_Page_3.jpg | 2025-11-20 |
| prescription | medication guide_Page_4.jpg | 2025-11-20 |
| prescription | d589a030-fb7b-4957-b543-8dafba6104ba.xml | 2023-05-17 |
| prescription | 89a0e03c-770c-44a1-8390-f4d0a873f316.xml | 2022-11-12 |
| prescription | c2f48a5a-db84-4ad4-9e5a-a86d8daf0133.xml | 2021-11-23 |
| prescription | 777c119d-7bb2-4642-8e29-d37adeaafdbd.xml | 2021-03-24 |
| prescription | 230ce77c-7245-4a50-a49c-1726ee5942b9.xml | 2019-10-12 |
| prescription | lamotrigine-01.jpg | 2019-10-12 |
| prescription | lamotrigine-02.jpg | 2019-10-12 |
| prescription | lamotrigine-03.jpg | 2019-10-12 |
| prescription | lamotrigine-04.jpg | 2019-10-12 |
| prescription | lamotrigine-05.jpg | 2019-10-12 |
| prescription | lamotrigine-06.jpg | 2019-10-12 |
| prescription | lamotrigine-07.jpg | 2019-10-12 |
| prescription | lamotrigine-08.jpg | 2019-10-12 |
| prescription | lamotrigine-09.jpg | 2019-10-12 |
| prescription | lamotrigine-10.jpg | 2019-10-12 |
| prescription | lamotrigine-11.jpg | 2019-10-12 |