Label: LAMICTAL XR- lamotrigine tablet, film coated, extended release
LAMICTAL XR- lamotrigine kit

  • NDC Code(s): 0173-0754-00, 0173-0755-00, 0173-0756-00, 0173-0757-00, view more
  • Packager: GlaxoSmithKline LLC
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated April 25, 2025

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  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use LAMICTAL XR safely and effectively. See full prescribing information for LAMICTAL XR. LAMICTAL XR (lamotrigine) extended-release ...
  • Table of Contents
    Table of Contents
  • BOXED WARNING (What is this?)

    WARNING: SERIOUS SKIN RASHES

    LAMICTAL XR can cause serious rashes requiring hospitalization and discontinuation of treatment. The incidence of these rashes, which have included Stevens-Johnson syndrome, is approximately 0.8% (8 per 1,000) in pediatric patients (aged 2 to 16 years) receiving immediate-release lamotrigine as adjunctive therapy for epilepsy and 0.3% (3 per 1,000) in adults on adjunctive therapy for epilepsy. In a prospectively followed cohort of 1,983 pediatric patients (aged 2 to 16 years) with epilepsy taking adjunctive immediate-release lamotrigine, there was 1 rash-related death. LAMICTAL XR is not approved for patients younger than 13 years. 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.

    The risk of serious rash caused by treatment with LAMICTAL XR is not expected to differ from that with immediate-release lamotrigine. However, the relatively limited treatment experience with LAMICTAL XR makes it difficult to characterize the frequency and risk of serious rashes caused by treatment with LAMICTAL XR.

    Other than age, there are as yet no factors identified that are known to predict the risk of occurrence or the severity of rash caused by LAMICTAL XR. There are suggestions, yet to be proven, that the risk of rash may also be increased by (1) coadministration of LAMICTAL XR with valproate (includes valproic acid and divalproex sodium), (2) exceeding the recommended initial dose of LAMICTAL XR, or (3) exceeding the recommended dose escalation for LAMICTAL XR. However, cases have occurred in the absence of these factors.

    Nearly all cases of life-threatening rashes caused by immediate-release 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 LAMICTAL XR, it is not possible to predict reliably which rashes will prove to be serious or life threatening. Accordingly, LAMICTAL XR 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)].

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  • 1 INDICATIONS AND USAGE
    1.1 Adjunctive Therapy - LAMICTAL XR is indicated as adjunctive therapy for primary generalized tonic-clonic (PGTC) seizures and partial-onset seizures with or without secondary generalization in ...
  • 2 DOSAGE AND ADMINISTRATION
    LAMICTAL XR extended-release tablets are taken once daily, with or without food. Tablets must be swallowed whole and must not be chewed, crushed, or divided. 2.1 General Dosing Considerations ...
  • 3 DOSAGE FORMS AND STRENGTHS
    3.1 Extended-Release Tablets - 25-mg, yellow with white center, round, biconvex, film-coated tablets printed with “LAMICTAL” and “XR 25.” 50-mg, green with white center, round, biconvex ...
  • 4 CONTRAINDICATIONS
    LAMICTAL XR is contraindicated in patients who have demonstrated hypersensitivity (e.g., rash, angioedema, acute urticaria, extensive pruritus, mucosal ulceration) to the drug or its ingredients ...
  • 5 WARNINGS AND PRECAUTIONS
    5.1 Serious Skin Rashes [see Boxed Warning] The risk of serious rash caused by treatment with LAMICTAL XR is not expected to differ from that with immediate-release lamotrigine [see Boxed ...
  • 6 ADVERSE REACTIONS
    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 ...
  • 7 DRUG INTERACTIONS
    Significant drug interactions with lamotrigine are summarized in this section. Additional details of these drug interaction studies, which were conducted using immediate-release lamotrigine, are ...
  • 8 USE IN SPECIFIC POPULATIONS
    8.1 Pregnancy - Pregnancy Exposure Registry - There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to AEDs, including LAMICTAL XR, during pregnancy. Encourage ...
  • 10 OVERDOSAGE
    10.1 Human Overdose Experience - Overdoses involving quantities up to 15 g have been reported for immediate-release lamotrigine, some of which have been fatal. Overdose has resulted in ataxia ...
  • 11 DESCRIPTION
    LAMICTAL XR (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 ...
  • 12 CLINICAL PHARMACOLOGY
    12.1 Mechanism of Action - The precise mechanism(s) by which lamotrigine exerts its anticonvulsant action are unknown. In animal models designed to detect anticonvulsant activity, lamotrigine was ...
  • 13 NONCLINICAL TOXICOLOGY
    13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility - No evidence of carcinogenicity was seen in mice or rats following oral administration of lamotrigine for up to 2 years at doses up to ...
  • 14 CLINICAL STUDIES
    14.1 Adjunctive Therapy for Primary Generalized Tonic-Clonic Seizures - The effectiveness of LAMICTAL XR as adjunctive therapy in subjects with PGTC seizures was established in a 19-week ...
  • 15 REFERENCES
    1. French JA, Wang S, Warnock B, Temkin N. Historical control monotherapy design in the treatment of epilepsy. Epilepsia. 2010; 51(10):1936-1943.
  • 16 HOW SUPPLIED/STORAGE AND HANDLING
    LAMICTAL XR (lamotrigine) extended-release tablets - 25-mg, yellow with a white center, round, biconvex, film-coated tablets printed on one face in black ink with “LAMICTAL” and “XR 25” ...
  • 17 PATIENT COUNSELING INFORMATION
    Advise the patient to read the FDA-approved patient labeling (Medication Guide). Rash - Prior to initiation of treatment with LAMICTAL XR, inform patients that a rash or other signs or symptoms of ...
  • MEDICATION GUIDE
    MEDICATION GUIDE - LAMICTAL (la-MIK-tal) XR (lamotrigine) extended-release tablets - What is the most important information I should know about LAMICTAL XR? 1. LAMICTAL XR may cause ...
  • PRINCIPAL DISPLAY PANEL
    PRINCIPAL DISPLAY PANEL - NDC 0173-0754-00 - LAMICTAL XR - (LAMOTRIGINE) EXTENDED-RELEASE TABLETS - 25 mg - Once A Day • LAMICTAL XR • Once a Day • LAMICTAL XR - RX only - CAUTION: Verify ...
  • PRINCIPAL DISPLAY PANEL
    PRINCIPAL DISPLAY PANEL - NDC 0173-0755-00 - LAMICTAL XR - (LAMOTRIGINE) EXTENDED-RELEASE TABLETS - 50 mg - Once A Day • LAMICTAL XR • Once a Day • LAMICTAL XR - Rx only - CAUTION: Verify ...
  • PRINCIPAL DISPLAY PANEL
    PRINCIPAL DISPLAY PANEL - NDC 0173-0756-00 - LAMICTAL XR - (LAMOTRIGINE) EXTENDED-RELEASE TABLETS - 100 mg - Once A Day • LAMICTAL XR • Once a Day • LAMICTAL XR - Rx only - CAUTION: Verify ...
  • PRINCIPAL DISPLAY PANEL
    PRINCIPAL DISPLAY PANEL - NDC 0173-0757-00 - LAMICTAL XR - (LAMOTRIGINE) EXTENDED-RELEASE TABLETS - 200 mg - Once A Day • LAMICTAL XR • Once a Day • LAMICTAL XR - Rx only - CAUTION: Verify ...
  • PRINCIPAL DISPLAY PANEL
    PRINCIPAL DISPLAY PANEL - NDC 0173-0781-00 - LAMICTAL XR - (LAMOTRIGINE) EXTENDED- RELEASE TABLETS - 250 mg - Once A Day • LAMICTAL XR • Once a Day • LAMICTAL XR - Rx only - CAUTION: Verify ...
  • PRINCIPAL DISPLAY PANEL
    PRINCIPAL DISPLAY PANEL - NDC 0173-0761-00 - LAMICTAL XR - (LAMOTRIGINE) EXTENDED- RELEASE TABLETS - 300 mg - Once A Day • LAMICTAL XR • Once a Day • LAMICTAL XR - Rx only - CAUTION: Verify ...
  • PRINCIPAL DISPLAY PANEL
    PRINCIPAL DISPLAY PANEL - NDC 0173-0758-00 - LAMICTALXR - (LAMOTRIGINE) EXTENDED-RELEASE TABLETS - LAMICTALXR • LAMICTAL XR • LAMICTAL XR • LAMICTAL XR - Rx only - For patients TAKING ...
  • PRINCIPAL DISPLAY PANEL
    PRINCIPAL DISPLAY PANEL - NDC 0173-0759-00 - LAMICTAL XR - (LAMOTRIGINE) EXTENDED-RELEASE TABLETS - LAMICTALXR • LAMICTAL XR • LAMICTAL XR • LAMICTAL XR - Rx only - For patients TAKING ...
  • PRINCIPAL DISPLAY PANEL
    PRINCIPAL DISPLAY PANEL - NDC 0173-0760-00 - LAMICTAL XR - (LAMOTRIGINE) EXTENDED-RELEASE TABLETS - LAMICTALXR • LAMICTAL XR • LAMICTAL XR • LAMICTAL XR - Rx only - For patients NOT TAKING ...
  • INGREDIENTS AND APPEARANCE
    Product Information