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Conversion From LAMICTAL or Immediate-Release Lamotrigine

Simple 1:1 conversion for appropriate* patients taking LAMICTAL

Direct conversion; no titration is necessary
Maintains trough serum concentrations (C_min) of lamotrigine following conversion to LAMICTAL XR¹
The initial dose of LAMICTAL XR should match the total daily dose of LAMICTAL Tablets

Important dosing considerations

Following conversion to LAMICTAL XR, all patients (but especially those on an enzyme-inducing AED) should be closely monitored for seizure control. Depending on the therapeutic response after conversion, the total daily dose may need to be adjusted within the recommended dosing instructions.
Dose escalation and maintenance doses are based on concomitant medications. Dose adjustments are recommended for patients with hepatic or renal impairment.
Adjustments to maintenance dose will be needed in most cases following introduction or withdrawal of estrogen-containing oral contraceptives, in order to maintain consistent lamotrigine plasma levels. Adjustments also may be necessary during pregnancy and following delivery. Adverse events consistent with elevated levels of lamotrigine (such as dizziness, ataxia, and diplopia) may occur during the week of inactive hormone preparation (pill-free week). See Dosage and Administration section of the Prescribing Information for additional details.
To avoid an increased risk of rash, the recommended initial dose and subsequent dose escalations of LAMICTAL XR should not be exceeded. The risk of rash may also be increased by coadministration of LAMICTAL XR with valproate.
Do not restart LAMICTAL XR in patients who discontinue due to rash unless the potential benefits clearly outweigh the risks.

*LAMICTAL XR is an antiepileptic drug (AED) indicated as adjunctive therapy for partial onset seizures with or without secondary generalization in patients ≥13 years of age. The safety and effectiveness of LAMICTAL XR in patients below the age of 13 have not been established.

There is no AB-rated generic for LAMICTAL XR²

Important Safety Information About LAMICTAL XR (lamotrigine) Extended-Release Tablets

Serious rashes and hypersensitivity reactions

Cases of life-threatening serious rashes, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and/or rash-related death, have been caused by lamotrigine. The rate of serious rash is greater in pediatric patients than in adults. Additional factors that may increase the risk of rash include:
- Coadministration with valproate
- Exceeding recommended initial dose of LAMICTAL XR
- Exceeding recommended dose escalation of LAMICTAL XR
Benign rashes are also caused by lamotrigine; however, it is not possible to predict which rashes will prove to be serious or life-threatening. LAMICTAL XR should be discontinued at the first sign of rash unless the rash is clearly not drug-related.
Hypersensitivity reaction may be fatal or life-threatening. Early signs of hypersensitivity (e.g., fever, lymphadenopathy) may present without rash; if signs present, patient should be evaluated immediately.
LAMICTAL XR should be discontinued if alternate etiology for hypersensitivity signs is not found.
Prior to initiation of treatment with LAMICTAL XR, the patient should be instructed that a rash or other signs or symptoms of hypersensitivity (e.g., fever, lymphadenopathy) may herald a serious medical event and that the patient should report any such occurrence to a physician immediately.

Suicidal thoughts or behavior

Antiepileptic drugs, including LAMICTAL XR, increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication.
Patients treated with any antiepileptic drug for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior.
Patients, their caregivers, and families should be informed that antiepileptic drugs increase the risk of suicidal thoughts and behavior and should be advised of the need to be alert for the emergence or worsening of the signs and symptoms of depression, any unusual changes in mood or behavior, or the emergence of suicidal thoughts, behavior, or thoughts about
self-harm. Behaviors of concern should be reported immediately to healthcare providers.

Other warnings

Acute multiorgan failure has resulted (some cases fatal).
Blood dyscrasias (e.g., neutropenia, thrombocytopenia, pancytopenia) may result, either with or without an associated hypersensitivity syndrome.

References:

¹Tompson D, Ali I, Oliver-Willwong R, et al. Steady-state pharmacokinetics of lamotrigine when converting from a twice-daily immediate-release to a once-daily extended-release formulation in subjects with epilepsy (The COMPASS Study). Epilepsia. 2008;49:410-417.

²US Department of Health and Human Services. Food and Drug Administration. Electronic Orange Book.
http://www.fda.gov/cder/ob/default.htm. Accessed July 30, 2009.

Complete Prescribing Information including Boxed Warning for LAMICTAL XR (lamotrigine) Extended-Release Tablets

Medication Guide for LAMICTAL XR (lamotrigine) Extended-Release Tablets

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