From the FDA Drug Label
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 70771-1514-3 Lamotrigine extended-release tablets, 25 mg Rx only 30 tablets NDC 70771-1515-3 Lamotrigine extended-release tablets, 50 mg Rx only 30 tablets NDC 70771-1516-3 Lamotrigine extended-release tablets, 100 mg Rx only 30 tablets NDC 70771-1517-3 Lamotrigine extended-release tablets, 200 mg Rx only 30 tablets NDC 70771-1518-3 Lamotrigine extended-release tablets, 250 mg Rx only 30 tablets NDC 70771-1519-3 Lamotrigine extended-release tablets, 300 mg Rx only 30 tablets
The maximum lamotrigine dose is not explicitly stated in the provided text.
- The available doses are listed as 25 mg, 50 mg, 100 mg, 200 mg, 250 mg, and 300 mg.
- However, the maximum recommended dose is not specified. 1
From the Research
The maximum dose of lamotrigine should not exceed 700 mg per day for adults with epilepsy and 400 mg daily for bipolar disorder maintenance, with careful titration and monitoring to minimize the risk of serious rash and other adverse reactions, as supported by the most recent study 2.
Key Considerations
- The maximum dose of lamotrigine varies by indication and patient factors, including kidney and liver function, age, and pregnancy status.
- For adults with epilepsy, the maximum recommended dose is typically 500-700 mg per day, divided into two doses, while for bipolar disorder maintenance, the maximum is generally 400 mg daily.
- Lamotrigine requires careful titration, starting at 25 mg daily for most adults and increasing slowly over 6-8 weeks to reach therapeutic levels, as noted in earlier studies 3, 4, 5.
- The maximum dose may be lower (200-300 mg daily) for patients taking valproate, which inhibits lamotrigine metabolism, and may need to be higher in patients taking enzyme-inducing medications like carbamazepine.
- Patients should never increase lamotrigine suddenly and should report any rash immediately, as this could indicate a serious adverse reaction, such as Stevens-Johnson syndrome.
- Regular monitoring of blood levels may be necessary to ensure safety and efficacy, especially at higher doses, as suggested by the latest research 6, 2.
Special Populations
- Patients with severe renal impairment and end-stage renal disease may require dose adjustments due to increased lamotrigine exposure, as predicted by physiologically based pharmacokinetic modeling 2.
- The developed lamotrigine PBPK model offers a strategy for assisting clinicians in therapeutic drug monitoring and dose adjustment for special populations, thereby providing a reference for safer administration regimens in clinical treatment.