From the FDA Drug Label
Although there are no independent trials demonstrating the efficacy of bupropion hydrochloride extended-release tablets (XL) in the acute treatment of MDD, studies have demonstrated similar bioavailability between the immediate-, sustained-, and extended-release formulations of bupropion HCl under steady-state conditions Bupropion hydrochloride extended-release tablets, USP (XL) are supplied as 300 mg, creamy-white to pale yellow round coated tablets
The maximum recommended dose of Wellbutrin XL (bupropion) is not explicitly stated in the provided drug label. However, based on the available information, the maximum dose that can be inferred is 300 mg once daily, as this is the highest dose mentioned for the extended-release tablets (XL) in the supplied strengths. 1
From the Research
The maximum recommended dose of Wellbutrin XL (bupropion hydrochloride extended-release) is 450 mg once daily, as supported by the most recent and highest quality study available 2. This maximum dose should not be exceeded due to increased risk of seizures at higher doses.
Key Considerations
- Treatment typically begins with 150 mg once daily in the morning for the first 3-4 days, then increases to 300 mg once daily if tolerated.
- For some patients, particularly those with depression who don't respond adequately to 300 mg, the dose may be increased to the maximum 450 mg once daily.
- Patients with severe hepatic cirrhosis or renal impairment should receive reduced doses, generally not exceeding 150 mg every other day.
Administration Guidelines
- Wellbutrin XL tablets should be swallowed whole and not crushed, divided, or chewed, as this can release the medication too quickly, increasing seizure risk.
- The medication should be taken at the same time each day, preferably in the morning to minimize insomnia, which is a common side effect.
- If a dose is missed, patients should skip it and resume their regular schedule the next day rather than taking a double dose, as indicated by studies such as 3 and 4.
Rationale
The recommendation to not exceed 450 mg once daily is based on the balance between efficacy and safety, particularly the risk of seizures, which is a well-documented side effect of bupropion 5, 6. By following these guidelines, patients can maximize the benefits of Wellbutrin XL while minimizing the risks.