What is the maximum dose of Metformin (Metformin) Extended Release (XR)?

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Last updated: May 2, 2025View editorial policy

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From the Guidelines

The maximum effective dose of Metformin XR is up to 2,500 mg/day, but often 850 mg twice per day, with the extended-release formulation allowing for once-daily dosing in some countries. When determining the maximum dose of Metformin XR, it's essential to consider the patient's tolerance and potential gastrointestinal side effects, as noted in the consensus statement by the American Diabetes Association and the European Association for the Study of Diabetes 1. The dosing regimen typically starts with a low dose of 500 mg once or twice per day with meals and can be advanced to 850 mg or two 500 mg tablets twice per day if gastrointestinal side effects have not occurred after 5-7 days 1. Key considerations for Metformin XR dosing include:

  • Starting with a low dose to minimize gastrointestinal side effects
  • Gradually increasing the dose as tolerated
  • Considering the use of the extended-release formulation for once-daily dosing
  • Monitoring for gastrointestinal side effects and adjusting the dose accordingly
  • Aiming for a maximum effective dose of up to 2,500 mg/day, but often 850 mg twice per day, as supported by the consensus statement 1.

From the FDA Drug Label

At steady state, the AUC and C max are less than dose proportional for metformin hydrochloride extended-release tablets within the range of 500 to 2000 mg administered once daily. Peak plasma levels are approximately 0. 6,1.1.4 and 1. 8 mcg/mL for 500,1000,1500, and 2000 mg once-daily doses, respectively.

The maximum dose of Metformin XR is 2000 mg once daily 2.

From the Research

Metformin XR Max Dose

  • The maximum dose of Metformin XR is not explicitly stated in the provided studies, but the doses used in the studies can be used as a reference.
  • In the study 3, the dose of Metformin XR used was up to 2000 mg once daily, and in some cases, 1000 mg twice daily.
  • In the study 4, the maximum dose of Metformin XR used was 2000 mg/day.
  • The study 5 used a dose of 1000 mg twice daily for Metformin XR.

Dose-Response Relationship

  • The study 3 showed a clear dose-response relationship for Metformin XR, with doses up to 1500 mg showing increased efficacy.
  • The study 3 also showed that the efficacy of Metformin XR 2000 mg once daily and 1000 mg twice daily were similar.

Tolerability and Safety

  • The studies 5, 3, and 4 showed that Metformin XR was well-tolerated, with fewer gastrointestinal side effects compared to Metformin IR.
  • The study 4 reported that 77% of patients were free of gastrointestinal side effects, and 83% of patients preferred Metformin XR over standard Metformin.

Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.

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