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These studies suggest the maximum dose of metformin extended-release is 2500 mg per day.
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Metformin extended-release (ER) is a widely used medication for managing type 2 diabetes mellitus. It offers the advantage of once-daily dosing, which can improve patient adherence compared to immediate-release (IR) formulations. Understanding the maximum effective and safe dose of metformin ER is crucial for optimizing treatment outcomes.
A study investigating the pharmacokinetics of metformin ER in healthy volunteers revealed that doses ranging from 1000 mg to 2500 mg resulted in a consistent and predictable increase in metformin exposure. The differences in pharmacokinetic parameters such as Cmax and AUC were within acceptable limits, indicating dose proportionality across this range.
Clinical trials have demonstrated that metformin ER is effective in controlling blood glucose levels. In a 24-week study, doses of 1500 mg and 2000 mg per day were found to be effective and well-tolerated, with no significant increase in adverse events at the higher dose . Another study confirmed that metformin ER at doses up to 2000 mg/day provided similar glycemic control to metformin IR, with a lower incidence of gastrointestinal side effects.
Despite guidelines recommending up-titration to a maximally effective dose of around 2000 mg/day, real-world data indicates that many patients remain on sub-maximal doses. A retrospective cohort study found that only 16% of patients were on doses greater than 1500 mg/day after 12 months of treatment. This suggests a gap between clinical guidelines and actual practice, potentially due to concerns about tolerability or patient adherence.
For patients with reduced kidney function, dose adjustments are necessary to avoid the risk of lactic acidosis. Research suggests that a maximum daily dose of 2250 mg is appropriate for patients with normal kidney function, while lower doses are recommended for those with varying degrees of renal impairment. This stratified dosing approach helps maintain efficacy while minimizing safety risks.
The maximum recommended dose of metformin ER is generally 2000 mg per day, based on clinical trial data and pharmacokinetic studies. However, real-world usage often falls short of this target, highlighting the need for better adherence to dosing guidelines. For patients with impaired kidney function, careful dose adjustments are essential to ensure both efficacy and safety. Overall, metformin ER remains a cornerstone in the management of type 2 diabetes, offering effective glycemic control with a favorable safety profile.
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