Maximum dosage of metformin extended release
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Maximum Dosage of Metformin Extended Release: Clinical Evidence
Recommended Maximum Dosage and Titration
Clinical studies consistently report that the maximum recommended dosage of metformin extended release (XR) for adults with type 2 diabetes is 2000 mg per day, typically administered as a once-daily dose with the evening meal to improve tolerability and absorption 1268. In randomized trials, patients were titrated up to this maximum dose, and 2000 mg/day was found to be both effective and well tolerated 128. Some studies have explored higher single doses (up to 2500 mg in healthy volunteers), but these are not standard for routine clinical use and are primarily for pharmacokinetic research .
Efficacy and Safety at Maximum Dosage
At the 2000 mg/day dosage, metformin XR provides glycemic control comparable to immediate-release formulations, with similar reductions in HbA1c and fasting plasma glucose 258. Importantly, the extended release formulation is associated with fewer gastrointestinal side effects, leading to better patient satisfaction and adherence 1258. Studies also show that increasing the dose from 1500 mg/day to 2000 mg/day does not significantly increase the severity or duration of gastrointestinal adverse events .
Pharmacokinetics and Dose Proportionality
Pharmacokinetic studies demonstrate a predictable, dose-proportional increase in metformin exposure with extended release formulations from 1000 mg up to 2500 mg . However, the standard clinical practice remains to use up to 2000 mg/day, as this dose balances efficacy and safety 12468.
Special Considerations: Food Effect and Combination Products
Taking metformin XR with food, especially the evening meal, increases its absorption and systemic availability, but does not increase the incidence of adverse events 910. Fixed-dose combination products (such as dapagliflozin/metformin XR or evogliptin/metformin XR) are available in strengths up to 1000 mg of metformin XR per tablet, allowing for flexible dosing up to the 2000 mg/day maximum 79.
Conclusion
The maximum recommended dosage of metformin extended release for adults with type 2 diabetes is 2000 mg per day, usually taken once daily with the evening meal. This dosage is supported by multiple clinical trials for its efficacy, safety, and improved gastrointestinal tolerability compared to immediate-release formulations. Higher doses have been studied for pharmacokinetic purposes but are not standard in clinical practice.
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