What is the information on Metformin (Metformin) Osmotic Extended Release (ER) 2000mg?

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Last updated: February 25, 2025View editorial policy

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From the Guidelines

Metformin Osmotic ER 2000 mg is a commonly used and effective medication for the treatment of type 2 diabetes, with a recommended starting dose of 500-1000 mg and gradual increase to 2000 mg to improve tolerance, as supported by the most recent and highest quality study 1.

Key Points

  • Metformin Osmotic ER 2000 mg is used to control blood sugar by improving insulin sensitivity and reducing glucose production by the liver.
  • The osmotic extended-release formulation allows for once-daily dosing, typically taken with the evening meal to minimize gastrointestinal side effects.
  • Patients should start at a lower dose (500-1000 mg) and gradually increase to 2000 mg to improve tolerance.
  • This medication should be taken consistently at the same time each day, and patients should maintain regular blood glucose monitoring.
  • Common side effects include nausea, diarrhea, and abdominal discomfort, which often improve over time.
  • Metformin may cause vitamin B12 deficiency with long-term use, so periodic monitoring is recommended, as suggested by 1 and 1.

Important Considerations

  • It's essential to maintain adequate hydration while taking this medication and temporarily discontinue it during procedures requiring contrast dye or if experiencing severe illness, dehydration, or kidney problems to prevent rare but serious lactic acidosis, as warned by 1.
  • The maximum daily dose of metformin is 2550 mg in the US and 3000 mg in the European Union, but doses above 2000 mg are generally associated with little additional efficacy and poorer tolerability, as stated in 1.
  • Metformin should not be used in patients with an eGFR <30 mL/min/1.73 m², and dose reduction should be considered when the eGFR is <45 mL/min/1.73 m², as recommended by 1.

From the FDA Drug Label

Following a single oral dose of metformin hydrochloride extended-release tablets, C max is achieved with a median value of 7 hours and a range of 4 to 8 hours Peak plasma levels are approximately 20% lower compared to the same dose of metformin hydrochloride tablets, however, the extent of absorption (as measured by AUC) is comparable to metformin hydrochloride tablets. 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 extent of metformin absorption (as measured by AUC) from metformin hydrochloride extended-release tablets at a 2000 mg once-daily dose is similar to the same total daily dose administered as metformin hydrochloride tablets 1000 mg twice daily

The Metformin Osmotic Extended Release (ER) 2000mg has a peak plasma level of approximately 1.8 mcg/mL at steady state, and the extent of absorption is similar to the same total daily dose administered as metformin hydrochloride tablets 1000 mg twice daily 2.

  • Key points:
    • Peak plasma level: approximately 1.8 mcg/mL
    • Extent of absorption: similar to metformin hydrochloride tablets 1000 mg twice daily
    • Administration: once daily
    • Dose: 2000 mg
    • Formulation: extended-release tablets

From the Research

Metformin Osmotic Extended Release (ER) 2000mg Information

  • Metformin is a first-line medication for type 2 diabetes, effective and safe when used with caution in specific populations 3
  • The extended-release formulation of metformin may help reduce gastrointestinal side effects, which are common during therapy initiation 3
  • There is no specific information available on Metformin Osmotic Extended Release (ER) 2000mg in the provided studies
  • However, metformin in general has been shown to be beneficial in patients with type 2 diabetes, including those with kidney disease, with a low risk of lactic acidosis 4, 5, 6
  • Patients with chronic kidney disease may require dose adjustments and regular monitoring of kidney function to minimize the risk of metformin accumulation and lactic acidosis 3, 4, 6

Key Considerations

  • Metformin should be discontinued when the estimated glomerular filtration rate (eGFR) falls below 30 mL/min/1.73m2 3
  • Patients with liver or respiratory insufficiency, sepsis, or acute heart failure are at increased risk of lactic acidosis and should not take metformin 3, 5
  • Vitamin B-12 levels should be monitored regularly in long-time metformin users due to the risk of clinical vitamin B-12 deficiency 3

Study Findings

  • A retrospective observational cohort study found that metformin use was associated with lower all-cause mortality and end-stage renal disease progression in patients with type 2 diabetic kidney disease 4
  • A systematic review found that the overall incidence of lactic acidosis in metformin users is low, and the risk is not substantially increased in patients with mild to moderate chronic kidney disease 6
  • A case report described a patient with metformin-associated lactic acidosis and acute renal failure, highlighting the importance of careful monitoring and dose adjustments in patients with kidney disease 7

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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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