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Metformin Extended-Release (Metformin Hydrochloride) - Summary

 
 



BOX WARNING

Lactic Acidosis:

Lactic acidosis is a rare, but serious, metabolic complication that can occur due to metformin accumulation during treatment with metformin hydrochloride extended-release tablets; when it occurs, it is fatal in approximately 50% of cases. Lactic acidosis may also occur in association with a number of pathophysiologic conditions, including diabetes mellitus, and whenever there is significant tissue hypoperfusion and hypoxemia. Lactic acidosis is characterized by elevated blood lactate levels (> 5 mmol/L), decreased blood pH, electrolyte disturbances with an increased anion gap, and an increased lactate/pyruvate ratio. When metformin is implicated as the cause of lactic acidosis, metformin plasma levels > 5 mcg/mL are generally found.

The reported incidence of lactic acidosis in patients receiving metformin hydrochloride is very low (approximately 0.03 cases/1000 patient-years, with approximately 0.015 fatal cases/1000 patient-years). In more than 20,000 patient-years exposure to metformin in clinical trials, there were no reports of lactic acidosis. Reported cases have occurred primarily in diabetic patients with significant renal insufficiency, including both intrinsic renal disease and renal hypoperfusion, often in the setting of multiple concomitant medical/surgical problems and multiple concomitant medications. Patients with congestive heart failure requiring pharmacologic management, in particular those with unstable or acute congestive heart failure who are at risk of hypoperfusion and hypoxemia, are at increased risk of lactic acidosis. The risk of lactic acidosis increases with the degree of renal dysfunction and the patient’s age. The risk of lactic acidosis may, therefore, be significantly decreased by regular monitoring of renal function in patients taking metformin hydrochloride extended-release tablets and by use of the minimum effective dose of metformin hydrochloride extended-release tablets. In particular, treatment of the elderly should be accompanied by careful monitoring of renal function. Metformin hydrochloride extended-release tablet treatment should not be initiated in patients ≥ 80 years of age unless measurement of creatinine clearance demonstrates that renal function is not reduced, as these patients are more susceptible to developing lactic acidosis. In addition, metformin hydrochloride extended-release tablets should be promptly withheld in the presence of any condition associated with hypoxemia, dehydration, or sepsis. Because impaired hepatic function may significantly limit the ability to clear lactate, metformin hydrochloride extended-release tablets should generally be avoided in patients with clinical or laboratory evidence of hepatic disease. Patients should be cautioned against excessive alcohol intake, either acute or chronic, when taking metformin hydrochloride extended-release tablets, since alcohol potentiates the effects of metformin hydrochloride on lactate metabolism. In addition, metformin hydrochloride extended-release tablets should be temporarily discontinued prior to any intravascular radiocontrast study and for any surgical procedure (see also PRECAUTIONS).

The onset of lactic acidosis often is subtle, and accompanied only by nonspecific symptoms such as malaise, myalgias, respiratory distress, increasing somnolence, and nonspecific abdominal distress. There may be associated hypothermia, hypotension, and resistant bradyarrhythmias with more marked acidosis. The patient and the patient’s physician must be aware of the possible importance of such symptoms and the patient should be instructed to notify the physician immediately if they occur (see also PRECAUTIONS). Metformin hydrochloride extended-release tablets should be withdrawn until the situation is clarified. Serum electrolytes, ketones, blood glucose and, if indicated, blood pH, lactate levels, and even blood metformin levels may be useful. Once a patient is stabilized on any dose level of metformin hydrochloride extended-release tablets, gastrointestinal symptoms, which are common during initiation of therapy, are unlikely to be drug related. Later occurrence of gastrointestinal symptoms could be due to lactic acidosis or other serious disease.

Levels of fasting venous plasma lactate above the upper limit of normal but less than 5 mmol/L in patients taking metformin hydrochloride extended-release tablets do not necessarily indicate impending lactic acidosis and may be explainable by other mechanisms, such as poorly controlled diabetes or obesity, vigorous physical activity, or technical problems in sample handling. (See also PRECAUTIONS.)

Lactic acidosis should be suspected in any diabetic patient with metabolic acidosis lacking evidence of ketoacidosis (ketonuria and ketonemia).

Lactic acidosis is a medical emergency that must be treated in a hospital setting. In a patient with lactic acidosis who is taking metformin hydrochloride extended-release tablets, the drug should be discontinued immediately and general supportive measures promptly instituted. Because metformin hydrochloride is dialyzable (with a clearance of up to 170 mL/min under good hemodynamic conditions), prompt hemodialysis is recommended to correct the acidosis and remove the accumulated metformin. Such management often results in prompt reversal of symptoms and recovery. (See also CONTRAINDICATIONS and PRECAUTIONS).

 

SUMMARY

METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS
Rx only

Metformin hydrochloride extended-release tablets are an oral antihyperglycemic drug used in the management of type 2 diabetes.

Metformin hydrochloride extended-release tablets, as monotherapy, are indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes. Metformin hydrochloride extended-release tablets are indicated in patients 17 years of age and older.

Metformin hydrochloride extended-release tablets may be used concomitantly with a sulfonylurea or insulin to improve glycemic control in adults (17 years of age and older).


See all Metformin Extended-Release indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Metformin Extended-Release (Metformin)

Diabetes Drug Metformin May Affect Thyroid in Some Patients
Source: MedicineNet Hypothyroidism Specialty [2014.09.23]
Title: Diabetes Drug Metformin May Affect Thyroid in Some Patients
Category: Health News
Created: 9/22/2014 12:35:00 PM
Last Editorial Review: 9/23/2014 12:00:00 AM

Metformin use linked to risk of low thyroid hormone levels
Source: Endocrinology News From Medical News Today [2014.09.22]
A new study links a common drug used for treatment of type 2 diabetes to a risk of low levels of thyroid hormone levels, potentially putting patients at cardiovascular risk.

Blacks May Respond Better Than Whites to Diabetes Drug Metformin
Source: MedicineNet metformin Specialty [2014.06.13]
Title: Blacks May Respond Better Than Whites to Diabetes Drug Metformin
Category: Health News
Created: 6/12/2014 2:35:00 PM
Last Editorial Review: 6/13/2014 12:00:00 AM

Metformin Outperforms Common Class of Diabetes Drugs in Study
Source: MedicineNet glimepiride Specialty [2012.06.25]
Title: Metformin Outperforms Common Class of Diabetes Drugs in Study
Category: Health News
Created: 6/24/2012 2:05:00 PM
Last Editorial Review: 6/25/2012 12:00:00 AM

Metformin: Safer for Heart Than Older Diabetes Drugs?
Source: MedicineNet chlorpropamide Specialty [2011.06.29]
Title: Metformin: Safer for Heart Than Older Diabetes Drugs?
Category: Health News
Created: 6/29/2011 11:01:00 AM
Last Editorial Review: 6/29/2011 12:00:00 AM

more news >>

Published Studies Related to Metformin Extended-Release (Metformin)

Effects of Metformin Versus Glipizide on Cardiovascular Outcomes in Patients With Type 2 Diabetes and Coronary Artery Disease. [2012]
OBJECTIVEThe two major classes of antidiabetic drugs, sulfonylureas and metformin, may differentially affect macrovascular complications and mortality in diabetic patients. We compared the long-term effects of glipizide and metformin on the major cardiovascular events in type 2 diabetic patients who had a history of coronary artery disease (CAD).RESEARCH DESIGN AND METHODSThis study is a multicenter, randomized, double-blind, placebo-controlled clinical trial...

Metformin's effect on first-year weight gain: a follow-up study. [2012]
on growth of the offspring are essentially unexplored... CONCLUSIONS: Women randomized to metformin were heavier in the first trimester,

Combination treatment with ipragliflozin and metformin: a randomized, double-blind, placebo-controlled study in patients with type 2 diabetes mellitus. [2012]
metformin... CONCLUSIONS: Combination treatment for 14 days with ipragliflozin and metformin

Comparison of metformin and insulin in the control of hyperglycaemia in non-diabetic critically ill patients. [2012]
metformin and insulin on hyperglycaemia in ICU patients... CONCLUSIONS: Both metformin and intensive insulin therapy significantly decreased

Metformin efficacy and safety for colorectal polyps: a double-blind randomized controlled trial. [2012]
BACKGROUND: Colorectal cancer is one of the major neoplasms and a leading cause of cancer death worldwide, and new preventive strategies are needed to lower the burden of this disease. Metformin, a biguanide, which is widely used for treating diabetes mellitus, has recently been suggestive to have a suppressive effect on tumorigenesis and cancer cell growth.

more studies >>

Clinical Trials Related to Metformin Extended-Release (Metformin)

Metabolic Effect of Metformin in Obese Insulin Resistant Adolescents With Normal Glucose Tolerance [Active, not recruiting]
The primary objective of this randomized, parallel group, double-blind, placebo-controlled study is to determine whether treatment with metformin enhances insulin sensitivity in a group of ethnically diverse obese insulin-resistant adolescents with normal glucose tolerance.

Drug Interaction With Metformin [Completed]
The purpose of the study is to determine the effect of metformin on dapagliflozin exposure and the effect of dapagliflozin on metformin exposure in healthy volunteers. Additionally, the safety and tolerability of dapagliflozin will be assessed in the presence and absence of metformin in healthy volunteers

Rosiglitazone-Metformin Combination Versus Metformin-Sulfonylurea Combination On Beta-Cell Function In Type 2 Diabetes [Active, not recruiting]
It has been shown in previous study that progressive glycemic deterioration was associated with progressive loss of b-cell function, measured by the decrease in plasma insulin levels, irrespective of the therapy used (diet, sulfonylureas or metformin).There is growing evidence that thiazolidinediones could have a positive action on the b-cell function. But it has not yet been demonstrated that they could protect from a deterioration in insulin secretion in the long term. So, it appears interesting to study the long term evolution of the b-cell function and the possible protection with rosiglitazone in patients with type 2 diabetes showing evidence of loss of b-cell function with metformin alone.

Efficacy and Safety of Prandial Inhalation of Technosphere/Insulin in Combination With Metformin or Technosphere/Insulin Alone Versus 2 Oral Anti-Diabetic Agents in Subjects With Type 2 Diabetes [Active, not recruiting]
to demonstrate the efficacy of inhaled Technosphere/Insulin in combination with metformin versus combination metformin and a secretagogue

To Compare the Effect of Liraglutide When Given Together With Metformin With the Effect of Metformin Given Alone and With the Effect of Glimepiride and Metformin Given Together [Active, not recruiting]
This trial is conducted in Europe, Oceania, Africa, Asia and South America.

This trial is designed to show the effect of treatment with liraglutide when adding to existing metformin therapy and to compare it with the effects of metformin monotherapy and combination therapy of metformin and glimepiride.

The 26 weeks double-blind period will be followed by an 18 months open label extension.

more trials >>


PATIENT REVIEWS / RATINGS / COMMENTS

Based on a total of 1 ratings/reviews, Metformin Extended-Release has an overall score of 10. The effectiveness score is 10 and the side effect score is 10. The scores are on ten point scale: 10 - best, 1 - worst.
 

Metformin Extended-Release review by 46 year old female patient

  Rating
Overall rating:  
Effectiveness:   Highly Effective
Side effects:   No Side Effects
  
Treatment Info
Condition / reason:   diabetes
Dosage & duration:   500 mg taken once a day in the morning for the period of have been on it for 12 months
Other conditions:   sarcoidosis, depression, anxiety
Other drugs taken:   plaquenil, paxil, trazodone
  
Reported Results
Benefits:   The drug significantly lower my blood glucose level. Currently my blood glucose runs an average of 115 with some days below 90.
Side effects:   Although it is supposed to have a side effect of diarrhea I have been fortunate. I make sure I take with food. Sometimes if I dont have enough food on my stomach it may cause some upset but nothing terrible. Otherwise I have not had any other side effect.s
Comments:   I take one tablet in the morning after or with my breakfast. So far no additional dosage is required.

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Page last updated: 2014-09-23

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