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Glucophage (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 GLUCOPHAGE or GLUCOPHAGE XR; 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 µg/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 GLUCOPHAGE or GLUCOPHAGE XR and by use of the minimum effective dose of GLUCOPHAGE or GLUCOPHAGE XR. In particular, treatment of the elderly should be accompanied by careful monitoring of renal function. GLUCOPHAGE or GLUCOPHAGE XR 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, GLUCOPHAGE and GLUCOPHAGE XR 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, GLUCOPHAGE and GLUCOPHAGE XR 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 GLUCOPHAGE or GLUCOPHAGE XR, since alcohol potentiates the effects of metformin hydrochloride on lactate metabolism. In addition, GLUCOPHAGE and GLUCOPHAGE XR 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). GLUCOPHAGE and GLUCOPHAGE XR 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 GLUCOPHAGE or GLUCOPHAGE XR, 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 GLUCOPHAGE or GLUCOPHAGE XR 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 GLUCOPHAGE or GLUCOPHAGE XR, 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.)

 

GLUCOPHAGE SUMMARY

GLUCOPHAGE® (metformin hydrochloride tablets) and GLUCOPHAGE® XR (metformin hydrochloride extended-release tablets) are oral antihyperglycemic drugs used in the management of type 2 diabetes.

GLUCOPHAGE (metformin hydrochloride tablets) and GLUCOPHAGE XR (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. GLUCOPHAGE is indicated in patients 10 years of age and older, and GLUCOPHAGE XR is indicated in patients 17 years of age and older.

GLUCOPHAGE or GLUCOPHAGE XR may be used concomitantly with a sulfonylurea or insulin to improve glycemic control in adults (17 years of age and older).


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NEWS HIGHLIGHTS

Media Articles Related to Glucophage (Metformin)

Study shows MicroBiome Therapeutics' NM505 may improve tolerability of metformin in type 2 diabetes
Source: Clinical Trials / Drug Trials News From Medical News Today [2014.09.30]
MicroBiome TherapeuticsTM LLC, (MBT) has reported positive topline results from a proof of concept study testing whether its investigational drug, NM 505, can improve the tolerability of 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

more news >>

Published Studies Related to Glucophage (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 Glucophage (Metformin)

Efficacy and Safety of Alogliptin Plus Metformin in Subjects With Type 2 Diabetes [Recruiting]
The purpose of this study is to evaluate the safety and effectiveness of alogliptin combined with metformin, once daily (QD) or twice daily (BID), in participants with Type 2 Diabetes.

Carotid Atherosclerosis: MEtformin for Insulin ResistAnce Study [Recruiting]
Hypothesis: Treatment with metformin in overweight non-diabetic individuals with coronary heart disease and on standard cardiovascular risk reducing agents including statins will have a beneficial impact on carotid artery atherosclerosis compared to placebo.

Rationale: Once subjects have a heart attack, they remain at much higher than average risk of another heart attack and stroke, despite the best current therapies to lower their cholesterol and blood pressure and thin their blood. Many subjects with heart disease also have problems metabolising (i. e. processing) sugar even if they do not have diabetes. There is some evidence that metformin, a drug which improves sugar metabolism, decreases the risk of future heart attacks in diabetic patients. However, whether metformin further reduces the risk of heart disease beyond established treatments in people without diabetes is unknown.

Method: The investigators will test the ability metformin, a drug with proven safety, to slow the progression of furring up (known as atherosclerosis) of blood vessels in non-diabetic subjects with heart disease. This will be achieved by treating 2 groups of subjects with metformin and placebo pills respectively. To measure atherosclerosis, the investigators will carry out ultrasound scans of the big blood vessels in the neck at the start of the study, after 1 year and after 1. 5 years of therapy. The investigators will then be able to assess whether metformin has had a beneficial impact.

Comparison of the Bioavailability of Metformin Between Medium Dose Linagliptin/Metformin Tablets and Medium Dose Glucophage Tablet Given With Linagliptin Tablet [Recruiting]
The data from this study will be used to compare the kinetic profile of metformin 500mg in linagliptin/metformin fixed dose combination tablet versus Canadian metformin reference product administered concomitantly with linagliptin 2. 5 mg tablet.

Study to Assess Safety and Pharmacokinetics (PK) of Double-Blind S-707106 Alone and in Combination With Open-Label Metformin in Patients With Type 2 Diabetes Mellitus [Recruiting]
Primary Objectives:

- to evaluate the safety and PK of multiple-dose oral administration of S-707106 tablet

in fed state in patients with type 2 diabetes mellitus

- to evaluate the safety and PK of multiple-dose oral co-administration of S-707106 and

metformin in fed state in patients with type 2 diabetes mellitus

Secondary Objectives:

- to evaluate the effect of multiple doses of S-707106 on PK of metformin

- to evaluate the effect of multiple doses of metformin on PK of S-707106

Bioavailability of a Fixed Dose Combination Tablet With BI 10773 and Metformin Compared With the Monocomponents and Effect of Food on Bioavailability [Recruiting]
The objective of the current study is to determine the relative bioavailability of a BI 10773 / metformin fixed dose combination tablet compared to single tablets of BI 10773 and metformin when administered together and to assess the effect of food on the bioavailability the fixed dose combination tablet

more trials >>

Reports of Suspected Glucophage (Metformin) Side Effects

Renal Failure Acute (56)Lactic Acidosis (51)Blood Glucose Increased (37)Nausea (37)Diarrhoea (37)Vomiting (35)Hypoglycaemia (30)Hyperkalaemia (28)Fatigue (25)Renal Failure (22)more >>


PATIENT REVIEWS / RATINGS / COMMENTS

Based on a total of 9 ratings/reviews, Glucophage has an overall score of 7.44. The effectiveness score is 7.56 and the side effect score is 7.11. The scores are on ten point scale: 10 - best, 1 - worst. Below are selected reviews: the highest, the median and the lowest rated.
 

Glucophage review by 57 year old female patient

  Rating
Overall rating:  
Effectiveness:   Highly Effective
Side effects:   No Side Effects
  
Treatment Info
Condition / reason:   diabetes type 2
Dosage & duration:   250 ml (dosage frequency: once per day) for the period of about a year now
Other conditions:   osteopinia, menopause symptons
Other drugs taken:   Fosomax, HRT, Zoloft
  
Reported Results
Benefits:   Lowering of blood sugar without risk of hypoglycemia
Side effects:   None
Comments:   For years I took 4 ml glimepiride daily for type 2 diabetes, but often awoke in the middle of the night due to hypoglycemia. Finally my doctor reduced my glimepiride to 2 ml daily and added 250 ml metformin daily. For me, this combination is very effective. It controls my blood sugar as well as the glimepiride alone without the concomitant hypoglycemia. I understand that some people with borderline type 2 diabetes control their sugar levels with metformin alone, and my doctor may try this if my glycohemoglobin blood tests (HbA1C) stay in the low 6s.

 

Glucophage review by 46 year old male patient

  Rating
Overall rating:  
Effectiveness:   Considerably Effective
Side effects:   No Side Effects
  
Treatment Info
Condition / reason:   Diabetes
Dosage & duration:   850 mg / 500 mg taken x 3 times a day for the period of 5 years 7 months
Other conditions:   high blood pressure
Other drugs taken:   none
  
Reported Results
Benefits:   the benefits of the treatment were that the blood sugar level that were very high in the beginning of the treatment went to controlled level. (it is controlled with the use of the medicine. I do not know what happens if I stop taking the medicine.)taking the medicine also helps in controlling hunger and so it help in having three meals, on regular times.
Side effects:   no side effect that I have experienced or can tell about. I was told that the medicine may damage my kidneys and I am taking regular check ups to test kidney function, however after over 5 years of taking the medicine every day (three times a day) there are no side effect and no problems to the kidneys.
Comments:   the treatment is taking the medicine every day, three times a day for the first three years the dosage I got was of 850 mg twice a day one pill after breakfast and one pill after supper. after three years the dosage was changed a bit and I have received 500 mg three times a day, one pill after each meal. recently (round six months ago) since the blood sugar leveled were under control, the dosage was reduced to 500 mg twice a day after breakfast and after supper

 

Glucophage review by 45 year old male patient

  Rating
Overall rating:  
Effectiveness:   Ineffective
Side effects:   Extremely Severe Side Effects
  
Treatment Info
Condition / reason:   Diabetes Type 2
Dosage & duration:   500mg daily taken 1 time a day for the period of 3 weeks
Other conditions:   Asthma
Other drugs taken:   Nexium, Albuterol
  
Reported Results
Benefits:   None that I could see. Made me very sick and weak.
Side effects:   Nausea,chills,difficulty breathing,indigestion,dizziness,lightheaded,tired,anxiety
Comments:   Prescribed about a month ago Recently diagnosed with Type 2 diabetes. Tried for the better part of three weeks. The side effects were mild at first, but intensified so much, I ended up in the ER. Stopped taking it two days ago and slowly regaining my strength.

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Page last updated: 2014-09-30

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