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Metformin Contraindications

Metformin (hcl) - Drug Monograph - Druginfosys.com

Metformin (hcl) - Drug Monograph - Druginfosys.com

18 Hormones and other endocrine drugs and contraceptives Metformin (HCl)'s dosage details are as follows: Frequency may be increased upto 3times/day, if needed. Gradually increase upto 2-3 g/day. No data regarding the neonatal dosage details of Metformin (HCl) is available. Manufacturers of Metformin (HCl) in Pakistan Site designed by Pharma Professional Services and developed by Hasan Computing Systems Information provided on this Web site is neither intended nor implied to be a substitute for professional medical advice. You should not use this information on this web site or the information on links from this site to diagnose or treat a health problem or disease without consulting with a qualified healthcare provider. Pharma Professional Services advises you to always seek the advice of your physician or other qualified health provider prior to starting any new treatment or with any questions you may have regarding a medical condition. You should check with your physician/health care provider before using any of the means or methods presented on this site. If you undertake any treatment methods displayed on this site without such supervision, you are solely and entirely responsible for it's outcome. Pharma Professional Services nor anyone connected with this site cannot be held responsible for your actions nor any conditions resulting thereof. Continue reading >>

Why Is Metformin Contraindicated In Chronic Kidney Disease?

Why Is Metformin Contraindicated In Chronic Kidney Disease?

To the Editor: In their article about the care of patients with advanced chronic kidney disease, Sakhuja et al1 mentioned that metformin is contraindicated in chronic kidney disease. Metformin is a good and useful drug. Not only is it one of the cheapest antidiabetic medications, it is the only one shown to reduce cardiovascular mortality rates in type 2 diabetes mellitus. Although metformin is thought to increase the risk of lactic acidosis, a Cochrane review2 found that the incidence of lactic acidosis was only 4.3 cases per 100,000 patient-years in patients taking metformin, compared with 5.4 cases per 100,000 patient-years in patients not taking metformin. Furthermore, in a large registry of patients with type 2 diabetes and atherothrombosis,3 the rate of all-cause mortality was 24% lower in metformin users than in nonusers, and in those who had moderate renal impairment (creatinine clearance 30–59 mL/min/1.73 m2) the difference was 36%.3 A trial by Rachmani et al4 raised questions about the standard contraindications to metformin. The authors reviewed 393 patients who had at least one contraindication to metformin but who were receiving it anyway. Their serum creatinine levels ranged from 1.5 to 2.5 mg/dL. There were no cases of lactic acidosis reported. The patients were then randomized either to continue taking metformin or to stop taking it. At 2 years, the group that had stopped taking it had gained more weight, and their glycemic control was worse. In the Cochrane analysis,2 although individual creatinine levels were not available, 53% of the studies reviewed did not exclude patients with serum creatinine levels higher than 1.5 mg/dL. This equated to 37,360 patient-years of metformin use in studies that included patients with chronic kidney disease, and did Continue reading >>

Contraindications Of Metformin

Contraindications Of Metformin

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They Are Available As Monotherapy Or Combination Therapies, With The Latter Involving Two (or, Less Commonly, Three) Antidiabetic Drugs And/or

They Are Available As Monotherapy Or Combination Therapies, With The Latter Involving Two (or, Less Commonly, Three) Antidiabetic Drugs And/or

Antidiabetic drugs (with the exception of insulin) are all pharmacological agents that have been approved for hypoglycemic treatment in type 2 diabetes mellitus (DM). If lifestyle modifications (weight loss, dietary modification, and exercise) do not sufficiently reduce A1C levels (target level: ∼ 7%), pharmacological treatment with antidiabetic drugs should be initiated. These drugs may be classified according to their mechanism of action as insulinotropic or non-insulinotropic. They are available as monotherapy or combination therapies, with the latter involving two (or, less commonly, three) antidiabetic drugs and/or insulin. The exact treatment algorithms are reviewed in the treatment section of diabetes mellitus. The drug of choice for all type 2 diabetic patients is metformin. This drug has beneficial effects on glucose metabolism and promotes weight loss or at least weight stabilization. In addition, numerous studies have demonstrated that metformin can reduce mortality and the risk of complications. If metformin is contraindicated, not tolerated, or does not sufficiently control blood glucose levels, another class of antidiabetic drug may be administered. Most antidiabetic drugs are not recommended or should be used with caution in patients with moderate or severe renal failure or other significant comorbidities. Oral antidiabetic drugs are not recommended during pregnancy or breastfeeding. Continue reading >>

Metformin Contraindications

Metformin Contraindications

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Contraindications To The Use Of Metformin

Contraindications To The Use Of Metformin

Contraindications to the use of metformin Evidence suggests that it is time to amend the list Department of Diabetes, Gartnavel General Hospital, Glasgow G12 0YN Copyright 2003, BMJ Publishing Group Ltd This article has been cited by other articles in PMC. According to the United Kingdom prospective diabetes study, patients with type 2 diabetes randomised to intensive treatment with metformin, sulphonylurea, or insulin had similar degrees of glycaemic control and significantly reduced microvascular end points. 1 The study showed that the use of metformin in obese patients reduced cardiovascular events. The group treated with metformin had no hypoglycaemia and less weight gain. Treatment with metformin rather than diet alone produced a significant reduction in relative risk in all cause mortality (36%, P=0.011), diabetes related deaths (42%, P=0.017), any diabetes related end point (32%, P=0.0023), and myocardial infarction (39%, P=0.01). Metformin is the only oral hypoglycaemic agent proved to reduce cardiovascular risk and is now recognised as the treatment of choice in overweight patients with type 2 diabetes. Lactic acidosis associated with metformin is a rare condition with an estimated prevalence of one to five cases per 100 000. 2 Although classically lactic acidosis associated with metformin has been thought of as lactic acidosis secondary to accumulation of metformin, the evidence for this is poor. Metformin does not affect lactate concentrations in patients with type 2 diabetes, 3 is excreted solely through the kidney, and has a short half lifeaccumulation of metformin therefore rarely occurs in the absence of advanced renal failure. 4 Accumulation of metformin alone is rarely reported as a cause of lactic acidosis, and tissue hypoxia acting as a trigger is fo Continue reading >>

Metformin In The Treatment Of Adults With Type 2 Diabetes Mellitus

Metformin In The Treatment Of Adults With Type 2 Diabetes Mellitus

INTRODUCTION Two classes of oral hypoglycemic drugs directly improve insulin action: biguanides (only metformin is currently available) and thiazolidinediones (TZDs). In the absence of contraindications, metformin is considered the first choice for oral treatment of type 2 diabetes (table 1). A 2006 consensus statement from the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD), updated regularly, proposed that metformin therapy (in the absence of contraindications) be initiated, concurrent with lifestyle intervention, at the time of diabetes diagnosis [1-3]. The pharmacology, efficacy, and side effects of metformin for the treatment of diabetes will be reviewed here. A general discussion of initial treatment of type 2 diabetes and the role of metformin in the prevention of diabetes, in the treatment of polycystic ovary syndrome, and in gestational diabetes are reviewed separately. Continue reading >>

Metformin In The Diabetic Elderly Patient: An Old, Safe And Effective Treatment

Metformin In The Diabetic Elderly Patient: An Old, Safe And Effective Treatment

Over-65 diabetics represent about half of the patients visiting general practitioners. Although diabetes pathogenesis in geriatric and young age are similar, treatment gold standards and clinical conditions are extremely variable, requiring a more individualised approach.1 In this context, a recent review points out that there is no clear evidence for the optimal glycaemic target in the elderly patient and that patient’s preferences and pharmacologic burden must be taken into consideration, within the therapeutic choices, together with the possible risks and benefits associated to single treatments.2 This study also suggests a HbA1c value between 7.5% and 9.0% as optimal glycaemic target in the elderly patient. Steps for the individualised treatment of diabetes in the elderly patient:2 Estimate desired benefits upon the life expectancy Estimate the risks potentially associated with intensive glycaemic control (age, polypharmacy, disease duration, social support) Identify the desired glycaemic target Minimise the risk of polypharmacy Consider patient preferences Adapted by bibliographic reference 2 Particularly in the elderly patient, the onset of hypoglycaemia is often associated with severe consequences and is facilitated by several factors, such as polypharmacy and the risk of subsequent interactions, the mistakes caused by the reduced ability of handling medicines, the inability of evaluating the relation between ingested carbohydrates and the therapy, the scarce symptomatology of neuropathies and the reduced adrenergic reaction.3 Hypoglycaemia absolute risk increases with age, therefore in elderly diabetics it is often preferable to avoid intensive hypoglycaemic treatments that increase the risk of hypoglycaemia4 whilst low hypoglycaemia risk treatments should be Continue reading >>

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Free Subscriptions For Doctors And Students... Click Here

Metformin is a biguanide oral hypoglycaemic which suppresses appetite. Metformin is first-line drug treatment for overweight patients with type 2 diabetes (1) in whom diet and exercise treatments have failed. The principle advantage of metformin treatment is that glycaemic control is improved but with significantly less weight gain than when sulphonylureas are used (2). It is unlikely to cause hypoglycaemia. Metformin is contraindicated if there is liver, kidney or heart failure, or in patients with a very high alcohol intake because of the perceived risk of serious lactic acidosis. however studies by Salpeter et al concluded that the use of metformin in type 2 diabetes does not increase the risk for fatal or non-fatal lactic acidosis or increase in blood lactate concentrations compared with placebo or other hypoglycaemic treatments (3,4) a commentary in the Evidence Based Medicine journal concerning this study stated...'in contrast to phenformin, no credible evidence exists that metformin increases the risk for lactic acidosis beyond what would be expected from underlying diseases' (5) this gap between evidence and prescribing guidelines makes management decisions difficult for the clinician - a clinician must therefore make decisions in the context of evidence, his or her own clinical experience and expertise in this area, prescribing guidelines and the summary of product characteristics Note that NICE guidance (6) states that: review the dose of metformin if the serum creatinine exceeds 130 micromol/litre or the estimated glomerular filtration rate (eGFR) is below 45 ml/minute/1.73-m2. stop the metformin if the serum creatinine exceeds 150 micromol/litre or the eGFR is below 30 ml/minute/1.73-m2 The summary of product characteristics should be consulted before prescr Continue reading >>

Fda Issues Guidance For Metformin Use In Renal Impairment

Fda Issues Guidance For Metformin Use In Renal Impairment

Chris Tanski received his PharmD from the University at Buffalo School of Pharmacy and Pharmaceutical Sciences and is now working as a clinical staff pharmacist for Pinnacle Health in Harrisburg, Pennsylvania. He entered the field of hospital pharmacy directly from school, and he was one of the first to pilot a decentralized pharmacist role in the hospital. His other notable work contributions include working on palliative projects and transition of care for COPD patients. Chris was an editor and contributor to a film theory blog, a sketch comedy writer throughout pharmacy school, and he has a significant amount of experience writing drug information papers on neurology and infectious disease topics for both school and work. The FDA has issued new guidance for the use of the first-line diabetes drug metformin in patients with renal impairment. Metformin was approved by the FDA in 1994 for the management of type 2 diabetes. Since its approval, its labeling has warned of a contraindication in elevated serum creatinine (>1.5 mg/dL for males, >1.4 mg/dL for females) due to a risk of lactic acidosis secondary to metformin accumulation.1 Other risk factors for lactic acidosis include contrast dye exposure within 48 hours, chronic or excessive alcohol intake, dehydration, sepsis, acute congestive heart failure, and age. This absolute contraindication was based on clinical trials of an older biguanide called phenformin, which showed a greater risk of lactic acidosis associated with significant mortality and was subsequently pulled off the market in 1977.2 Although phenformin is no longer available in the United States, it’s still available in European and South American markets. Notably, the incidence of lactic acidosis associated with metformin is as low as 0.03 cases per 10 Continue reading >>

Metformin In People With Kidney Disease

Metformin In People With Kidney Disease

Just over one year ago here at Diabetes Flashpoints, we discussed the possibility that hundreds of thousands of people with both diabetes and kidney disease might benefit from taking the diabetes drug metformin. As we noted then, this drug has carried a “black box” warning on its label — mandated by the U.S. Food and Drug Administration (FDA) — ever since it became available in the United States in 1994, due to concerns about lactic acidosis. This rare but extremely serious reaction was found to be an unacceptably common side effect of a drug related to metformin — phenformin — which was pulled from the U.S. market in 1977. Lactic acidosis is much more common in people with impaired kidney function. Since metformin’s warning label is based, in part, on concerns about a different drug entirely, many researchers have tried to estimate how safe metformin is for people with diabetes whose kidney function is impaired. Last year, we noted that many researchers believe metformin is safe for people with mild to moderate kidney disease, defined as having an estimated glomerular filtration rate (eGFR) of 30–60 ml/min. And one study found that using a safety cutoff of an eGFR of 30 ml/min, nearly one million people in the United States who currently don’t take metformin because of the FDA’s labeling might be able to safely do so. So what’s changed in the last year? The evidence, it seems, has only grown stronger in favor of metformin being more widely prescribed to people with kidney disease. As noted in a recent article at DiabetesInControl.com, the blood-glucose-lowering benefits of loosening restrictions on metformin could be enormous. One study cited in the article, published last August in the journal Diabetes Care, found that depending on how eGFR is ca Continue reading >>

Should Fda Change Metformin's Black Box Warning?

Should Fda Change Metformin's Black Box Warning?

Diabetes experts are building a case to lift restrictions on using metformin in patients with moderate chronic kidney disease. Two groups of researchers who have separately filed citizens petitions with the FDA have published studies in JAMA journals in the past few weeks showing a lack of evidence for metformin-associated lactic acidosis -- a severe complication that prompted the FDA to warn against the drug's use in CKD patients when it came on the market 20 years ago. Silvio Inzucchi, MD, and Kasia Lipska, MD, MHS, of Yale, published a review in the Dec. 24/31 issue of JAMA concluding that most observational data -- there are no randomized controlled trials -- confirm the "overall safety profile" of metformin in mild-to-moderate CKD patients. And James Flory, MD, of Weill Cornell, and Sean Hennessy, PharmD, PhD, of the University of Pennsylvania, reported in a research letter in the Jan. 5 issue of the Archives of Internal Medicine, that nearly 1 million patients who have diabetes and CKD could be taking metformin but aren't. Both groups have asked the FDA to lift its black box warning that limits prescribing in CKD patients based on serum creatinine levels (1.5 mg/dL or above for men, 1.4 mg/dL for women), and asks the agency to use eGFR cutoffs instead -- typically, at 30 mL/min, where several professional societies and other international regulators draw the line. How the Black Box Came to Be When the FDA approved metformin in 1994, it slapped on the black box warning about lactic acidosis because of a similar problem with another biguanide, phenformin. This cousin to metformin was withdrawn from the market in 1977 because of an increased risk of lactic acidosis. Since metformin is also renally cleared, the agency was concerned that metabolism of the drug could co Continue reading >>

Metformin Contraindications Levels

Metformin Contraindications Levels

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Metformin - Oral, Glucophage

Metformin - Oral, Glucophage

are allergic to dapagliflozin or any of the ingredients in FARXIGA. Symptoms of a serious allergic reaction may include skin rash, raised red patches on your skin (hives), swelling of the face, lips, tongue, and throat that may cause difficulty in breathing or swallowing. If you have any of these symptoms, stop taking FARXIGA and contact your healthcare provider or go to the nearest hospital emergency room right away have severe kidney problems or are on dialysis. Your healthcare provider should do blood tests to check how well your kidneys are working before and during your treatment with FARXIGA Dehydration (the loss of body water and salt), which may cause you to feel dizzy, faint, lightheaded, or weak, especially when you stand up (orthostatic hypotension). You may be at a higher risk of dehydration if you have low blood pressure; take medicines to lower your blood pressure, including water pills (diuretics); are 65 years of age or older; are on a low salt diet, or have kidney problems Ketoacidosis occurred in people with type 1 and type 2 diabetes during treatment with FARXIGA. Ketoacidosis is a serious condition which may require hospitalization and may lead to death. Symptoms may include nausea, tiredness, vomiting, trouble breathing, and abdominal pain. If you get any of these symptoms, stop taking FARXIGA and call your healthcare provider right away. If possible, check for ketones in your urine or blood, even if your blood sugar is less than 250 mg/dL Kidney problems. Sudden kidney injury occurred in people taking FARXIGA. Talk to your doctor right away if you reduce the amount you eat or drink, or if you lose liquids; for example, from vomiting, diarrhea, or excessive heat exposure Serious urinary tract infections (UTI), some that lead to hospitalization, occu Continue reading >>

European Medicines Agency - Human Medicines - Metformin And Metformin-containing Medicines

European Medicines Agency - Human Medicines - Metformin And Metformin-containing Medicines

Metformin and metformin-containing medicines Use of metformin to treat diabetes now expanded to patients with moderately reduced kidney function Recommendations for patients with kidney impairment updated in product information On 13 October 2016, the European Medicines Agency (EMA) concluded that metformin-containing medicines can now be used in patients with moderately reduced kidney function (GFR [glomerular filtration rate] = 3059 ml/min) for the treatment of type 2 diabetes. The product information for these medicines will be updated to revise the current contraindication and give information about doses, monitoring and precautions in patients with reduced kidney function. The recommendations were the result of a review by EMA of metformin-containing medicines following concerns that current scientific evidence does not justify a contraindication in patients with moderate reduction of kidney function. The current product information also varies between countries and products in the EU and is no longer consistent with clinical guidelines. Metformin may increase the risk of a rare but serious complication called lactic acidosis, which occurs when naturally produced lactic acid builds up in the blood faster than it can be removed. Currently, the product information states that metformin must not be used in patients with reduced kidney function because these patients are considered to be at a higher risk of developing lactic acidosis as their kidneys do not remove metformin efficiently enough. However, after considering the scientific literature, clinical data, epidemiological studies and clinical guidelines from medical bodies, EMA concluded that the large patient population with moderately reduced kidney function can benefit from use of metformin. Clear dosing recom Continue reading >>

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