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Metformin Immediate Release

Metformin Extended-release Versus Immediate-release: An International, Randomized, Double-blind, Head-to-head Trial In Pharmacotherapy-naïve Patients With Type 2 Diabetes.

Metformin Extended-release Versus Immediate-release: An International, Randomized, Double-blind, Head-to-head Trial In Pharmacotherapy-naïve Patients With Type 2 Diabetes.

Abstract This international, randomized, double-blind trial (NCT01864174) compared the efficacy and safety of metformin extended-release (XR) and immediate-release (IR) in patients with type 2 diabetes. After a 4-week placebo lead-in, pharmacotherapy-naïve adults with glycated haemoglobin (HbA1c) at 7.0% to 9.2% were randomized (1:1) to receive once-daily metformin XR 2000 mg or twice-daily metformin IR 1000 mg for 24 weeks. The primary endpoint was change in HbA1c after 24 weeks. Secondary endpoints were change in fasting plasma glucose (FPG), mean daily glucose (MDG) and patients (%) with HbA1c <7.0% after 24 weeks. Overall, 539 patients were randomized (metformin XR, N = 268; metformin IR, N = 271). Adjusted mean changes in HbA1c, FPG, MDG and patients (%) with HbA1c <7.0% after 24 weeks were similar for XR and IR: -0.93% vs -0.96%; -21.1 vs -20.6 mg/dL (-1.2 vs -1.1 mmol/L); -24.7 vs -27.1 mg/dL (-1.4 vs -1.5 mmol/L); and 70.9% vs 72.0%, respectively. Adverse events were similar between groups and consistent with previous studies. Overall, metformin XR demonstrated efficacy and safety similar to that of metformin IR over 24 weeks, with the advantage of once-daily dosing. Continue reading >>

Fortamet

Fortamet

FORTAMET® (metformin hydrochloride) Extended-Release Tablets DESCRIPTION FORTAMET® (metformin hydrochloride) Extended-Release Tablets contain an oral antihyperglycemic drug used in the management of type 2 diabetes. Metformin hydrochloride (N, Ndimethylimidodicarbonimidic diamide hydrochloride) is a member of the biguanide class of oral antihyperglycemics and is not chemically or pharmacologically related to any other class of oral antihyperglycemic agents. The empirical formula of metformin hydrochloride is C4H11N5•HCl and its molecular weight is 165.63. Its structural formula is: Metformin hydrochloride is a white to off-white crystalline powder that is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. FORTAMET® Extended-Release Tablets are designed for once-a-day oral administration and deliver 500 mg or 1000 mg of metformin hydrochloride. In addition to the active ingredient metformin hydrochloride, each tablet contains the following inactive ingredients: candellila wax, cellulose acetate, hypromellose, magnesium stearate, polyethylene glycols (PEG 400, PEG 8000), polysorbate 80, povidone, sodium lauryl sulfate, synthetic black iron oxides, titanium dioxide, and triacetin. FORTAMET® meets USP Dissolution Test 5. System Components And Performance FORTAMET® was developed as an extended-release formulation of metformin hydrochloride and designed for once-a-day oral administration using the patented single-composition osmotic technology (SCOT™). The tablet is similar in appearance to other film-coated oral administered tablets but it consists of an osmotically active core formulation that is surrounded by a semipermeable membra Continue reading >>

Metformin Extended Versus Immediate Release In Saudi Arabia: A Cost-effectiveness Analysis

Metformin Extended Versus Immediate Release In Saudi Arabia: A Cost-effectiveness Analysis

Metformin extended release (XR) has higher treatment adherence than immediate release (IR) formulation, due to lower pill burden and better gastrointestinal tolerability, leading to better glycated hemoglobin (HbA1c) levels control. This study aimed to compare metformin XR versus metformin IR monotherapy for type 2 diabetes mellitus (T2DM) considering the long-term cost-effectiveness outcomes. To access this article, please choose from the options below Continue reading >>

Formulation And Evaluation Of Immediate Release Tablets Of Metformin Hydrochloride On Laboratory Scale

Formulation And Evaluation Of Immediate Release Tablets Of Metformin Hydrochloride On Laboratory Scale

Abstract The purpose of this research is to prepare metformin hydrochloride immediate release tablets by wet granulation technique. In order to obtain the best, optimized product ten different formulations were developed. Different binder, disintegrants and lubricants taken as variables. Weight variation, thickness, hardness, friability, disintegration time, in-vitro release and pharmaceutical assay were studied as response variables. Capping was observed in formulation containing PVP K-30. However, in the remaining formulation containing PVP K-90, no capping was observed. The formulation A7 was selected as optimized formulation. The different physical properties and in-vitro release profile showed best comparable with the reference product. Optimization has proven an effective tool in product development. Discover the world's research 14+ million members 100+ million publications 700k+ research projects Join for free granulation technique. In order to obtain the best, optimized product ten different formulations were thickness, hardness, friability, disintegration time, in-vitro release and pharmaceutical assay were showed best comparable with the reference product. Optimization has proven an effective tool in Sodium starch glycolate -- -- 20 -- -- -- -- -- -- -- Povidone k-30 30 30 30 30 30 -- -- Povidone k-90 -- -- -- -- -- 30 40 40 40 40 Sodium stearyl fumarate -- -- -- -- -- -- -- 8 -- 16 30 71.6 70.20 70.8 76.1 80.2 80.1 80.9 76.7 74 71.6 80.1 45 76.7 73.5 75.8 79.6 81.3 82.8 83.8 80.2 75.6 73.8 83.8 60 82.9 78.4 78.3 80.2 83.4 84.4 86.7 81.3 78.2 77.3 89.3 Continue reading >>

Metformin Vs Metformin Er

Metformin Vs Metformin Er

I'm seeing quite a few posts on BBSes from people who are having problems with metformin because of side effects that could be eliminated if they were taking the extended release form of this drug. For some reason, many family doctors don't seem to be aware that there is a ER version of this drug that has such benefits. This is probably because metformin is a cheap generic and isn't promoted by herds of beautiful ex-cheerleaders turned drug company salespushers who "educate" doctors about far more expensive--and less effective--newer drugs. Here are the facts: Metformin (also sold under the brand name Glucophage) comes in a regular version which is taken at meal time, three times a day, and an extended release form (marketed as ER or XR) which is taken once a day. Almost always, when people report diarrhea or intense heartburn with metformin, they are taking regular version. I experienced the heartburn on the regular drug. It was very disturbing because the pain was localized over my heart and felt just like the description of a heart attack you read in articles. My doctor assured me it was coming from the metformin, but that didn't make it any easier to live with because I kept wondering how, if I were having a real heart attack, I'd know it wasn't a pain from the drug? The ER version releases the drug more slowly and this usually eliminates the gastrointestinal problems. The trade off with taking the ER form is that the amount of blood sugar lowering you see might be a bit less than with the regular form as the drug acts in a slower smoother fashion rather than hitting all at once. But if you can't take the regular at all drug because of the side effects, the slight weakening in effect is a reasonable trade off. Plus, you only have to remember to take one dose rather Continue reading >>

Gastrointestinal Tolerability Of Extended-release Metformin Tablets Compared To Immediate-release Metformin Tablets: Results Of A Retrospective Cohort Study

Gastrointestinal Tolerability Of Extended-release Metformin Tablets Compared To Immediate-release Metformin Tablets: Results Of A Retrospective Cohort Study

Objective: Metformin, a biguanide antihyperglycemic medication, lowers blood glucose in patients with type 2 diabetes with minimal risk of hypoglycemia. Most common side effects include diarrhea, nausea and vomiting. Extended-release metformin (Glucophage XR)*, a once-daily tablet using the patented GelShield Diffusion System release mechanism, may be better tolerated than immediate-release metformin (Glucophage). This retrospective chart review examined the overall gastrointestinal (GI) tolerability of both formulations. Research design and methods: Patient charts were reviewed and data were collected from October 2001 to May 2002. Adult patients with type 2 diabetes started on extended-release metformin (metformin-XR) or switched from immediate-release metformin to metformin-XR within the previous 2 years were eligible for inclusion in the metformin-XR cohort. Patients started on immediate-release metformin within the previous 2 years were eligible for inclusion in the immediate-release metformin cohort. Previous experience of GI side effects while taking immediate-release metformin did not prevent inclusion in either cohort, though patients with significant underlying GI disease or moderate to severe hepatic or renal impairment were excluded. GI tolerability was assessed during the first year of treatment with immediate-release metformin or metformin-XR. Primary endpoints were overall GI tolerability and frequency of diarrhea during the first year of treatment. Results: A total of 471 patients’ charts were reviewed and data were collected from four diabetes clinics; 310 (metformin-XR) and 158 (immediate-release metformin) eligible patients were included. Patients were, on average, 56 years old, and overweight (mean body mass index 33 kg/m2). The majority of patient Continue reading >>

Glucophage Sr 500mg, 750mg And 1000mg Prolonged Release Tablets

Glucophage Sr 500mg, 750mg And 1000mg Prolonged Release Tablets

500 mg: One prolonged release tablet contains 500mg metformin hydrochloride corresponding to 390 mg metformin base. 750 mg: One prolonged release tablet contains 750 mg metformin hydrochloride corresponding to 585 mg metformin base. 1000 mg: One prolonged release tablet contains 1000 mg metformin hydrochloride corresponding to 780 mg metformin base. For the full list of excipients, see section 6.1. Prolonged release tablet. 500 mg: White to off-white, round, biconvex tablet, debossed on one side with '500'. 750 mg: White capsule-shaped, biconvex tablet, debossed on one side with '750' and on the other side with 'Merck'. 1000 mg: White to off-white capsule-shaped, biconvex tablet, debossed on one side with '1000' and on the other side with 'MERCK'. • Reduction in the risk or delay of the onset of type 2 diabetes mellitus in adult, overweight patients with IGT* and/or IFG*, and/or increased HbA1C who are: - at high risk for developing overt type 2 diabetes mellitus (see section 5.1) and - still progressing towards type 2 diabetes mellitus despite implementation of intensive lifestyle change for 3 to 6 months Treatment with Glucophage SR must be based on a risk score incorporating appropriate measures of glycaemic control and including evidence of high cardiovascular risk (see section 5.1). Lifestyle modifications should be continued when metformin is initiated, unless the patient is unable to do so because of medical reasons. *IGT: Impaired Glucose Tolerance; IFG: Impaired Fasting Glucose • Treatment of type 2 diabetes mellitus in adults, particularly in overweight patients, when dietary management and exercise alone does not result in adequate glycaemic control. Glucophage SR may be used as monotherapy or in combination with other oral antidiabetic agents, or with in Continue reading >>

Get Unlimited Access On Medscape.

Get Unlimited Access On Medscape.

WARNING: RISK OF THYROID C-CELL TUMORS In rodents, semaglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures. It is unknown whether Ozempic® causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans as human relevance of semaglutide-induced rodent thyroid C-cell tumors has not been determined. Ozempic® is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Counsel patients regarding the potential risk for MTC with the use of Ozempic® and inform them of symptoms of thyroid tumors (e.g. a mass in the neck, dysphagia, dyspnea, persistent hoarseness). Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with Ozempic®. Ozempic® is not recommended as a first-line therapy for patients who have inadequate glycemic control on diet and exercise because of the uncertain relevance of rodent C-cell tumor findings to humans. Ozempic® has not been studied in patients with a history of pancreatitis. Consider other antidiabetic therapies in patients with a history of pancreatitis. Ozempic® is not a substitute for insulin. Ozempic® is not indicated for use in patients with type 1 diabetes mellitus or for the treatment of patients with diabetic ketoacidosis. Pancreatitis: Acute and chronic pancreatitis have been reported in clinical studies. Observe patients carefully for signs and symptoms of pancreatitis (persistent severe abdominal pain, sometimes radiating to the back with or without vomiting). If pancreatitis is suspected, discontinue Ozempic® promptly and if pancreatitis is confirmed, do not restart. Diabetic Ret Continue reading >>

Comparison Of Conventional And Sustained-release Formulation Of Metformin In Type 2 Diabetics

Comparison Of Conventional And Sustained-release Formulation Of Metformin In Type 2 Diabetics

DOI: Abstract Background: To investigate the effects of metformin sustained-release (MSR) compared with metformin immediate-release (MIR) on glycaemic control, blood pressure, lipid profile and metabolic parameters like weight, waist circumference in type 2 diabetes. Methods: A prospective, randomized, double blind study was conducted at tertiary healthcare and teaching hospital at Pune, Maharashtra. After obtaining institutional ethical committee approval and written informed consent, 40 newly diagnosed type 2 diabetic patient were randomly assigned to receive metformin immediate release formulation (MIR) 500 mg once 1 week and then twice daily and metformin sustained release formulation (MSR) 500 mg once 1 week and then 1000mg once daily for 18 weeks. Fasting and post prandial blood glucose level (BGL), HbA1c, blood pressure, lipid profile, weight and waist circumference, were recorded at the start and end of study. Results: Both MIR and MSR significantly decreased fasting; post prandial BGL and HbA1c at 18 weeks. But no significant difference was seen between two groups. Study did not show any effect on blood pressure and on lipid profile. Both formulations decreased obesity as evident by significant reduction in weight and waist circumference. All patients tolerated both formulations of metformin. Though overall incidences of adverse effects are less with sustained release formulation, difference was not significant between two groups. Conclusions: To conclude, both metformin immediate release and sustained release formulations achieved comparable glycaemic control and sustained release formulation would be as effective as immediate release formulation with advantage of being reduce daily intake of tablets. References Powers AC. Diabetes mellitus. In D.L. Kasper, E. Continue reading >>

Efficacy, Tolerability, And Safety Of A Novel Once-daily Extended-release Metformin In Patients With Type 2 Diabetes

Efficacy, Tolerability, And Safety Of A Novel Once-daily Extended-release Metformin In Patients With Type 2 Diabetes

OBJECTIVE—The purpose of this study was to determine the efficacy and safety of a novel extended-release metformin in patients with type 2 diabetes. RESEARCH DESIGN AND METHODS—Adults with type 2 diabetes (newly diagnosed, treated with diet and exercise only, or previously treated with oral diabetic medications) were randomly assigned to receive one of three extended-release metformin treatment regimens (1,500 mg/day q.d., 1,500 mg/day twice daily, or 2,000 mg/day q.d.) or immediate-release metformin (1,500 mg/day twice daily) in a double-blind 24-week trial. RESULTS—Significant decreases (P < 0.001) in mean HbA1c (A1C) levels were observed by week 12 in all treatment groups. The mean changes from baseline to end point in the two groups given 1,500 mg extended-release metformin (−0.73 and −0.74%) were not significantly different from the change in the immediate-release metformin group (−0.70%), whereas the 2,000-mg extended-release metformin group showed a greater decrease in A1C levels (−1.06%; mean difference [2,000 mg extended-release metformin − immediate-release metformin]: −0.36 [98.4% CI −0.65 to −0.06]). Rapid decreases in fasting plasma glucose levels were observed by week 1, which continued until week 8, and were maintained for the duration of the study. The overall incidence of adverse events was similar for all treatment groups, but fewer patients in the extended-release metformin groups discontinued treatment due to nausea during the initial dosing period than in the immediate-release metformin group. CONCLUSIONS—Once- or twice-daily extended-release metformin was as safe and effective as twice-daily immediate-release metformin and provided continued glycemic control for up to 24 weeks of treatment. Metformin hydrochloride has been w Continue reading >>

Effects Of Metformin Extended Release Compared To Immediate Release Formula On Glycemic Control And Glycemic Variability In Patients With Type 2 Diabetes.

Effects Of Metformin Extended Release Compared To Immediate Release Formula On Glycemic Control And Glycemic Variability In Patients With Type 2 Diabetes.

Abstract PURPOSE: The purpose of this study is to evaluate, in a randomized clinical trial, the effects of metformin immediate release (IR) compared with metformin extended release (XR) on the gastrointestinal tolerability and glycemic control. MATERIALS AND METHODS: We enrolled 253 Caucasian patients with type 2 diabetes not well controlled by diet (glycated hemoglobin [HbA1c] >7.0% and <8.5%). Patients were randomized to metformin IR or metformin XR for a period of 6 months at the maximum tolerated dose. The average dose of metformin IR used was 2,000±1,000 mg/day, while that of metformin XR was 1,000±500 mg/day. We evaluated body weight, HbA1c, fasting and postprandial glucose, fasting plasma insulin (FPI) and homeostasis model assessment insulin resistance (HOMA-IR), lipid profile, and levels of some adipocytokines, including tumor necrosis factor-α (TNF-α), high-sensitivity C-reactive protein (hs-CRP), visfatin, and vaspin. Moreover, at the baseline and after 6 months, we administered patients some validated questionnaires to assess patients' satisfaction toward treatments. RESULTS: After 6 months, both formulations gave a similar reduction in body weight and body mass index (BMI); however, metformin XR gave a greater improvement in glycemic control, FPI, and HOMA-IR, compared with both baseline and metformin IR. A reduction in total cholesterol (TC) and low-density lipoprotein (LDL) cholesterol was observed with metformin XR compared with IR. Levels of TNF-α, hs-CRP, and vaspin were reduced by metformin XR but not by the IR formulation. Metformin XR also raised the levels of visfatin. CONCLUSION: Metformin XR formulation seems to be more effective than metformin IR in improving glyco-metabolic control, lipid profile, and levels of some adipocytokines in patie Continue reading >>

Metformin, Oral Tablet

Metformin, Oral Tablet

Metformin oral tablet is available as both a generic and brand-name drug. Brand names: Glucophage, Glucophage XR, Fortamet, and Glumetza. Metformin is also available as an oral solution but only in the brand-name drug Riomet. Metformin is used to treat high blood sugar levels caused by type 2 diabetes. FDA warning: Lactic acidosis warning This drug has a Black Box Warning. This is the most serious warning from the Food and Drug Administration (FDA). A black box warning alerts doctors and patients to potentially dangerous effects. Lactic acidosis is a rare but serious side effect of this drug. In this condition, lactic acid builds up in your blood. This is a medical emergency that requires treatment in the hospital. Lactic acidosis is fatal in about half of people who develop it. You should stop taking this drug and call your doctor right away or go to the emergency room if you have signs of lactic acidosis. Symptoms include tiredness, weakness, unusual muscle pain, trouble breathing, unusual sleepiness, stomach pains, nausea (or vomiting), dizziness (or lightheadedness), and slow or irregular heart rate. Alcohol use warning: You shouldn’t drink alcohol while taking this drug. Alcohol can affect your blood sugar levels unpredictably and increase your risk of lactic acidosis. Kidney problems warning: If you have moderate to severe kidney problems, you have a higher risk of lactic acidosis. You shouldn’t take this drug. Liver problems warning: Liver disease is a risk factor for lactic acidosis. You shouldn’t take this drug if you have liver problems. Metformin oral tablet is a prescription drug that’s available as the brand name drugs Glucophage, Glucophage XR, Fortamet, and Glumetza. Glucophage is an immediate-release tablet. All of the other brands are extended-r Continue reading >>

Metformin Ir Versus Xr Pharmacokinetics In Humans

Metformin Ir Versus Xr Pharmacokinetics In Humans

1University of Petra, Amman, Jordan 2Jordan Center for Pharmaceutical Research (JCPR), Amman, Jordan 3University of Jordan, Amman, Jordan *Corresponding Author: Dr. Nasir Idkaidek University of Petra, Pharmacy College PO Box 961343, Amman, Jordan Tel: 96265715553 Fax: 96265715570 E-mail: [email protected] Citation: Idkaidek N, Arafat T, Melhim M, Alawneh J, Hakooz N (2011) Metformin IR versus XR Pharmacokinetics in Humans. J Bioequiv Availab 3: 233-235. doi: 10.4172/jbb.1000092 Copyright: © 2011 Idkaidek N, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Visit for more related articles at Journal of Bioequivalence & Bioavailability Abstract Pharmacokinetics of metformin extended release (XR) formulation were studied under fasting and fed conditions and compared to those of immediate release (IR) under fasting conditions in humans. 78 healthy human volunteers participated in 3 independent studies (26 subjects per study) were given either 1000 mg oral dose metformin IR or 750 mg metformin XR. Plasma samples were obtained up to 24 hours after dosing. Pharmacokinetic parameters in plasma were calculated by non compartmental analysis using Kinetica program. Results have shown increased XR bioavailability and delayed time to reach the maximum concentration (Cmax ) in the fed state as compared to fasted state, with no significant difference in Cmax and half life values. On the other hand, the IR formulation showed significant differences in all parameters as compared to XR formulation, yet the half life was similar. In conclusion, XR formulation was shown similar to IR formulation Continue reading >>

Support Article

Support Article

As you were browsing PracticeUpdate, something about your browser made us think you were a bot. There are a few reasons this might happen: You're a power user moving through this website with super-human speed. You've disabled JavaScript in your web browser. A third-party browser plugin, such as Ghostery or NoScript, is preventing JavaScript from running. Additional information is available in this . After completing the CAPTCHA below, you will immediately regain access to PracticeUpdate. ​ You reached this page when attempting to access from 35.184.106.120 on 2018-01-11 11:59:14 UTC. Trace: 2df9f229-771d-47ce-ac52-4155696019af via 0894b646-a920-4bbe-adae-63c4b22043a0 Continue reading >>

Effects Of Metformin Extended Release Compared To Immediate Release Formula On Glycemic Control And Glycemic Variability In Patients With Type 2 Diabetes

Effects Of Metformin Extended Release Compared To Immediate Release Formula On Glycemic Control And Glycemic Variability In Patients With Type 2 Diabetes

Go to: Abstract The purpose of this study is to evaluate, in a randomized clinical trial, the effects of metformin immediate release (IR) compared with metformin extended release (XR) on the gastrointestinal tolerability and glycemic control. Materials and methods We enrolled 253 Caucasian patients with type 2 diabetes not well controlled by diet (glycated hemoglobin [HbA1c] >7.0% and <8.5%). Patients were randomized to metformin IR or metformin XR for a period of 6 months at the maximum tolerated dose. The average dose of metformin IR used was 2,000±1,000 mg/day, while that of metformin XR was 1,000±500 mg/day. We evaluated body weight, HbA1c, fasting and postprandial glucose, fasting plasma insulin (FPI) and homeostasis model assessment insulin resistance (HOMA-IR), lipid profile, and levels of some adipocytokines, including tumor necrosis factor-α (TNF-α), high-sensitivity C-reactive protein (hs-CRP), visfatin, and vaspin. Moreover, at the baseline and after 6 months, we administered patients some validated questionnaires to assess patients’ satisfaction toward treatments. After 6 months, both formulations gave a similar reduction in body weight and body mass index (BMI); however, metformin XR gave a greater improvement in glycemic control, FPI, and HOMA-IR, compared with both baseline and metformin IR. A reduction in total cholesterol (TC) and low-density lipoprotein (LDL) cholesterol was observed with metformin XR compared with IR. Levels of TNF-α, hs-CRP, and vaspin were reduced by metformin XR but not by the IR formulation. Metformin XR also raised the levels of visfatin. Metformin XR formulation seems to be more effective than metformin IR in improving glyco-metabolic control, lipid profile, and levels of some adipocytokines in patients with type 2 diabet Continue reading >>

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