Metformin ER 500 mg

Metformin ER 500 mg is an FDA-registered drug product whose active ingredient is METFORMIN ER 500 MG. It is labelled by Granules India Ltd taken by oral and marketed as a human prescription drug product. Identifiers on file: NDC 62207-491, application ANDA209313, label effective 20260717. It is one of 4 FDA drug label records sharing the active ingredient METFORMIN ER 500 MG. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing METFORMIN ER 500 MG are most often described in connection with: metformin hydrochloride, extended-release tablets, indicated adjunct, exercise improve, glycemic control, type diabetes. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

1 INDICATIONS AND USAGE Metformin hydrochloride extended-release tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Metformin hydrochloride extended-release tablets are biguanide indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

2 DOSAGE AND ADMINISTRATION NA Recommended Dosage in Adults: • Swallow Metformin hydrochloride extended-release tablets whole and never crush, cut or chew ( 2.2 ) • Starting dosage: 500 mg orally once daily with the evening meal ( 2.2 ) • Increase the dosage in increments of 500 mg weekly, up to a maximum dosage of 2,000 mg once daily with the evening meal ( 2.2 ) • Patients receiving Metformin hydrochloride immediate-release tablets may be switched to Metformin hydrochloride extended-release tablets once daily at the same total daily dosage, up to 2,000 mg once daily ( 2.2 ) Recommended Dosage in Patients with Renal Impairment •Prior to initiation, assess renal function with estimated glomerular filtration rate (eGFR) ( 2.4 ) o Do not use in patients with eGFR below 30 mL/minute/1.73 m 2 ( 2.4 ) o Initiation is not recommended in patients with eGFR between 30 to 45 mL/minute/1.73 m 2 ( 2.4 ) o Assess risk/benefit of continuing if eGFR falls below 45 mL/minute/1.73 m 2 ( 2.4 ) o Discontinue if eGFR falls below 30 mL/minute/1.73 m 2 ( 2.4 ) Discontinuation for Iodinated Contrast Imaging Procedures: • Metformin hydrochloride extended-release tablets may need to be discontinued at time of, or prior to, iodinated contrast imaging procedures ( 2.5 ) 2.2 Recommended Dosage for Metformin Hydrochloride Extended-Release Tablets in Adults With Type 2 Diabetes Mellitus • Swallow metformin hydrochloride extended-release tablets whole and never crush, cut or chew. • The recommended starting dosage of metformin hydrochloride extended-release is 500 mg orally once daily with the evening meal. • Increase the dosage in increments of 500 mg weekly on the basis of glycemic control and tolerability, up to a maximum of 2,000 mg once daily with the evening meal. • If glycemic control is not achieved with metformin hydrochloride extended-release tablets 2,000 mg once daily, consider a trial of metformin hydrochloride extended-release tablets 1,000 mg twice daily. • If a dose of metformin hydrochloride extended-release tablets is missed, instruct patients not to take two doses the same day and to resume their usual dose of metformin hydrochloride extended-release tablets with the next schedule dose. 2.3 Switching Between Metformin Hydrochloride Immediate-Release Tablets and Metformin Hydrochloride Extended-Release Tablets • Patients may switch between metformin hydrochloride immediate-release tablets and metformin hydrochloride extended-release tablets at the same total daily dosage. • Patients receiving metformin hydrochloride extended-release tablets who require dosages higher than 2,000 mg daily may switch to metformin hydrochloride immediate-release tablets and titrate to the maximum total daily dosage of 2,550 mg. 2.4 Recommended Dosage in Patients With Renal Impairment • Assess renal function prior to initiation of metformin hydrochloride extended-release tablets and periodically thereafter. • Metformin hydrochloride extended-release tablets are contraindicated in patients with an estimated glomerular filtration rate (eGFR) below 30 mL/minute/1.73 m 2 . • Initiation of metformin hydrochloride extended-release tablets in patients with an eGFR between 30 to 45 mL/minute/1.73 m 2 is not recommended. • In patients taking metformin hydrochloride extended-release tablets whose eGFR later falls below 45 mL/min/1.73 m2, assess the benefit risk of continuing therapy. • Discontinue metformin hydrochloride extended-release tablets if the patient’s eGFR later falls below 30 mL/minute/1.73 m 2 [see Warnings and Precautions (5.1) ]. 2.5 Discontinuation for Iodinated Contrast Imaging Procedures Discontinue metformin hydrochloride extended-release tablets at the time of, or prior to, an iodinated contrast imaging procedure in patients with an eGFR between 30 and 60 mL/min/1.73 m 2 ; in patients with a history of liver disease, alcoholism, or heart failure; or in patients who will be administered intra-arterial iodinated contrast. Re-evaluate eGFR 48 hours after the imaging procedure; restart metformin hydrochloride extended-release tablets if renal function is stable.

4 CONTRAINDICATIONS Metformin hydrochloride extended-release tablets, USP are contraindicated in patients with: Severe renal impairment (eGFR below 30 mL/min/1.73 m 2 ) [see Warnings and Precautions (5.1)]. Hypersensitivity to metformin. Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. • Severe renal impairment (eGFR below 30 mL/min/1.73 m 2 ) ( 4 , 5.1) • Hypersensitivity to metformin (4) • Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma.

6 ADVERSE REACTIONS The following adverse reactions are also discussed elsewhere in the labeling: Lactic Acidosis [see Boxed Warning and Warnings and Precautions (5.1) ] Vitamin B 12 Deficiency [see Warnings and Precautions (5.2) ] Hypoglycemia [see Warnings and Precautions (5.3) ] For Metformin hydrochloride extended-release tablets, the most common adverse reactions (>5%) are diarrhea, nausea/vomiting, flatulence, asthenia, indigestion, abdominal discomfort, and headache. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Granules Pharmaceuticals Inc. at 1-877-770-3183 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Studies Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Metformin Hydrochloride Extended-Release Tablets In placebo-controlled trials, in adults with type 2 diabetes mellitus, 781 patients were administered metformin hydrochloride extended-release tablets. Adverse reactions reported in greater than 5% of the metformin hydrochloride extended-release tablets patients, and that were more common in metformin hydrochloride extended-release tablets - than placebo-treated patients, are listed in Table 1. Table 1: Adverse Reactions from Clinical Trials of Metformin Hydrochloride Extended-Release Tablets Occurring >5% and More Common than Placebo in Adults with Type 2 Diabetes Mellitus Metformin Hydrochloride Extended- Released Tablets (n=781) Placebo (n=195) Diarrhea 10% 3% Nausea/Vomiting 7% 2% Diarrhea led to discontinuation of metformin hydrochloride extended-release tablets in 0.6% of patients. Additionally, the following adverse reactions were reported in ≥1% to ≤5% of metformin hydrochloride extended-release tablets patients and were more commonly reported with metformin hydrochloride extended-release tablets than placebo: abdominal pain, constipation, distention abdomen, dyspepsia/heartburn, flatulence, dizziness, headache, upper respiratory infection, taste disturbance. 6.2 Postmarketing Experience The following adverse reactions have been identified during post approval use of metformin. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Cholestatic, hepatocellular, and mixed hepatocellular liver injury have been reported with postmarketing use of metformin.

FDA lists 4 drug label records with METFORMIN ER 500 MG as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

What is Metformin ER 500 mg used for?
1 INDICATIONS AND USAGE Metformin hydrochloride extended-release tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Metformin hydrochloride extended-release tablets are biguanide indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Who makes Metformin ER 500 mg?
Granules India Ltd is the labeler of record for Metformin ER 500 mg. 4 FDA label records share the active ingredient METFORMIN ER 500 MG, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does Metformin ER 500 mg come in?
administered by oral. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Metformin ER 500 mg prescription or over-the-counter?
The FDA label for this product is recorded as human prescription drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing METFORMIN ER 500 MG?
Yes. 4 FDA drug label records list METFORMIN ER 500 MG as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has Metformin ER 500 mg been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.