Metformin hydrochloride ER

Metformin hydrochloride ER is an FDA-registered drug product whose active ingredient is METFORMIN HYDROCHLORIDE. It is labelled by Aphena Pharma Solutions - Tennessee, LLC taken by oral and marketed as a human prescription drug product. Identifiers on file: NDC 71610-666, application ANDA207427, label effective 20230414. It is one of 111 FDA drug label records sharing the active ingredient METFORMIN HYDROCHLORIDE. 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 HYDROCHLORIDE are most often described in connection with: metformin hydrochloride, extended-release tablets, indicated adjunct, exercise improve, glycemic control, type diabetes, indications usage. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

1 INDICATIONS & USAGE Metformin hydrochloride extended-release tablets are indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus. Metformin Hydrochloride Extended-release Tablets are a biguanide indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. (1)

2 DOSAGE & ADMINISTRATION 2.1 Adult Dosage • Swallow Metformin hydrochloride extended- release tablets whole and never crush, cut or chew. • The recommended starting dose of Metformin hydrochloride extended- release tablets is 500 mg orally once daily with the evening meal. • Increase the dose in increments of 500 mg weekly on the basis of glycemic control and tolerability, up to a maximum of 2000 mg once daily with the evening meal. • If glycemic control is not achieved with Metformin hydrochloride extended- release tablets 2000 mg once daily, consider a trial of Metformin hydrochloride extended-release tablets 1000 mg twice daily. If higher doses are required, switch to metformin hydrochloride tablets at total daily doses up to 2550 mg administered in divided daily doses, as described above. • Patients receiving Metformin hydrochloride tablets may be switched to Metformin hydrochloride extended-release tablets once daily at the same total daily dose, up to 2000 mg once daily. 2.3 Recommendations for Use in Renal Impairment • Assess renal function prior to initiation of Metformin hydrochloride extended-release tablets and periodically thereafter. • Metformin hydrochloride extended-release tablets is 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 30-45 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 m 2 , 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) ]. 2.4 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. Adult Dosage for Metformin hydrochloride extended-release tablets: • Swallow Metformin hydrochloride extended-release tablets whole and never crush, cut or chew (2.1) • Starting dose:500 mg orally once daily with the evening meal (2.1) • Increase the dose in increments of 500 mg weekly, up to a maximum of 2000 mg once daily with the evening meal (2.1) • Patients receiving Metformin hydrochloride tablets may be switched to Metformin hydrochloride extended-release tablets once daily at the same total daily dose, up to 2000 mg once daily (2.1) Renal Impairment •Prior to initiation, assess renal function with estimated glomerular filtration rate (eGFR) (2.3) o Do not use in patients with eGFR below 30 mL/minute/1.73 m 2 (2.3) o Initiation is not recommended in patients with eGFR between 30-45 mL/minute/1.73 m 2 (2.3) o Assess risk/benefit of continuing if eGFR falls below 45 mL/minute/1.73 m 2 (2.3) o Discontinue if eGFR falls below 30 mL/minute/1.73 m 2 (2.3) 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 (2.4)

4 CONTRAINDICATIONS Metformin hydrochloride extended-release tablets, USP are contraindicated in patients with: Severe Renal Impairment (eGFR below 30mL/min/1.73m 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 B12 Deficiency [see Warnings and Precautions (5.2) ] Hypoglycemia [see Warnings and Precautions (5.3) ] 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 Tablets In a U.S. clinical trial of Metformin Hydrochloride Tablets in patients with type 2 diabetes mellitus, a total of 141 patients received Metformin Hydrochloride Tablets up to 2550 mg per day. Adverse reactions reported in greater than 5% of Metformin Hydrochloride Tablets treated patients and that were more common than in placebo-treated patients, are listed in Table 1. Table 1: Adverse Reactions from a Clinical Trial of Metformin Hydrochloride Tablets Occurring >5% and More Common than Placebo in Patients with Type 2 Diabetes Mellitus Metformin Hydrochloride Tablets (n=141) Placebo (n=145) Diarrhea 53% 12% Nausea/Vomiting 26% 12% Flatulence 12% 6% Asthenia 9% 6% Indigestion 7% 4% Abdominal Discomfort 6% 5% Headache 6% 5% Diarrhea led to discontinuation of Metformin Hydrochloride Tablets in 6% of patients. Additionally, the following adverse reactions were reported in ≥1% to ≤5% of Metformin Hydrochloride Tablets treated patients and were more commonly reported with Metformin Hydrochloride Tablets than placebo: abnormal stools, hypoglycemia, myalgia, lightheaded, dyspnea, nail disorder, rash, sweating increased, taste disorder, chest discomfort, chills, flu syndrome, flushing, palpitation. In Metformin Hydrochloride Tablets clinical trials of 29-week duration, a decrease to subnormal levels of previously normal serum vitamin B12 levels was observed in approximately 7% of patients. Pediatric Patients In clinical trials with Metformin Hydrochloride Tablets in pediatric patients with type 2 diabetes mellitus, the profile of adverse reactions was similar to that observed in adults. Metformin Hydrochloride Extended-Release Tablets In placebo-controlled trials, 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 2. Table 2: Adverse Reactions from Clinical Trials of Metformin Hydrochloride Extended-Release Tablets Occurring >5% and More Common than Placebo in Patients with Type 2 Diabetes Mellitus Metformin Hydrochloride Extended- Release 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 1.0% to 5.0% of metformin hydrochloride extended-release tabletspatients 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. For Metformin hydrochloride extended-release tablets, the most common adverse reactions (>5.0%) are diarrhea, nausea/vomiting, flatulence, asthenia, indigestion, abdominal discomfort, and headache. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Beximco Pharmaceuticals USA Inc at 877-372-6093 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

FDA lists 111 drug label records with METFORMIN HYDROCHLORIDE 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 hydrochloride ER used for?
1 INDICATIONS & USAGE Metformin hydrochloride extended-release tablets are indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus. Metformin Hydrochloride Extended-release Tablets are a biguanide indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. (1)

Who makes Metformin hydrochloride ER?
Aphena Pharma Solutions - Tennessee, LLC is the labeler of record for Metformin hydrochloride ER. 111 FDA label records share the active ingredient METFORMIN HYDROCHLORIDE, 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 hydrochloride ER 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 hydrochloride ER 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 HYDROCHLORIDE?
Yes. 111 FDA drug label records list METFORMIN HYDROCHLORIDE 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 hydrochloride ER 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.