METFORMIN HCL ER TABS 500 MG 90CT
Generic: Metformin ER 500 mg
METFORMIN HCL ER TABS 500 MG 90CT
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Identification
Metformin ER 500 mg
Metformin
Granules Pharmaceuticals Inc.
HUMAN PRESCRIPTION DRUG
Administration
TABLET, EXTENDED RELEASE
ORAL
ANDA209313
Active Ingredients
| Ingredient | Strength |
|---|---|
| METFORMIN HYDROCHLORIDE | 500 mg/1 |
Pharmacological Class
Data sourced from openFDA / DailyMed. For full prescribing information, consult the drug label.
Wholesale compliance resources
Drug Resources
Clinical Drug Information
Indications & Usage
1 INDICATIONS AND USAGE Metformin hydrochloride extended-release tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older 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 and pediatric patients 10 years of age and older with type 2 diabetes mellitus. ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION N/A Recommended Dosage in Adults and Pediatric Patients Aged 10 Years and Older: • 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 ( 2.3 ) 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 and Pediatric Patients Aged 10 Years and Older 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 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) ]. 2.5 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.
Adverse Reactions
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-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% 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.
Clinical data sourced from openFDA drug labeling. For complete prescribing information, consult the full drug label.