Metformin ER 500 mg 500 mg/1
Metformin ER 500 mg · TABLET · Granules India Ltd
Metformin ER 500 mg is a tablet containing metformin er 500 mg at 500 mg/1, taken oral. Manufactured by Granules India Ltd.
Key Facts
- Brand Name
- Metformin ER 500 mg
- Generic Name
- Metformin ER 500 mg
- NDC Code (Product)
62207-491- Manufacturer
- Granules India Ltd
- Strength
- 500 mg/1
- Dosage Form
- TABLET
- Route
- ORAL
- Marketing Status
- Application #
- ANDA209313
- Marketing Start
- 06/28/2018
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing 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.
Dosage & Administration
2 DOSAGE AND ADMINISTRATION NA 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 (2.2) 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 n…
Contraindications
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.
Drug Interactions
7 DRUG INTERACTIONS Table 2 presents clinically significant drug interactions with metformin hydrochloride extended-release tablets. Table 2: Clinically Significant Drug Interactions with Metformin Hydrochloride Extended-Release Tablets Carbonic Anhydrase Inhibitors Clinical Impact: Carbonic anhydrase inhibitors frequently cause a decrease in serum bicarbonate and induce non-anion gap, hyperchloremic metabolic acidosis. Concomitant use of these drugs with metformin hydrochloride extended-release tablets may increase the risk for lactic acidosis. Intervention: Consider more frequent monitoring of these patients. Examples: Topiramate, zonisamide, acetazolamide or dichlorphenamide. Drugs that Reduce Metformin Hydrochloride Extended-release Tablets Clearance Clinical Impact: Concomitant use of drugs that interfere with common renal tubular transport systems involved in the renal elimination of metformin (e.g., organic cationic transporter-2 [OCT2] / multidrug and toxin extrusion [MATE] inhibitors) could increase systemic exposure to metformin and may increase the risk for lactic acidosis [see Clinical Pharmacology (12.3) ]. Intervention: Consider the benefits and risks of concomitant u…
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 hydrochlori…
Frequently Asked Questions
What is Metformin ER 500 mg used for?
Metformin ER 500 mg contains Metformin ER 500 mg. It is a tablet taken oral. Consult your doctor for specific uses.
Is Metformin ER 500 mg a controlled substance?
Metformin ER 500 mg is not classified as a controlled substance by the DEA.
What is the generic name for Metformin ER 500 mg?
The generic name for Metformin ER 500 mg is Metformin ER 500 mg. There are 10 other brand versions of Metformin ER 500 mg.
What is the NDC code for Metformin ER 500 mg 500 mg/1?
The NDC (National Drug Code) for Metformin ER 500 mg 500 mg/1 is 62207-491, listed by Granules India Ltd.