Metformin hydrochloride ER 750 mg/1

Metformin hydrochloride · TABLET, EXTENDED RELEASE · PD-Rx Pharmaceuticals, Inc.

No Recall History

Plain English

Metformin hydrochloride ER is a tablet, extended release containing metformin hydrochloride at 750 mg/1, taken oral. Manufactured by PD-Rx Pharmaceuticals, Inc..

Key Facts

Brand Name: Metformin hydrochloride ER
Generic Name: Metformin hydrochloride
NDC Code (Product): 72789-106
Manufacturer: PD-Rx Pharmaceuticals, Inc.
Strength: 750 mg/1
Dosage Form: TABLET, EXTENDED RELEASE
Route: ORAL
Marketing Status
Application #: ANDA207427
Marketing Start: 06/28/2018

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

lactic acidosis4,356 reports

diarrhoea4,108 reports

nausea3,364 reports

acute kidney injury3,067 reports

fatigue2,942 reports

drug ineffective2,623 reports

dyspnoea2,487 reports

vomiting2,487 reports

headache2,146 reports

off label use2,092 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS & 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 a biguanide indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. (1)

Dosage & Administration

2 DOSAGE & ADMINISTRATION 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…

Contraindications

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. (4)

Drug Interactions

7 DRUG INTERACTIONS Table 3 presents clinically significant drug interactions with metformin hydrochloride extended-release tablets. Table 3: 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 B12 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 (>5.0%) 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 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 Me…

Frequently Asked Questions

What is Metformin hydrochloride ER used for?

Metformin hydrochloride ER contains Metformin hydrochloride. It is a tablet, extended release taken oral. Consult your doctor for specific uses.

Is Metformin hydrochloride ER a controlled substance?

Metformin hydrochloride ER is not classified as a controlled substance by the DEA.

What is the generic name for Metformin hydrochloride ER?

The generic name for Metformin hydrochloride ER is Metformin hydrochloride. There are 11 other brand versions of Metformin hydrochloride.

What is the NDC code for Metformin hydrochloride ER 750 mg/1?

The NDC (National Drug Code) for Metformin hydrochloride ER 750 mg/1 is 72789-106, listed by PD-Rx Pharmaceuticals, Inc..

Product NDC

72789-106

Package NDC

72789-106-01

Other Metformin Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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