Glumetza 500 mg/1

metformin hydrochloride · TABLET, FILM COATED, EXTENDED RELEASE · Santarus, Inc.

No Recall History

Plain English

Glumetza is an extended-release oral tablet containing metformin, a medication commonly used to help control blood sugar levels in people with type 2 diabetes. Because it's designed to release slowly in your body, it's typically taken once daily with food.

Key Facts

Brand Name: Glumetza
Generic Name: metformin hydrochloride
NDC Code (Product): 68012-002
Manufacturer: Santarus, Inc.
Strength: 500 mg/1
Dosage Form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Marketing Status
Application #: NDA021748
Marketing Start: 08/01/2006

Recall History

No Recall History

Side Effects Reported to FDA

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

diarrhoea4,258 reports

lactic acidosis4,249 reports

nausea3,469 reports

fatigue3,047 reports

acute kidney injury3,020 reports

drug ineffective2,694 reports

vomiting2,550 reports

dyspnoea2,534 reports

headache2,217 reports

off label use2,142 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE GLUMETZA is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. GLUMETZA is 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 AND ADMINISTRATION • Starting dose: 500 mg orally once daily with the evening meal ( 2.1 ) • Increase the dose in increments of 500 mg every 1 to 2 weeks, up to a maximum of 2,000 mg once daily with the evening meal. ( 2.1 ) • Patients receiving metformin hydrochloride (HCl) tablets may be switched to GLUMETZA once daily at the same total daily dose, up to 2,000 mg once daily. ( 2.1 ) • Swallow GLUMETZA tablets whole and never crush, cut or chew. ( 2.1 ) Renal Impairment: • Prior to initiation, assess renal function with estimated glomerular filtration rate (eGFR). ( 2.2 ) o Do not use in patients with eGFR below 30 mL/minute/1.73 m 2 . o Initiation is not recommended in patients with eGFR between 30 to 45 mL/minute/1.73 m 2 . o Assess risk/benefit of continuing GLUMETZA if eGFR falls below 45 mL/minute/1.73 m 2 . o Discontinue if eGFR falls below 30 mL/minute/1.73 m 2 . Discontinuation for Iodinated Contrast Imaging Procedures: • GLUMETZA may need to be discontinued at time of, or prior to, iodinated contrast imaging procedures. ( 2.3 ) 2.1 Adult Dosage and Administration • The recommended starting dose of GLUMETZA is 500 mg orally once daily with the evening meal. • Incr…

Contraindications

4 CONTRAINDICATIONS GLUMETZA is contraindicated in patients with: • Severe renal impairment (eGFR below 30 mL/minute/1.73 m 2 ) [see Warnings and Precautions ( 5.1 )] . • Known hypersensitivity to metformin. • Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. • Severe renal impairment: (eGFR below 30 mL/minute/1.73 m 2 ) ( 4 , 5.1 ) • Known hypersensitivity to metformin ( 4 ) • Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma ( 4 )

Drug Interactions

7 DRUG INTERACTIONS Table 2 presents clinically significant drug interactions with GLUMETZA. Table 2: Clinically Significant Drug Interactions with GLUMETZA 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 GLUMETZA may increase the risk for lactic acidosis. Intervention: Consider more frequent monitoring of these patients. Examples: Topiramate, zonisamide, acetazolamide or dichlorphenamide. Drugs that Reduce GLUMETZA 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 use with GLUMETZA. Examples: Ranolazine, vandetanib, dolutegravir, and cimetidine. Alcohol Clinical Impact: Alcohol is known to potentiate the effect of metform…

Adverse Reactions

6 ADVERSE REACTIONS Adverse reactions occurring >5% in GLUMETZA clinical trials: hypoglycemia, diarrhea, and nausea. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Salix Pharmaceuticals at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience The following adverse reactions are discussed in more detail in other sections of 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 )] 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. In clinical trials conducted in the U.S., over 1,000 patients with type 2 diabetes mellitus have been treated with GLUMETZA 1,500 to 2,000 mg/day in active-controlled and placebo-controlled studies with the 500 mg dosage form. In the add-on to sulfonylurea study, patients receiving background glyburide therapy were randomized to receive add-on treatme…

Frequently Asked Questions

What is Glumetza used for?

Is Glumetza a controlled substance?

Glumetza is not classified as a controlled substance by the DEA.

What is the generic name for Glumetza?

The generic name for Glumetza is metformin hydrochloride. There are 12 other brand versions of metformin hydrochloride.

What is the NDC code for Glumetza 500 mg/1?

The NDC (National Drug Code) for Glumetza 500 mg/1 is 68012-002, listed by Santarus, Inc..

Product NDC

68012-002

Package NDC

68012-002-13

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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