Label: METFORMIN HYDROCHLORIDE ER- metformin hydrochloride tablet, extended release

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated January 15, 2025

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  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    Metformin Hydrochloride Extended-release Tablets, USP - Rx Only - These highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and ...
  • Table of Contents
    Table of Contents
  • BOXED WARNING (What is this?)

    WARNING: LACTIC ACIDOSIS

    Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metformin­ associated lactic acidosis is often subtle, accompanied only by nonspecific symptoms such as malaise, myalgias, respiratory distress, somnolence, and abdominal pain. Metformin­ associated lactic acidosis was characterized by elevated blood lactate levels (>5 mmol/Liter), anion gap acidosis (without evidence of ketonuria or ketonemia), an increased lactate/pyruvate ratio; and metformin plasma levels generally >5 mcg/mL [seeWarnings and Precautions (5.1)].



    Risk factors for metformin-associated lactic acidosis include renal impairment, concomitant use of certain drugs (e.g. carbonic anhydrase inhibitors such as topiramate), age 65 years old or greater, having a radiological study with contrast, surgery and other procedures, hypoxic states (e.g., acute congestive heart failure), excessive alcohol intake, and hepatic impairment.

    Steps to reduce the risk of and manage metformin-associated lactic acidosis in these high risk groups are provided [see Dosage and Administration (2.3), (2.7), Contraindications (4),Warnings and Precautions (5.1)].


    If metformin-associated lactic acidosis is suspected, immediately discontinue metformin hydrochloride extended-release tablets and institute general supportive measures in a hospital setting. Prompt hemodialysis is recommended [seeWarnings and Precautions (5.1)].

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  • 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.
  • 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 ...
  • 3 DOSAGE FORMS & STRENGTHS
    Metformin hydrochloride extended-release tablets is available as: •   500 mgwhite to off-white color, round, biconvex tablet having ‘B115’ on one side and plain on the other. ...
  • 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 ...
  • 5 WARNINGS AND PRECAUTIONS
    5.1 Lactic Acidosis - There have been postmarketing cases of metformin-associated lactic acidosis, including fatal cases. These cases had a subtle onset and were accompanied by nonspecific ...
  • 6 ADVERSE REACTIONS
    The following adverse reactions are also discussed elsewhere in the labeling: Lactic Acidosis [see - Boxed Warning andWarnings and Precautions (5.1)] Vitamin B12 Deficiency [see ...
  • 7 DRUG INTERACTIONS
    Table 3 presents clinically significant drug interactions with metformin hydrochloride extended-release tablets. Table 3: Clinically Significant Drug Interactions with Metformin ...
  • 8 USE IN SPECIFIC POPULATIONS
    8.1 Pregnancy - Risk Summary - Limited data with metformin hydrochloride extended-release tablets in pregnant women are not sufficient to determine a drug-associated risk for major birth ...
  • 10 OVERDOSAGE
    Overdose of metformin hydrochloride has occurred, including ingestion of amounts greater than 50 grams. Hypoglycemia was reported in approximately 10% of cases, but no causal association with ...
  • 11 DESCRIPTION
    Metformin Hydrochloride Extended-release Tablets, USP contain the antihyperglycemic agent metformin, which is a biguanide, in the form of monohydrochloride. The chemical name of metformin ...
  • 12 CLINICAL PHARMACOLOGY
    12.1 Mechanism of Action - Metformin is an antihyperglycemic agent which improves glucose tolerance in patients with type 2 diabetes mellitus, lowering both basal and postprandial plasma glucose ...
  • 13 NONCLINICAL TOXICOLOGY
    13.1 Carcinogenesis, Mutagenesis & Impairment Of Fertility - Long-term carcinogenicity studies have been performed in rats (dosing duration of 104 weeks) and mice (dosing duration of 91 weeks) at ...
  • 14 CLINICAL STUDIES
    14.1 Metformin Hydrochloride Tablets - Adult Clinical Studies - A double-blind, placebo-controlled, multicenter US clinical trial involving obese patients with type 2 diabetes mellitus whose ...
  • 16 HOW SUPPLIED/STORAGE AND HANDLING
    16.1 How Supplied - Table 12: Metformin Hydrochloride Extended-release Tablets Available Strengths, Units, and Appearance - Metformin Hydrochloride Extended-release Tablets - 500 ...
  • 17 PATIENT COUNSELING INFORMATION
    Advise the patient to read the FDA-approved patient labeling (Patient Information). Lactic Acidosis: Explain the risks of lactic acidosis, its symptoms, and conditions that predispose to its ...
  • SPL PATIENT PACKAGE INSERT SECTION
    PATIENT INFORMATION - Metformin Hydrochloride Extended-Release Tablets USP, 500 mg and 750 mg - (met-FOR-min HYE-droe-KLOR-ide) Read the Patient Information that comes with metformin ...
  • REPACKAGING INFORMATION
    Please reference the HOW SUPPLIED section listed above for a description of individual drug products listed below. This drug product has been received by Aphena Pharma Solutions - Tennessee, LLC ...
  • PRINCIPAL DISPLAY PANEL - 750mg
    NDC 71610-867 - Metformin HCl ER, USP 750mg Tablets - Rx Only
  • INGREDIENTS AND APPEARANCE
    Product Information