Label: METFORMIN HYDROCHLORIDE ER- metformin hydrochloride tablet, extended release
- NDC Code(s): 71610-867-53, 71610-867-60, 71610-867-70, 71610-867-80
- Packager: Aphena Pharma Solutions - Tennessee, LLC
- This is a repackaged label.
- Source NDC Code(s): 42291-824
- 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 INFORMATIONMetformin 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 ...
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Table of ContentsTable of Contents
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BOXED WARNING
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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)]. -
1 INDICATIONS & USAGEMetformin hydrochloride extended-release tablets are indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus.
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2 DOSAGE & ADMINISTRATION2.1 Adult Dosage - • Swallow Metformin hydrochloride extended- release tablets whole and never crush, cut or chew. • The recommended starting dose of Metformin hydrochloride extended ...
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3 DOSAGE FORMS & STRENGTHSMetformin 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. ...
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4 CONTRAINDICATIONSMetformin 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 ...
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5 WARNINGS AND PRECAUTIONS5.1 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 ...
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6 ADVERSE REACTIONSThe following adverse reactions are also discussed elsewhere in the labeling: Lactic Acidosis [see - Boxed Warning andWarnings and Precautions (5.1)] Vitamin B12 Deficiency [see ...
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7 DRUG INTERACTIONSTable 3 presents clinically significant drug interactions with metformin hydrochloride extended-release tablets. Table 3: Clinically Significant Drug Interactions with Metformin ...
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8 USE IN SPECIFIC POPULATIONS8.1 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 ...
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10 OVERDOSAGEOverdose 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 ...
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11 DESCRIPTIONMetformin Hydrochloride Extended-release Tablets, USP contain the antihyperglycemic agent metformin, which is a biguanide, in the form of monohydrochloride. The chemical name of metformin ...
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12 CLINICAL PHARMACOLOGY12.1 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 ...
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13 NONCLINICAL TOXICOLOGY13.1 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 ...
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14 CLINICAL STUDIES14.1 Metformin Hydrochloride Tablets - Adult Clinical Studies - A double-blind, placebo-controlled, multicenter US clinical trial involving obese patients with type 2 diabetes mellitus whose ...
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16 HOW SUPPLIED/STORAGE AND HANDLING16.1 How Supplied - Table 12: Metformin Hydrochloride Extended-release Tablets Available Strengths, Units, and Appearance - Metformin Hydrochloride Extended-release Tablets - 500 ...
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17 PATIENT COUNSELING INFORMATIONAdvise 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 ...
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SPL PATIENT PACKAGE INSERT SECTIONPATIENT 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 ...
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REPACKAGING INFORMATIONPlease 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 ...
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PRINCIPAL DISPLAY PANEL - 750mgNDC 71610-867 - Metformin HCl ER, USP 750mg Tablets - Rx Only
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INGREDIENTS AND APPEARANCEProduct Information