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Metformin Er 500 Mg

Source: OpenFDA label data · Not medical advice · For personal tracking only

The most user-facing sections are shown first. FDA professional label details are kept below and collapsed because they can be technical, repetitive, or difficult to read out of context.

Safety Warning Highlights

1

Important warning themes extracted from the FDA label. Review the full label warnings below for source wording.

Heart

Heart Failure

BOXED WARNING 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 [see Warnings 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, hepatic impairment, and mitochondrial diseases [see Warnings and Precautions (5.1)] Steps to reduce the risk of and manage metformin-associated lactic acidosis in these high risk groups are provided [see Dosage and Administration (2) , 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 [see Warnings and Precautions (5.1) ] WARNING: LACTIC ACIDOSIS See full prescribing information for complete boxed warning Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias Symptoms included malaise, myalgias, respiratory distress, somnolence, and abdominal pain Laboratory abnormalities included elevated blood lactate levels, anion gap acidosis, increased lactate/pyruvate ratio and metformin plasma levels generally >5 mcg/mL.

Reported Side Effects

22

Serious — Get Medical Help

These may signal more serious reactions and may require prompt medical attention.

Common or Likely

Frequently reflected in adverse reaction or label text.

Abdominal Pain

Pain, cramping, or aching in the stomach or belly area.

FDA label warnings

19

Show full FDA warning text

Source label wording. This may be long, technical, or formatted for the original package label.

BOXED WARNING 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 [see Warnings and Precautions (5.1) ]

Risk factors for metformin-associated lactic acidosis include renal impairment, concomitant use of certain drugs (e.g

Professional label: Usage and Indications

2

Show FDA label use text

Technical label wording. It may be incomplete, repetitive, or written for clinicians.

This label section may be messy because it contains repeated wording. Use it as source-label context, not as a simplified explanation.
  • 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 biguanide indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus

Professional label: Dosage Details

10

Show FDA label dosage text

Not dosing guidance. Follow your clinician, pharmacist, or product label.

This dosage label section may be difficult to read because it contains large label paragraphs and many dosing values and repeated wording. Do not use it to decide how much medicine to take.
  • Adults: Swallow Metformin hydrochloride extended-release tablets whole and never crush, cut or chew Starting dosage: 500 mg orally once daily with the evening meal Increase the dosage in increments of 500 mg weekly, up to a maximum dosage of 2,000 mg once daily with the evening meal 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
  • Recommended Dosage in Patients with Renal Impairment Prior to initiation
  • assess renal function with estimated glomerular filtration rate (eGFR) Do not use in patients with eGFR below 30 mL/minute/1.73 m 2 Initiation is not recommended in patients with eGFR between 30 to 45 mL/minute/1.73 m 2

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, hepatic impairment, and mitochondrial diseases [see Warnings and Precautions (5.1)]

Steps to reduce the risk of and manage metformin-associated lactic acidosis in these high risk groups are provided [see Dosage and Administration (2) , 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 [see Warnings and Precautions (5.1) ]

WARNING: LACTIC ACIDOSIS See full prescribing information for complete boxed warning

Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias

Symptoms included malaise, myalgias, respiratory distress, somnolence, and abdominal pain

Laboratory abnormalities included elevated blood lactate levels, anion gap acidosis, increased lactate/pyruvate ratio

and metformin plasma levels generally >5 mcg/mL. ( 5.1 )

Risk factors include renal impairment, concomitant use of certain drugs, age >65 years old, radiological studies with contrast, surgery and other procedures, hypoxic states, excessive alcohol intake, hepatic impairment, and mitochondrial diseases

Steps to reduce the risk of and manage metformin­ associated lactic acidosis in these high risk groups are provided in the Full Prescribing Information

( 5.1 )

If lactic acidosis is suspected, discontinue Metformin hydrochloride extended-release tablets and institute general supportive measures in a hospital setting

Prompt hemodialysis is recommended