Metformin Hydrochloride 500 mg · Uses, Side Effects, Dosage

How it works

From this product’s own US prescribing label.

Metformin is an antihyperglycemic agent which improves glucose tolerance in patients with type 2 diabetes mellitus, lowering both basal and postprandial plasma glucose.
Metformin decreases hepatic glucose production, decreases intestinal absorption of glucose, and improves insulin sensitivity by increasing peripheral glucose uptake and utilization.

Half-life6.2 h

Mostly cleared after≈ 31 hfive half-lives — our arithmetic

How it leaves the body

Intravenous single-dose studies in normal subjects demonstrate that metformin is excreted unchanged in the urine and does not undergo hepatic metabolism (no metabolites have been identified in humans) nor biliary excretion.

Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2020-12-26

Serious warning

The strongest warning the FDA requires. It is printed in a box at the top of the label.

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, 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) , Contraindications (4) , Warnings and Precautions (5.1) ].
If metformin-associated lactic acidosis is suspected, immediately discontinue metformin 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, and hepatic impairment.
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 Tablets and institute general supportive measures in a hospital setting.
Prompt hemodialysis is recommended.
( 5.1 )

Quoted from the official label, section “Boxed Warning”.

Do not take it if

Metformin Hydrochloride Tablets are contraindicated in patients with:
Severe renal impairment (eGFR below 30 mL/min/1.73 m 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 )

Quoted from the official label, section “Contraindications”.

How to take it

These directions are for this exact strength and form. Another one is different.

Adult Dosage for Metformin Hydrochloride Tablets:
Starting dose:
500 mg orally twice a day or 850 mg once a day, with meals ( 2.1 ) Increase the dose in increments of 500 mg weekly or 850 mg every 2 weeks, up to a maximum dose of 2550 mg per day, given in divided doses ( 2.1 ) Doses above 2000 mg may be better tolerated given 3 times a day with meals ( 2.1 ) Pediatric Dosage for Metformin Hydrochloride Tablets:
Starting dose:
500 mg orally twice a day, with meals ( 2.2 ) Increase dosage in increments of 500 mg weekly up to a maximum of 2000 mg per day, given in divided doses twice daily ( 2.2 ) Renal Impairment:
Prior to initiation, assess renal function with estimated glomerular filtration rate (eGFR) ( 2.3 )
Do not use in patients with eGFR below 30 mL/minute/1.73 m 2 ( 2.3 ) Initiation is not recommended in patients with eGFR between 30-45 mL/minute/1.73 m 2 ( 2.3 ) Assess risk/benefit of continuing if eGFR falls below 45 mL/minute/1.73 m 2 ( 2.3 ) Discontinue if eGFR falls below 30 mL/minute/1.73 m 2 ( 2.3 ) Discontinuation for Iodinated Contrast Imaging Procedures:
Metformin Hydrochloride Tablets may need to be discontinued at time of, or prior to, iodinated contrast imaging procedures ( 2.4 )
2.1 Adult Dosage Metformin Hydrochloride Tablets The recommended starting dose of Metformin Hydrochloride Tablets is 500 mg orally twice a day or 850 mg once a day, given with meals.
Increase the dose in increments of 500 mg weekly or 850 mg every 2 weeks on the basis of glycemic control and tolerability, up to a maximum dose of 2550 mg per day, given in divided doses.
Doses above 2000 mg may be better tolerated given 3 times a day with meals.
2.2 Pediatric Dosage for Metformin Hydrochloride Tablets The recommended starting dose of Metformin Hydrochloride Tablets for pediatric patients 10 years of age and older is 500 mg orally twice a day, given with meals.
Increase dosage in increments of 500 mg weekly on the basis of glycemic control and tolerability, up to a maximum of 2000 mg per day, given in divided doses twice daily.
2.3 Recommendations for Use in Renal Impairment Assess renal function prior to initiation of Metformin Hydrochloride Tablets and periodically thereafter.
Metformin Hydrochloride Tablets are contraindicated in patients with an estimated glomerular filtration rate (eGFR) below 30 mL/minute/1.73 m 2 .
Initiation of Metformin Hydrochloride Tablets in patients with an eGFR between 30– 45 mL/minute/1.73 m 2 is not recommended.
In patients taking Metformin Hydrochloride Tablets whose eGFR later falls below 45 mL/min/1.73 m 2 , assess the benefit risk of continuing therapy.
Discontinue Metformin Hydrochloride Tablets if the patient’s eGFR later falls below 30 mL/minute/1.73 m 2 [see Warnings and Precautions (5.1) ].
2.4 Discontinuation for Iodinated Contrast Imaging Procedures Discontinue Metformin Hydrochloride Tablets at the time of, or prior to, an iodinated contrast imaging procedure in patients with an eGFR between 30 and 60 mL/min/1.73 m 2 ; in patients with a history of liver disease, alcoholism, or heart failure; or in patients who will be administered intra-arterial iodinated contrast.
Re-evaluate eGFR 48 hours after the imaging procedure; restart Metformin Hydrochloride Tablets if renal function is stable.
2.1 Adult Dosage Metformin Hydrochloride Tablets The recommended starting dose of Metformin Hydrochloride Tablets is 500 mg orally twice a day or 850 mg once a day, given with meals.
Increase the dose in increments of 500 mg weekly or 850 mg every 2 weeks on the basis of glycemic control and tolerability, up to a maximum dose of 2550 mg per day, given in divided doses.
Doses above 2000 mg may be better tolerated given 3 times a day with meals.
2.2 Pediatric Dosage for Metformin Hydrochloride Tablets The recommended starting dose of Metformin Hydrochloride Tablets for pediatric patients 10 years of age and older is 500 mg orally twice a day, given with meals.
Increase dosage in increments of 500 mg weekly on the basis of glycemic control and tolerability, up to a maximum of 2000 mg per day, given in divided doses twice daily.
2.3 Recommendations for Use in Renal Impairment Assess renal function prior to initiation of Metformin Hydrochloride Tablets and periodically thereafter.
Metformin Hydrochloride Tablets are contraindicated in patients with an estimated glomerular filtration rate (eGFR) below 30 mL/minute/1.73 m 2 .
Initiation of Metformin Hydrochloride Tablets in patients with an eGFR between 30– 45 mL/minute/1.73 m 2 is not recommended.
In patients taking Metformin Hydrochloride Tablets whose eGFR later falls below 45 mL/min/1.73 m 2 , assess the benefit risk of continuing therapy.
Discontinue Metformin Hydrochloride Tablets if the patient’s eGFR later falls below 30 mL/minute/1.73 m 2 [see Warnings and Precautions (5.1) ].
2.4 Discontinuation for Iodinated Contrast Imaging Procedures Discontinue Metformin Hydrochloride Tablets at the time of, or prior to, an iodinated contrast imaging procedure in patients with an eGFR between 30 and 60 mL/min/1.73 m 2 ; in patients with a history of liver disease, alcoholism, or heart failure; or in patients who will be administered intra-arterial iodinated contrast.
Re-evaluate eGFR 48 hours after the imaging procedure; restart Metformin Hydrochloride Tablets if renal function is stable.

Quoted from the official label, section “Dosage & Administration”.

Other warnings

See boxed warning.( 5.1) Vitamin B 12 Deficiency:
Metformin may lower vitamin B 12 levels.
Measure hematological parameters annually and vitamin B 12 at 2 to 3 year intervals and manage any abnormalities.
( 5.2 ) Hypoglycemia with Concomitant Use with Insulin and Insulin Secretagogues:
Increased risk of hypoglycemia when used in combination with insulin and/or an insulin secretagogue.
Lower dose of insulin or insulin secretagogue may be required ( 5.3 )
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 symptoms such as malaise, myalgias, abdominal pain, respiratory distress, or increased somnolence; however, hypotension and resistant bradyarrhythmias have occurred with severe acidosis.
Metformin associated lactic acidosis was characterized by elevated blood lactate concentrations (>5 mmol/L), anion gap acidosis (without evidence of ketonuria or ketonemia), and an increased lactate:
pyruvate ratio; metformin plasma levels were generally >5 mcg/mL.
Metformin decreases liver uptake of lactate increasing lactate blood levels which may increase the risk of lactic acidosis, especially in patients at risk.
If metformin-associated lactic acidosis is suspected, general supportive measures should be instituted promptly in a hospital setting, along with immediate discontinuation of Metformin Hydrochloride.
In Metformin Hydrochloride Tablets treated patients with a diagnosis or strong suspicion of lactic acidosis, prompt hemodialysis is recommended to correct the acidosis and remove accumulated metformin (metformin hydrochloride is dialyzable with a clearance of up to 170 mL/min under good hemodynamic conditions).
Hemodialysis has often resulted in reversal of symptoms and recovery.
Educate patients and their families about the symptoms of lactic acidosis and, if these symptoms occur, instruct them to discontinue Metformin Hydrochloride Tablets and report these symptoms to their healthcare provider.
For each of the known and possible risk factors for metformin-associated lactic acidosis, recommendations to reduce the risk of and manage metformin-associated lactic acidosis are provided below:
Renal impairment —The postmarketing metformin-associated lactic acidosis cases primarily occurred in patients with significant renal impairment.
The risk of metformin accumulation and metformin-associated lactic acidosis increases with the severity of renal impairment because metformin is substantially excreted by the kidney.
Clinical recommendations based upon the patient’s renal function include [see Dosage and Administration (2.1) , Clinical Pharmacology (12.3) ]:
Before initiating Metformin Hydrochloride, obtain an estimated glomerular filtration rate (eGFR).
Metformin Hydrochloride is contraindicated in patients with an eGFR less than 30 mL/min/1.73 m 2 [see Contraindications (4) ].
Initiation of Metformin Hydrochloride is not recommended in patients with eGFR between 30-45 mL/min/1.73 m 2 .
Obtain an eGFR at least annually in all patients taking Metformin Hydrochloride.
In patients at risk for the development of renal impairment (e.g., the elderly), renal function should be assessed more frequently.
In patients taking Metformin Hydrochloride whose eGFR falls below 45 mL/min/1.73 m 2 , assess the benefit and risk of continuing therapy.
Drug interactions — The concomitant use of Metformin Hydrochloride with specific drugs may increase the risk of metformin-associated lactic acidosis:
those that impair renal function, result in significant hemodynamic change, interfere with acid-base balance, or increase metformin accumulation.
Consider more frequent monitoring of patients.
Age 65 or greater — The risk of metformin-associated lactic acidosis increases with the patient’s age because elderly patients have a greater likelihood of having hepatic, renal, or cardiac impairment than younger patients.
Radiologic studies with contrast — Administration of intravascular iodinated contrast agents in metformin-treated patients has led to an acute decrease in renal function and the occurrence of lactic acidosis.
Stop Metformin Hydrochloride at the time of, or prior to, an iodinated contrast imaging procedure in patients with an eGFR between 30 and 60 mL/min/1.73 m 2 ; in patients with a history of hepatic impairment, alcoholism or heart failure; or in patients who will be administered intra-arterial iodinated contrast.
Re-evaluate eGFR 48 hours after the imaging procedure, and restart Metformin Hydrochloride if renal function is stable.
Surgery and other procedures — Withholding of food and fluids during surgical or other procedures may increase the risk for volume depletion, hypotension, and renal impairment.
Metformin Hydrochloride should be temporarily discontinued while patients have restricted food and fluid intake.
Hypoxic states — Several of the postmarketing cases of metformin-associated lactic acidosis occurred in the setting of acute congestive heart failure (particularly when accompanied by hypoperfusion and hypoxemia).
Cardiovascular collapse (shock), acute myocardial infarction, sepsis, and other conditions associated with hypoxemia have been associated with lactic acidosis and may cause prerenal azotemia.
When such an event occurs, discontinue Metformin Hydrochloride Tablets.
Excessive alcohol intake — Alcohol potentiates the effect of metformin on lactate metabolism.
Patients should be warned against excessive alcohol intake while receiving Metformin Hydrochloride Tablets.
Hepatic impairment — Patients with hepatic impairment have developed cases of metformin-associated lactic acidosis.
This may be due to impaired lactate clearance resulting in higher lactate blood levels.
Therefore,
avoid use of Metformin Hydrochloride Tablets in patients with clinical or laboratory evidence of hepatic disease.
5.2 Vitamin B12 Deficiency In Metformin Hydrochloride clinical trials of 29-week duration, a decrease to subnormal levels of previously normal serum vitamin B 12 levels was observed in approximately 7% of patients.
Such decrease, possibly due to interference with B 12 absorption from the B 12 -intrinsic factor complex, may be associated with anemia but appears to be rapidly reversible with discontinuation of Metformin Hydrochloride or vitamin B 12 supplementation.
Certain individuals (those with inadequate vitamin B 12 or calcium intake or absorption) appear to be predisposed to developing subnormal vitamin B 12 levels.
Measure hematologic parameters on an annual basis and vitamin B 12 at 2 to 3 year intervals in patients on Metformin Hydrochloride and manage any abnormalities [see Adverse Reactions (6.1) ].
5.3 Hypoglycemia with Concomitant Use with Insulin and Insulin Secretagogues Insulin and insulin secretagogues (e.g., sulfonylurea) are known to cause hypoglycemia.
Metformin Hydrochloride tablets may increase the risk of hypoglycemia when combined with insulin and/or an insulin secretagogue.
Therefore, a lower dose of insulin or insulin secretagogue may be required to minimize the risk of hypoglycemia when used in combination with Metformin Hydrochloride Tablets [see Drug Interactions (7) ].
5.4 Macrovascular Outcomes There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with Metformin Hydrochloride Tablets.
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 symptoms such as malaise, myalgias, abdominal pain, respiratory distress, or increased somnolence; however, hypotension and resistant bradyarrhythmias have occurred with severe acidosis.
Metformin associated lactic acidosis was characterized by elevated blood lactate concentrations (>5 mmol/L), anion gap acidosis (without evidence of ketonuria or ketonemia), and an increased lactate:
pyruvate ratio; metformin plasma levels were generally >5 mcg/mL.
Metformin decreases liver uptake of lactate increasing lactate blood levels which may increase the risk of lactic acidosis, especially in patients at risk.
If metformin-associated lactic acidosis is suspected, general supportive measures should be instituted promptly in a hospital setting, along with immediate discontinuation of Metformin Hydrochloride.
In Metformin Hydrochloride Tablets treated patients with a diagnosis or strong suspicion of lactic acidosis, prompt hemodialysis is recommended to correct the acidosis and remove accumulated metformin (metformin hydrochloride is dialyzable with a clearance of up to 170 mL/min under good hemodynamic conditions).
Hemodialysis has often resulted in reversal of symptoms and recovery.
Educate patients and their families about the symptoms of lactic acidosis and, if these symptoms occur, instruct them to discontinue Metformin Hydrochloride Tablets and report these symptoms to their healthcare provider.
For each of the known and possible risk factors for metformin-associated lactic acidosis, recommendations to reduce the risk of and manage metformin-associated lactic acidosis are provided below:
Renal impairment —The postmarketing metformin-associated lactic acidosis cases primarily occurred in patients with significant renal impairment.
The risk of metformin accumulation and metformin-associated lactic acidosis increases with the severity of renal impairment because metformin is substantially excreted by the kidney.
Clinical recommendations based upon the patient’s renal function include [see Dosage and Administration (2.1) , Clinical Pharmacology (12.3) ]:
Before initiating Metformin Hydrochloride, obtain an estimated glomerular filtration rate (eGFR).
Metformin Hydrochloride is contraindicated in patients with an eGFR less than 30 mL/min/1.73 m 2 [see Contraindications (4) ].
Initiation of Metformin Hydrochloride is not recommended in patients with eGFR between 30-45 mL/min/1.73 m 2 .
Obtain an eGFR at least annually in all patients taking Metformin Hydrochloride.
In patients at risk for the development of renal impairment (e.g., the elderly), renal function should be assessed more frequently.
In patients taking Metformin Hydrochloride whose eGFR falls below 45 mL/min/1.73 m 2 , assess the benefit and risk of continuing therapy.
Drug interactions — The concomitant use of Metformin Hydrochloride with specific drugs may increase the risk of metformin-associated lactic acidosis:
those that impair renal function, result in significant hemodynamic change, interfere with acid-base balance, or increase metformin accumulation.
Consider more frequent monitoring of patients.
Age 65 or greater — The risk of metformin-associated lactic acidosis increases with the patient’s age because elderly patients have a greater likelihood of having hepatic, renal, or cardiac impairment than younger patients.
Radiologic studies with contrast — Administration of intravascular iodinated contrast agents in metformin-treated patients has led to an acute decrease in renal function and the occurrence of lactic acidosis.
Stop Metformin Hydrochloride at the time of, or prior to, an iodinated contrast imaging procedure in patients with an eGFR between 30 and 60 mL/min/1.73 m 2 ; in patients with a history of hepatic impairment, alcoholism or heart failure; or in patients who will be administered intra-arterial iodinated contrast.
Re-evaluate eGFR 48 hours after the imaging procedure, and restart Metformin Hydrochloride if renal function is stable.
Surgery and other procedures — Withholding of food and fluids during surgical or other procedures may increase the risk for volume depletion, hypotension, and renal impairment.
Metformin Hydrochloride should be temporarily discontinued while patients have restricted food and fluid intake.
Hypoxic states — Several of the postmarketing cases of metformin-associated lactic acidosis occurred in the setting of acute congestive heart failure (particularly when accompanied by hypoperfusion and hypoxemia).
Cardiovascular collapse (shock), acute myocardial infarction, sepsis, and other conditions associated with hypoxemia have been associated with lactic acidosis and may cause prerenal azotemia.
When such an event occurs, discontinue Metformin Hydrochloride Tablets.
Excessive alcohol intake — Alcohol potentiates the effect of metformin on lactate metabolism.
Patients should be warned against excessive alcohol intake while receiving Metformin Hydrochloride Tablets.
Hepatic impairment — Patients with hepatic impairment have developed cases of metformin-associated lactic acidosis.
This may be due to impaired lactate clearance resulting in higher lactate blood levels.
Therefore,
avoid use of Metformin Hydrochloride Tablets in patients with clinical or laboratory evidence of hepatic disease.
5.2 Vitamin B12 Deficiency In Metformin Hydrochloride clinical trials of 29-week duration, a decrease to subnormal levels of previously normal serum vitamin B 12 levels was observed in approximately 7% of patients.
Such decrease, possibly due to interference with B 12 absorption from the B 12 -intrinsic factor complex, may be associated with anemia but appears to be rapidly reversible with discontinuation of Metformin Hydrochloride or vitamin B 12 supplementation.
Certain individuals (those with inadequate vitamin B 12 or calcium intake or absorption) appear to be predisposed to developing subnormal vitamin B 12 levels.
Measure hematologic parameters on an annual basis and vitamin B 12 at 2 to 3 year intervals in patients on Metformin Hydrochloride and manage any abnormalities [see Adverse Reactions (6.1) ].
5.3 Hypoglycemia with Concomitant Use with Insulin and Insulin Secretagogues Insulin and insulin secretagogues (e.g., sulfonylurea) are known to cause hypoglycemia.
Metformin Hydrochloride tablets may increase the risk of hypoglycemia when combined with insulin and/or an insulin secretagogue.
Therefore, a lower dose of insulin or insulin secretagogue may be required to minimize the risk of hypoglycemia when used in combination with Metformin Hydrochloride Tablets [see Drug Interactions (7) ].
5.4 Macrovascular Outcomes There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with Metformin Hydrochloride Tablets.

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

IN SPECIFIC POPULATIONS Females and Males of Reproductive Potential:
Advise premenopausal females of the potential for an unintended pregnancy.
( 8.3 ) Geriatric Use: Assess renal function more frequently.
( 8.5 ) Hepatic Impairment: Avoid use in patients with hepatic impairment.
( 8.7 )
8.1 Pregnancy Risk Summary Limited data with Metformin Hydrochloride in pregnant women are not sufficient to determine a drug-associated risk for major birth defects or miscarriage.
Published studies with metformin use during pregnancy have not reported a clear association with metformin and major birth defect or miscarriage risk [see Data].
There are risks to the mother and fetus associated with poorly controlled diabetes mellitus in pregnancy [see Clinical Considerations].
No adverse developmental effects were observed when metformin was administered to pregnant Sprague Dawley rats and rabbits during the period of organogenesis at doses up to 2-and 5times, respectively, a 2550 mg clinical dose, based on body surface area [see Data].
The estimated background risk of major birth defects is 6–10% in women with pre-gestational diabetes mellitus with an HbA1C >7 and has been reported to be as high as 20–25% in women with a HbA1C >10.
The estimated background risk of miscarriage for the indicated population is unknown.
In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2–4% and 15–20%, respectively.
Clinical Considerations Disease-associated maternal and/or embryo/fetal risk Poorly-controlled diabetes mellitus in pregnancy increases the maternal risk for diabetic ketoacidosis, pre-eclampsia, spontaneous abortions, preterm delivery, stillbirth and delivery complications.
Poorly controlled diabetes mellitus increases the fetal risk for major birth defects, stillbirth, and macrosomia related morbidity.
Data Human Data Published data from post-marketing studies have not reported a clear association with metformin and major birth defects, miscarriage, or adverse maternal or fetal outcomes when metformin was used during pregnancy.
However, these studies cannot definitely establish the absence of any metformin-associated risk because of methodological limitations, including small sample size and inconsistent comparator groups.
Animal Data Metformin hydrochloride did not adversely affect development outcomes when administered to pregnant rats and rabbits at doses up to 600 mg/kg/day.
This represents an exposure of about 2 and 5 times a 2550 mg clinical dose based on body surface area comparisons for rats and rabbits, respectively.
Determination of fetal concentrations demonstrated a partial placental barrier to metformin.
8.2 Lactation Risk Summary Limited published studies report that metformin is present in human milk [see Data].
However, there is insufficient information to determine the effects of metformin on the breastfed infant and no available information on the effects of metformin on milk production.
Therefore, the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Metformin Hydrochloride and any potential adverse effects on the breastfed child from Metformin Hydrochloride or from the underlying maternal condition.
Data Published clinical lactation studies report that metformin is present in human milk which resulted in infant doses approximately 0.11% to 1% of the maternal weight-adjusted dosage and a milk/plasma ratio ranging between 0.13 and 1.
However, the studies were not designed to definitely establish the risk of use of metformin during lactation because of small sample size and limited adverse event data collected in infants.
8.3 Females and Males of Reproductive Potential Discuss the potential for unintended pregnancy with premenopausal women as therapy with Metformin Hydrochloride Tablets may result in ovulation in some anovulatory women.
8.4 Pediatric Use Metformin Hydrochloride Tablets The safety and effectiveness of Metformin Hydrochloride Tablets for the treatment of type 2 diabetes mellitus have been established in pediatric patients 10 to 16 years old.
Safety and effectiveness of Metformin Hydrochloride have not been established in pediatric patients less than 10 years old.
Use of Metformin Hydrochloride Tablets in pediatric patients 10 to 16 years old for the treatment of type 2 diabetes mellitus is supported by evidence from adequate and well-controlled studies of Metformin Hydrochloride Tablets in
adults with additional data from a controlled clinical study in pediatric patients 10 to 16 years old with type 2 diabetes mellitus, which demonstrated a similar response in glycemic control to that seen in
adults [see Clinical Studies (14.1) ] .
In this study, adverse reactions were similar to those described in adults.
A maximum daily dose of 2000 mg of Metformin Hydrochloride Tablets are recommended. [See Dosage and Administration (2.2) ].
8.5 Geriatric Use Controlled clinical studies of Metformin Hydrochloride Tablets did not include sufficient numbers of elderly patients to determine whether they respond differently from younger patients.
In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy and the higher risk of lactic acidosis.
Assess renal function more frequently in elderly patients [see Warnings and Precautions (5.1) ].
8.6 Renal Impairment Metformin is substantially excreted by the kidney, and the risk of metformin accumulation and lactic acidosis increases with the degree of renal impairment.
Metformin Hydrochloride is contraindicated in severe renal impairment, patients with an estimated glomerular filtration rate (eGFR) below 30 mL/min/1.73 m 2 [see Dosage and Administration (2.3) , Contraindications (4) , Warnings and Precautions (5.1) , and Clinical Pharmacology (12.3) ].
8.7 Hepatic Impairment Use of metformin in patients with hepatic impairment has been associated with some cases of lactic acidosis.
Metformin Hydrochloride is not recommended in patients with hepatic impairment. [see Warnings and Precautions (5.1) ].
Risk Summary Limited data with Metformin Hydrochloride in pregnant women are not sufficient to determine a drug-associated risk for major birth defects or miscarriage.
Published studies with metformin use during pregnancy have not reported a clear association with metformin and major birth defect or miscarriage risk [see Data].
There are risks to the mother and fetus associated with poorly controlled diabetes mellitus in pregnancy [see Clinical Considerations].
No adverse developmental effects were observed when metformin was administered to pregnant Sprague Dawley rats and rabbits during the period of organogenesis at doses up to 2-and 5times, respectively, a 2550 mg clinical dose, based on body surface area [see Data].
The estimated background risk of major birth defects is 6–10% in women with pre-gestational diabetes mellitus with an HbA1C >7 and has been reported to be as high as 20–25% in women with a HbA1C >10.
The estimated background risk of miscarriage for the indicated population is unknown.
In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2–4% and 15–20%, respectively.
Clinical Considerations Disease-associated maternal and/or embryo/fetal risk Poorly-controlled diabetes mellitus in pregnancy increases the maternal risk for diabetic ketoacidosis, pre-eclampsia, spontaneous abortions, preterm delivery, stillbirth and delivery complications.
Poorly controlled diabetes mellitus increases the fetal risk for major birth defects, stillbirth, and macrosomia related morbidity.
Data Human Data Published data from post-marketing studies have not reported a clear association with metformin and major birth defects, miscarriage, or adverse maternal or fetal outcomes when metformin was used during pregnancy.
However, these studies cannot definitely establish the absence of any metformin-associated risk because of methodological limitations, including small sample size and inconsistent comparator groups.
Animal Data Metformin hydrochloride did not adversely affect development outcomes when administered to pregnant rats and rabbits at doses up to 600 mg/kg/day.
This represents an exposure of about 2 and 5 times a 2550 mg clinical dose based on body surface area comparisons for rats and rabbits, respectively.
Determination of fetal concentrations demonstrated a partial placental barrier to metformin.
Risk Summary Limited published studies report that metformin is present in human milk [see Data].
However, there is insufficient information to determine the effects of metformin on the breastfed infant and no available information on the effects of metformin on milk production.
Therefore, the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Metformin Hydrochloride and any potential adverse effects on the breastfed child from Metformin Hydrochloride or from the underlying maternal condition.
Data Published clinical lactation studies report that metformin is present in human milk which resulted in infant doses approximately 0.11% to 1% of the maternal weight-adjusted dosage and a milk/plasma ratio ranging between 0.13 and 1.
However, the studies were not designed to definitely establish the risk of use of metformin during lactation because of small sample size and limited adverse event data collected in infants.
8.3 Females and Males of Reproductive Potential Discuss the potential for unintended pregnancy with premenopausal women as therapy with Metformin Hydrochloride Tablets may result in ovulation in some anovulatory women.
Metformin Hydrochloride Tablets The safety and effectiveness of Metformin Hydrochloride Tablets for the treatment of type 2 diabetes mellitus have been established in pediatric patients 10 to 16 years old.
Safety and effectiveness of Metformin Hydrochloride have not been established in pediatric patients less than 10 years old.
Use of Metformin Hydrochloride Tablets in pediatric patients 10 to 16 years old for the treatment of type 2 diabetes mellitus is supported by evidence from adequate and well-controlled studies of Metformin Hydrochloride Tablets in
adults with additional data from a controlled clinical study in pediatric patients 10 to 16 years old with type 2 diabetes mellitus, which demonstrated a similar response in glycemic control to that seen in
adults [see Clinical Studies (14.1) ] .
In this study, adverse reactions were similar to those described in adults.
A maximum daily dose of 2000 mg of Metformin Hydrochloride Tablets are recommended. [See Dosage and Administration (2.2) ].
Controlled clinical studies of Metformin Hydrochloride Tablets did not include sufficient numbers of elderly patients to determine whether they respond differently from younger patients.
In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy and the higher risk of lactic acidosis.
Assess renal function more frequently in elderly patients [see Warnings and Precautions (5.1) ].
8.6 Renal Impairment Metformin is substantially excreted by the kidney, and the risk of metformin accumulation and lactic acidosis increases with the degree of renal impairment.
Metformin Hydrochloride is contraindicated in severe renal impairment, patients with an estimated glomerular filtration rate (eGFR) below 30 mL/min/1.73 m 2 [see Dosage and Administration (2.3) , Contraindications (4) , Warnings and Precautions (5.1) , and Clinical Pharmacology (12.3) ].
8.7 Hepatic Impairment Use of metformin in patients with hepatic impairment has been associated with some cases of lactic acidosis. Metformin Hydrochloride is not recommended in patients with hepatic impairment. [see Warnings and Precautions (5.1) ].

Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.

Other medicines

Table 3 presents clinically significant drug interactions with Metformin Hydrochloride tablets.
Table 3:
Clinically Significant Drug Interactions with Metformin Hydrochloride 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 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 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 Metformin Hydrochloride.
Examples: Ranolazine, vandetanib, dolutegravir, and cimetidine.
Alcohol Clinical Impact:
Alcohol is known to potentiate the effect of metformin on lactate metabolism.
Intervention:
Warn patients against excessive alcohol intake while receiving Metformin Hydrochloride.
Insulin Secretagogues or Insulin Clinical Impact:
Coadministration of Metformin Hydrochloride with an insulin secretagogue (e.g., sulfonylurea) or insulin may increase the risk of hypoglycemia.
Intervention:
Patients receiving an insulin secretagogue or insulin may require lower doses of the insulin secretagogue or insulin.
Drugs Affecting Glycemic Control Clinical Impact:
Certain drugs tend to produce hyperglycemia and may lead to loss of glycemic control.
Intervention:
When such drugs are administered to a patient receiving Metformin Hydrochloride, observe the patient closely for loss of blood glucose control.
When such drugs are withdrawn from a patient receiving Metformin Hydrochloride tablets, observe the patient closely for hypoglycemia.
Examples:
Thiazides and other diuretics, corticosteroids, phenothiazines, thyroid products, estrogens, oral contraceptives, phenytoin, nicotinic acid, sympathomimetics, calcium channel blockers, and isoniazid.
Carbonic anhydrase inhibitors may increase risk of lactic acidosis.
Consider more frequent monitoring ( 7 ) Drugs that reduce metformin clearance (such as ranolazine, vandetanib, dolutegravir, and cimetidine) may increase the accumulation of metformin.
Consider the benefits and risks of concomitant use ( 7 ) Alcohol can potentiate the effect of metformin on lactate metabolism.
Warn patients against excessive alcohol intake ( 7 )
In Vivo Assessment of Drug Interactions Table 5:
Effect of Coadministered Drug on Plasma Metformin Systemic Exposure Coadministered Drug Dose of Coadministered Drug Dose of Metformin All metformin and coadministered drugs were given as single doses Geometric Mean Ratio (ratio with/without coadministered drug) No Effect =
1.00 AUC AUC = AUC(INF) C max No dosing adjustments required for the following:
Glyburide 5 mg 850 mg metformin
Ratio of arithmetic means
0.93 Furosemide 40 mg 850 mg metformin 1.09
1.22 Nifedipine 10 mg 850 mg metformin 1.16
1.21 Propranolol 40 mg 850 mg metformin 0.90
0.94 Ibuprofen 400 mg 850 mg metformin 1.05
1.07 Cationic drugs eliminated by renal tubular secretion may reduce metformin elimination.
Cimetidine 400 mg 850 mg metformin 1.40
1.61 Carbonic anhydrase inhibitors may cause metabolic acidosis [See Warnings and Precautions (5.1) ] Topiramate 100 mg At steady state with topiramate 100 mg every 12 hours and metformin 500 mg every 12 hours;
AUC = AUC 0-12h 500 mg metformin 1.25
1.17 Table 6:
Effect of Metformin on Coadministered Drug Systemic Exposure Coadministered Drug Dose of Coadministered Drug All metformin and coadministered drugs were given as single doses Dose of Metformin Geometric Mean Ratio (ratio with/without metformin) No Effect =
1.00 AUC AUC = AUC(INF) unless otherwise noted C max No dosing adjustments required for the following:
Glyburide 5 mg 850 mg glyburide
0.78 Ratio of arithmetic means, p-value of difference <0.05
0.63 Furosemide 40 mg 850 mg furosemide 0.87
Nifedipine 10 mg 850 mg nifedipine
AUC(0-24 hr) reported
1.08 Propranolol 40 mg 850 mg propranolol 1.01
Ibuprofen 400 mg 850 mg ibuprofen
Ratio of arithmetic means
1.01 Cimetidine 400 mg 850 mg cimetidine 0.95 1.01

Quoted from the official label, section “Drug Interactions”.

If you take too much

In an emergency, call your local emergency number or a poison control centre.

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 metformin has been established.
Lactic acidosis has been reported in approximately 32% of metformin overdose cases [see Warnings and Precautions (5.1) ].
Metformin is dialyzable with a clearance of up to 170 mL/min under good hemodynamic conditions.
Therefore, hemodialysis may be useful for removal of accumulated drug from patients in whom metformin overdosage is suspected.

Quoted from the official label, section “Overdosage”.

Side effects

The following adverse reactions are also discussed elsewhere in 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) ] For Metformin Hydrochloride 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 ACI Healthcare USA, Inc. at 1-888-802-1213 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 in patients with type 2 diabetes mellitus, a total of 141 patients received Metformin Hydrochloride up to 2550 mg per day.
Adverse reactions reported in greater than 5% of Metformin Hydrochloride treated patients and that were more common than in placebo-treated patients, are listed in Table 1.
Table 1:
Adverse Reactions from a Clinical Trial of Metformin Hydrochloride Occurring >5% and More Common than Placebo in Patients with Type 2 Diabetes Mellitus Metformin Hydrochloride (n=141) Placebo (n=145) Diarrhea 53% 12% Nausea/Vomiting 26% 8% Flatulence 12% 6% Asthenia 9% 6% Indigestion 7% 4% Abdominal Discomfort 6% 5% Headache 6% 5% Diarrhea led to discontinuation of Metformin Hydrochloride in 6% of patients.
Additionally, the following adverse reactions were reported in ≥1% to ≤5% of Metformin Hydrochloride treated patients and were more commonly reported with Metformin Hydrochloride than placebo:
abnormal stools, hypoglycemia, myalgia, lightheaded, dyspnea, nail disorder, rash, sweating increased, taste disorder, chest discomfort, chills, flu syndrome, flushing, palpitation.
In Metformin Hydrochloride clinical trials of 29-week duration, a decrease to subnormal levels of previously normal serum vitamin B 12 levels was observed in approximately 7% of patients.
Pediatric Patients In clinical trials with Metformin Hydrochloride Tablets in pediatric patients with type 2 diabetes mellitus, the profile of adverse reactions was similar to that observed in
adults.
6.2 Postmarketing Experience The following adverse reactions have been identified during post approval use of metformin.
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Cholestatic, hepatocellular, and mixed hepatocellular liver injury have been reported with postmarketing use of metformin.
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 in patients with type 2 diabetes mellitus, a total of 141 patients received Metformin Hydrochloride up to 2550 mg per day.
Adverse reactions reported in greater than 5% of Metformin Hydrochloride treated patients and that were more common than in placebo-treated patients, are listed in Table 1.
Table 1:
Adverse Reactions from a Clinical Trial of Metformin Hydrochloride Occurring >5% and More Common than Placebo in Patients with Type 2 Diabetes Mellitus Metformin Hydrochloride (n=141) Placebo (n=145) Diarrhea 53% 12% Nausea/Vomiting 26% 8% Flatulence 12% 6% Asthenia 9% 6% Indigestion 7% 4% Abdominal Discomfort 6% 5% Headache 6% 5% Diarrhea led to discontinuation of Metformin Hydrochloride in 6% of patients.
Additionally, the following adverse reactions were reported in ≥1% to ≤5% of Metformin Hydrochloride treated patients and were more commonly reported with Metformin Hydrochloride than placebo:
abnormal stools, hypoglycemia, myalgia, lightheaded, dyspnea, nail disorder, rash, sweating increased, taste disorder, chest discomfort, chills, flu syndrome, flushing, palpitation.
In Metformin Hydrochloride clinical trials of 29-week duration, a decrease to subnormal levels of previously normal serum vitamin B 12 levels was observed in approximately 7% of patients.
Pediatric Patients In clinical trials with Metformin Hydrochloride Tablets in pediatric patients with type 2 diabetes mellitus, the profile of adverse reactions was similar to that observed in
adults.
6.2 Postmarketing Experience The following adverse reactions have been identified during post approval use of metformin.
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Cholestatic, hepatocellular, and mixed hepatocellular liver injury have been reported with postmarketing use of metformin.

Quoted from the official label, section “Adverse Reactions”.

What to discuss with your doctor

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 development.
Advise patients to discontinue Metformin Hydrochloride Tablets immediately and to promptly notify their healthcare provider if unexplained hyperventilation, myalgias, malaise, unusual somnolence or other nonspecific symptoms occur.
Counsel patients against excessive alcohol intake and inform patients about importance of regular testing of renal function while receiving Metformin Hydrochloride Tablets.
Instruct patients to inform their doctor that they are taking Metformin Hydrochloride Tablets prior to any surgical or radiological procedure, as temporary discontinuation may be required [see Warnings and Precautions (5.1) ].
Hypoglycemia Inform patients that hypoglycemia may occur when Metformin Hydrochloride Tablets are coadministered with oral sulfonylureas and insulin.
Explain to patients receiving concomitant therapy the risks of hypoglycemia, its symptoms and treatment, and conditions that predispose to its development [see Warnings and Precautions (5.3) ].
Vitamin B 12 Deficiency:
Inform patients about importance of regular hematological parameters while receiving Metformin Hydrochloride Tablets [see Warnings and Precautions (5.2) ].
Females of Reproductive Age:
Inform females that treatment with Metformin Hydrochloride Tablets may result in ovulation in some premenopausal anovulatory women which may lead to unintended pregnancy [see Use in Specific Populations (8.3) ].
All trademarks are the property of their respective owners.
Manufactured by:
ScieGen Pharmaceuticals Inc Hauppauge NY 11788 Distributed by:
ACI Healthcare USA, Inc. 10100 W.
Sample Road, Suite 406 Coral Springs, FL 33065 Rev: 06/19

Quoted from the official label, section “Patient Counseling Information”.

Strengths and forms

FORMS AND STRENGTHS Metformin Hydrochloride Tablets, USP are available as:
Metformin Hydrochloride Tablets, USP 500 mg are blackberry flavored, white to off-white, round, biconvex, beveled edge film coated tablets, debossed with ‘SG’ on one side ‘105’ on other side.
Metformin Hydrochloride Tablets, USP 850 mg are blackberry flavored, white to off-white, round, biconvex, beveled edge film coated tablets, debossed with ‘SG’ on one side ‘106’ on other side.
Metformin Hydrochloride Tablets, USP 1000 mg tablets are blackberry flavored, white to off-white, oval, biconvex, film coated tablets debossed on one side with S on the left side of bisect and G on the right side of bisect and other side 1 on the left side and 07 on the right side of the bisect.
Metformin Hydrochloride Tablets, USP: 500 mg, 850 mg, and 1000 mg ( 3 )

Quoted from the official label, section “Dosage Forms & Strengths”.

What it looks like and how it is packed

16.1 How Supplied Table 13:
Metformin Hydrochloride Tablets Available Strengths, Units, and Appearance Metformin Hydrochloride Tablets 500 mg Bottles of 100 NDC 71093-132-04 Metformin Hydrochloride Tablets, USP 500 mg are blackberry flavored, white to off-white, round, biconvex, beveled edge film coated tablets, debossed with ‘SG’ on one side ‘105’ on other side.
Bottles of 500 NDC 71093-132-05 Bottles of 1000 NDC 71093-132-06 850 mg Bottles of 100 NDC 71093-133-04 Metformin Hydrochloride Tablets, USP 850 mg are blackberry flavored, white to off-white, round, biconvex, beveled edge film coated tablets, debossed with ‘SG’ on one side ‘106’ on other side.
Bottles of 500 NDC 71093-133-05 1000 mg Bottles of 100 NDC 71093-134-04 Metformin Hydrochloride Tablets, USP 1000 mg tablets are blackberry flavored, white to off-white, oval, biconvex, film coated tablets debossed on one side with S on the left side of bisect and G on the right side of bisect and other side 1 on the left side and 07 on the right side of the bisect.
Bottles of 500 NDC 71093-134-05
Storage
Store at 20°to 25° C (68°to 77° F); excursions permitted to 15° to 30° C (59° to 86° F). [See USP Controlled Room Temperature.]
Table 13:
Metformin Hydrochloride Tablets Available Strengths, Units, and Appearance Metformin Hydrochloride Tablets 500 mg Bottles of 100 NDC 71093-132-04 Metformin Hydrochloride Tablets, USP 500 mg are blackberry flavored, white to off-white, round, biconvex, beveled edge film coated tablets, debossed with ‘SG’ on one side ‘105’ on other side.
Bottles of 500 NDC 71093-132-05 Bottles of 1000 NDC 71093-132-06 850 mg Bottles of 100 NDC 71093-133-04 Metformin Hydrochloride Tablets, USP 850 mg are blackberry flavored, white to off-white, round, biconvex, beveled edge film coated tablets, debossed with ‘SG’ on one side ‘106’ on other side.
Bottles of 500 NDC 71093-133-05 1000 mg Bottles of 100 NDC 71093-134-04 Metformin Hydrochloride Tablets, USP 1000 mg tablets are blackberry flavored, white to off-white, oval, biconvex, film coated tablets debossed on one side with S on the left side of bisect and G on the right side of bisect and other side 1 on the left side and 07 on the right side of the bisect.
Bottles of 500 NDC 71093-134-05
Store at 20°to 25° C (68°to 77° F); excursions permitted to 15° to 30° C (59° to 86° F). [See USP Controlled Room Temperature.]

Quoted from the official label, section “How Supplied”.

What is in it

Metformin Hydrochloride Tablets, USP contain the antihyperglycemic agent metformin, which is a biguanide, in the form of monohydrochloride. The chemical name of metformin hydrochloride is N,N -dimethylimidodicarbonimidic diamide hydrochloride. The structural formula is as shown below Metformin hydrochloride is a white crystalline compound with a molecular formula of C 4 H 11 N 5
HCl and a molecular weight of 165.63. Metformin hydrochloride is freely soluble in water, slightly soluble in alcohol, practically insoluble in acetone and in methylene hydrochloride. The pK a of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. Metformin Hydrochloride Tablets contain 500 mg, 850 mg, or 1000 mg of metformin hydrochloride, which is equivalent to 389.93 mg, 662.88 mg, 779.86 mg metformin base, respectively. Each tablet contains the inactive ingredients pregelatinized starch (maize), povidone, crospovidone, magnesium stearate. In addition, the coating for the tablets contains Hypromellose, polyethylene glycol, titanium dioxide and flavoring agent contains dextrose, ethyl alcohol, gum arabic, propylene glycol and silicon dioxide. Chem-structure

Quoted from the official label, section “Description”.

Ingredients people check for

Lactose, gluten, dyes, sugars and other ingredients that matter with an allergy, intolerance or diet — as this product’s FDA label lists them.

This label’s list of inactive ingredients names none of: lactose, wheat or gluten, colour dyes, sugars, sugar alcohols, alcohol (ethanol), aspartame (phenylalanine), gelatin, peanut oil, soy, parabens, sulfites, titanium dioxide.

Quoted from the FDA label. A label that does not name an ingredient is not a guarantee that the product is free of it, and formulations change. With an allergy, check the pack and ask a pharmacist.

Every version of this medicine (122)

The same active substance, strength and kind of form, from every company that sells it — with what each label lists.

Showing 80 of 80 (the first 80 are listed)

Same active substance, strength and form in other countries

Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.

Medicine passport: one printable page to show a pharmacist abroad

Canada39 matching products

Every strength and form (80)

Details

Made by	ACI Healthcare USA, Inc.
Active substance	Metformin Hydrochloride
Used in	Digestion, stomach, diabetes and nutrition
Strength	500 mg
Form	Tablet
Route	Oral
Packs	100 TABLET in 1 BOTTLE, PLASTIC · 500 TABLET in 1 BOTTLE, PLASTIC
NDC	71093-132

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

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Other strengths and forms

250 products are sold under this name. Grouped by form; a number on a strength means several companies make it.

Tablet75 products
- 500 mg25
  500 mg · 25 companies
  - A-S Medication Solutions
  - ACI Healthcare USA, Inc. · this page
  - Amneal Pharmaceuticals of New York LLC
  - Aphena Pharma Solutions - Tennessee, LLC
  - Bryant Ranch Prepack
  - Cardinal Health 107, LLC
  - Chartwell RX, LLC
  - Coupler LLC
  +17 more
- 625 mg4
  625 mg · 4 companies
- 750 mg4
  750 mg · 4 companies
- 850 mg19
  850 mg · 19 companies
  +11 more
- 1000 mg23
  1000 mg · 23 companies
  +15 more
Tablet, Extended Release71 products
- 500 mg36
  500 mg · 36 companies
  +28 more
- 750 mg24
  750 mg · 24 companies
  +16 more
- 1000 mg11
  1000 mg · 11 companies
  +3 more
Tablet, Film Coated70 products
- 500 mg25
  500 mg · 25 companies
  +17 more
- 850 mg19
  850 mg · 19 companies
  +11 more
- 1000 mg26
  1000 mg · 26 companies
  +18 more
Tablet, Film Coated, Extended Release19 products
- 500 mg9
  500 mg · 9 companies
  +1 more
- 1000 mg10
  1000 mg · 10 companies
  +2 more

Show all forms · 6 forms

Tablet, Coated13 products
- 500 mg4
  500 mg · 4 companies
- 850 mg3
  850 mg · 3 companies
- 1000 mg6
  1000 mg · 6 companies
Solution2 products
- 500 mg/5mL2
  500 mg/5mL · 2 companies
  - Camber Pharmaceuticals, Inc.
  - VistaPharm, LLC

Same active substance

These contain the same substance. That does not mean one can replace another — ask a pharmacist.

Glumetza500 mgPrescription onlyTablet, Film Coated, Extended Release Santarus, Inc. · Metformin Hydrochloride Glumetza1000 mgPrescription onlyTablet, Film Coated, Extended Release Santarus, Inc. · Metformin Hydrochloride Metformin Hydrochloride500 mgPrescription onlyTablet, Film Coated Mylan Pharmaceuticals Inc. · Metformin Hydrochloride Metformin Hydrochloride850 mgPrescription onlyTablet, Film Coated Mylan Pharmaceuticals Inc. · Metformin Hydrochloride Metformin Hydrochloride1000 mgPrescription onlyTablet, Film Coated Mylan Pharmaceuticals Inc. · Metformin Hydrochloride Metformin Hydrochloride500 mgPrescription onlyTablet, Film Coated NCS HealthCare of KY, LLC dba Vangard Labs · Metformin Hydrochloride

See every product with Metformin Hydrochloride

Metformin Hydrochloride

At a glance

What it is for