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Check Drug InteractionsMetformin Hcl Prescribing Information
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, 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 Hydrochloride Tablets and institute general supportive measures in a hospital setting. Prompt haemodialysis is recommended [see Warnings and Precautions (5.1) ]. |
Metformin Hydrochloride Tablets, USP is indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus.
2.1 Adult Dosage
- The recommended starting dose of Metformin Hydrochloride Tablet 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 Tablet
- The recommended starting dose of Metformin Hydrochloride Tablet 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 Tablet and periodically thereafter.
- Metformin Hydrochloride Tablet is contraindicated in patients with an estimated glomerular filtration rate (eGFR) below 30 mL/minute/1.73 m
2. - Initiation of Metformin Hydrochloride Tablet in patients with an eGFR between 30 – 45 mL/minute/1.73 m
2is not recommended. - In patients taking Metformin Hydrochloride Tablet whose eGFR later falls below 45 mL/min/1.73 m
2, assess the benefit risk of continuing therapy. - Discontinue Metformin Hydrochloride Tablet 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 Tablet 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 intraarterial iodinated contrast. Re-evaluate eGFR 48 hours after the imaging procedure; restart Metformin Hydrochloride Tablet if renal function is stable.
Metformin Hydrochloride Tablet is available as:
- 500 mg:white to off-white colored, film coated, round shaped tablet with beveled edges on both side and debossed with ‘134’ on one side and plain on other side.
- 850 mg:white to off-white colored, film coated, round shaped tablet with beveled edges on both side and debossed with ‘131’ on one side and plain on other side.
- 1000 mg:white to off-white colored, film coated, oval shaped tablet with ‘132’ debossed on one side and breakline on both sides.
8.1
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.
We receive information directly from the FDA and PrescriberPoint is updated as frequently as changes are made available