Glyburide And Metformin Hydrochloride - Glyburide And Metformin Hydrochloride tablet
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Check Drug InteractionsGlyburide And Metformin Hydrochloride - Glyburide And Metformin Hydrochloride tablet Prescribing Information
Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metforminassociated 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)
and Warnings and Precautions (5.1)
].If metformin-associated lactic acidosis is suspected, immediately discontinue glyburide and metformin hydrochloride and institute general supportive measures in a hospital setting. Prompt hemodialysis is recommended [see
Warnings and Precautions (5.1)
].Glyburide and metformin hydrochloride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Adult Dosage:
- Give glyburide and metformin hydrochloride tablets in divided doses, twice daily, with meals. (2.1)
- For patients not treated with either glyburide (or another sulfonylurea) or metformin HCl, initiate treatment with another formulation with a dose of 1.25 mg glyburide and 250 mg metformin HCl orally, once or twice daily with meals. (2.1)
- For patients not adequately controlled on either glyburide (or another sulfonylurea) or metformin HCl alone, the recommended starting dose is 2.5 mg/500 mg or 5 mg/500 mg orally twice daily with meals. (2.1)
- For patients previously treated with a combination therapy of glyburide (or another sulfonylurea) and metformin HCl, the starting dose should not exceed the daily dose of glyburide (or equivalent dose of another sulfonylurea) and metformin HCl already being taken. (2.1)
- Increase the dose gradually on the basis of glycemic control and tolerability, up to a maximum to a maximum dose of 20 mg glyburide/2,000 mg metformin HCl daily. (2.1)
Renal Impairment:
Prior to initiation, assess renal function with estimated glomerular filtration rate (eGFR) (2.4)
- Do not use in patients with eGFR below 30 mL/minute/1.73 m2(2.4)
- Initiation is not recommended in patients with eGFR between 30 to 45 mL/minute/1.73 m2(2.4)
- Assess risk/benefit if eGFR falls below 45 mL/minute/1.73 m2(2.4)
- Discontinue if eGFR falls below 30 mL/minute/1.73 m2(2.4)
Discontinuation for Iodinated Contrast Imaging Procedures:
- Glyburide and metformin hydrochloride tablets may need to be discontinued at time of, or prior to, iodinated contrast imaging procedures (2.5)
Glyburide and metformin hydrochloride tablets, USP are available as:
- Tablets:Glyburide, USP 1.25 mg and metformin hydrochloride, USP 250 mg white to off-white colored, capsule shaped, biconvex coated tablets, debossed with "653" on one side and plain on the other side
- Tablets:Glyburide, USP 2.5 mg and metformin hydrochloride, USP 500 mg tan to scarlet yellow colored, capsule shaped, biconvex coated tablets debossed with "654" on one side and plain on the other side
- Tablets:Glyburide, USP 5 mg and metformin hydrochloride, USP 500 mg are pale yellow colored, capsule shaped, biconvex coated tablets, debossed with "655" on one side and plain on the other side
- Pregnancy: Glyburide and metformin hydrochloride tablets should be discontinued at least two weeks before expected delivery. (8.1)
- 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)
Glyburide and metformin hydrochloride tablets are contraindicated in patients with:
- Severe renal impairment (eGFR below 30 mL/min/1.73 m2) [see WarningsandPrecautions (5.1)].
- Hypersensitivity to metformin or glyburide.
- Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma.
- Concomitant administration of bosentan [see Drug Interactions (7)].
We receive information directly from the FDA and PrescriberPoint is updated as frequently as changes are made available