Glyburide And Metformin Hydrochloride Medication Summary
No separate FDA Medication Guide was found for this label. This summary is based on FDA/DailyMed prescribing information.
What is this medication?
glyburide and metformin hydrochloride is described in FDA/DailyMed prescribing information. No separate FDA Medication Guide was found for this label. This summary is based on FDA/DailyMed prescribing information.
What is this medication used for?
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.
What should I know before taking it?
Glyburide and metformin hydrochloride tablets are contraindicated in patients with: Severe renal impairment (eGFR below 30 mL/min/1.73 m2) [see Warnings and Precautions (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) ].
What important warnings are listed?
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. Risk factors for metformin-associated lactic acidosis include renal impairment, concomitant use of certain drugs.
How is this medication usually taken?
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
What side effects are listed?
The following adverse reactions are also discussed elsewhere in the labeling: Lactic Acidosis [see Boxed Warning and Warnings and Precautions (5.1) ]Hypoglycemia [see Warnings and Precautions (5.2) ]Cardiovascular mortality [see Warnings and Precautions (5.3) ]Hemolytic anemia [see Warnings and Precautions (5.4 )]Vitamin B12Deficiency [see Warnings and Precautions (5.5) ]
What interactions are listed?
Table 3 presents clinically significant drug interactions with glyburide and metformin hydrochloride. 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 glyburide and metformin hydrochloride may increase the risk for lactic acidosis. Intervention: Consider more frequent monitoring of these patients. Examples: Topiramate, zonisamide, acetazolamide and dichlorphenamide. Drugs that Reduce Metformin Clearance Clinical Impact: Concomitant use of drugs that interfere with common renal tubular transport systems involved in the.
Where can I find the official prescribing information?
Review the full prescribing information on DailyMed: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=2239742b-74e1-4bc2-b5a8-15c4758d6f7b
⚠️ Disclaimer
This summary is for educational purposes only and is not medical advice. Always consult your doctor, pharmacist, or other licensed healthcare professional before starting, stopping, or changing any medicine. Read full medical disclaimer.