Glyburide / metformin

Class
Hypoglycemic agents
Subclass
Sulfonylurea / biguanide combination
Substance name
Glyburide / metFORMIN, glibenclamide / metformin
Brand names
Glucovance®
Contains
Glyburide
Metformin
Common formulations
Film-coated tablet
See also
Metformin ER (Fortamet®, Glumetza®)
Dosage and administration
Adults patients
Treatment of diabetes mellitus type 2
Start at: 1.25/250 mg PO q12-24h
Maintenance: 1.25-10/250-1,000 mg PO q12-24h
Maximum: 20/2,000 mg per day
Taken with food. Titrate in 1.25/250 mg increments every 2 weeks to target blood glucose level. Start at 2.5/500 mg or 5/500 mg BID in patients with an inadequate response to sulfonylurea and/or metformin, and titrate in 5/500 mg increments.
Indications for use
Labeled indications
Adults
Treatment of diabetes mellitus type 2
Safety risks
Contraindications
Hypersensitivity to glyburide/metformin or its components
G6PD deficiency
Metabolic acidosis
Do not use metformin in patients with acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma.
T1DM or diabetic ketoacidosis
Use of iodine-containing contrast medium
Discontinueg glyburide/metformin in patients undergoing imaging studies involving intravascular administration of iodinated contrast materials.
Concomitant use of bosentan
Warnings and precautions
Cardiovascular mortality
Maintain a high level of suspicion, as the risk of increased cardiovascular mortality observed with tolbutamide may also apply to other sulfonylureas.
Decreased blood glucose
Use caution in patients at risk for hypoglycemia, including elderly patients, concomitant use of other hypoglycemic medications or alcohol, patients with renal, hepatic, adrenal, or pituitary impairment, malnutrition, calorie deficit, or after severe or prolonged exercise.
Decreased serum glyburide levels
Use caution in patients taking colesevelam. Advise taking glyburide/metformin at least 4 hours before colesevelam.
Decreased serum vitamin B12
Maintain a high level of suspicion, as metformin has been associated with an increased risk of vitamin B12 deficiency. Assess hematologic parameters annually and vitamin B12 every 2-3 years.
Lactic acidosis
Use extreme caution in patients with renal impairment, concomitant use of certain drugs (carbonic anhydrase inhibitors, such as topiramate), age ≥ 65 years, undergoing a radiological evaluation with contrast, surgery, and other procedures, hypoxic states (such as acute congestive HF), excessive alcohol intake, and hepatic impairment. Assess eGFR before initiating metformin and monitor annually or more frequent in patients at risk of renal impairment.
Specific populations
Renal impairment
eGFR > 45 mL/min/1.73 m²
Use with caution. Monitor for hypoglycemia.
eGFR 30-45 mL/min/1.73 m²
Do not initiate. Assess the benefit/risk of continuing therapy in patients previously on treatment.
eGFR < 30 mL/min/1.73 m²
Do not use.
Renal replacement therapy
Any modality
Do not use.
Hepatic impairment
Any severity
Avoid use.
Substantial chronic alcohol consumption
Avoid use.
Pregnancy and breastfeeding
Pregnancy
All trimesters • Australia Category: C
Consider safer alternatives. Insulin is the preferred first-line treatment for diabetes in pregnancy.
The ACOG guidelines suggest metformin as a second-line choice in patients declining insulin or are unable to safely administer insulin. The American Diabetes Association guidelines recommend discontinuing metformin, when used to treat PCOS and induce ovulation, by the end of the first trimester.
Glyburide can be considered as a third-line option for gestational diabetes mellitus. Discontinue glyburide, if being used during pregnancy, at least 2 weeks before the expected delivery date to decrease the risk of neonatal hypoglycemia.
Breastfeeding
Use only if benefits outweigh potential risks.
The Endocrine Society guidelines recommend that breastfeeding patients with overt diabetes, who have successfully used metformin or glyburide during pregnancy, continue to use these medications during breastfeeding if necessary.
Low levels in breastfed infants (5-25%).
May potentially cause adverse effects in breastfed infants.
Adverse reactions
Very common > 10%
↓ blood glucose, diarrhea
Common 1-10%
Abdominal pain, dizziness, headache, nausea, vomiting, pruritus, urticaria, skin erythema, morbilliform rash, maculopapular rash
Unknown frequency
Angioedema, arthralgia, myalgia, photosensitivity of skin, ↓ WBC count, ↓ platelet count, agranulocytosis, purpura, pancytopenia, jaundice, ↓ serum sodium, blurred vision, vasculitis, porphyria cutanea tarda, hemolytic anemia, aplastic anemia, cholestasis, hepatitis, hepatic porphyria, disulfiram-like reaction, syndrome of inappropriate antidiuretic hormone secretion
Interactions
Drug(s)
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