A-Z Drug Facts > Glyburide/Metformin Hydrochloride

Glyburide / Metformin Hydrochloride

Pronouncation: (glie-BYOO-ride/met-FORE-min HIGH-droe-KLOR-ide)
Class: Antidiabetic combination

Trade Names:
Glucovance
- Tablets 1.25 mg (glyburide)/250 mg (metformin)
- Tablets 2.5 mg (glyburide)/500 mg (metformin)
- Tablets 5 mg (glyburide)/500 mg (metformin)

Pharmacology

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Glyburide

Decreases blood glucose by stimulating insulin release from pancreas and may decrease hepatic glucose production or increase response to insulin.

Metformin

Decreases blood glucose by decreasing hepatic glucose production and may decrease intestinal absorption of glucose and increase response to insulin.

Indications and Usage

Adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes whose hyperglycemia cannot be satisfactorily managed by diet and exercise alone; second-line therapy when diet, exercise, and initial treatment with a sulfonylurea or metformin do not result in adequate glycemic control in patients with type 2 diabetes.

Contraindications

Patients with renal disease or dysfunction, which may also result from conditions such as CV collapse, acute MI, and septicemia; CHF requiring pharmacologic treatment; acute or chronic metabolic acidosis (including diabetic ketoacidosis, with or without coma); known hypersensitivity to any component of product.

Dosage and Administration

Initial Therapy
Adults

PO Starting dose 1.25 mg glyburide/250 mg metformin (1.25 mg/250 mg) every day with a meal; if glycosylated hemoglobin is greater than 9% or fasting plasma glucose is greater than 200 mg/dL, start with 1.25 mg/250 mg twice daily with morning and evening meals. Dosage increases may be made in increments of 1.25 mg/250 mg/day every 2 wk up to the minimum effective dose (there is no experience with daily doses greater than 10 mg glyburide/2,000 mg metformin).

Second-Line Therapy
Adults

PO Start with 2.5 mg/500 mg or 5 mg/500 mg twice daily with morning and evening meals but not exceeding the daily dose of glyburide or metformin already being taken. Titrate the daily dose in increments of no more than 5 mg/500 mg up to the minimum effective dose (max, 20 mg glyburide/2,000 mg metformin daily).

Storage/Stability

Store at controlled room temperature (up to 77°F).

Drug Interactions

Alcohol

The effects of metformin on lactate metabolism may be potentiated.

Beta adrenergic blocking agents, chloramphenicol, ciprofloxacin, coumarin anticoagulants, MAOIs, NSAIDs, miconazole, probenecid, salicylates, sulfonamides

May potentiate the hypoglycemic action of glyburide.

Calcium channel blocking agents, corticosteroids, estrogens, isoniazid, nicotinic acid, oral contraceptives, phenothiazines, phenytoin, sympathomimetics, thiazides and other diuretics, thyroid products

These agents tend to produce hyperglycemia and may lead to loss of blood glucose control.

Furosemide

Metformin plasma levels may be elevated while furosemide levels may be decreased.

Nifedipine

Metformin plasma levels may be increased.

Laboratory Test Interactions

None well documented.

Adverse Reactions

CNS

Headache, dizziness (greater than 5%).

GI

Diarrhea, nausea, vomiting, abdominal pain (greater than 5%).

Metabolic

Hypoglycemia (greater than 5%).

Respiratory

Upper respiratory tract infection (greater than 5%).

Precautions

Warnings Lactic acidosis is a rare, but serious metabolic complication that can occur caused by metformin accumulation during treatment with glyburide/metformin. When it occurs, it is fatal in approximately 50% of cases.

Monitor Blood sugar Check blood sugars frequently and observe for signs of hypoglycemia. Inform health care provider if blood sugar readings are outside target range or if hypoglycemic events are noted. Be prepared to treat hypoglycemic reactions.

Pregnancy

Category B .

Lactation

Undetermined.

Children

Safety and efficacy not established.

Elderly

In general, elderly patients are not titrated to the max dose because of age-related decreases in renal function.

Renal Function

Decreased renal function results in decreased renal Cl and prolongation of the metformin t _½ . Concomitant medications that affect renal function may result in hemodynamic changes or interfere with disposition of metformin (eg, cationic drugs) and should be used with caution. Determine CrCl in patient older than 80 yr of age before initiating therapy.

CV mortality

The administration of oral hypoglycemic drugs has been reported to be associated with increased CV mortality as compared with treatment with diet alone or diet plus insulin.

Hepatic disease

Avoid metformin in patients with clinical or laboratory evidence of hepatic disease.

Iodinated contrast material

Withhold metformin therapy at time of or prior to parenteral contrast studies with iodinated materials. Reinstitute therapy 48 h after the study and after renal function has been determined to be normal.

Lactic acidosis

Can occur as a result of metformin accumulation (eg, renal impairment) or in pathophysiologic conditions associated with tissue hypoperfusion and hypoxia. The risk of lactic acidosis increases with the degree of renal dysfunction and the age of the patient. Monitor patient for signs or symptoms of metabolic acidosis (eg, malaise, myalgia, respiratory distress, unexplained drowsiness, nausea, vomiting, abdominal pain). Inform health care provider immediately if noted and be prepared to discontinue therapy.

Surgery

Hold therapy in patient undergoing surgical procedure until oral intake has resumed and renal function has been documented to be normal.

Vitamin B ₁₂

A decrease in vitamin B ₁₂ levels to subnormal may occur. Supplementation may be necessary.

Overdosage

Symptoms

Glyburide

Hypoglycemia, coma, seizures, neurological impairment

Metformin

Lactic acidosis

Patient Information

• Educate patient regarding diabetes and its management, including target ranges for blood sugar control. Instruct patient that medication is not a substitute for diet and exercise and to continue to follow prescribed regimens.
• Educate patient or caregiver regarding potential long-term complications of diabetes and need for regular general physical and eye examinations.
• Advise patient to read patient information leaflet before starting therapy and with each refill.
• Advise patient to take prescribed dose twice daily and to take with food to decrease GI distress.
• Advise patient that dose may be gradually increased every 2 wk until max benefit is obtained.
• Advise patient to take as prescribed and not to stop taking or change the dose unless advised by health care provider.
• Ensure that patient understands how to use home glucose monitor and has a plan for monitoring and recording blood sugar measurements (eg, log). Advise patient to take log to each visit with health care provider.
• Educate patient regarding value of periodic hemoglobin A1c testing to confirm level of glucose control.
• Advise patient to carry medical identification indicating diabetes (eg, card, bracelet).
• Caution patient to avoid excessive alcohol intake to reduce risk of lactic acidosis.
• Instruct patient to report any of the following to health care provider immediately: general body discomfort, muscle aches, unexplained rapid breathing or shortness of breath, unexplained drowsiness, nausea, vomiting, abdominal pain.
• Review symptoms of hypoglycemia and hyperglycemia and action plans to undertake in the event either occur.
• Advise patient to discuss with health care provider a plan for managing each of the following situations: medication dosing during intercurrent conditions (eg, vomiting, infection, trauma, stress, sick days); accidental administration of too little or too much medication; missed dose; inadequate food intake or a skipped meal; travel across time zones; change in physical activity.
• Instruct patient to notify health care provider if experiencing hypoglycemic episodes or if measured blood sugars are outside target range.

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