Blood glucose regulation agents

Diabetes, type 2

FDA Pregnancy Category B

Diet or diet/insulin is recommended to prevent maternal and fetal problems; importance of controlling and monitoring blood glucose during pregnancy; alerting physician if planning to become pregnant

Breast-feeding

It is not known whether Glibenclamide or metformin passes into human breast milk.

Hypersensitivity to Glibenclamide or metformin

Regular visits to physician to check progress

Recognizing symptoms of lactic acidosis, such as abdominal discomfort; decreased appetite; diarrhea; fast, shallow breathing; general feeling of discomfort; muscle pain or cramping; or unusual sleepiness, tiredness, or weakness

Getting immediate emergency medical help if symptoms of lactic acidosis occur

Carefully following special instructions of health care team:

Discussing use of alcohol and tobacco

Not taking other medications unless discussed with physician

Getting counseling for family members to help the patient with diabetes; also, special counseling for pregnancy planning and contraception

Making travel plans that include readiness for diabetic emergencies and eating meals at the usual times, even with changing time zones

Preparing for and understanding what to do in case of diabetic emergency; carrying medical history and current medication list and wearing medical identification

Recognizing symptoms of hypoglycemia: anxiety; behavior change similar to drunkenness; blurred vision; cold sweats; coma; confusion; cool, pale skin; difficulty in concentrating; drowsiness; excessive hunger; fast heartbeat; headache (continuing); nausea; nervousness; nightmares; restless sleep; seizures; shakiness; slurred speech; and unusual tiredness or weakness

Recognizing what brings on symptoms of hypoglycemia, such as delaying or missing a meal or snack; drinking significant amounts of alcohol; exercising more than usual; having an illness, including vomiting or diarrhea; taking certain medications; or using other antidiabetic medication

Knowing what to do if symptoms of hypoglycemia occur, such as eating glucose tablets or gel, corn syrup, honey, or sugar cubes; drinking fruit juice, nondiet soft drink, or sugar dissolved in water; or injecting glucagon if symptoms are severe

Recognizing symptoms of hyperglycemia and ketoacidosis: blurred vision; drowsiness; dry mouth; flushed, dry skin; fruit-like breath odor; increased urination (frequency and volume); ketones in urine; loss of appetite; somnolence (sleepiness); stomachache, nausea, or vomiting; tiredness; troubled breathing (rapid and deep); unconsciousness; and unusual thirst

Recognizing what brings on symptoms of hyperglycemia, such as exercising less than usual, having a fever or infection, not taking enough or skipping a dose of antidiabetic medication, or overeating or not following meal plan

Knowing what to do if symptoms of hyperglycemia occur, such as checking blood glucose and contacting a member of the health care team

Contraindications

Acute or chronic metabolic acidosis, acute myocardial infarction, cardiovascular collapse, congestive heart failure, diabetic coma or ketoacidosis, diagnostic radiologic exams using intravascular iodinated contrast media, hepatic function impairment, major surgery, renal function impairment, septicemia, or severe dehydration

Drug interactions

Alcohol, beta adrenergic blockers, cimetidine, or furosemide

Type 2 diabetes-

As initial therapy: Oral, 1.25 mg of Glibenclamide and 250 mg of metformin one or two times a day with meals. Dosage may be increased in increments of 1.25 mg of Glibenclamide and 250 mg of metformin per day every two weeks until the minimum dose necessary to achieve glycemic control is attained.

As second-line therapy: Oral, 2.5 mg of Glibenclamide and 500 mg of metformin or 5 mg of Glibenclamide and 500 mg of metformin two times a day, with the morning and evening meals. Dosage may be increased in increments of no more than 5 mg of Glibenclamide and 500 mg of metformin until the minimum dose necessary to achieve glycemic control is attained.

Note:  When switching patients from a sulfonylurea plus metformin to the Glibenclamide and metformin combination, the initial dose should not exceed the daily dose of Glibenclamide (or equivalent dose of another sulfonylurea) and metformin that was being taken.

Usual adult prescribing limits

20 mg Glibenclamide and 2000 mg metformin daily.

Safety and efficacy have not been established.

Signs of potential side effects, especially hypoglycemia, upper respiratory infection, and lactic acidosis.

Store below 30°C (86°F). Protect from light and moisture.