PREGNANCY AND BREASTFEEDING SAFETY:
- Glipizide/metformin has not been adequately evaluated in pregnant women. Due to the lack of conclusive safety data, glipizide/metformin should be avoided during pregnancy if possible. Glipizide/metformin is classified as FDA pregnancy risk category C (animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks).
- It is not known if glipizide/metformin is excreted in breast milk. Due to the lack of safety data and the potential risk for hypoglycemia in the nursing infant, use of glipizide/metformin during breastfeeding is not recommended.
STORAGE: Tablets should be stored at room temperature between 15 C to 30 C (59 F to 86 F).
- For patients inadequately controlled on diet and exercise alone: Generally, the recommended starting dose of glipizide/metformin is 2.5/250 mg administered once or twice daily. A starting dose of 2.5/500 mg twice daily may be considered for patients with fasting plasma glucose (FPG) of 280-320 mg/dL. If necessary, dosage may be increased by 1 tablet daily every 2 weeks to achieve adequate blood glucose control. The maximum daily dose is 20/2000 mg. Avoid starting treatment with the 5/500 mg strength due to the risk of hypoglycemia (low blood glucose levels).
- For patients inadequately controlled on glipizide or metformin monotherapy: Treatment may be started with either 2.5/500 mg or 5/500 mg administered by mouth twice daily with meals. To avoid hypoglycemia, the starting dose must not exceed the current dose of glipizide or metformin that the patient has been already taking.
- For patients who are already taking a combination of sulfonylurea/metformin who desire to switch to a combination pill: To avoid hypoglycemia, avoid exceeding the current dose of sulfonylurea and metformin. If necessary, the dose may be increased gradually to the minimum dosage required to achieve adequate blood glucose control.
- Patients with liver disease: Use of glipizide/metformin in patients with liver disease is generally not recommended. Liver disease increases the risk of metformin associated lactic acidosis, a rare but potentially fatal condition which causes an accumulation of acid in the body.
- Patients with kidney disease: Metformin should not be used in females with serum creatinine concentration > 1.4 mg/dL or in males with serum creatinine concentration > 1.5 mg/dL.
- Pediatrics: The safety and efficacy of glipizide/metformin has not been established in pediatric patients. Therefore, use of glipizide/metformin in this patient population is not recommended.
DRUG CLASS AND MECHANISM:
Glipizide/metformin is a
combination antidiabetic medication that contains two commonly used glucose
lowering agents, glipizide (Glucotrol) and metformin (Glucophage). These agents
work in different, yet complementary ways to improve
blood glucose control in
type 2 diabetes.
- Glipizide is a second generation oral sulfonylurea that lowers blood glucose by stimulating the production of insulin from the pancreas. It is the major hormone responsible for regulating blood sugar.
- Metformin is an oral biguanide antidiabetic medication that decreases the production of glucose in the liver, decreases the absorption of glucose by the intestines, and increases response to insulin.
- In clinical studies, glipizide/metformin therapy was superior in improving fasting plasma glucose, postprandial plasma glucose (blood glucose levels after a meal), and HbA1c versus treatment with either agent alone.
- Glipizide/metformin was approved by the FDA in October 2002.
FDA Prescribing Information.
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