See Supplemental Patient Information
- Risk of lactic acidosis associated with the metformin component of this combination drug has been found in diabetic patients with significant renal insufficiency often in the setting of multiple concomitant medical/surgical problems, multiple concomitant medications, concomitant CHF with increased risk of hypoperfusion and hypoxemia. Extent of renal dysfunction and the patient’s age increases lactic acidosis risk. Monitoring of renal functions regularly in patients receiving therapy is advised with minimum effective dose of metformin, particulary in elderly patients. Do not start therapy in patients
80 yrs and abnormal renal function [US Black Box Warning] - Discontinue therapy in conditions associated with hypoxemia, dehydration, sepsis, or in patients with clinical or laboratory evidence of hepatic disease; also, discontinue therapy temporarily prior to any intravascular radiocontrast study and surgical procedure [US Black Box Warning]
- Avoid excessive alcohol consumption during therapy [US Black Box Warning]
- Instruct patients to promptly inform their physician if symptoms including malaise, myalgias, respiratory distress, increasing somnolence, and nonspecific abdominal distress occur (nonspecific symptoms of lactic acidosis) during therapy; withdraw therapy until the situation is verified [US Black Box Warning]
- Monitoring of serum electrolytes, ketones, blood glucose, blood pH, lactate levels, and blood metformin levels may be helpful in diagnosis of lactic acidosis [US Black Box Warning]
- GI symptoms that are common during therapy initiation with metformin, are unlikely to be drug related. Later occurrence of GI symptoms could be due to lactic acidosis or other serious disease [US Black Box Warning]
- Rx lactic acidosis in a hospital setting; discontinue therapy and institute general supportive measures immediately. Prompt hemodialysis is recommended to correct the acidosis [US Black Box Warning]
- Oral hypoglycemic drugs have been reported to be associated with increased CV mortality compared to treatment with diet alone or diet plus insulin (As per the University Group Diabetes Program: UGDP)
- Inform patients of the potential risks and benefits of glipizide and of alternative modes of therapy
- Decrease in vitamin B12 levels to subnormal levels may occur during therapy which may require supplementation
- Glipizide/metformin therapy does not reduce macrovascular risk
- Glipizide/metformin therapy may produce hypoglycemia; the risk of hypoglycemia increases with renal or hepatic insufficiency and also in elderly, debilitated, or malnourished patients and those with adrenal or pituitary insufficiency or alcohol intoxication. Follow proper patient selection, dosing, and instructions to avoid potential hypoglycemic episodes
- Sulfonylurea agents may cause hemolytic anemia in patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency. Consider a non-sulfonylurea alternative in G6PD deficiency patients
- Impairment of renal function increases the risk of metformin accumulation and lactic acidosis. Monitor renal functions prior to initiation of therapy and periodically thereafter; carefully titrate the dose in patients with advanced age to establish the minimum dose for adequate glycemic effect. Discontinue therapy if there is an evidence of renal dysfunction
- Temporarily discontinue therapy in patients undergoing intravascular contrast studies with iodinated materials as it is associated with increased risk of renal dysfunction and lactic acidosis
- Immediately discontinue therapy in case of cardiovascular collapse, acute CHF, acute MI and other conditions characterized by hypoxemia, as these conditions may be associated with lactic acidosis and may cause prerenal azotemia
- Temporarily discontinue therapy in patients undergoing major surgical procedures associated with restricted intake of food and fluids; do not restart until the patient's oral intake has been resumed and renal function has been evaluated as normal
- Evaluate serum electrolytes and ketones, blood glucose and, if indicated, blood pH, lactate, pyruvate and metformin levels in type 2 diabetic patients, previously well controlled on metformin who developed laboratory abnormalities or clinical illness for evidence of ketoacidosis or lactic acidosis. On development of acidosis, stop therapy and initiate alternative corrective measures
Cautions: Use cautiously in
- Renal impairment
- Hepatic impairment
- CHF
- Risk of hypoglycemia
- G6PD deficiency
- Elderly patients
- Concomitant use of medicines affecting renal function
- Concomitant use of medications causing significant hemodynamic changes
- Concomitant cationic drugs
- Hypoxemia
- Alcohol abuse
Supplemental Patient Information
- Inform patients about the importance of adherence to dietary instructions; a regular exercise program; and regular testing of blood glucose, glycosylated hemoglobin, renal function, and hematologic parameters
- Instruct patients to promptly inform their physician if symptoms such as malaise, myalgias, respiratory distress, increasing somnolence, nonspecific abdominal distress, hypothermia, hypotension, and resistant bradyarrhythmias occur during therapy
- Warn patients against excessive intake of alcohol while receiving this combination drug
Pregnancy Category:C
Breastfeeding: Limited data indicate that glipizide is excreted to a low extent in human milk. However, an alternate drug with more data available may be preferred, especially while nursing a newborn or preterm infant. Monitoring of the breastfed infant's blood glucose levels is advisable during maternal therapy with hypoglycemic agents. Although metformin is excreted in human milk to a low extent, it is sometimes detected in low levels in the serum of breastfed infants. Caution should be exercised while nursing newborn and premature infants. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 5 August 2011). As per manufacturer's information, it is unknown whether both the component of this combination drug are excreted in human milk. Because the potential for hypoglycemia in nursing infants may exist, a decision should be made whether to discontinue nursing or to discontinue the drug analyzing the importance of the drug to the mother.
US Trade Name(s)
US Availability
glipizide/metformin (generic)
- TABS:
- 2.5 mg/250 mg
- 2.5 mg/500 mg
- 5 mg/500 mg
Metaglip (glipizide/metformin)
- TABS:
- 2.5 mg/250 mg
- 2.5 mg/500 mg
- 5 mg/500 mg
Canadian Trade Name(s)
Canadian Availability
UK Trade Name(s)
UK Availability
Australian Trade Name(s)
Australian Availability
[Outline]
Pricing data from www.DrugStore.com in U.S.A.
- GlipiZIDE-MetFORMIN HCl 2.5-500 MG TABS [Bottle] (HERITAGE PHARMACEUTICALS)
60 mg = $57.99
180 mg = $159.97 - Metaglip 2.5-250 MG TABS [Bottle] (B-M SQUIBB U.S. (PRIMARY CARE))
30 mg = $33.99
90 mg = $97.97 - Metaglip 5-500 MG TABS [Bottle] (B-M SQUIBB U.S. (PRIMARY CARE))
30 mg = $42.99
90 mg = $109.97 - GlipiZIDE-MetFORMIN HCl 5-500 MG TABS [Bottle] (HERITAGE PHARMACEUTICALS)
60 mg = $58.99
180 mg = $169.99
Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.
