Glipizide and Metformin hydrochloride is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Combination Oral hypoglycemic preparations
Metformin is a biguanide antihyperglycemic agent, which improves glucose tolerance in patients with type 2 diabetes, lowering both basal and postprandial plasma glucose. Its pharmacological mechanisms of action are different from other classes of oral antihyperglycemic agents. Metformin decreases hepatic glucose production, decreases intestinal absorption of glucose, and improves insulin sensitivity by increasing peripheral glucose uptake and utilization. Unlike sulfonylurea, metformin does not produce hypoglycemia in either patient with type 2 diabetes or normal subjects and does not cause hyperinsulinemia.
Glipizide is a sulfonylurea which appears to lower blood glucose by stimulating the release of insulin from the pancreas, an effect dependent upon functioning beta cells in the pancreatic islets. Extrapancreatic effects may play a part in the mechanism of action of oral sulfonylurea hypoglycemic drugs.
Initial therapy: For patients with type 2 diabetes whose hyperglycemia can not be satisfactorily managed with diet and exercise alone: the recommended starting dose of combination is Glipizide 2.5 mg + Metformin 250 mg once daily with meal. In clinical trials of this combination as initial therapy, there was no experience, with total daily doses greater than Glipizide 10 mg + Metformin 2000 mg per day. Second line therapy: For patients not adequately controlled on either glipizide or metformin alone, the recommended starting dose of this combination is Glipizide 2.5 mg + Metformin 500 mg or Glipizide 5 mg + Metformin 500 mg twice daily with the morning and evening meals. The daily dose should be titrated in increments of not more than Glipizide 5 mg + Metformin 500 mg up to the minimum effective dose to achieve adequate control of blood glucose or to a maximum dose of Glipizide 20 mg + Metformin 2000 mg per day.
Cimetidine reduces the renal clearance of Metformin. Alcohol potentiates the antihyperglycemic & hyperlactataemic effect of Metformin. It may enhance the effects of anti-coagulants. Such patients receiving the two drugs may need adjustment of the anti-coagulant dosage. Nifedipine appears to enhance the absorption of Metformin but Metformin has minimal effects on Nifedipine. The hypoglycemic action of sulfonylureas may be potentiated by certain drugs including nonsteroidal anti-inflammatory agents, some azoles, and other drugs that are highly protein bound, salicylates, sulfonamides, chloramphenicol, probenecid, coumarins, monoamine oxidase inhibitors, and beta adrenergic blocking agents.
Hypersensitivity. Type 2 diabetes mellitus; ketoacidosis; severe renal or hepatic insufficiency, diabetic coma, cardiac failure, recent Ml, CHF. IDDM; severe infection; acute or chronic metabolic acidosis with or without coma; stress, trauma; severe impairment of thyroid function; dehydration, acute or chronic alcoholism. Pregnancy, lactation.
Glipizide: Gl upsets, diarrhoea, nausea; allergic skin reactions, leucopaenia, thrombocytopaenia, agranulocytosis, hyponatraemia; jaundice; haemolytic anaemia, pancytopaenia. Metformin: Anorexia, nausea, vomiting, diarrhoea, wt loss, flatulence, occasional metallic taste; weakness; hypoglycaemia; rash, malabsorption of Vitamin Potentially Fatal: Glipizide: Hypoglycaemia in presence of renal or hepatic damage and alcohol. Metformin: Lactic acidosis in presence of renal failure and alcoholism.
Pregnancy 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 Lactation: Enters breast milk; not recommended
Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
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