Gluco-A100 mg

Gluco-A 100 mg is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Alpha-Glucosidase inhibitor

In contrast to sulfonylureas, Gluco-A 100 mg does not enhance insulin secretion. The antihyperglycemic action of Gluco-A 100 mg results from a competitive, reversible inhibition of pancreatic alpha-amylase and membrane-bound intestinal alpha-glucoside hydrolase enzymes. Pancreatic alpha-amylase hydrolyzes complex starches to oligosaccharides in the lumen of the small intestine, while the membrane-bound intestinal alpha-glucosidases hydrolyze oligosaccharides, trisaccharides, and disaccharides to glucose and other monosaccharides in the brush border of the small intestine. In diabetic patients, this enzyme inhibition results in a delayed glucose absorption and a lowering of postprandial hyperglycemia. Because its mechanism of action is different, the effect of Gluco-A 100 mg to enhance glycemic control is additive to that of sulfonylureas, insulin or metformin when used in combination. In addition, Gluco-A 100 mg diminishes the insulinotropic and weight-increasing effects of sulfonylureas. Gluco-A 100 mg has no inhibitory activity against lactase and consequently would not be expected to induce lactose intolerance.

The recommended starting dosage of Gluco-A 100 mg is 25 mg given orally three times daily at the start (with the first bite) of each main meal. However, some patients may benefit from more gradual dose titration to minimize gastrointestinal side effects. This may be achieved by initiating treatment at 25 mg once per day and subsequently increasing the frequency of administration to achieve 25 mg t.i.d. Maintenance Dosage Once a 25 mg t.i.d. dosage regimen is reached, dosage of Gluco-A 100 mg should be adjusted at 4–8 week intervals based on one-hour postprandial glucose or glycosylated hemoglobin levels, and on tolerance. The dosage can be increased from 25 mg t.i.d. to 50 mg t.i.d. Some patients may benefit from further increasing the dosage to 100 mg t.i.d. The maintenance dose ranges from 50 mg t.i.d. to 100 mg t.i.d.

The recommended starting dosage of Gluco-A 100 mg is 25 mg given orally three times daily at the start (with the first bite) of each main meal. However, some patients may benefit from more gradual dose titration to minimize gastrointestinal side effects. This may be achieved by initiating treatment at 25 mg once per day and subsequently increasing the frequency of administration to achieve 25 mg t.i.d. Maintenance Dosage Once a 25 mg t.i.d. dosage regimen is reached, dosage of Gluco-A 100 mg should be adjusted at 4–8 week intervals based on one-hour postprandial glucose or glycosylated hemoglobin levels, and on tolerance. The dosage can be increased from 25 mg t.i.d. to 50 mg t.i.d. Some patients may benefit from further increasing the dosage to 100 mg t.i.d. The maintenance dose ranges from 50 mg t.i.d. to 100 mg t.i.d.

Certain drugs tend to produce hyperglycemia and may lead to loss of blood glucose control. These drugs include the thiazides and other diuretics, corticosteroids, phenothiazines, thyroid products, estrogens, oral contraceptives, phenytoin, nicotinic acid, sympathomimetics, calcium channel-blocking drugs, and isoniazid. When such drugs are administered to a patient receiving Gluco-A 100 mg, the patient should be closely observed for loss of blood glucose control. When such drugs are withdrawn from patients receiving Gluco-A 100 mg in combination with sulfonylureas or insulin, patients should be observed closely for any evidence of hypoglycemia.Patients Receiving Sulfonylureas or Insulin: Sulfonylurea agents or insulin may cause hypoglycemia. Gluco-A 100 mg given in combination with a sulfonylurea or insulin may cause a further lowering of blood glucose and may increase the potential for hypoglycemia. If hypoglycemia occurs, appropriate adjustments in the dosage of these agents should be made. Very rarely, individual cases of hypoglycemic shock have been reported in patients receiving Gluco-A 100 mg therapy in combination with sulfonylureas and/or insulin.

Gluco-A 100 mg is contraindicated in patients with known hypersensitivity to the drug. Precose is contraindicated in patients with diabetic ketoacidosis or cirrhosis. Gluco-A 100 mg is also contraindicated in patients with inflammatory bowel disease, colonic ulceration, partial intestinal obstruction or in patients predisposed to intestinal obstruction. In addition, Gluco-A 100 mg is contraindicated in patients who have chronic intestinal diseases associated with marked disorders of digestion or absorption and in patients who have conditions that may deteriorate as a result of increased gas formation in the intestine.

Diarrhea, gas, upset stomach, constipation, or stomach pain may occur in the first few weeks of treatment as your body adjusts to this medication but usually improve with time. Follow your prescribed diet to help lessen these side effects. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Pregnancy Category B. The safety of Gluco-A 100 mg in pregnant women has not been established. A small amount of radioactivity has been found in the milk of lactating rats after administration of radiolabeled Gluco-A 100 mg. It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, Gluco-A 100 mg should not be administered to a nursing woman.

Because of its mechanism of action, Gluco-A 100 mg when administered alone should not cause hypoglycemia in the fasted or postprandial state. Sulfonylurea agents or insulin may cause hypoglycemia. Because Gluco-A 100 mg given in combination with a sulfonylurea or insulin will cause a further lowering of blood glucose, it may increase the potential for hypoglycemia. Hypoglycemia does not occur in patients receiving metformin alone under usual circumstances of use, and no increased incidence of hypoglycemia was observed in patients when Gluco-A 100 mg was added to metformin therapy.Oral glucose (dextrose), whose absorption is not inhibited by Gluco-A 100 mg, should be used instead of sucrose (cane sugar) in the treatment of mild to moderate hypoglycemia. Sucrose, whose hydrolysis to glucose and fructose is inhibited by Gluco-A 100 mg, is unsuitable for the rapid correction of hypoglycemia. Severe hypoglycemia may require the use of either intravenous glucose infusion or glucagon injection.

Unlike sulfonylureas or insulin, an overdose of Gluco-A 100 mg will not result in hypoglycemia. An overdose may result in transient increases in flatulence, diarrhea, and abdominal discomfort which shortly subside. In cases of overdosage the patient should not be given drinks or meals containing carbohydrates (polysaccharides, oligosaccharides and disaccharides) for the next 4–6 hours.

Store below 25° C. Protect from moisture.

Pediatric Use: safety and effectiveness of Gluco-A 100 mg in pediatric patients have not been established.Geriatric Use: of the total number of subjects in clinical studies of Gluco-A 100 mg in the United States, 27% were 65 and over, while 4% were 75 and over. No overall differences in safety and effectiveness were observed between these subjects and younger subjects.

Alpha-Glucosidase inhibitor

In contrast to sulfonylureas, Gluco-A 100 mg does not enhance insulin secretion. The antihyperglycemic action of Gluco-A 100 mg results from a competitive, reversible inhibition of pancreatic alpha-amylase and membrane-bound intestinal alpha-glucoside hydrolase enzymes. Pancreatic alpha-amylase hydrolyzes complex starches to oligosaccharides in the lumen of the small intestine, while the membrane-bound intestinal alpha-glucosidases hydrolyze oligosaccharides, trisaccharides, and disaccharides to glucose and other monosaccharides in the brush border of the small intestine. In diabetic patients, this enzyme inhibition results in a delayed glucose absorption and a lowering of postprandial hyperglycemia. Because its mechanism of action is different, the effect of Gluco-A 100 mg to enhance glycemic control is additive to that of sulfonylureas, insulin or metformin when used in combination. In addition, Gluco-A 100 mg diminishes the insulinotropic and weight-increasing effects of sulfonylureas. Gluco-A 100 mg has no inhibitory activity against lactase and consequently would not be expected to induce lactose intolerance.

Pregnancy Category B. The safety of Gluco-A 100 mg in pregnant women has not been established. A small amount of radioactivity has been found in the milk of lactating rats after administration of radiolabeled Gluco-A 100 mg. It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, Gluco-A 100 mg should not be administered to a nursing woman.

Pediatric Use: safety and effectiveness of Gluco-A 100 mg in pediatric patients have not been established.Geriatric Use: of the total number of subjects in clinical studies of Gluco-A 100 mg in the United States, 27% were 65 and over, while 4% were 75 and over. No overall differences in safety and effectiveness were observed between these subjects and younger subjects.