Voglibose is an alpha-glucosidase inhibitor indicated for:

• Management of non-insulin-dependent diabetes mellitus (NIDDM) patients as monotherapy
• Use in combination with other oral hypoglycemic agents
• Use alongside insulin therapy in diabetes mellitus patients
• Prevention of the onset of type 2 diabetes mellitus in individuals with impaired glucose tolerance
• Elderly patients and patients with hepatic dysfunction or mild to moderate renal impairment, where other oral hypoglycemic agents may be contraindicated or require cautious use
• Glycogen storage disease: helpful in preventing hypoglycemia in patients with type Ib glycogen storage disease
• Non-diabetic hyperinsulinemia: useful in preventing hypoglycemic episodes
• Use medicines according to the advice of a registered physician.

Alpha-glucosidase inhibitors are saccharides that competitively inhibit enzymes responsible for carbohydrate digestion, particularly alpha-glucosidase enzymes located at the brush border of the small intestine. These membrane-bound intestinal alpha-glucosidases break down oligosaccharides, trisaccharides, and disaccharides into glucose and other monosaccharides in the small intestine. Voglibose also inhibits pancreatic alpha-amylase in addition to membrane-bound alpha-glucosidases. Pancreatic alpha-amylase converts complex starches into oligosaccharides within the intestinal lumen. Inhibition of these enzyme systems slows the digestion of complex carbohydrates. As a result, less glucose is absorbed because carbohydrates are not completely broken down into glucose molecules. In diabetic patients, the short-term effect of this therapy is a reduction in current blood glucose levels, while long-term use may produce a modest reduction in hemoglobin A1c levels.

Adult Dose: Usually, Voglibose tablets are orally administered in a single dose of 0.2 mg, 3 times a day, before each meal. If the effect is not sufficient, the quantity of a single dose may be increased up to 0.3 mg.

Paediatrics: The safety and effectiveness of Voglibose in children has not been established.

Geriatrics: Since elderly patients generally have a physiological hypofunction, it is desirable that such caution should be taken as starting the administration at a lower dose (e.g. 0.1 mg at a time). Furthermore, this drug should be carefully administered under close observation, through the course of the disease condition, with careful attention to the blood sugar level and the onset of gastrointestinal symptoms.

Dosage in Renal Failure: Voglibose is poorly absorbed after oral doses and renal excretion is negligible, suggesting that no dose adjustment is required. However, pharmacokinetic studies in patients with renal insufficiency are not available.

Voglibose should be used cautiously when administered together with the following medications: antidiabetic drugs such as sulfonylureas, biguanide derivatives, insulin preparations, and agents that improve insulin sensitivity.

For concurrent administration with antidiabetic drugs and medications that may enhance or reduce the hypoglycemic effects of antidiabetic agents:

• Drugs that may enhance the hypoglycemic action of antidiabetic agents include: β-blockers, salicylic acid preparations, monoamine oxidase inhibitors, fibrate derivatives, warfarin, etc.
• Drugs that may reduce the hypoglycemic action of antidiabetic agents include: adrenaline, adrenocortical hormones, thyroid hormones, etc.

Voglibose is contraindicated in patients with hypersensitivity to Voglibose or any of its excipients; diabetic ketoacidosis, diabetic pre-coma, severe infection, before and after surgery, or severe trauma; gastrointestinal obstruction or patients predisposed to intestinal obstruction.

Voglibose is unlikely to cause hypoglycemia in overdose, although abdominal discomfort and diarrhea may occur. Other possible adverse effects include loose stool, abdominal pain, constipation, loss of appetite, nausea, vomiting, heartburn, excessive gas formation, and symptoms resembling intestinal obstruction due to increased intestinal gas. When Voglibose is used in combination with oral hypoglycemic agents, hypoglycemia may occur (0.1% to <5%), along with delayed digestion and absorption of disaccharides. Serious adverse reactions such as fulminant hepatitis, severe hepatic dysfunction with elevated liver enzymes, jaundice, anemia, numbness, edema, blurred vision, hot flushes, malaise, weakness, hyperkalemia, and increased pancreatic enzymes (serum amylase) have also been reported.

The safety of Voglibose during pregnancy has not been established. Adequate and well-controlled studies in pregnant women are not available. Although only minimal amounts of Voglibose are detected in human breast milk, its use is generally not recommended during lactation.

Voglibose tablets should be prescribed only to patients with confirmed diabetes mellitus, as certain other conditions such as renal glycosuria, impaired glucose tolerance, and abnormal thyroid function may present symptoms similar to diabetes. In patients undergoing lifestyle modification therapy (diet and/or exercise), Voglibose should be initiated only when 2-hour postprandial blood glucose levels are ≥200 mg/dL. During therapy, disease progression should be monitored regularly through blood glucose measurements. If satisfactory control of postprandial blood glucose is not achieved after 2 to 3 months of treatment (postprandial glucose ≥200 mg/dL), consideration should be given to changing to a more appropriate therapy. When adequate blood glucose control is achieved (postprandial glucose ≤160 mg/dL) and maintained with lifestyle management or in combination with oral hypoglycemic agents or insulin, Voglibose therapy should be discontinued and the patient monitored regularly.

Unlike sulfonylureas or insulin, overdose of Voglibose tablets does not usually result in hypoglycemia. Overdose may cause temporary flatulence, diarrhea, and abdominal discomfort. Since Voglibose has minimal extra-intestinal effects, serious systemic reactions are not generally expected following overdose.

Alpha-Glucosidase inhibitor

Store in a cool and dry place below 30°C, protected from light. Keep out of the reach of children.