Voglibose is used in diabetes mellitus (DM) for reduction in Post-Prandial Hyperglycaemia (PPHG), only when diet and/or exercise with lifestyle modification or Oral Hypoglycaemic Agents (OHAs) or insulin preparations, in addition to diet and/or exercise, do not result in an adequate glycaemic control.

Thus, Voglibose is indicated:

• In non-insulin-dependent diabetes mellitus (NIDDM) patients as immunotherapy
• In combination with other OHAs
• In addition to insulin in diabetes mellitus patients
• In prevention of onset of type 2 diabetes mellitus in impaired glucose tolerance (only for Voglibose 0.2 mg Tablets) (However, Voglibose Tablets should be used only when impaired glucose tolerance has not been improved in patients already undergoing appropriate dietary treatment and/or exercise therapy.)
• In elderly patients and in those with hepatic dysfunction or mild to moderate renal impairments in whom other OHAs are contraindicated or they need to be used with caution, Voglibose will be helpful.
• In glycogen storage disease: Voglibose is helpful in prevention of hypoglycaemia in patients with type lb glycogen storage disease, it being an amylase (a glucosidase) inhibitor.
• In non-diabetic Hyperinsulinemia, Voglibose is helpful in preventing hypoglycaemic attacks.
• In steroid induced diabetes mellitus also, Voglibose is helpful. However, clinical data in this setting are limited.

Alpha-Glucosidase inhibitor

Voligbose has general properties similar to acarbose and selectively inhibits α-glucosidase in the enteric canal, delaying the digestion and absorption of carbohydrate, thereby suppressing sharp increase in post-prandial plasma glucose.

Alpha-glucosidase inhibitors are saccharides that act as competitive inhibitors of enzymes needed to digest carbohydrates: specifically alpha-glucosidase enzymes in the brush border of the small intestines. The membrane-bound intestinal alpha-glucosidases hydrolyze oligosaccharides, trisaccharides, and disaccharides to glucose and other monosaccharides in the small intestine. Acarbose also blocks pancreatic alpha-amylase in addition to inhibiting membrane-bound alpha-glucosidases. Pancreatic alpha-amylase hydrolyzes complex starches to oligosaccharides in the lumen of the small intestine. Inhibition of these enzyme systems reduces the rate of digestion of complex carbohydrates. Less glucose is absorbed because the carbohydrates are not broken down into glucose molecules. In diabetic patients, the short-term effect of these drugs therapies is to decrease current blood glucose levels: the long term effect is a small reduction in hemoglobin-A1c level.

Normal 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.

Pediatrics: 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 be taken as starting the administration at a lower dose (eg, 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.

Voglibose should be administered with care when co-administered with the following drugs:

Antidiabetic drugs: Derivative(s) of sulfonylamide and sulfonylurea, biguanide derivatives, insulin preparations and improving agents for insulin resistance.

For the concomitant use of antldlabetlc drugs and the drugs which enhance or diminish the hypoglycaemic action of antldlabetlc drugs:

• Drugs enhancing the hypoglycaemic action of antidiabetic drugs: β-blockers, salicylic acid preparations, monoamine oxidase inhibitors, fibrate derivatives for the treatment of hyperlipemia, warfarin, etc.
• Drugs diminishing the hypoglycemic actton of antidiabetic drugs: Adrenaline, adrenocortical hormone, thyroid hormone, etc.

Contraindicated in patients with Hypersensitivity to Voglibose or to any of the excipients; Diabetic ketoacidosis, diabetic pre-coma; Severe infection, before and after operation or with serious trauma; Gastrointestinal obstruction or predisposed to it.

Diarrhoea, loose stools, abdominal pain, constipation, loss of appetite, urge to vomit (nausea), vomiting, heartburn, increased gas, and intestinal obstruction like symptoms due to increased intestinal gas. OHAs plus voglibose may cause hypoglycaemia (0.1% to <5%), delay in digestion and absorption of disaccharides, fulminant hepatitis, serious liver dysfunction with increased liver enzymes, jaundice, anaemia, numbness, edema, blurred vision, hot flushes, malaise, weakness, hyperkalemia, increased pancreatic enzyme (serum amylase).

Pregnancy: The safety of Voglibose in pregnancy has not been established. However, no adequate and well controlled studies have been done on pregnant women.

Lactatlng and Nursing Mothers: Although the levels of Voglibose reached in human milk are exceedingly low, it is recommended that Voglibose may not be administered to such women.

Careful Administration (should be administered with care in following patients):

• Patients who are receiving other antidiabetic drugs as hypoglycaemia may occur
• Patients with a history of laparotomy or ileus (intestinal obstruction-like symptoms are liable to develop due to an increase in intestinal gas, etc.)
• Patients with chronic intestinal disease accompanied by a disturbance in digestion and absorption (the action of this drug may aggravate the pathologic conditions)
• Patients with Roemheld’s Syndrome, severe hernia, Stenosis or ulceration of the large intestine, etc. (Symptoms may worsen due to an increase in the intestinal gas, etc.)
• Patients with serious hepatic dysfunction (Because of possible changes in metabolic condition, the status of plasma glucose control may greatly vary. In patients with severe liver cirrhosis, hyperammonemia may worsen, followed by disturbance of consciousness.)
• Patients with serious renal dysfunction (Because of possible changes in metabolic conditions, the status of plasma glucose control may greatly vary.)
• Elderly patients

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.

Unlike sulfonylureas or insulin, an overdose of Voglibose tablets will not result in hypoglycaemia. An overdose may result is transient increase in flatulence, diarrhoea and abdominal discomfort. Because of lack of extra-intestinal effects soon with Voglibose, no serious systemic reactions are expected in the event of an overdose.

Keep in a cool and dry place. Keep out of the reach of children. Protect from light.