Voglibose

Voglibose is an Antidiabetic Agent belonging to pharmacology class of Alpha-Glucosidase Inhibitor.

Voglibose can be used in the treatment of Diabetes mellitus, type 2, treatment.

Voglibose is available in the form of Tablets.

The molecule is available in India, USA, Japan, Germany.

Voglibose, an alpha-glucosidase inhibitor, is a synthetic compound with potent and enduring therapeutic efficacies against disorders of sensory, motor and autonomic nerve systems due to diabetes mellitus. Alpha-glucosidase inhibitors are oral anti-diabetic drugs used for diabetes mellitus type 2 that work by preventing the digestion of complex carbohydrates (such as starch). Complex carbohydrates are normally converted into simple sugars (monosaccharides) which can be absorbed through the intestine. Hence, alpha-glucosidase inhibitors reduce the impact of complex carbohydrates on blood sugar.

Voglibose can be used in the treatment of Diabetes mellitus, type 2, treatment.

Voglibose is an alpha-glucosidase inhibitor used for lowering post-prandial blood glucose levels in people with diabetes mellitus.

Voglibose is approved for use in the following clinical indications:

Diabetes mellitus, type 2 (noninsulin-dependent, NIDDM): Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

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.

Dosage of voglibose must be individualized on the basis of tolerance and effectiveness observed in patients. Total dose of maximum recommended dose of 0.6 mg, three times a day, should not be exceeded.

In NIDDM patients, a dose of 0.2 mg tid before meals has been effective and it has been recommended. Voglibose should be co administered in conjunction with diet treatment or diet plus oral hypoglycaemic drugs and dose titration must be recommended only if a response is not seen with 0.2 mg tid of voglibose.

The higher dose (0.3 mg three times daily) is effective in decreasing the reaction of VAT( visceral adipose tissue) to SATC (Subcutaneous Adipose Tissue) and glycaemic control was related to changes in VAT but not SATC.

Some investigations recommend the use of voglibose only in patients who have an active satisfactory fasting glucose level (<140mg/dl) with strict diet plus sulfonylurea therapy, but who still have significant post-prandial glucose elevations (> 200mg/dl).

For IDDM patients, dose of 0.2 to 0.3 mg tid before meals is administered along with insulin administration in non-diabetic hyperinsulinemia and steroid included diabetes, voglibose can be given in dose of 0.2mg tid before meals. In glycogen storage disease, 0.1mg voglibose with lunch and dinner reduces incidence of hypoglycemic episodes as compared to that in cases who are given no treatment

Tablets: 0.3 mg

Tablets.

• Dose Adjustment in Kidney impairment patient:

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.

• Dose Adjustment in Pediatric Patient:

It can be used for treatment of glycogen storage disease, to prevent hypoglycemic episodes.

Limit the intake of high-carbohydrate foods, especially those with a high glycemic index (GI), as Voglibose primarily affects carbohydrate metabolism. Foods like rice, bread, potatoes, and sugary items should be consumed in moderation.

Voglibose may be contraindicated in the following conditions:-

Inflammatory bowel disease; GI obstruction or patients predisposed to it; conditions which may deteriorate as a result of increased gas formation eg, hernia; severe ketosis; diabetic coma or pre-coma; severe infection; hypersensitivity; pregnancy; lactation. Not to be used as monotherapy in IDDM.

Voglibose tablets dissolve in the mouth and need not be swallowed. The administration of Voglibose tablets should be limited to patients who have established diabetes as there are certain other disease conditions such as abnormal glucose tolerance and positive urinary sugar that represent diabetes-like symptoms (renal glycosuria, senile abnormal glucose tolerance, abnormal thyroid function, etc).

In patients who are being managed with lifestyle modifications (diet and/or exercise), this drug must be given only when the 2-hour post prandial blood glucose levels ar α e 200 mg/dL.

During administration of this drug, disease progression should be closely observed with monitoring of blood glucose levels at regular intervals. If the effect on post prandial glucose levels is not satisfactory even after the administration of this drug for 2 to 3 months (post prandial glucose α200 mg/dL), consider a change to more appropriate treatment. After administration of this drug, if sufficient control of blood glucose is achieved (post prandial glucose α160 mg/dL) and can satisfactorily be maintained with lifestyle therapy or with additional use of oral hypoglycemic drugs or insulin preparations, the administration of Voglibose tablets should be discontinued, and subsequent progress of disease should be monitored. Voglibose tablets should be administered with caution to the following patients: patients with history of laparotomy or ileus; patients with chronic intestinal disease accompanied by disturbance in digestion and absorption; patients with aggravating symptoms due to increased generation of intestinal gas (eg, Roemheld syndrome, severe hernia, and stenosis and ulcer of the large intestine); and patients with serious hepatic or renal disorders.

Other Precautions:

• All patients should continue their dietary restriction with a regular distribution of carbohydrate intake during the day. Overweight patients should continue their energy restricted diet.

• The usual laboratory tests for diabetes monitoring should be performed regularly. • Patients should be instructed and explained to recognize hypoglycemic symptoms and its management.

• When patients with diabetes are exposed to unusual stress such as fever, trauma, infection, or surgery, a temporary loss of control of blood glucose may occur. At such times insulin therapy may be necessary for some time.

There is no sufficient scientific evidence traceable regarding use and safety of Voglibose in concurrent use with alcohol.

The adverse reactions related to Voglibose can be categorized as

Common Adverse effects:

Abdominal pain, Diarrhea, and Flatulence

The clinically relevant drug interactions of Voglibose is briefly summarized here:

May enhance effects of other antidiabetics including insulin.

The most common side effects of Voglibose includes: Abdominal pain, Diarrhea, and Flatulence.

Voglibose competitively and reversibly inhibits the α- glucosidase enzymes (glucoamylase, sucrase, maltase, and isomaltase) in the brush border of the small intestine, which delays the hydrolysis of complex carbohydrates. It is unlikely to produce hypoglycemia in overdose, but abdominal discomfort and diarrhea may occur.

• Pharmacodynamics:

Voglibose, an alpha-glucosidase inhibitor, is a synthetic compound with potent and enduring therapeutic efficacies against disorders of sensory, motor and autonomic nerve systems due to diabetes mellitus. Alpha-glucosidase inhibitors are oral anti-diabetic drugs used for diabetes mellitus type 2 that work by preventing the digestion of complex carbohydrates (such as starch). Complex carbohydrates are normally converted into simple sugars (monosaccharides) which can be absorbed through the intestine. Hence, alpha-glucosidase inhibitors reduce the impact of complex carbohydrates on blood sugar.

• Pharmacokinetics:

Absorption: <2% (as active drug) and approx 35% (as metabolites) are absorbed from the gastrointestinal tract. Time to peak plasma concentration: Approx 1 hour (active drug).

Metabolism: Exclusively metabolised in the gastrointestinal tract mainly by intestinal bacteria and digestive enzymes into at least 13 metabolites, including sulfate, methyl, and glucuronide conjugates as the major metabolites.

Excretion: Via urine (approx 34% as inactive metabolites; <2% as unchanged drug and active metabolites); faeces (approx 51% as unabsorbed drug). Elimination half-life: Approx 2 hours.

1. https://www.uptodate.com/contents/ Voglibose -drug-information?search= Voglibose &source=panel_search_result&selectedTitle=1~148&usage_type=panel&kp_tab=drug_general&display_rank=1#F154338
2. https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022352s017lbl.pdf
3. https://www.medicaid.nv.gov/Downloads/provider/ Voglibose _2015-1215.pdf
4. https://www.mims.com/india/drug/info/ Voglibose ?type=full&mtype=generic#mechanism-of-action