Voglinorm-0.2/Voglinorm-0.3

Voglinorm-0.2/Voglinorm-0.3

voglibose

Manufacturer:

Micro Labs

Distributor:

Zizawa Healthcare
Full Prescribing Info
Contents
Voglibose.
Description
Each uncoated tablet contains voglibose 0.2 mg and 0.3 mg, respectively.
Action
Pharmacology: Pharmacodynamics: Voglibose is an α-glucosidase inhibitor which reduces intestinal absorption of starch, dextrin and disaccharides by inhibiting the action of α-glucosidase in the intestinal brush border. Inhibition of this enzyme halts the decomposition of disaccharides into monosaccharide's and slows the digestion and absorption of carbohydrates; the postprandial rise in plasma glucose is blunted in both normal and diabetic subjects resulting in improvement of postprandial hyperglycemia and various disorders caused by hyperglycemia. α-glucosidase inhibitors do not stimulate insulin release and therefore do not result in hypoglycemia. These agents may be considered as monotherapy in elderly patients or in patients with predominantly postprandial hyperglycemia.
α-glucosidase inhibitors are typically used in combination with other oral antidiabetic agents and/or insulin. Voglibose should be administered at the start of a meal as it is poorly absorbed.
Pharmacokinetics: Absorption: Voglibose is poorly absorbed after oral dosing. Plasma concentrations after oral doses have usually been undetectable. After an 80 mg dose (substantially higher than the recommended dose), peak plasma levels of about 20 ng/mL were observed in 1-1.5 hrs. When voglibose tablets were repeatedly administered to healthy male adults (6 subjects) in a single dose of 0.2 mg, 3 times a day for 7 consecutive days, voglibose was not detected in plasma or urine. Similarly, when voglibose was administered to healthy male adults (10 subjects) as a single dose of 2 mg, voglibose was not detected in plasma or urine.
Distribution: After ingestion of voglibose (and other glucosidase inhibitors), the majority of active unchanged drug remains in the lumen of the gastrointestinal tract to exert its pharmacological activity.
Metabolism: Voglibose is metabolized by intestinal enzymes and by the microbial flora.
Elimination: Voglibose is excreted in the urine and feces.
In a study in which a single dose of 1 mg/kg of C14-Voglibose was administered to rats, the transfer of voglibose to the fetus and to mother's milk was observed, and the rates of excretion into urine and feces were about 5% and 98%, respectively.
Indications/Uses
Treatment of diabetes. It is specifically used for lowering postprandial blood glucose levels thereby reducing the risk of macro vascular complications.
Dosage/Direction for Use
Adults: Normal 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.
Elderly: Since elderly patients generally have a physiological hypo function, it is desirable that such caution be taken as starting the administration at a low dose (eg, 0.1 mg at a time). Furthermore, Voglinorm-0.2/Voglinorm-0.3 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.
Renal Impairment: 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.
Overdosage
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.
Contraindications
Diabetic ketoacidosis, diabetic pre-coma; severe infection, before and after operation or with serious trauma; gastrointestinal obstruction or predisposed to it; renal failure or renal dysfunction [creatinine clearance (CrCl) <60 mL/min]; acute conditions with the potential to alter renal function eg, dehydration, severe infection, shock, IV administration of iodinated contrast agents, acute or chronic disease which may cause tissue hypoxia eg, cardiac or respiratory failure, recent myocardial infarction, shock; hepatic insufficiency, acute alcohol intoxication, alcoholism.
Special Precautions
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.
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.
Patients should be instructed and explained to recognize hypoglycemic symptoms and its management.
When patients with diabetes are exposed to unusual stress eg, 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.
Use in pregnancy: To date, no relevant epidemiological data are available. Animal studies do not indicate harmful effects with respect to pregnancy, embryonal or fetal development, parturition or postnatal development, therefore, Voglinorm-0.2/Voglinorm-0.3 should be given to pregnant women or women suspected of being pregnant only when the potential benefits outweigh the possible hazards.
Use in lactation: Voglibose is excreted into milk in lactating rats. Similar data is not available in humans and a decision should be made whether to discontinue nursing or to discontinue voglibose in taking into account the benefit of using the compound in the mother. Animal studies (rats) have revealed a suppressive action of voglibose on body weight increase in newborns presumably due to suppression of milk production in mother animals resulting from suppression of carbohydrate absorption. Therefore, it is desirable not to give voglibose to women during lactation. When the administration is unavoidable, nursing should be avoided.
Use in children: The safety and effectiveness of voglibose in children has not been established.
Use In Pregnancy & Lactation
Use in pregnancy: To date, no relevant epidemiological data are available. Animal studies do not indicate harmful effects with respect to pregnancy, embryonal or fetal development, parturition or postnatal development, therefore, Voglinorm-0.2/Voglinorm-0.3 should be given to pregnant women or women suspected of being pregnant only when the potential benefits outweigh the possible hazards.
Use in lactation: Voglibose is excreted into milk in lactating rats. Similar data is not available in humans and a decision should be made whether to discontinue nursing or to discontinue voglibose in taking into account the benefit of using the compound in the mother. Animal studies (rats) have revealed a suppressive action of voglibose on body weight increase in newborns presumably due to suppression of milk production in mother animals resulting from suppression of carbohydrate absorption. Therefore, it is desirable not to give voglibose to women during lactation. When the administration is unavoidable, nursing should be avoided.
Adverse Reactions
Gastrointestinal disorders eg, diarrhea, loose stools, abdominal pain, constipation, anorexia, nausea, vomiting, abdominal pain and loss of appetite may occur with the combination of voglibose. These adverse reactions occur most frequently during initiation of therapy and resolve spontaneously in most cases. To prevent them, it is recommended that metformin hydrochloride be taken in 2 or 3 daily doses during or after meals. A slow increase of the dose may also improve gastrointestinal tolerability.
Skin and Subcutaneous Tissue Disorders: Very rarely skin reactions eg, erythema, pruritus, and urticaria have been seen. In such a case, voglibose tablets should be discontinued. Increased AST or ALT may also occur. When voglibose is used in combination with other antidiabetic drugs, hypoglycemia may occur (0.1% to <5%).
Drug Interactions
May enhance effects of other antidiabetic including insulin.
Potentially Fatal: May enhance effects of other antidiabetic including insulin.
Storage
Store below 30°C.
MIMS Class
ATC Classification
A10BF03 - voglibose ; Belongs to the class of alpha glucosidase inhibitors. Used in the treatment of diabetes.
Presentation/Packing
Tab 0.2 mg x 3 x 10's. 0.3 mg x 3 x 10's.
Register or sign in to continue
Asia's one-stop resource for medical news, clinical reference and education
Sign up for free
Already a member? Sign in