COMPOSITION : Each tablet contains:-
Metformin SR 500mg
- Metformin belongs to class of medications called antidiabetics. It decreases the amount of glucose absorbed from the food and the amount of glucose made by liver. Metformin also increases the body’s response to insulin (a natural substance that controls the amount of glucose in the blood).
- Voglibose belongs to the class of medications that lowers blood sugar called anti-hyperglycemics (alphaglucosidase inhibitor). Voglibose delays the digestion and absorption of carbohydrate in the intestine by inhibiting intestinal enzyme (alpha glucosidase) which results in reduction of increase in blood glucose level after meal.
- Metformin: Metformin improves glucose tolerance in patients with type 2 diabetes (NIDDM), lowering both basal and postprandial plasma glucose. Metformin decreases hepatic glucose production, decreases intestinal absorption of glucose, and improves insulin sensitivity by increasing peripheral glucose uptake and utilization.
- Voglibose: Voglibose is an alpha 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 catalyzes the decomposition of disaccharides into monosaccharides and slows the digestion and absorption of carbohydrates; the post-prandial rise in plasma glucose is blunted in both normal and diabetic subjects resultingin improvement of post prandial hyperglycemia and various disorders caused by hyperglycemia. α-Glucosidase inhibitors do not stimulate insulin release and therefore do not result in hypoglycemia.
Metformin sustained release: The absolute bioavailability of a metformin 500-mg tablet given under fasting conditions is approximately 50-60%. Following a single oral dose of metformin sustainedrelease, Cmax is achieved with in 4-8 hours. Both high and low fat meals had the same effect on the pharmacoki-netics of sustained release. Voglibose: Voglibose is poorly absorbed after oral doses. Plasma concentrations after oral doses have usually been undetectable. After an 80 mg dose (substantially higher than recommended dose), peak plasma levels of about 20 ng/mL were observed in 1 to 1.5 hours.
Metformin sustained release: Metformin is negligibly bound to plasma proteins,in contrast to sulphonylureas, which are more than 90% protein bound. Metformin partitions into erythrocytes, most likely as a function of time. Distribution studies with metformin sustained release have not been conducted. At usual clinical doses and dosing schedules of immediate-release metformin, steady state plasma concentrations of metformin are reached within 24-48 hours and are generally <1 μg/mL.
Voglibose: 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.
Metformin sustained-release: Metabolism studies with metformin sustained release have not been conducted. However, intravenous single-dose studies in normal subjects demonstrate that metformin immediate release does not undergo hepatic metabolism or biliary excretion.
Voglibose: Voglibose is metabolized by intestinal enzymes and by the microbial flora.
Metformin: Intravenous single-dose studies in normal subjects demonstrate that metformin is excreted unchanged in the urine and does not undergo hepatic metabolism or biliary excretion. Renal clearance of metformin is approximately 3.5 times greater than creatinine clearance, which indicates that tubular secretion is the major route of metformin elimination. Following oral administration, approximately 90% of the absorbed drug is eliminated via the renal route within the first 24 hours, with a plasma elimination half-life of approximately 6.2 hours. In blood, the elimination half-life is approximately 17.6 hours, suggesting that the erythrocyte mass may be a compartment of distribution.
Voglibose: 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
INDICATION : Type 2 diabetes mellitus.
DOSAGE: As directed by the physician
SIDE EFFECTS : Blurred vision, Nausea, Feeling of discomfort, Increased intestinal gas, Numbness, Abdominal pain, Heartburn, Abnormal blood counts, Vomiting, Edema of face, Diarrhea, Hot flushes, Low hemoglobin, Constipation, Loss of appetite, Perspiration may occur, Hair loss, Rash, Weakness.