COMPOSITION

Each uncoated tablet contains:

Gliclazide ........... 80mg

Metformin Hydrochloride ....  500mg


DESCRIPTION :

GLYSISS M contains Gliclazide and Metformin Hydrochloride .Gliclazide, chemically is 1-(3-azabicyclo {3.3.0} oct-3-yl)-3-p- tolylsulphonylurea. Metformin Hydrochloride is 1, 1-dimethyl biguanide hydrochloride. The two drugs in GLYSISS-M act complementary to each other. Gliclazide reduces blood glucose levels by correcting both defective insulin secretion and peripheral insulin resistance. This occurs by closure of K+ channels in β-cells of pancreas. Subsequently, Ca2+ channel opens leading to increase in intracellular calcium and induction of insulin release. Gliclazide also increases the sensitivity of β -cells to glucose. Gliclazide restores peripheral insulin sensitivity such as decreasing hepatic glucose production and increasing glucose clearance. Gliclazide has anti-platelet adhesive activity and reduces level of free radicals, thereby preventing vascular complications. Gliclazide has been reported to reduce plasma cholesterol and triglyceride levels after reported administration. The combination is quite useful in achieving satisfactory glycemic control and thus obviate the need for insulin in some patients. Metformin acts as an anti- hyperglycaemic agent by improving hepatic and peripheral tissue sensitivity to insulin, thus enhancing glucose uptake & utilization. It also appears to have beneficial effect on serum lipid levels and on fibrinolytic activity. Metformin therapy is not associated with increase in body weight. However, it normalizes weight in overweight patients.
 
RATIONALE
Pharmacokinetically the two drugs appear to be compatible, as metformin is not plasma protein bound and does not get metabolized in liver. So interaction with gliclazide (having 80-90% plasma protein binding and metabolized via liver) does not appear to be possible. Hence the combination of gliclazide and metformin would help in treatment of NIDDM and probably prevention of its associated macrovascular and microvascular complications.
 
INDICATIONS:
GLYSISS-M is indicated in obese and non-obese type 2 diabetic patients with in adequate glycemic control with diet alone & in non-insulin dependent diabetes mellitus.
 
DOSAGE AND ADMINISTRATION:
1-2 tablets once or twice daily with meals to a maximum of 4 tablets/day.
 
CONTRAINDICATIONS:
GLYSISS-M is contraindicated in patients with renal or hepatic failure, alcoholism, NIDDIM complicated by severe ketosis and acidosis, diabetes precoma & coma, peripheral vascular disease, pregnancy & chronic obstructive pulmonary disease.