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GLIZID-M

New delhi



A Quality Product from
Panacea Biotec Ltd. [View Profile]
New Delhi - India

Description :
Description:

Glizid-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. Glizid -M is a white, oblong, biconvex tablet imprinted with ?Glizid-M? on one side and scored on the other.

Each uncoated tablet contains:
Gliclazide BP 80mg
Metformin Hydrochloride IP 500mg

Pharmacology:

The two drugs in Glizid-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 b-cells of pancreas. Subsequently, Ca2+ channel opens leading to increase in intracellular calcium and induction of insulin release. Gliclazide also increases the sensitivity of b -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.

Pharmacokinetics:

Single oral dose of gliclazide, 40 to 120 mg results in a Cmax of 2.2 to 8 mg/l within 2 to 8 hours. Steady state concentrations are achieved after 2 days of administration of 40-120 mg of gliclazide. Administration of gliclazide with food reduces Cmax and delays Tmax. The volume of distribution is low due to extensive protein binding (85-97%). The half life of gliclazide varies from 8.1 - 20.5 hours after single dose administration. Gliclazide is extensively metabolized to 7 metabolites predominantly excreted in the urine, the most abundant being the carboxylic acid derivative; 60-70% of the dose is excreted in the urine and 10-20% in the faeces.

Metformin has absolute oral bioavailability of 50-60%. GIT absorption is complete within 6 hrs of ingestion within metformin is rapidly distributed in body after absorption. The renal elimination of metformin is biphasic. 95% of the absorbed metformin is eliminated during primary elimination phase having half-life of 6 hours. Rest of the 5% is eliminated during slow terminal elimination phase with mean half-life of 20 hours. Metformin is not bound to plasma proteins, 40-60% of the dose is recovered as unchanged drug in urine with a further 30% recovered as unchanged drug in faeces.

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:

Glizid-M is indicated in obese and non-obese type ?2 diabetic patients with inadequate glycemic control with diet alone & in non-insulin dependent diabetes mellitus.

Contraindications:

Glizid-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.

Adverse Reactions:

Gastrointestinal disturbances - Nausea, diarrhoea, gastric pain, constipation, vomiting, metallic taste in mouth.
Dermatological effects - Rash, pruritus, urticaria, erythema and flushing.
Dermatological effects- Rash, pruritus, urticaria, erythema and flushing.
Miscellaneous - Headache and dizziness.
Gliclazide appears to be associated with a low incidence of hypoglycaemia. Gliclazide may have the potential to produce adverse cardiovascular effects, however gliclazide has been an established agent for the treatment of NIDDM for a number of years without adverse cardiovascular effects. Impaired gastrointestinal absorption of vitamin B12 and folic acid has been associated with long term metformin therapy.

Dosage and Administration:

1-2 tablets once or twice daily with meals to a maximum of 4 tablets/day.


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Panacea Biotec Ltd. deals in :
Manufacturer and marketer of branded vaccines, pharmaceutical and biotechnology-based products : Tablets, Capsules, Liquid orals (bottles), Gel/Ointment (tubes), Vaccines (doses), Recombinant Proteins (doses) Pain Management : Nimulid :- Nimulid Tablet, Nimulid MD, Nimulid MR, Nimulid Transgel, Nimulid Nugel, Nimulid SP, Nimulid Safeinject, Willgo, Kondro, Upright Diabetes Management : Glizid :- Glizid, Glizid 40, Glizid - M, Glizid MR 30, Glizid MR 60, Oglo, Betaglim, Rosimet, Metlong, Heartfelt, Betaglim - M, Pioryl, Myelogen, Myelogen Injection, Lower, Lower Forte Anti-bactrials : Mygat :- Mygat Tab, Mygat I.V. Anti-Osteoporotic : Alphadol, Alphadol C, Calcom Vaccines : Enivac HB, Enivac HB Safsy, Ecovac - 4, Ecovac Safsy, Easyfour, Easyfive Renal - disease management : Panimun Bioral, Mycept, Efecient, PanGraf Anti-pyretic, Anti-inflamatory , Analgesic : Nimulid Suspension, Nimulid MD Kid Tab Anti-tubercular : Myser, Myobid, Xeed - 2, Xeed -3, Xeed -4 Constipation : Livoluk- 60ml, Gush Cough and cold : toff MD Anti-allergic : Awayke MD, Ralif ? Giro, Ocimix, ThankGod Piles Management System Kit?, ThankGod Relief Capsules?, ThankGod Anytime Cream?, ThankGod Ispaghula Husk?, ThankGod Pain & Itch Relief Cream?.

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