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SMAGLIC-M

₹51.50

Gliclazide 80 mg, Metformin HCL 500 mg


These tablets are used to control sugar level in the blood and are highly demanded in the market due to fast relief and effectiveness. This tablet contains two oral anti – hyperglycemic drugs Gliclazide and Metformin HCl used in the management of type 2 diabetes, which has not come under control by diet and exercise alone.

Key Features:
  • Quick result
  • Accurate composition
  • Purity
  • Long shelf life

Indications

Used in the treatment of type 2 diabetes.

Mechanism of Action

Gliclazide increases the amount of insulin released by the pancreas in order to lower the blood glucose.
Metformin restores body's ability to use insulin to lower blood sugar level. Also, decreases amount of glucose absorbed from food in the intestine and decreases glucose production from liver.

Rationality

Sulfonylureas & biguanides act complementary to each other. Both compounds have an additive antihyperglycaemic effect without increasing the adverse effects of either pharmacological class. Gliclazide acts via stimulating Β cells of pancreas to release in sulin & also increases peripheral sensitivity of insulin. Metformin acts via enhanced peripheral glucose uptake & utilization. It also reduces hepatic glucose production, thereby metformin diminishes insulin resistance.The combination may therefore provide additional glycaemic control (blood glucose lowering effect by 20%) & thus obviate the need for insulin in some patients.

Gliclazide appears to be useful in both macro-vascular & micro-vascular complications, which occurs due to either hyperinsulinaemia, hypertens ion, hyperglycaemia, hyperlipidaemia, platelet aggregation.
Metformin is associated with a decrease in fast ing & postprandial plasma insulin & triglyceride levels, increase in HDL-cholesterol, increase of tissue plasminogen activator, decrease in platelet aggregation.

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.

Dosage

As directed by the physician

Interactions

Diuretics, barbiturates, phenytoin, rifampicin, corticosteroids, estrogens, and pure progestogens may reduce the glycemic control.

Contraindications

Insulin-dependent diabetes mellitus, renal or hepatic failure, alcoholism, NIDDM complicated by severe ketosis and acidosis, diabetic precoma and coma, patients undergoing surgery, after severe trauma or during infections, chronic obstructive pulmonary disease, coronary heart disease, cardiac failure, peripheral vascular disease, pregnancy, known hypersensitivity to any of the ingredients.

Side Effects

Gastrointestinal disturbances – Nausea, diarrhoea, gastric pain, constipation, vomiting, metallic taste in mouth.
Dermatological effects – Rash, pruritus, urticaria, erythema and flushing.
Miscellaneous – Headache and dizziness.

Warning

Hypoglycemia may occur if the patient's dietary intake is reduced or after accidental or deliberate overdose or after severe exercise, trauma and stress. Hypoglycemic symptoms can be reduced by prescribing a diabetic meal plan. Immediate intervention should be done if signs and symptoms of hypoglycemia occur.

Precautions

Adjust dose of combination according to blood and urinary glucose levels during the first few months. However, there have been few reports of lactic acidosis in patients of renal or liver disease.

Storage

Store in a cool and dry place. Keep out of reach of children.

Contact Details

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