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Each tablet contains 80 mgGliclazide..
Gliclazide is a hypoglycaemic sulfonylurea which stimulates insulin secretion by pancreas. Its action on insulin secretion
is mainly due to the restoration of the early phase, resulting in a physiological release of insulin. In addition to this
pancreatic action, it has been demonstrated that gliclazide administration improves the metabolic utilization of glucose
at a peripheral level. This extra pancreatic action is not due to a modification in the number of insulin receptors, but
may be due to the potentiation of the post-receptor pathways. Thus, gliclazide restores glycaemic control throughout
24 hrs. It normalizes fasting and postprandial blood sugar.
In man, apart from having hypoglycaemic affect, gliclazide has been shown to reduce platelet hyper-adhesiveness and
hyper-aggregation and to increase fibrinolytic activity ( These factors are thought to be implicated in the pathogenesis
of the long-term complications of diabetes mellitus).
Controlled studies in patients with diabetic retinopathy suggest that these effects of gliclazide are beneficial in slowing
down the progression of retinopathy.
Gliclazide is well absorbed and peak plasma concentrations occur 2-4 hrs after administration. Gliclazide is 85 % bound
to plasma proteins. Metabolism is extensive and all the metabolism are devoid of hypoglycaemic activity. 60-70 % of
the dose is excreted in the urine, < 5 % of the dose is excreted unchanged in the urine and 10-20 % in the faeces as
metabolites. The elimination half-life of gliclazide is 10-12 hrs.
DOSAGE & ADMINISTRATION :
The total daily dose may vary from 40-320 mg taken orally. The dose should be adjusted according to the individual patient’s
response, commencing with 40-80 mg daily and increasing until adequate control is achieved. A single dose should not
exceed 160 mg and when higher doses are required, a twice-daily split dosage is advised and should be divided according to
the main meals of the day.
In the majority of cases, 2 tabs/day with meals, 1 tab with breakfast, 1 tab with dinner.
The symptom to be expected of overdose would be hypoglycaemia. The treatment is gastric lavage and correction of the
hypoglycaemia by appropriate means with continued monitoring of the patient’s blood sugar until the effect of the drug has
Linodiab should not be used alone in insulin-dependent diabetes ; diabetes complicated by ketosis and acidosis ; pregnancy ;
diabetic undergoing surgery, after severe trauma or during infections ; patients know to have hypersensitivity to other
sulfonylureas and related drugs.
Care should be exercised in patients with hepatic and / or renal impairment and a small starting dose should be used with
careful patient monitoring. As with other sulfonylureas, hypoglycaemia will occur if the patients’ dietary intake is reduced or if
they are receiving a larger dose of Linodiab than required.
ADVERSE REACTIONS :
Linodiab is generally well tolerated. Nausea, headache, rashes and gastrointestinal disturbances have been reported.
Potentiation of the hypoglycaemic action of the drug may occur with the concomitant administration of sulfonamides,
salicylates, phenylbutazone, -adrenoreceptor blocking agents, MAOIs. Ketoconazole and miconazole.
Diminution of hypoglycaemic action of the drug may occur with the concomitant administration of thiazide diuretics,
corticosteroids and oestrogens.
Adjustment of dosage of hypoglycaemic agents may be required in patients suffering from inter-current infections, traumas,
shock or after anesthesia.
When major surgery is to be performed, insulin therapy should be substituted for oral hypoglycaemics.
Box of 10x10’s . Reg.No.DKL9421008910A1
On medical prescription only.