PHARMACOLOGICAL ACTION: Gliclazide stimulates the secretion of insulin by the beta cells of the pancreas. In addition to this pancreatic action, it has been demonstrated that gliclazide administration may improve the metabolic utilisation of glucose at a peripheral level.
Gliclazide is well absorbed, and peak plasma concentrations occur 2-8 hours after administration. Gliclazide is 85-97% bound to plasma proteins. Metabolism is extensive and all metabolites are devoid of hypoglycaemic activity. 60-70% of the dose is excreted in the urine, and 10-20% in the faeces as metabolites. The elimination half-life of gliclazide is 10-12 hours.
INDICATIONS: Therapy of maturity onset Diabetes Mellitus (non-insulin dependent or Type II), where dietary management alone has been insufficient.
CONTRA-INDICATIONS: Keto-acidosis or severe renal, hepatic, adrenal or thyroid dysfunction.
Patients with sulphonylurea intolerance.
"Brittle" or unstable diabetes. Safety in pregnancy and lactation has not been established.
Severe infection, stress, trauma or patients undergoing major surgery.
The administration of oral hypoglycaemics may be associated with increased cardiovascular mortality as compared to treatment with diet alone or diet with insulin.
A reduction in dosage may be necessary in patients with renal dysfunction.
DOSAGE AND DIRECTIONS FOR USE: The final dosage regimen depends upon the individual requirements of the patient and is at the discretion of the doctor. According to the severity of the diabetic state, the dose will generally be between 1 tablet (80 mg) for mild cases, and 4 tablets (320 mg) daily for severe cases, taken in divided doses preferably with meals.
In the majority of cases: 2 tablets per day with meals (1 tablet with breakfast and 1 tablet with dinner).
GLUCOMED may be used in conjunction with insulin in insulin-dependent diabetes, but in that case, diabetic control should be checked by blood sugar readings, because of the possibility of hypoglycaemia. In combined therapy with a biguanide there may be a greater risk of cardiovascular mortality than with the use of gliclazide alone.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS: Weight changes - most studies report no significant overall change in weight. Hypoglycaemic reactions may occur.
Skin reactions; Headache; Gastro-intestinal disturbances, such as nausea, vomiting, epigastric pain; heartburn; anorexia, diarrhoea, metallic taste. Dizziness; Weakness; Paraesthesia; Sensitivity reactions with fever, eosinophilic jaundice and skin rashes; Blood disorders, including leucopenia, thrombocytopenia, aplastic anaemia, agranulocytosis, pruritus, and photosensitivity. Other severe reactions may be manifestations of a hypersensitivity reaction. They include cholestatic jaundice, blood disorders (as listed above); haemolytic anaemia, erythema multiforme or the Stevens-Johnson syndrome, exfoliative dermatitis, and erythema nodosum. Interactions: Potentiation of the hypoglycaemic action of the drug may occur with the concomitant administration of sulphonamides, salicylates, phenylbutazone, beta-adrenoreceptor blocking agents, monoamine oxidase inhibitors, ketoconazole and miconazole, chloramphenicol, clofibrate or halofenate, cyclophosphamide, dicoumarol and cimetidine.
Diminution of hypoglycaemic action of the drug may occur with the concomitant administration of thiazide diuretics, corticosteroids, oestrogens and adrenalin.
Beta-blockers may mask symptoms of hypoglycaemia and may inhibit normal physiological response to hypoglycaemia.
Adjustment of dosage of hypoglycaemic agents may be required in patients suffering from intercurrent infections, traumas, shock or after anaesthesia. When major surgery is to be performed, insulin therapy should be substituted for oral hypoglycaemics.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT: Hypoglycaemic reactions should be treated by gastric lavage and correction of the hypoglycaemia by the administration of intravenous glucose. The patient's blood sugar should be continuously monitored until the effect of the medicine has ceased. (This may take several days). Hypoglycaemic reactions should alert the doctor to the possibility of renal dysfunction.
IDENTIFICATION: A white, flat-faced, bevel-edged, round tablet, quadrisected on one side.
PRESENTATION: Blisters of 60 and 500 tablets.
STORAGE INSTRUCTIONS: Store in a cool place (below 25°C).
KEEP OUT OF REACH OF CHILDREN.
REGISTRATION NUMBER: 32/21.2/0089
NAME AND BUSINESS ADDRESS OF APPLICANT: ADCOCK INGRAM LIMITED
Adcock Ingram Park
17 Harrison Avenue
Bryanston Ext. 77
Private Bag X69
DATE OF PUBLICATION OF THIS PACKAGE INSERT: 21 October 1997
Updated on this site: May 2004
Source: Pharmaceutical Industry