INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION
DIAMICRON®

SCHEDULING STATUS:
S3

PROPRIETARY NAME
(and dosage form):

DIAMICRON^®

COMPOSITION:
Each tablet contains 80 mg of gliclazide.

PHARMACOLOGICAL CLASSIFICATION:
A 21.2 Oral Hypoglycaemics

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:
Do not use in the presence of keto-acidosis or severe renal, hepatic, adrenal or thyroid dysfunction.
Do not use in patients with sulphonylurea intolerance.
Do not use in "brittle" or unstable diabetes.
Do not use in the first trimester of pregnancy, as safety in pregnancy has not been established.
Do not use in juvenile diabetes.

WARNING: 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 physician. 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 two 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.
Diamicron 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.
Drug interactions - Potentiation of the hypoglycaemic action of the drug may occur with the concomitant administration of sulphonamides, salicylates, phenylbutazone, beta-adrenoreceptor blocking agents, mono amine oxidase inhibitors, ketoconazole, 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.

Treatment with sulphonylureas may be associated with:
Skin reactions; headache; gastro-intestinal disturbances, such as nausea, vomiting, epigastric pain; dizziness; weakness; paraesthesia; sensitivity reactions with fever, eosinophylic jaundice and skin rashes; Blood disorders, including leucopenia, thrombocytopenia, aplastic anaemia and agranulocytosis.

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 drug has ceased. (This may take several days). Hypoglycaemic reactions should alert the physician to the possibility of renal dysfunction.

IDENTIFICATION:
White, circular, flat bevel-edged, cross-scored tablets.

PRESENTATION:
In blister packs of 60 and 500 tablets.
For State Use: Blister packs of 56 tablets.

STORAGE INSTRUCTIONS:
Store below 25°C in a dry place.
Keep out of the reach of children.

REGISTRATION NUMBER:
J/21.2/190

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
SERVIER LABORATORIES SOUTH AFRICA (PTY) LTD
Rivonia Gate South, 381 Rivonia Boulevard, Rivonia, 2128.

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
October 1997.

        830/08/2003

Updated on this site: January 2005
Source: Community Pharmacy
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