INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION
GLYGARD

2250 A
JPA-4

SCHEDULING STATUS:
S3

PROPRIETARY NAME
(and dosage form):

GLYGARD
(Tablets)

COMPOSITION:
Each tablet contains 80 mg of gliclazide.

PHARMACOLOGICAL CLASSIFICATION:
A 21.2. Oral hypoglycaemics.

PHARMACOLOGICAL ACTION:
Gliclazide is a second generation hypoglycaemic sulphonylurea. Sulphonylureas stimulate insulin release from the pancreatic beta-cells, and are therefore only effective when the pancreas is capable of producing insulin.
In addition gliclazide may have a direct influence on the intracellular transport of calcium, that specifically improves the biphasic response of the beta-cells after food ingestion. This includes the immediate first phase insulin release, as well as the delayed, second phase insulin release.
In addition, it has been demonstrated that the metabolic utilisation of glucose may be improved at a peripheral level by the administration of gliclazide.
Gliclazide is extensively bound to the plasma proteins (85-97%) after being rapidly absorbed from the gastro-intestinal tract.
Gliclazide is metabolised by the liver and the metabolites excreted in the urine and in the faeces.
The half-life is approximately 10-12 hours.

INDICATIONS:
For the control of hyperglycaemia in non-insulin-dependent diabetes mellitus or Type II diabetes mellitus, when appropriate control cannot be achieved by diet alone.
Continued dietary restrictions should be observed.

CONTRA-INDICATIONS:
Hypersensitivity to gliclazide or other sulphonylureas.
Cross-sensitivity to other sulphonamide or thiamine-type medications may occur.
Do not use in patients with insulin-dependent diabetes mellitus.
Do not use in patients with significant hepatic or renal insufficiency. The use of gliclazide in the presence of keto-acidosis and adrenal or thyroid dysfunction, is not recommended.
Safety in pregnancy and lactation has not been established.
Pediatrics: safety and efficacy have not been proven.
'Brittle' or unstable diabetes.
Gliclazide should be avoided in the following cases: acidosis, severe burns, coma, major surgery, trauma or in conditions where the blood glucose level may be severely influenced or when the need for insulin changes rapidly.

WARNINGS:

The administration of oral hypoglycaemics may be associated with increased cardiovascular mortality compared to treatment with diet in patients with renal dysfunction.

The risk benefit should be considered in the following conditions: severe diarrhoea, intestinal obstruction, prolonged vomiting and gastro paresis. Because of its shorter half-life, gliclazide may be prescribed to patients with renal impairment, but with caution and under close supervision (see boxed "Warnings").

DOSAGE AND DIRECTION FOR USE:
Take GLYGARD tablets 30 minutes before a meal or with a meal. The dose must be guided by the individual patient's response and must be carefully monitored.

Initial dose:	40-80 mg per day, taken in divided doses, at breakfast and at dinner.
Maximum dose:	320 mg per day, taken in divided doses, at breakfast and at dinner.
General dosage:	2 tablets per day taken with meals. Take 1 tablet with breakfast and one tablet with dinner.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Side-effects:
Hypoglycaemic reactions including coma, may occur, especially in the elderly patient.
Weight changes - most studies indicate no significant overall weight changes.
Dermatological reactions: skin rashes, pruritus, photosensitivity.
Blood disorders, such as aplastic anaemia, agranulocytosis, thrombocytopenia, haemolytic anaemia and leucopenia may occur.
Gastro-intestinal disturbances such as nausea and vomiting, epigastric pain, anorexia, diarrhoea and a metallic taste.
Generalized hypersensitivity reactions, such as fever, cholestatic jaundice, erythema multiforme or Stevens-Johnson syndrome, exfoliative dermatitis and erythema nodosum may occur.
Special precautions:
GLYGARD should be used with caution in patients with renal or hepatic insufficiency, especially the elderly (See "Contra-indications" and "Warnings").
Severe hypoglycaemia in the elderly may present as an acute neurological emergency. It is therefore advised that the plasma glucose level be checked in any elderly patient with acute neurological symptoms (headache, mental confusion, unusual tiredness, irritability, drowsiness).
The blood glucose concentration should be monitored whenever there is a need to administer any medication that may affect the metabolic or glycaemic control of the diabetes mellitus.
Interactions:
Compounds that may increase the hypoglycaemic effect of gliclazide: Anti-coagulants (coumarin), antifungals (miconazole, fluconazole), barbiturates, cimetidine, MAO-inhibitors, ranitidine, beta-blockers, cyclophosphamide, salicylate, hepatic enzyme inhibitors (e.g. chloramphenicol), tetracyclines, sulphonamides, phenylbutazone, halofenate, ketoconazole, clofibrate and dicoumarol.
Compounds that may decrease the hypoglycaemic effect of gliclazide: Hyperglycaemic causing agents (estrogen), corticosteroids, diuretics (thiazide) and adrenalin.
Beta-blockers may mask the symptoms of hypoglycaemia.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
The stomach should be emptied by emesis or gastric lavage and the blood sugar levels corrected by intravenous glucose administration.
The blood sugar levels should be monitored continuously, until the effects of the overdosage has ceased. This may be necessary for several days. Should the patient develop hypoglycaemia, it should be treated with urgency and the general management for hypoglycaemia followed. Hypoglycaemic reactions may indicate possible renal dysfunction.

IDENTIFICATION:
White, circular, flat, bevelled, tablets with a cross-line on one side and plain on the other side.

PRESENTATION:
An alu-poly strip with 10 tablets, packed in 60's and 500's

STORAGE INSTRUCTIONS:
Store below 25°C, in a dry place.
KEEP OUT OF REACH OF CHILDREN

REGISTRATION NUMBER:
34/21.2/0070

NAME AND BUSINESS ADDRESS OF APPLICANT:
CIPLA MEDPRO (PTY) LTD
Rosen Heights, Pasita Street,
Rosen Park, Bellville 7530, RSA

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
August 2002

© 2002 Cipla Medpro (Pty) Ltd

2250 A
JPA-4

Updated on this site: March 2003
Source: Community Pharmacy
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