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

Logo NORTON-GLIBENCLAMIDE (Tablets)

SCHEDULING STATUS:
S3

PROPRIETARY NAME
(and dosage form):

NORTON-GLIBENCLAMIDE (Tablets)

COMPOSITION:
Each tablet contains 5 mg
glibenclamide.

PHARMACOLOGICAL CLASSIFICATION:
A 21.2 Oral hypoglycaemics

PHARMACOLOGICAL ACTION:
NORTON-GLIBENCLAMIDE is an oral antidiabetic preparation with a hypoglycaemic effect.

INDICATIONS:
NORTON-GLIBENCLAMIDE is indicated as an adjunct to diet to lower the blood glucose in patients with non-insulin-dependant diabetes mellitus (type II) whose hyperglycaemia cannot be controlled by diet alone.

CONTRA-INDICATIONS:
Diabetes mellitus complicated by fever, trauma, or gangrene, and in patients with impaired renal or hepatic function or serious impairment of thyroid or adrenal function.
Diabetes mellitus in patients with a history of metabolic decompensation eg. acidosis, diabetic pre-coma and coma.
Diabetes mellitus in young people.
Pregnancy.

WARNINGS:
The administration of oral hypoglycaemic drugs has been reported to be associated with increased cardiovascular mortality as compared to treatment with diet alone or diet plus insulin, although controversy exists concerning interpretation of these findings.

DOSAGE AND DIRECTIONS FOR USE:
Dosage should be adapted to each individual patient and is determined by results of medical examinations.
In general the initial dose is 2,5 mg daily (half a NORTON-GLIBENCLAMIDE tablet). The daily dose can then be raised gradually in steps of half tablets, but only after repeating medical examination. Raising the dose beyond three tablets daily does not produce any increased response.
When changing over from another oral antidiabetic preparation, with a similar mode of action, the dosage of NORTON-GLIBENCLAMIDE is determined by the amount of the previously administered dose and the medical examination. It may be considered that the effect of 1 g tolbutamide or glycodiazine, 0,5 g carbutamide or 250 mg chlorpropamide corresponds roughly to that of 5 mg NORTON-GLIBENCLAMIDE (1 tablet).
In combination 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:
Side-effects include nausea, vomiting, epigastric pain, dizziness, headache, weakness, and paraesthesia. Sensitivity reactions with fever, eosinophilia skin rashes, jaundice and blood disorders, including leucopenia, thrombocytopenia, aplastic anaemia, and agranulocytosis have occurred. Intolerance to alcohol, characterised by facial flushing, may also occur.
Hypoglycaemic reactions may occur. The incidence of hypoglycaemia can be reduced if NORTON-GLIBENCLAMIDE is taken with or immediately after a meal.
The hypoglycaemic effects may be enhanced by chloramphenicol, clofibrate or halofenate, cyclophosphamide, dicoumarol, monoamine oxidase inhibitors, salicylates, phenylbutazone. propranolol and other beta-adrenergic blocking agents and sulphonamides. The hypoglycaemic effects may be diminished by adrenaline, oestrogens, corticosteroids or diuretics. Propranolol may mask the symptoms of hypoglycaemia, and may inhibit normal physiological response to hypoglycaemia. First signs of pregnancy must be reported to the doctor without delay, because a change to insulin and/or dietary treatment is necessary. Adjustment of dosage of NORTON- GLIBENCLAMIDE may be required in patients suffering from recurrent infections, traumas, shock or after anaesthesia. When major surgery is to be performed, insulin therapy should be substituted for NORTON -GLIBENCLAMIDE.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Hypoglycaemic symptoms, eg. excessive perspiration, light-headedness, etc. can be treated by giving the patient a glucose load.

IDENTIFICATION:
White, oval shaped tablets coded "GLI 5" and a breakline on one side and a twin triangle logo on the reverse.

PRESENTATION:
100 or 500 tablets per securitainer.

STORAGE INSTRUCTIONS:
Store below 25°C.
Protect from light.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
V/21.2/345

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Norton Healthcare (Pty) Ltd
59 Greenfield Road
Greenside
2193

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
17 December 1992

New addition to this site: October 2004
Source: Pharmaceutical Industry

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