GLIBENCLAMIDE

Treatment of previously untreated diabetes:

Stabilisation can be started with one 5mg tablet daily with or immediately after breakfast or the first main meal. If control is satisfactory one tablet is continued as the maintenance dose. 5 or 5mg at weekly intervals. The total daily dosage rarely exceeds 15mg and increasing the daily dosage above this does not generally produce any additional effect.

The total daily requirement should normally be given as a single dose at breakfast, or with the first main meal. The patient’s diet and activity should be taken into account.

Children:

Glibenclamide is not recommenced for use in children. 5mg tablet daily.

Changeover from other sulphonylureas:

The changeover to glibenclamide from other drugs with similar mode of action can be carried out without any break in therapy. Treatment is commenced with the equivalent dose of glibenclamide without exceeding an initial dose of 10mg.

If response is inadequate, the dose can be raised in a stepwise fashion to 15mg daily. One 5mg tablet of glibenclamide is approximately equivalent to 1g tolbutamine or glymidine, 250mg chlorpropamide or tolazamide, 500mg acetohexamide, 25mg glibornuride or 5mg glipizide.

5mg tablet. 5mg to achieve control.

Combination with biguanides:

If adequate control is not possible with diet and 15mg of glibenclamide, control may be established by combined administration of glibenclamide and a biguanide derivative.

Changeover from insulin:

While it is appreciated that most patients who are on insulin therapy will continue to need it, there may be a few patients, particularly those on low daily doses, who will remain stabilised if transferred from insulin to glibenclamide.

Hypoglycaemia occurs with all hypoglycaemic agents. : nausea, vomiting, heartburn, anorexia, diarrhoea, metallic taste) are usually mild and dose dependant. Increased appetite and weight gain may occur, also rashes (usually hypersensitivity reactions), pruritus and photosensitivity.

Severe manifestations of hypersensitivity include cholestatic jaundice, leucopenia, thrombocytopenia, aplastic anaemia, agranulocytosis, haemolytic anaemia, erythema multiforme, Stevens-Johnson syndrome, exfoliative dermatitis and erythema nodosum.

Infrequently a syndrome of inappropriate secretion of antidiuretic hormone may be induced.

Care is necessary in elderly, debilitated or malnourished patients who are particularly susceptible to the hypoglycaemic effects of sulphonylureas, and during excessive exercise as hypoglycaemia may be provoked.

i) Those patients who have or have ever had diabetic ketoacidosis. ii) Insulin dependent diabetes mellitus. iii) Severe impairment of renal, hepatic, thyroid or adrenocortical function. iv) Circumstances of unusual stress such as surgery, severe infection and trauma.

v) Hypersensitivity to glibenclamide.