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Glibenclamide
DESCRIPTION
White, oblong tablets with characteristic markings on both sides.
COMPOSITION
Each tablet contains Glibenclamide 5mg
INDICATIONS
Non-insulin-dependent diabetes mellitus (type II, maturity-onset diabetes),
whenever dietary treatment alone proves inadequate.
CONTRAINDICATIONS
Insulin-dependent diabetes mellitus (type I, growth-onset diabetes),
diabetic coma, diabetic metabolic decompensation (e.g. ketoacidosis), severe
renal impairment, hypersensitivity to glibenaclamide, pregnancy.
ADVERSE REACTIONS
Nausea and sensations of gastric fullness are very rare. The same is true
for hypersensitivity reactions of the skin. Changes of the haemopoietic
system (e.g. decrease in the number of platelets, white and red blood cells)
are rare.
INTERACTIONS
If glibenclamide is taken at the same time as certain other drugs including
alcohol, there may be an undesirable potentiation or attenuation of the
blood-sugar-lowering action of glibenclamide. Therefore, other drugs should
be taken only with the doctor's approval or prescription.
Drugs that may potentiate the hypoglycaemic action of glibenclamide are :
| Beta-receptor blockers |
Pentoxifylline in high parenteral dosage |
| Bezafibrate |
Phenylbutazone |
| Biguanides |
Phenyramidol |
| Chloramphenicol |
Phosphamides |
| Clofibrate |
Salicylates |
| Coumarin derivatives |
Sulphinpyrazone |
| Fenfluramin |
Sulphonamides |
| MAO-inhibitors |
Tetracyclines |
An attenuation of the
hypoglycaemic action of glibenclamide may be caused by :
|
Abuse of laxatives |
Phenotiazine derivatives |
|
Corticosteroids |
Saluretics |
|
Nicotinic acid in high
doses |
Sympathomimetic agents |
|
Oestrogens, gestagens |
Thyroid hormones |
SPECIAL NOTES
Compliance to diet and regular tablet intake are of utmost importance for
successful treatment and will prevent undesirable changes in blood sugar
levels. Hypoglycaemic reactions may result from overdosage of glibenclamide,
from interactions with certain drugs, or from dietary errors (e.g. omission
of meals). Warning signs are headache, irritability, restlessness, profuse
sweating, insomnia, tremor, impairment of performance an alertness.
Such hypoglycaemic episodes are nearly always promptly relieved by the
intake of sugar. Their occurrence must be reported to the doctor without
delay. the treatment of diabetes requires regular checks. Until optimal
control is achieved, or when changing the anti-diabetic preparation, or when
the tablets are not taken regularly, the patient's alertness and reactivity
maybe impaired to such an extent as to make him unable to cope with road
traffic or operate machinery.
When situations of unusual stress arise (e.g. emergency surgery, febrile
infections), a temporary change to insulin may become necessary.
DOSAGE AND ADMINISTRATION
Stabilisation on glibenclamide
may be instituted by a doctor only.
The tablets are to be swallowed whole with some liquid. Treatment is
started with a daily dose of half a tablet (2.5mg) taken immediately before
breakfast. If necessary, raise the dose in increments of 2.5mg until the
blood glucose levels have normalised as a rule, the maximum effect is
obtained with 3 tablets daily, in exceptional cases 4 tablets daily.
A maximum single dose of 2 tablets (10mg) should not be exceeded. It is
to be taken before breakfast, any remaining portion before the evening meal.
STORAGE CONDITIONS
Store below 25°C.
Keep container tightly closed.
Protect from light.
SHELF LIFE
Product should not be used beyond
the expiry date imprinted on the product packaging.
PRESENTATION
Bottles of 1000 tablets.
Cartons of 10, 20, 30, 50, 100,
250 and 500 tablets in blisters of 10 tablets. |
