Negara: Israel
Bahasa: Inggris
Sumber: Ministry of Health
GLIBENCLAMIDE
DEXCEL LTD, ISRAEL
A10BB01
TABLETS
GLIBENCLAMIDE 5 MG
PER OS
Required
DEXCEL LTD, ISRAEL
GLIBENCLAMIDE
GLIBENCLAMIDE
Control of hyperglycemia in stable, mild, nonketosis prone Glibenclamide responsive type II diabetes mellitus, which cannot be controlled by proper dietary management or when insulin therapy is inappropriate.
2014-03-31
1. NAME OF THE MEDICINAL PRODUCT GLUBEN 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Glibenclamide 5mg. Excipients : contains lactose monohydrate 133.00mg. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet. White, biconvex tablets, scored on one side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Control of hyperglycemia in stable, mild, nonketosis prone Glibenclamide responsive type II diabetes mellitus, which cannot be controlled by proper dietary management or when insulin therapy is inappropriate 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The dosage of glibenclamide is governed by the desired blood glucose level. The dosage of glibenclamide must be the lowest possible dose which is effective. Mistakes, e.g. forgetting to take a dose, must never be corrected by subsequently taking a larger dose. The usual total daily dosage is 2.5mg to 15mg daily with a usual initial dose of 5mg daily. Weekly adjustments can be made to increase the dosage to the optimal level. Doses of 10mg or less may be taken as a single dose immediately before breakfast, but should the daily dose exceed 10mg, the remainder should be taken immediately before the evening meal. The elderly usually require lower dosage. DOSE OMISSION A physician should be consulted in the event that a dose has not been taken at the prescribed time, a meal has been skipped or an extra dose has been taken. It is very important not to skip meals after the tablets have been taken. SECONDARY DOSAGE ADJUSTMENT As an improvement in control of diabetes is, in itself, associated with higher insulin sensitivity, glibenclamide requirements may fall as treatment proceeds. To avoid hypoglycaemia, timely dose reduction or cessation of GLUBEN therapy must therefore be considered. Correction of dosage must also be considered, whenever: - the patients weight changes - the patients life-style changes - other factors arise, which cause an increased susceptibility to hypoglycaemia or hyperglycaemia. CHANGEOVER FROM OTHER ORAL ANTIDIABETICS TO GLUBEN Baca dokumen lengkapnya