PHARMACOLOGICAL CLASSIFICATION: A 21.2 Oral hypoglycaemics.
PHARMACOLOGICAL ACTION: Glycomin (glibenclamide) is a sulphonylurea which is an oral hypoglycaemic agent. Sulphonylureas stimulate the pancreatic islet tissue to secrete insulin by causing degranulation of the ß-cells.
INDICATIONS: Glycomin (glibenclamide) is used as an adjunct in the treatment of maturity-onset diabetics for whom dietary management alone has been insufficient and insulin cannot be used.
CONTRA-INDICATIONS: Hypersensitivity to sulphonylureas.
Diabetes in young people.
Glycomin (glibenclamide) is contra-indicated in diabetes mellitus complicated by ketoacidosis and in those with severe infection, stress, trauma and severe impairment of renal, hepatic or thyroid function. The safety of Glycomin (glibenclamide) in pregnancy is not established.
Chronic liver disease including that caused by uncompensated cardiac failure or alcoholism.
WARNING: The administration of Glycomin (glibenclamide) may be associated with increased cardiovascular mortality compared to treatment with diet alone or diet plus insulin.
DOSAGE AND DIRECTIONS FOR USE: The usual initial dose is 5 mg daily, with or immediately before breakfast, adjusted after about 7 days by amounts of 2,5 mg daily up to 15 mg daily. Daily doses in excess of 10 mg may be given in two divided doses. Elderly patients may require smaller doses. In combination with a biguanide, there may be greater risk of cardiovascular mortality than with the use of Glycomin alone.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS: See "Warning".
Side-effects which are usually dose-dependent, are vomiting, constipation anorexia, heartburn, diarrhoea, tinnitus, a metallic taste, dizziness, weakness, paraesthesia and headache. Nausea and pruritus may also occur.
Allergic skin rashes, which may progress to more serious disorders and photosensitivity have been reported.
Severe allergic effects may occur such as cholestatic jaundice, leucopenia, thrombocytopenia, aplastic anaemia, agranulocytosis, haemolytic anaemia, erythema multiforme, exfoliative dermatitis, and erythema nodosum.
Acute porphyrias may be exacerbated.
Intolerance to alcohol, characterised by facial flushing, may also occur.
Glibenclamide may exert a mild diuretic action.
Adjustment of the dosage of Glycomin 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 Glycomin.
Interactions: The hypoglycaemic effects of Glycomin (glibenclamide) may be enhanced by antibiotics or anti-infectives such as chloramphenicol and sulphonamides including co-trimoxazole, coumarin anticoagulants, anti-inflammatory agents and analgesics including azapropazone, phenylbutazone, and salicylates, lipid regulating agents such as clofibrate and halofenate, cimetidine and ranitidine, fenfluramine, indobufen, methyldopa, miconazole and sulphinpyrazone.
The hypoglycaemic effects may be diminished by adrenaline, corticosteroids, thiazide diuretics, rifampicin and oral contraceptives.
Beta-blockers may mask some of the symptoms of hypoglycaemia.
Interactions due to displacement from binding sites may be less likely with glibenclamide than with other sulphonylureas.
The absorption of glibenclamide from the GIT may be reduced if it is taken together with guar gum.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT: Hypoglycaemia or hypoglycaemic coma, due to low blood sugar.
If untreated, hypoglycaemia may lead to convulsions, coma and death.
Treatment: In acute poisoning the stomach should be emptied by aspiration and lavage.
Treatment is symptomatic and supportive.
IDENTIFICATION: A white, oblong bevelled edged tablet, scored on both sides, engraved with a mortar and pestle on one side.
PRESENTATION: Packs of 30, 100 and 500 tablets
STORAGE INSTRUCTIONS: Store below 25°C in a dry place and protect from light.
KEEP OUT OF REACH OF CHILDREN.
REGISTRATION NUMBER: Q/21.2/24.
NAME AND BUSINESS ADDRESS OF APPLICANT: Pharmacare Limited
7 Fairclough Road
PORT ELIZABETH 6001
DATE OF PUBLICATION OF THIS PACKAGE INSERT: 03.01.1983.
A & S PRINTERS
Updated on this site: May 2000 Current: September 2004 Source: Community Pharmacy