PHARMACOLOGICAL CLASSIFICATION: A 21.2. Oral hypoglycaemics
PHARMACOLOGICAL ACTION: Glipizide, a sulphonylurea, is an orally active hypoglycaemic agent which reduces the blood sugar concentration. It acts by stimulating the pancreatic beta-cells to produce insulin, with consequent increase in insulin plasma levels. Since the preparation is rapidly absorbed, an evident lowering of blood sugar is already observed half an hour after the oral administration of a 2,5 mg dose.
The following pharmacological actions have been attributed to glipizide, namely:
i)
Enhancement of in vivo insulin action by extra-pancreatic mechanism(s);
ii)
Reduction of both fasting (basal) and postprandial plasma glucose concentrations.
INDICATIONS: MINIDIAB is indicated in the therapy of maturity onset Diabetes Mellitus (non-insulin dependant or Type II) which cannot be controlled by diet alone.
CONTRA-INDICATIONS: Diabetes Mellitus which is complicated by fever, trauma or gangrene. Juvenile diabetes, diabetic ketosis and acidosis, diabetic coma, hepatic and renal insufficiency, infections and febrile diseases. Safety in pregnancy has not been established.
WARNINGS: The administration of oral hypoglycaemics may be associated with increased cardiovascular mortality as compared to treatment with diet alone or diet with insulin.
DOSAGE AND DIRECTIONS FOR USE: There is no fixed dosage regimen for the management of Diabetes Mellitus with MINIDIAB or any other oral hypoglycaemic agent. In addition to the usual monitoring of urinary glucose, the patient’s blood glucose must also be monitored periodically. Glycosylated hemoglobin levels may also be of value in monitoring the patient’s response to therapy. Short term administration of MINIDIAB may be sufficient during periods of transient loss of control in patients usually well-controlled on diet.
In combined therapy with a sulphonylurea there may be a greater risk of cardiovascular mortality than with the use of glipizide alone. Initial Dose: The recommended starting dose is 2,5 mg given 30 minutes before breakfast. Titration: Dosage adjustments should ordinarily be in increments of 2,5-5 mg, as determined by the response. At least several days should elapse between titration steps. If response to a single dose is not satisfactory, dividing that dose may prove effective. The maximum recommended single dose is 15 mg. Doses above 15 mg should ordinarily be divided and given before meals of adequate kilojoule content. The maximum recommended total daily dose is 30 mg. Maintenance: Some patients may be effectively controlled on a once-a-day regimen, while others show better response with divided dosing. Total daily doses above 30 mg have been safely given on a twice daily basis to long term patients.
In elderly patients, debilitated or malnourished patients, and patients with impaired renal or hepatic function, the initial and maintenance dosing should be conservative to avoid hypoglycaemic reactions.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS: Nausea, vomiting, anorexia, heartburn, epigastric discomfort, headache, dizziness, pruritus and skin rash.
Hypoglycaemic coma may occur.
A disulfiram-like reaction may occur in patients taking alcohol during treatment with MINIDIAB®.
The hypoglycaemic effects may be enhanced by alcohol, salicylates, cyclophosphamide, dicoumarol and derivatives, mono-amine oxidase inhibitors, phenylbutazone, propranolol, and other beta-adrenergic blocking agents and some sulphonamides. Beta-blockers may mask symptoms of hypoglycaemia and may inhibit normal physiological response to hypoglycaemia. The hypoglycaemic effects may be diminished by adrenaline, corticosteroids and thiazide diuretics, estrogens and barbiturates.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT: Prolonged hypoglycaemia and hypoglycaemic coma.
Treatment is symptomatic.
IDENTIFICATION: A white to whitish, round, biconvex tablet, scored on both sides.
PRESENTATION: Cartons with 100 and 500 blister-packed tablets.
STORAGE INSTRUCTIONS: Store below 25°C, protect from light and moisture. Keep out of reach of children.
REGISTRATION NUMBER: L/21.2/248
NAME AND BUSINESS ADDRESS OF APPLICANT: Pharmacia South Africa (Pty) Limited
Alphen West G
George St
Midrand
1685
DATE OF PUBLICATION OF THIS PACKAGE INSERT: April 1987
New addition to this site: January 2005
Source: Pharmaceutical Industry
MINIDIAB® (Tablets)