MINODIAB

Posology As for any hypoglycaemic agent, dosage must be adapted for each individual case. Short term administration of glipizide may be sufficient during periods of transient loss of control in patients usually controlled well on diet.

In general, glipizide should be given shortly before a meal to achieve the greatest reduction in post-prandial hyperglycaemia. Initial Dose The recommended starting dose is 5 mg, given before breakfast or the midday meal. 5 mg. 5 mg or 5 mg, as determined by blood glucose response.

At least several days should elapse between titration steps. The maximum recommended single dose is 15 mg. If this is not sufficient, splitting the daily dosage may prove effective. Doses above 15 mg should ordinarily be divided. Maintenance Some patients may be effectively controlled on a once-a-day regimen.

Total daily dosage above 15 mg should ordinarily be divided. The maximum recommended daily dosage is 20 mg. Paediatric population Safety and effectiveness in children have not been established. 4). Patients Receiving Other Oral Hypoglycaemic Agents As with other sulfonylurea class hypoglycaemics, no transition period is necessary when transferring patients to glipizide.

g. chlorpropamide) to glipizide due to potential overlapping of drug effect. Method of administration For oral use only

The majority of side effects have been dose related, transient, and have responded to dose reduction or withdrawal of the medication. However, clinical experience thus far has shown that, as with other sulfonylureas, some side effects associated with hypersensitivity may be severe and deaths have been reported in some instances.

The reported adverse reactions, which may possibly be associated with glipizide, are listed in the following table by system organ class and frequency group: Very common (≥1/10), Common (≥1/100 to <1/10), Uncommon (≥1/1,000 to <1/100), Rare (≥1/10,000 to < 1/1,000), Very rare (< 1/10,000), Not known (cannot be estimated from available data).

Blood and lymphatic system disorders:

Not known - Leukopenia, agranulocytosis, thrombocytopenia, haemolytic anaemia, pancytopenia Metabolism and nutrition disorders: Common – Hypoglycaemia Not known – Hyponatremia Psychiatric disorders: Not known – Confusional state# Nervous system disorders: Uncommon – Dizziness#, somnolence#, tremor# Not known – Headache# Eye disorders: Uncommon – Vision blurred# Not known – Diplopia#, visual impairment#, visual acuity reduced# Gastrointestinal disorders: Common – Nausea$, diarrhoea$, abdominal pain and upper$, abdominal pain Uncommon – Vomiting Not known – Constipation$ Hepatobiliary disorders: Uncommon – Jaundice cholestatic† Not known – Hepatic function abnormal, hepatitis Skin and subcutaneous tissue disorders: Uncommon – Eczema‡ Not known – Dermatitis allergic‡, erythema‡, rash morbilliform‡, rash maculopapular‡, urticaria‡, pruritus‡, photosensitivity reaction Congenital, familial and genetic disorders: Not known – Porphyria non-acute General disorders and administration site conditions: Not known – Malaise# Investigations: Not known – Aspartate aminotransferase increased§, blood lactate dehydrogenase increased§, blood alkaline phosphatase increased§, blood urea increased§, blood creatinine increased§ # This is usually transient and do not require discontinuance of therapy; however, they may also be symptoms of hypoglycaemia.

Glucose-6-phosphate dehydrogenase deficiency Since glipizide belongs to the class of sulfonylurea agents, caution should be used in patients with G6PD deficiency. Treatment of patients with G6PD deficiency with sulfonylurea agents can lead to haemolytic anaemia and a non-sulfonylurea alternative should be considered.

Hypoglycaemia All sulfonylurea agents are capable of producing severe hypoglycaemia. Renal or hepatic insufficiency may cause elevated blood levels of glipizide and the latter may also diminish gluconeogenic capacity, both of which increase the risk of serious hypoglycaemic reactions.

Elderly, debilitated or malnourished patients and those with adrenal or pituitary insufficiency are particularly susceptible to the hypoglycaemic action of glucose-lowering drugs. 5). Hypoglycaemia is more likely to occur when caloric- intake is deficient, after severe or prolonged exercise, when alcohol is ingested, or when more than one glucose-lowering drug is used.

Loss of control of blood glucose When a patient stabilised on a diabetic regimen is exposed to stress such as fever, trauma, infection, or surgery, a loss of control may occur. At such times, it may be necessary to discontinue glipizide and administer insulin.

The effectiveness of any oral hypoglycaemic drug, including glipizide, in lowering blood glucose to a desired level decreases in many patients over a period of time, which may be due to progression of the severity of diabetes or due to diminished responsiveness to the drug.

This phenomenon is known as secondary failure, to distinguish it from primary failure in which the drug is ineffective in an individual patient when first given. Adequate adjustment of dose and adherence to diet should be assessed before classifying a patient as a secondary failure.

Renal and Hepatic Disease The pharmacokinetics and/or pharmacodynamics of glipizide may be affected in patients with impaired renal or hepatic function. If hypoglycaemia should occur in such patients, it may be prolonged and appropriate management should be instituted.

1. 1. 2. Insulin-dependent diabetes mellitus, diabetic ketoacidosis, diabetic coma. 3. Severe renal or hepatic insufficiency. 4. 5). 5. Pregnancy and lactation.