MINODIAB Tablet Ref.[27643] Active ingredients: Glipizide

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. Mild diabetics, geriatric patients or those with liver disease may be started on 2.5 mg.

Titration

Dosage adjustments should ordinarily be in increments of 2.5 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.

Use in Elderly and High-Risk Patients

In elderly, debilitated and malnourished patients or patients with an impaired renal or hepatic function, the initial and maintenance dosing should be conservative to avoid hypoglycaemic reactions (see Initial Dose and section 4.4).

Patients Receiving Other Oral Hypoglycaemic Agents

As with other sulfonylurea class hypoglycaemics, no transition period is necessary when transferring patients to glipizide. Patients should be observed carefully (1-2 weeks) for hypoglycaemia when being transferred from longer half-life sulfonylureas (e.g. chlorpropamide) to glipizide due to potential overlapping of drug effect.

Method of administration

For oral use only.

There is no well documented experience with glipizide overdosage. Overdosage of sulfonylureas including glipizide can produce glycaemia. Mild hypoglycaemic symptoms without loss of consciousness or neurologic findings should be treated actively with oral glucose and adjustments in drug dosage and/or meal patterns. Close monitoring should continue until the physician is assured that the patient is out of danger. Severe hypoglycaemic reactions with coma, seizure, or other neurological impairment occur infrequently, but constitute medical emergencies requiring immediate hospitalisation. If hypoglycaemic coma is diagnosed or suspected, the patient should be given a rapid intravenous injection of concentrated (50%) glucose solution. This should be followed by a continuous infusion of a more dilute (10%) glucose solution at a rate that will maintain the blood glucose at a level above 100 mg/dL (5.55 mmol/L). Patients should be closely monitored for a minimum of 48 hours and depending on the status of the patient at this time the physician should decide whether further monitoring is required. Clearance of glipizide from plasma may be prolonged in people with liver disease. Because of the extensive protein binding of glipizide, dialysis is unlikely to be of benefit.

2 years.

This medicinal product does not require any special storage conditions.

Blister strips containing 28 or 60 tablets in a carton.

Not all pack sizes may be marketed.

No special requirements.