Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2017 Publisher: Generics [UK] Ltd t/a Mylan, Station Close, Potters Bar, Hertfordshire, EN6 1TL
Glipizide is indicated in the control of blood glucose levels in addition to the control of diet for patients with non insulin dependent diabetes mellitus (Type II NIDDM), when hyperglycaemia cannot be controlled by diet alone and advice has been given on weight reduction and exercise.
Stable patients with non insulin dependent diabetes mellitus not controlled by regulation of their diet alone are likely to be controlled by glipizide.
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.
Initial dose: The recommended starting dose is 5 mg, given before breakfast or the midday meal. Mild diabetics, elderly 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 dosages above 15 mg should ordinarily be divided.
The maximum recommended daily dosage is 20 mg.
Safety and effectiveness in children have not been established.
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).
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.
For oral use only.
In general, glipizide should be taken 30 minutes before a meal to achieve the greatest reduction in post-prandial hyperglycaemia.
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.
Shelf life:
Store below 25°C and keep in the original package in order to protect from light.
Glipizide 5 mg Tablets are available either in cartoned blister packs, high density polyethylene containers or in polypropylene containers with polyethylene caps.
Either 10 or 14 tablets are packed in PVC/PVDC/Aluminium foil blister strips. The blister strips are then packed in cardboard cartons to produce packs containing 20, 28, 30, 50, 56, 60 or 100 tablets.
High density polyethylene containers fitted with polypropylene tamper evident caps are available in pack sizes of 20, 30, 50, 60, 100, 250 and 500 tablets.
Polypropylene Containers with Polyethylene caps (Securitainers) are available in pack sizes of 20, 30, 50, 60, 100, 250 and 500 tablets.
Not all pack sizes may be marketed.
No special requirements.
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