Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2017 Publisher: Bayer plc, 400 South Oak Way, Reading, RG2 6AD
Glucobay is recommended for the treatment of non-insulin dependent (NIDDM) diabetes mellitus in patients inadequately controlled on diet alone, or on diet and oral hypoglycaemic agents.
Glucobay is a competitive inhibitor of intestinal alpha-glucosidases with maximum specific inhibitory activity against sucrase. Under the influence of Glucobay, the digestion of starch and sucrose into absorbable monosaccharides in the small intestine is dose-dependently delayed. In diabetic subjects, this results in a lowering of postprandial hyperglycaemia and a smoothing effect on fluctuations in the daily blood glucose profile.
In contrast to sulphonylureas Glucobay has no stimulatory action on the pancreas.
Treatment with Glucobay also results in a reduction of fasting blood glucose and to modest changes in levels of glycated haemoglobin (HbA1, HbA1c). The changes may be a reduction or reduced deterioration in HbA1 or HbA1c levels, depending upon the patient’s clinical status and disease progression. These parameters are affected in a dosedependent manner by Glucobay.
Following oral administration, only 1-2% of the active inhibitor is absorbed.
Owing to the great individual variation of glucosidase activity in the intestinal mucosa, there is no fixed dosage regimen, and patients should be treated according to clinical response and tolerance of intestinal side-effects.
The recommended initial dose is 50 mg three times a day. However, some patients may benefit from more gradual initial dose titration to minimise gastrointestinal side-effects. This may be achieved by initiating treatment at 50 mg once or twice a day, with subsequent titration to a three times a day regimen.
If after six to eight weeks' treatment patients show an inadequate clinical response, the dosage may be increased to 100 mg three times a day. A further increase in dosage to a maximum of 200 mg three times a day may occasionally be necessary.
If distressing complaints develop in spite of strict adherence to the diet, the dose should not be increased further and if necessary should be reduced according to the severity of the side-effects and the clinical judgment of the prescriber.
Glucobay is intended for continuous long-term treatment.
No modification of the normal adult dosage regimen is necessary.
The efficacy and safety of Glucobay in children and adolescents have not been established. Glucobay is not recommended for patients under the age of 18 years.
Glucobay tablets are taken orally and should be chewed with the first mouthful of food, or swallowed whole with a little liquid directly before the meal.
When Glucobay tablets are taken with drinks and/or meals containing carbohydrates overdose may lead to meteorism, flatulence and diarrhoea. If Glucobay tablets are taken in overdose independently of food, excessive intestinal symptoms need not be anticipated.
No specific antidotes to Glucobay are known.
Intake of carbohydrate-containing meals or beverages should be avoided for 4-6 hours.
Diarrhoea should be treated by standard conservative measures
Shelf life: 3 years.
The tablets should be stored in the manufacturer’s original container in a dry place at temperatures below 25°C.
Blister strips comprising 300μm polypropylene foil (colourless) with a 20μm soft aluminium backing foil, in cardboard outers.
Pack sizes: 90.
None stated.
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