GLYBOSAY

What it is

GLYBOSAY is acarbose provided as tablets in 50 mg or 100 mg strengths. Acarbose works by inhibiting intestinal enzymes (alpha-glucosidases) involved in the degradation of ingested disaccharides, oligosaccharides, and polysaccharides. This leads to delayed digestion of carbohydrates, so that absorbable monosaccharides are released more slowly and taken up into blood more slowly.

Approved indications

— Management of blood glucose concentrations in non-insulin dependent diabetic patients who are inadequately controlled by diet alone or by diet and oral hypoglycaemic agents, as an adjunct to prescribed diet and exercise.

Dosing overview

The optimal dosage of GLYBOSAY must be individualised since activity and tolerability varies from individual to individual. In adults, GLYBOSAY should be started at a low initial dose and increased slowly to minimise gastrointestinal side effects, usually commencing at 50 mg once daily for the first week, 50 mg twice daily for the second week, and 50 mg three times a day for the third week. A further increase in dose may be necessary after 4–8 weeks on the basis of blood glucose level, with the average adult dose being 100 mg GLYBOSAY three times daily. A further increase to 200 mg GLYBOSAY three times daily may occasionally be necessary. GLYBOSAY should be swallowed whole with a little liquid directly before a meal or chewed with the first few mouthfuls of the meal.

Key safety warnings

If acarbose is prescribed in addition to drugs containing sulfonylureas or metformin or insulin, a fall of blood glucose levels into the hypoglycaemic range may necessitate a suitable decrease in the sulfonylurea, metformin or insulin dose. In the event of acute hypoglycaemia, cane sugar (sucrose) is broken down into fructose and glucose more slowly during acarbose treatment and is therefore unsuitable for rapid elimination of hypoglycaemic phenomena; glucose (dextrose) should be used instead. Patients' liver enzyme values should be monitored regularly, preferably at monthly intervals for the first 6 to 12 months after initiation of acarbose therapy, and if elevated transaminases are observed, a reduction in dosage or withdrawal of therapy may be warranted, particularly if the elevations persist. Cases of fulminant hepatitis have been reported during acarbose therapy. The majority of adverse experiences with acarbose are gastrointestinal, such as flatulence, diarrhoea and abdominal pain, and the majority of symptoms are of mild or moderate intensity and are dose-dependent. Ingestion of sucrose and food containing sucrose can easily lead to considerable intestinal symptoms (such as flatulence and bloating) or even diarrhoea during treatment with acarbose, as a result of increased carbohydrate fermentation in the colon.

Contraindications

GLYBOSAY is contraindicated in patients with hypersensitivity to acarbose and/or any of the inactive tablet constituents, pregnancy and lactation. Acarbose should not be used in patients under 18 years of age. Acarbose is contraindicated in patients with severe renal impairment (creatinine clearance <25 mL/min). Acarbose is contraindicated in patients with severe hepatic impairment. Acarbose should not be used in patients with gastrointestinal disorders associated with malabsorption, inflammatory bowel disease (such as ulcerative colitis and Crohn's disease), colonic ulceration, partial intestinal obstruction, or in patients predisposed to intestinal obstruction or ileus. Acarbose is contraindicated in patients with diabetic ketoacidosis.

PBS listing

GLYBOSAY 100 mg tablets are listed on the PBS with 2 items under restricted and unrestricted restrictions at an ex-manufacturer price of A$19.09. GLYBOSAY 50 mg tablets are listed on the PBS with 2 items under restricted and unrestricted restrictions at an ex-manufacturer price of A$13.48.

Regulatory history

GLYBOSAY 50 mg and 100 mg tablets were first registered on the ARTG on 14 May 2015.