APX-GLICLAZIDE

What it is

APX-GLICLAZIDE is a tablet containing 80 mg of gliclazide. It is a white to off white round, bevel-edged, uncoated tablet with a cross score on one face. Gliclazide stimulates insulin secretion from functional pancreatic beta-cells and increases the sensitivity of the beta-cells to a glucose stimulus.

Approved indications

— Diabetes mellitus of the maturity onset type, which cannot be controlled by diet alone.

Dosing overview

APX-GLICLAZIDE is for adult use only. Dosage should be initiated at 40 mg (1/2 tablet) daily and may be increased if necessary up to 320 mg (four tablets) daily. Doses up to 160 mg daily may be taken in a single dose but preferably at the same time each morning. Doses in excess of 160 mg should be taken in divided doses in the morning and evening. Treatment with gliclazide does not obviate the necessity of maintaining standard dietary regulations.

Key safety warnings

Acute complications such as severe trauma, fever, infection or surgery provoke additional metabolic stress which accentuate the predisposition to hyperglycaemia and ketosis. Patients presenting with such conditions may require insulin to maintain control. It is not appropriate to increase the dosage of gliclazide. Close observation and careful initiation and adjustment of dosage is mandatory in patients who are elderly and debilitated, malnourished, semi starved or simply neglecting dietary restrictions. In such patients severe hypoglycaemia may occur with all sulfonylureas and may require corrective therapy over a period of several days. Gliclazide should only be prescribed if the patient is likely to have a regular food intake (including breakfast). It is important to have a regular carbohydrate intake due to the increased risk of hypoglycaemia if a meal is delayed, an inadequate amount of food is consumed or the food is low in carbohydrate. The most frequent adverse reaction with gliclazide is hypoglycaemia. Hypoglycaemic reactions have been reported following gliclazide administration. However, a number of studies have shown that hypoglycaemia is less common with gliclazide than with glibenclamide. Treatment of patients with G6PD-deficiency with sulphonylurea agents can lead to haemolytic anaemia. Since gliclazide belongs to the chemical class of sulphonylurea drugs, caution should be used in patients with G6PD-deficiency and a non-sulphonylurea alternative should be considered.

Contraindications

Gliclazide should not be used in diabetes complicated by acidosis, ketosis or coma, or in patients with a history of repeated episodes of ketoacidosis or coma. Gliclazide should not be used in juvenile onset diabetes and unstable or brittle diabetes. Gliclazide should not be used with patients with known sensitivity to sulfonylureas. Gliclazide is contraindicated in severe renal insufficiency. Gliclazide is contraindicated in severe hepatic insufficiency. Gliclazide use with miconazole (systemic route, oromucosal gel) is contraindicated. Gliclazide should not be used in pregnant women. Gliclazide is contra-indicated during pregnancy and insulin is the drug of first choice for treatment of diabetes during pregnancy. Gliclazide is contra-indicated in women who are breast feeding. Gliclazide should not be used during lactation.

PBS listing

APX-GLICLAZIDE 80 mg tablets are listed on the PBS with an ex-manufacturer price of A$4.77.

Regulatory history

APX-GLICLAZIDE was first registered on the ARTG on 23 June 2020.