ARDIX

What it is

ARDIX is a modified release tablet containing gliclazide 60 mg. The 60 mg tablet is white to off-white and oblong shaped, scored with a break bar on both sides, engraved with "G L" on one face. Gliclazide reduces blood glucose levels by stimulating insulin secretion from the β-cells of the islets of Langerhans. Gliclazide shows high affinity, strong selectivity and reversible binding to the β-cells KATP channels with a low affinity for cardiac and vascular KATP channels.

Approved indications

— Type II diabetes in association with dietary measures when dietary measures alone are inadequate to control blood glucose.

Dosing overview

The daily dose may vary from 30 mg to 120 mg taken orally. The initial recommended dose is 30 mg, even in elderly patients (≥ 65 years). The daily dose should not exceed 120 mg. A single daily dose provides an effective blood glucose control. Titration should be carried out in steps of 30 mg, according to the fasting blood glucose response. Each step should last for at least two weeks. ARDIX should be taken with food because there is an increased risk of hypoglycaemia if a meal is taken late, if an inadequate amount of food is consumed or if the food is low in carbohydrate. It is recommended that the medication be taken at breakfast time.

Key safety warnings

Hypoglycaemia may occur following administration of sulphonylureas. Rarely cases may be severe and prolonged. This may involve hospitalisation and glucose infusion may need to be continued for 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. Severe renal or hepatic impairment may affect the distribution of gliclazide and hepatic impairment may also reduce the capacity for neoglucogenesis. These two effects increase the risk of severe hypoglycaemic reactions. A hypoglycaemic episode in these patients may be prolonged and appropriate management should be initiated. 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. The most frequent adverse reaction with gliclazide is hypoglycaemia. As is the case with all sulphonylurea drugs, 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.

Contraindications

ARDIX is contra-indicated in hypersensitivity to gliclazide, other sulphonylureas, sulfonamides, or to any of the excipients. ARDIX is contra-indicated in Type I diabetes, diabetic keto-acidosis, diabetic pre-coma and coma. ARDIX is contra-indicated in severe renal or hepatic impairment; in these cases the use of insulin is recommended. ARDIX is contra-indicated with concomitant treatment with miconazole, and in pregnancy and lactation.

PBS listing

ARDIX 60 mg modified release tablet is listed on the PBS with 2 items. The restriction type is listed as both restricted and unrestricted, with an ex-manufacturer price of A$3.92.

Regulatory history

ARDIX gliclazide 60 mg modified release was first listed on the ARTG on 2009-11-11.