APO-GLICLAZIDE MR

What it is

APO-GLICLAZIDE MR contains gliclazide 80 mg as the active ingredient. It is presented as an uncoated tablet: round, white, flat-sided tablets with bevelled edges.

Approved indications —

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

Dosing overview

APO-GLICLAZIDE MR is for adult use only. The daily dose may vary from 40 to 320 mg taken orally, with the initial recommended dose being 40 mg daily even in elderly patients, and may be increased if necessary up to 320 mg daily. Doses up to 160 mg daily may be taken in a single dose preferably at the same time each morning, while doses in excess of 160 mg should be taken in divided doses in the morning and evening. APO-GLICLAZIDE MR should be taken with food because there is 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, and it is recommended that the medication be taken at breakfast time.

Key safety warnings

The risks of hypoglycaemia, together with its symptoms, treatment and conditions that predispose to its development, should be explained to the patient and to family members. Hypoglycaemia may occur following administration of APO-GLICLAZIDE MR. Rarely cases may be severe and prolonged, and require hospitalisation where glucose infusion may need to be continued for several days. Factors that may increase the risk of hypoglycaemia include non-adherence to treatment advice (particularly in elderly patients), malnutrition, irregular mealtimes, skipping meals, periods of fasting or dietary changes, imbalance between physical exercise and carbohydrate intake, renal impairment, severe hepatic impairment, overdose of anti-diabetic agents, and certain endocrine disorders. 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 APO-GLICLAZIDE MR can lead to haemolytic anaemia, and caution should be used in patients with G6PD-deficiency and a non-sulphonylurea alternative should be considered. Disturbances in blood glucose, including hypoglycaemia and hyperglycaemia have been reported in diabetic patients receiving concomitant treatment with fluoroquinolones, especially in elderly patients, and careful monitoring of blood glucose is recommended in all patients receiving APO-GLICLAZIDE MR and a fluoroquinolone at the same time.

Contraindications

APO-GLICLAZIDE MR is contraindicated in patients with hypersensitivity to gliclazide, other sulphonylureas, sulfonamides, or to any of the excipients. It is contraindicated in Type I diabetes, diabetic keto-acidosis, diabetic pre-coma and coma, and severe renal or hepatic impairment. Treatment with miconazole, pregnancy and lactation are contraindications. It is generally not recommended to use APO-GLICLAZIDE MR in combination with phenylbutazone or danazol.

Regulatory history

APO-GLICLAZIDE MR was first approved on 7 August 2002. The modified-release formulation (30 mg strength) was first listed on the Australian Register of Therapeutic Goods on 20 May 2009.