ARX-GLIMEPIRIDE

What it is

ARX-GLIMEPIRIDE is a sulfonylurea anti-diabetic agent which decreases blood glucose concentrations. ARX-GLIMEPIRIDE tablets are available in four strengths: 1 mg, 2 mg, 3 mg and 4 mg. The primary mechanism of action of glimepiride appears to be dependent on stimulating the release of insulin from functioning pancreatic beta cells.

Approved indications

— As an adjunct to diet, exercise and weight loss, to lower the blood glucose in patients with non-insulin-dependent (type 2) diabetes mellitus.

Dosing overview

The initial dose of glimepiride is one 1 mg tablet once daily. The tablet should be swallowed whole with adequate liquid immediately before breakfast. If metabolic control is unsatisfactory after 1–2 weeks of treatment, increase the daily dose in increments of 1 mg at 1 to 2 week intervals, until satisfactory metabolic control is achieved. Most patients will achieve optimum control at doses of 1 mg to 4 mg once daily. Normally, a single daily dose will maintain good blood glucose control for 24 hours.

Key safety warnings

Hypoglycaemia is a potential risk from treatment with any sulfonylurea, particularly in the first month of treatment or when dosage is increased. Debilitated patients, malnourished patients and patients with adrenal, pituitary, renal or hepatic insufficiency are particularly susceptible to the hypoglycaemic action of sulfonylureas and should therefore be carefully monitored. The dosage of glimepiride should be carefully adjusted in these patients. Treatment of patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency with sulfonylurea agents can lead to haemolytic anaemia. Since glimepiride belongs to the class of sulfonylurea agents, caution should be used in patients with G6PD-deficiency and a non-sulfonylurea alternative should be considered. Alertness and reactions may be impaired due to hypo- or hyperglycaemia, especially when beginning or after altering treatment or when ARX-GLIMEPIRIDE is not taken regularly. This may, for example, affect the ability to drive or to operate machinery.

Contraindications

Hypersensitivity to glimepiride, other sulfonylureas, other sulfonamides or any excipient. Severe impairment of renal function (CrCl < 30 mL/min). Dialysis patients. Severe hepatic dysfunction. Pregnancy. Lactation. Not suitable for the treatment of insulin-dependent (type 1) diabetes mellitus (for example, for the treatment of patients with a history of ketoacidosis), nor for the treatment of diabetic ketoacidosis, nor for the treatment of diabetic precoma or coma.

Regulatory history

ARX-GLIMEPIRIDE was first listed on the Australian Register of Therapeutic Goods on 17 March 2017.