GLIMIRIDE

What it is

GLIMIRIDE tablets contain 1 mg, 2 mg, 3 mg or 4 mg of glimepiride. Glimepiride is a member of the sulfonylurea group of oral antidiabetic agents. Glimepiride is a sulfonylurea anti-diabetic agent which decreases blood glucose concentrations, with the primary mechanism of action appearing 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 GLIMIRIDE is one 1 mg tablet once daily, taken 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, with most patients achieving 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, with debilitated patients, malnourished patients and patients with adrenal, pituitary, renal or hepatic insufficiency being particularly susceptible and requiring careful monitoring and careful dosage adjustment. Alcohol ingestion, severe or prolonged exercise, deficient caloric intake or use of more than one antidiabetic agent may predispose patients to the development of hypoglycaemia, and if risk factors are present, it may be necessary to adjust the dosage of glimepiride or the entire therapy. Treatment of patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency with sulfonylurea agents can lead to haemolytic anaemia, and caution should be used in patients with G6PD-deficiency with consideration of a non-sulfonylurea alternative. Alertness and reactions may be impaired due to hypo- or hyperglycaemia, especially when beginning or after altering treatment or when glimepiride is not taken regularly, and this may 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) and dialysis patients. Severe hepatic dysfunction. Pregnancy. Lactation. GLIMIRIDE is 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.

PBS listing

No information is available in the provided source documents regarding PBS listing for GLIMIRIDE.

Regulatory history

GLIMIRIDE was first approved on 03 August 2016. All four strengths (1 mg, 2 mg, 3 mg and 4 mg) were registered on the ARTG on 2016-08-03 under licence category RE.