Product Dossier

GLIRIDE

Product Dossier for GLIRIDE (glimepiride, Medsurge Pharma). ARTG record, PBS listing, PBAC outcomes — compiled by arcimedes.

What it is

GLIRIDE tablets contain glimepiride in strengths of 1 mg, 2 mg, 3 mg or 4 mg. Glimepiride is a sulfonylurea anti-diabetic agent which decreases blood glucose concentrations, with the primary mechanism of action dependent on stimulating the release of insulin from functioning pancreatic beta cells.

Approved indications

— Type 2 diabetes mellitus, as an adjunct to diet, exercise and weight loss, to lower blood glucose in patients with non-insulin-dependent diabetes.

Dosing overview

The initial dose of GLIRIDE is one 1 mg tablet once daily, swallowed whole without chewing with adequate liquid immediately before breakfast. If good metabolic control is achieved within the first week of treatment, continue the daily dose of one 1 mg tablet as maintenance therapy. If metabolic control is unsatisfactory after 1 to 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, and only in exceptional cases will doses of more than 4 mg glimepiride per day give better results.

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. 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. 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 glimepiride is not taken regularly. 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). Dialysis patients. Severe hepatic dysfunction. Pregnancy. Lactation. GLIRIDE is not suitable for the treatment of insulin-dependent (type 1) diabetes mellitus (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

GLIRIDE was first listed on the Australian Register of Therapeutic Goods on 3 August 2016 in all four strengths (1 mg, 2 mg, 3 mg and 4 mg).