GLUCOBETE

What it is

GLUCOBETE contains metformin hydrochloride. Metformin is a biguanide with antihyperglycaemic effects, lowering both basal and postprandial plasma glucose. It does not stimulate insulin secretion and therefore does not cause hypoglycaemia. GLUCOBETE is available in three strengths: 500 mg, 850 mg and 1000 mg tablets.

Approved indications

— Type 2 diabetes mellitus in adults, children from 10 years of age and adolescents, particularly in overweight patients, when dietary management and exercise alone does not result in adequate glycaemic control. — In adult patients, as initial treatment or in sulfonylurea failures either alone or in combination with a sulfonylurea and other oral agents or as adjuvant therapy in insulin requiring type 2 diabetes.

Dosing overview

Tablets should be taken in divided doses with meals. Initially 500 mg should be taken once or twice a day and if necessary increased over a few weeks up to 1 g three times per day. The dose should be titrated with gradual dose increments until the desired effect is obtained. 500 mg three times a day is often sufficient to obtain diabetic control. If necessary, the dose can be increased to 1 g three times daily, which is the maximum recommended daily dose. In children from 10 years of age and adolescents, the usual starting dose is one tablet of 500 mg or 850 mg once daily, given during meals or after meals. The maximum recommended dose of metformin is 2 g daily, taken as two or three divided doses. In elderly patients, initial and maintenance dosing should be conservative due to the potential for decreased renal function in this population. Any dosage adjustment should be based on a careful assessment of renal function. Generally, elderly patients should not be titrated to the maximum dose of metformin.

Key safety warnings

Life threatening lactic acidosis can occur due to accumulation of metformin. Risk factors include renal impairment, old age and the use of high doses of metformin above 2 g per day. Lactic acidosis is a rare but serious (high mortality in the absence of prompt treatment) metabolic complication that can occur due to metformin accumulation. Reported cases of lactic acidosis in patients on metformin have occurred primarily in diabetic patients with significant renal failure. Metformin induces a reduction in thyrotropin (thyroid stimulating hormone (TSH)) levels in patients with treated or untreated hypothyroidism. Regular monitoring of TSH levels is recommended in patients with hypothyroidism. Gastrointestinal disorders such as diarrhoea, nausea, vomiting, abdominal pain and loss of appetite are very common. These undesirable effects occur most frequently during initiation of therapy and resolve spontaneously in most cases. To prevent them, it is recommended that metformin be taken in 2 or 3 daily doses during or after meals. Vitamin B12 deficiency is common. Therefore, serum B12 levels should be appropriately monitored or periodic parenteral B12 supplementation should be considered.

Contraindications

GLUCOBETE is contraindicated in juvenile diabetes mellitus that is uncomplicated and well regulated on insulin; diabetes mellitus regulated by diet alone; during or immediately following surgery where insulin is essential; any type of metabolic acidosis (such as lactic acidosis, diabetic ketoacidosis); hypersensitivity to metformin hydrochloride or to any of the excipients; diabetic pre-coma; renal failure or renal dysfunction (creatinine clearance < 60 mL/min); acute conditions with the potential to alter renal function such as dehydration, severe infection, shock; intravascular administration of iodinated contrast materials; acute or chronic disease which may cause tissue hypoxia such as cardiac failure, recent myocardial infarction, respiratory failure, pulmonary embolism, shock, acute significant blood loss, sepsis, gangrene; pancreatitis; elective major surgery; severe hepatic insufficiency; acute alcohol intoxication; alcoholism; and lactation.

PBS listing

No information regarding PBS listing details is available in the provided documents.

Regulatory history

GLUCOBETE was first listed on the Australian Register of Therapeutic Goods on 24 November 2011, with three registered variants: GLUCOBETE 500 (ARTG 180445), GLUCOBETE 850 (ARTG 180433), and GLUCOBETE 1000 (ARTG 180437).