Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2018 Publisher: Focus Pharmaceuticals Ltd, Capital House, 85 King William Street, London EC4N 7BL, United Kingdom
Treatment of type 2 diabetes mellitus, particularly in overweight patients, when dietary management and exercise alone does not result in adequate glycaemic control.
In adults, metformin hydrochloride may be used as monotherapy or in combination with other oral anti-diabetic agents or with insulin.
A reduction of diabetic complications has been shown in overweight type 2 diabetic adult patients treated with metformin as first-line therapy after diet failure (see section 5.1.).
In children from 10 years of age and adolescents, metformin hydrochloride may be used as monotherapy or in combination with insulin.
Metformin and insulin may be used in combination therapy to achieve better blood glucose control. Metformin hydrochloride is given at the usual starting dose of 500mg (5ml) or 850mg (8.5ml) 2-3 times daily, while insulin dosage is adjusted on the basis of blood glucose measurements.
A GFR should be assessed before initiation of treatment with metformin containing products and at least annually thereafter. In patients at increased risk of further progression of renal impairment and in the elderly, renal function should be assessed more frequently, e.g. every 3-6 months.
Metformin may be used in patients with moderate renal impairment, stage 3a (creatinine clearance [CrCl] 45-59 ml/min or estimated glomerular filtration rate [eGFR] 45-59 ml/min/1.73m²) only in the absence of other conditions that may increase the risk of lactic acidosis and with the following dose adjustments:
| GFR mL/min | Total maximum daily dose (to be divided into 2-3 daily doses) | Additional considerations |
|---|---|---|
| 60-89 | 3000 mg | Dose reduction may be considered in relation to declining renal function. |
| 45-59 | 2000 mg | Factors that may increase the risk of lactic acidosis (see 4.4) should be reviewed before considering initiation of metformin. The starting dose is at most half of the maximum dose. |
| 30-44 | 1000 mg | |
| <30 | - | Metformin is contraindicated. |
Metformin is contraindicated in patients with severe renal failure (GFR <30 mL/min).
Due to the potential for decreased renal function in elderly subjects, the metformin dosage should be adjusted based on renal function. Regular assessment of renal function is necessary (see section 4.4).
Metformin oral solution is for oral administration.
Hypoglycaemia has not been seen with metformin hydrochloride doses of up to 85g, although lactic acidosis has occurred in such circumstances. High overdose of metformin or concomitant risks may lead to lactic acidosis.
Lactic acidosis is a medical emergency and must be treated in hospital. The most effective method to remove lactate and metformin is haemodialysis.
Do not store above 25°C.
Once opened, use within 28 days.
Amber (Type III) glass bottle, with tamper evident and child resistant screw-cap with either a LDPE or HDPE seal, along with a 10ml oral syringe.
Pack size: 150ml
Any unused product or waste material should be disposed of in accordance with local requirements.
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