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During treatment with Amaryl M SR glucose levels in blood and urine must be measured regularly. In addition, it is recommended that regular determinations of the proportion of glycated haemoglobin be carried out.
Mistakes, e.g. forgetting to take a dose, must never be corrected by subsequently taking a larger dose.
Measures for dealing with such mistakes (in particular forgetting a dose or skipping a meal) or situations where a dose cannot be taken at the prescribed time must be discussed and agreed between physician and patient beforehand.
As an improvement in control of diabetes is, in itself, associated with higher insulin sensitivity, glimepiride requirements may fall as treatment proceeds. To avoid hypoglycaemia timely dose reduction or cessation of Amaryl M SR therapy must therefore be considered.
Amaryl M SR should be administered once per day during breakfast or the first main meal.
Due to the sustained release formulation, Amaryl M SR must be swallowed whole and not crushed or chewed.
The highest recommended dose per day should be 8 mg of glimepiride and 2,000 mg of metformin.
Daily doses of glimepiride of more than 6 mg are more effective only in a minority of patients.
In order to avoid hypoglycaemia the starting dose of Amaryl M SR should not exceed the daily doses of glimepiride or metformin already being taken.
When switching from combination therapy of glimepiride plus metformin as separate tablets, Amaryl M SR should be administered on the basis of dosage currently being taken.
Titration: The daily dose should be titrated, based on the glycaemic control, in increments of 1 tablet only, corresponding to the lowest strength (in case various strengths are available).
Duration of treatment: Treatment with Amaryl M SR is normally a long-term therapy.
Special population: Children: Data are insufficient to recommend pediatric use of Amaryl M SR.
Renal impairment: 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. The maximum daily dose of metformin should preferably be divided into 2-3 daily doses. Factors that may increase the risk of lactic acidosis (see Precautions) should be reviewed before considering initiation of metformin in patients with GFR<60 mL/min.
If no adequate strength of Amaryl M SR is available, individual monocomponents should be used instead of the fixed dose combination. (See table.)
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