Amaryl Special Precautions



PT. Aventis Pharma
Full Prescribing Info
Special Precautions
To achieve optimal control of blood sugar, a correct diet, regular and sufficient physical exercise and, if necessary, reduction of body weight are just as important as regular intake of Amaryl. Clinical signs of hyperglycaemia are e.g. increased urinary frequency, intense thirst, dryness of the mouth and dry skin. When starting treatment, the patient must be informed about the effects and risks of Amaryl and about its role in conjunction with dietary measures and physical exercise; the importance of adequate cooperation must also be stressed.
In the initial weeks of treatment, the risk of hypoglycaemia may be increased and necessitates especially careful monitoring. Factors favouring hypoglycaemia include: Unwillingness or (more commonly in older patients) incapacity of the patient to cooperate; Undernourishment, irregular meal-times, or skipped meals; Imbalance between physical exertion and carbohydrate intake; Alterations of diet; Consumption of alcohol, especially in combination with skipped meals; Impaired renal function; Severe impairment of liver function; Overdosage with Amaryl; Certain uncompensated disorders of the endocrine system affecting carbohydrate metabolism or counter-regulation of hypoglycaemia (as for example in certain disorders of thyroid function and in anterior pituitary or adrenocortical insufficiency); Concurrent administration of certain other medicines (see Interactions).
The doctor must be informed about such factors and about hypoglycaemic episodes, since these require particularly careful monitoring. If such risk factors for hypoglycaemia are present, it may be necessary to adjust the dosage of Amaryl or the entire therapy. This also applies whenever illness occurs during therapy or the patient's lifestyle changes.
Those symptoms of hypoglycaemia which reflect the body's adrenergic counter-regulation (see Adverse Reactions) may be milder or absent in those situations where hypoglycaemia develops gradually, in the elderly, and in patients with a certain type of nervous disease (autonomic neuropathy) or those receiving concurrent treatment with beta-blockers, clonidine, reserpine, guanethidine, or other sympatholytic drugs.
Hypoglycaemia can almost always be promptly controlled by immediate intake of sugar, e.g., in the form of glucose, sugar cubes or sugar sweetened beverages. Patients should always carry at least 20 grams of glucose with them for this purpose (food or beverages containing artificial sweeteners - such as diet foods or drinks are ineffective in controlling hypoglycaemia). They may require the assistance of other persons to avoid complications. It is known from other sulfonylureas that, despite initially successful counter-measures, hypoglycaemia may recur. Therefore, continued close observation is necessary.
Severe hypoglycaemia requires, in addition, immediate treatment and follow-up by a doctor and in some circumstances, hospitalization. If treated by different doctor (upon e.g. admission to hospital after an accident, illness while on holiday), the patients must inform them of their diabetic condition and previous treatment.
In exceptional stress situations (e.g., trauma, surgery, infections with fever) blood sugar control may deteriorate, and a temporary change to insulin may be necessary.
During treatment with Amaryl, fasting glucose levels in blood and urine must be checked regularly, as should, additionally, the proportion of glycosylated haemoglobin. Usually every 3 to 6 months to more precisely assess long term glycemic control.
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.
Use in Children: Safety and effectiveness in paediatric patients have not been established.Alertness and reactions may be impaired due to hypo- or hyperglycaemia, especially when beginning or after altering treatment or when Amaryl is not taken regularly. Such impairment may, for example, affect the ability to operate a vehicle or machinery.
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