Sugril Special Precautions

The administration of Glibenclamide is associated with an increased risk of cardiovascular mortality, when compared to treatment with metformin or gliclazide, especially in patients with diagnosed coronary disease.
Clinical signs of hyperglycemia are: increased urinary frequency, intense thirst, dryness of the mouth and dry skin.
In exceptional stress situation (e.g., trauma, surgery, febrile infections), blood glucose regulation may deteriorate, and a temporary change to insulin may be necessary to maintain good metabolic control.
Persons allergic to sulfonamide derivatives may develop an allergic reaction to Glibenclamide as well.
To achieve the goal of treatment with Glibenclamide optimal control of blood glucose-adherence to correct diet, regular and sufficient physical exercise and reduction of body weight (if necessary) are just as necessary as regular intake of Glibenclamide.
During treatment with Glibenclamide, glucose levels in blood and urine must be measured regularly. In addition, it is recommended that regular determinations of the proportion of glycated hemoglobin (HbA1C) be carried out.
When starting treatment the patient must be informed about the effects and risks of Glibenclamide and about its interaction with dietary measures and physical exercise the importance of adequate cooperation must also be stressed.
As is necessary during treatment with any blood-glucose-lowering drug, the patient and the doctor must be aware of the risk of hypoglycemia (excessive reduction in blood glucose). Factors that cause hypoglycemia include: Unwillingness or (more commonly in older patients) incapacity of the patient to cooperate; Undernutrition, irregular mealtimes or missed meals; Alternations of diet or unaccustomed physical exertion; Impaired renal function; Serious liver dysfunction; Overdose with Glibenclamide; Uncompensated disorders of the endocrine system affecting carbohydrate metabolism or counter-regulation of hypoglycemia (as for thyroid function and in anterior pituitary gland or adrenocortical insufficiency); Concurrent administration of certain other medicines.
The patients must inform the doctor about such factors and about hypoglycemia episodes since they may indicate the need or particularly careful monitoring, if necessary, the dosage of Glibenclamide or the entire therapy must be modified. This is also applies, whenever illness occurs during therapy or the patient's life-style changes.
Those symptoms of hypoglycemia (excessive reduction blood glucose) which reflect the body's adrenergic counter-regulation where hypoglycemia develops gradually, where there is autonomic neuropathy (disorder of part of the nervous system) or where the patient is receiving concurrent treatment with beta-blockers, clonidine, reserpine, guanidine or other sympatholytic drugs may be milder or absent.
Hypoglycemia can, almost always, be promptly controlled by immediate intake of carbohydrates (glucose or sugar, e.g., in the form of sugar lumps, sugar sweetened fruit juice or tea). For this purpose patients must carry a minimum of 20 grams of glucose with them at all times. They may require the assistance of other person to avoid complications. Artificial sweeteners are ineffective in controlling hypoglycemia.
Despite initially successful countermeasures, hypoglycemia may recur. Patients must, therefore, remain under close observation. Severe hypoglycemia or a protracted episode, which can only be temporarily controlled by usual amounts of sugar, further requires immediate treatment and follow-up by a doctor and in some circumstances, in-patient hospital care. If treated by different doctors (e.g., hospital stay, after an accident, illness while on holiday), the patients must inform them of their diabetic condition and previous treatment.
Sulfonylurea therapy in patients with G6PD deficiency can result in hemolytic anemia. Glibenclamide should be used with caution in patients with G6PD deficiency, and a non-sulfonylurea alternative should be considered.
Effects on ability to drive and use machine: Glibenclamide may produce severe hypoglycemia. The patient's ability to concentrate and react may be impaired as a result of hypoglycemia. These impairments may present a risk in situations where these abilities are especially important, such as driving or operating other machinery. Patients need to be particularly careful to avoid hypoglycemia and should be warned of the problem.
Use in the Elderly: Elderly patients are particularly susceptible to hypoglycemic action of glucose-lowering drugs but difficult to recognize. The initial and maintenance dosing should be conservative to avoid hypoglycemic reactions.