Glimin Special Precautions

SPECIAL WARNING ON INCREASED RISK OF CARDIOVASCULAR MORTALITY. The administration of oral hypoglycaemic drugs has been reported to be associated with increased cardiovascular mortality as compared to treatment with diet alone or diet plus insulin. This warning is based on the study conducted by the University Group Diabetes Program (UGDP), a long-term, prospective clinical trial designed to evaluate the designed the evaluate the effectiveness of glucose-lowering drugs in preventing or delaying vascular complications in patients with non-insulin-dependent diabetes. The study involved 823 patients who were randomly assigned to one of four treatment group. UGDP reported that patients treated for 5 to 8 years with diet plus a fixed dose of tolbutamide (1.5 grams per day) had a rate of cardiovascular mortality approximately 2-1/2 times that of patients treated with diet alone. A significant increase in total mortality was not observed but the use of tolbutamide was discontinued based on the increase in cardiovascular mortality, thus limiting the opportunity for the study to shown an increase in overall mortality.
Despite controversy regarding the interpretation of these results, the findings of the UGDP study provide an adequate basis for this morning. The patient should be informed of the potential risks and advantages of Glimepiride (Glimepiride tablets) and of alternative modes of therapy. Although only one drug in the sulfonylurea class (tolbutamide) was included on this study, it is prudent from a safety standpoint to consider that this warning may also apply to other oral hypoglycaemic drugs in this class. In view of their close similarities in mode of action and chemical structure.
Glimepiride can encourage weight gain and should be prescribed only if poor control and symptoms persist despite adequate attempts at dieting.
Special precautions: Treatment with Glimepiride must be initiated and monitored by a physician. The patient must take Glimepiride at the times and in the doses prescribed by the doctor, normally at the same time every day. To achieve the goal of treatment of Glimepiride - optimal control of blood glucose - adherence to correct diet, regular and sufficient physical exercise and if necessary, reduction of body weight are just as necessary as regular ingestion of Glimepiride.
Clinical signs of still insufficiently lowered blood glucose (hyperglycaemia) are e.g. increased urinary frequency (polyuria), intense thirst, dryness of the mouth and dry skin.
In the initial weeks of treatment the risk of hypoglycaemia may be increased and necessitates especially careful monitoring.
Factors favouring hypoglycaemias include: Unwillingness or (more commonly in older patients) incapacity of the patient to co-operate.
Undernourishment, irregular meal times or skipped meals.
Imbalance between physical exertion and carbohydrate intake.
Alteration of diet.
Consumption of alcohol, especially in combination with skipped meals.
Impaired renal function.
Severe impairment of liver function.
Overdosage with Glimepiride.
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 corticoadrenal insufficiency).
Concurrent administration of certain other medicines.
Treatment with Glimepiride in the absence of any indication.
The patient must inform the physician about such factors and about hypoglycaemic episodes since they may indicate the need for particularly careful monitoring. If such risk factors for hypoglycaemia are present, it may be necessary to adjust the dosage of Glimepiride or the entire therapy. This also applies whenever illness occurs during therapy or the patient's life-style changes.
Those symptoms of hypoglycaemia which reflect the body's adrenergic counter-regulation (refer to "Adverse Reactions") may be milder or absent where hypoglycaemia develops gradually, in the elderly and where there is autonomic neuropathy or where the patient is receiving concurrent treatment with beta-blockers, clonidine, reserpine, guanethidine or other sympatholytic drugs.
Hypoglycaemia 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 sugar sweetened 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 persons to avoid complications. Artificial sweeteners are ineffective in controlling hypoglycaemia.
It is known from other sulfonylureas that, despite initially successful countermeasures, hypoglycaemia may recur. Patients must therefore remain close observation. Severe hypoglycaemia further requires immediate treatment and follow-up by a physician and in some circumstances, in patient hospital care.
In exceptional stress situations (e.g. trauma, surgery, febrile infections) blood glucose regulation may deteriorate and a temporary changes to insulin may be necessary to maintain good metabolic control.
Insulin is the treatment of choice for non-insulin dependent diabetes mellitus (NIDDM) with renal and hepatic dysfunction. No experience has been gained concerning the use of Glimepiride in patients with impairment of liver function. In patient with severe impairment of renal function, changes over to insulin is indicates, to achieve optimal metabolic control. (See Contraindications).