Lupimet Special Precautions

Glimepiride: If risk factors for hypoglycemia 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 lifestyle changes.
Symptoms of hypoglycemia may be milder or absent in those situations where hypoglycemia develops gradually, in the elderly and in the patients with autonomic neuropathy or those receiving concurrent treatment with beta-blockers, clonidine, reserpine, guanethidine or other sympatholytic drugs.
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 sugar sweetened tea). For this purpose, patients must carry a minimum of 20 grams of glucose with them at all times. They may require assistance of other persons to avoid complication. Artificial sweeteners are ineffective in controlling hypoglycemia.
Continued close observation is necessary. Severe hypoglycemia requires immediate treatment and follow-up by a physician and in some circumstances, hospitalization.
In exceptional stress situations (e.g. trauma, surgery, infections with fever) blood sugar control may deteriorate, and temporary change to insulin may be necessary.
During treatment with glimepiride, glucose levels in blood and urine must be checked regularly, as should, additionally, the proportion of glycated hemoglobin. Alertness and reactions may be impaired due to hypoglycemia or hyperglycemia, especially when beginning or after altering treatment, or when glimepiride is not taken regularly. This may affect the ability to operate vehicle or machinery.
Metformin: Lactic Acidosis: Metformin can provoke lactic acidosis; however, the reported incidence is very low. Conditions like impaired hepatic function, renal dysfunction, hypoxemia, dehydration, sepsis, excessive alcohol intake can increase the risk of lactic acidosis. The risk can be decreased by regular monitoring of renal function and by use of minimum effective dose. In a patient with lactic acidosis, who is on metformin treatment, the drug should be discontinued immediately. Supportive measures and prompt hemodialysis should be started.
Impaired renal function: Caution should be exercised with concomitant therapies that may affect renal function or interfere with the disposition of metformin (eg, cationic drugs).
Use of Iodinated Contrast Media: The drug should be stopped at least two days before X-ray examination with iodinated contrast material and reinstituted only after renal function has been re-evaluated and found to be normal.
Hypoxic States: Metformin therapy should be promptly discontinued when such events occur in patients.
Surgical Procedures: The drug should be temporarily discontinued and restarted only when the patient resumes oral intake and has normal renal function.
Alcohol Intake: Patients should be warned against excessive alcohol intake, acute or chronic, while receiving metformin.
Impaired hepatic function: The drug should be generally avoided in patients with hepatic disease.
Hypoglycemia: Hypoglycemia does not normally occur when the drug is given alone but has been observed when given in combination with sulfonylureas and/or alcohol.
Deficiencies of folic acid, iron and vitamin B12: Serum vitamin B12 concentrations should be measured annually during long-term treatment.
Laboratory Tests: Monitoring of response to therapy to be done periodically through measurement of fasting blood glucose and glycosylated hemoglobin levels.
During initial dose titration, fasting glucose can be used to determine the response. Subsequently, both glucose and glycosylated hemoglobin must be monitored, which may be useful in evaluating long-term control.
Additional Safety Information: As part of the Risk Minimization Measures for the Important Identified Risks "Coadministration of iodinated contrast media" and "Use in Perioperative period": Intravascular administration of iodinated contrast media may lead to kidney failure, resulting in metformin build up and a risk of lactic acid accumulation in the blood.
It is recommended to discontinue metformin treatment, 48 hours before elective surgery, involving general, spinal or peridural anesthesia.
Therapy may be started no earlier than 48 hours following surgery or resumption of eating normally, provided normal kidney function has.