Zoliget Special Precautions

Pioglitazone HCl, like other thiazolidinediones, can cause fluid retention when used alone or in combination with other antidiabetic agents, including insulin. Fluid retention may lead to or exacerbate heart failure. Patients should be observed for signs and symptoms of heart failure. If these signs and symptoms develop, the heart failure should be managed according to current standards of care. Furthermore, discontinuation or dose reduction of pioglitazone HCl must be considered.
All sulfonylurea drugs are capable of producing severe hypoglycemia. Proper patient selection, dosage and instructions are important to avoid hypoglycemic episodes. Patients with impaired renal function may be more sensitive to the glucose-lowering effect of glimepiride. Hypoglycemia may be difficult to recognize in the elderly and in people who are taking β-adrenergic blocking drugs or other sympatholytic agents. Patients who are debilitated, malnourished and with adrenal, pituitary, renal or hepatic insufficiency are particularly susceptible to the hypoglycemic action of sulfonylureas and should therefore be carefully monitored. The dosage of glimepiride should be carefully adjusted in these patients.
Pioglitazone HCl may cause decline in hematocrit value along with the decline in mean hemoglobin values by 2-4% causing anemia. These changes primarily occurred within the first 4-12 weeks of therapy and remained relatively constant thereafter. These changes may be related to increased plasma volume and have rarely been associated with any significant hematological clinical effects.
In patients with type 2 diabetes (mean duration of diabetes 9.5 years), an increased incidence of bone fracture in female patients taking pioglitazone is observed. The risk of fracture should be considered in the care of patients, especially female patients, treated with pioglitazone HCl and attention should be given to assessing and maintaining bone health according to current standards of care.
Alcohol ingestion, severe or prolonged exercise, deficient caloric intake or use of >1 antidiabetic agent may predispose patients to the development of hypoglycemia.
When a patient stabilized on any diabetic regimen is exposed to stress eg, fever, trauma, infection or surgery, a loss of control may occur. At such times, it may be necessary to add insulin in combination with glimepiride or even use insulin monotherapy.
The patient's fasting blood glucose and HbA1c must be measured periodically to determine the minimum effective dose of pioglitazone plus glimepiride for the patient.
Liver enzyme monitoring is recommended prior to initiation of therapy with pioglitazone plus glimepiride in all patients and periodically thereafter per clinical judgment of the healthcare professional.