Zolid/ZolidPlus Warnings

Zolid: Cardiac Failure and Other Cardiac Effects: Pioglitazone, like other thiazolidinediones, can cause fluid retention when used alone or in combination with other antidiabetic agents including insulin. Patients should be observed for signs and symptoms of heart failure. Fluid retention may lead to or exacerbate heart failure. Pioglitazone should be discontinued if any deterioration in cardiac status occurs.
ZolidPlus: Pioglitazone: Congestive Heart Failure: Thiazolidinediones cause or exacerbate congestive heart failure in some patients. After initiation of pioglitazone and after dose increases, the patient should be observed carefully for sign and symptoms of heart failure including excessive, rapid weight gain, dyspnea and/or edema. If these signs and symptoms develop, the heart failure should be managed according to the current standard of care. Furthermore, discontinuation or dose reduction of drug must be considered.
Pioglitazone is not recommended in patients with symptomatic heart failure. Initiation of ZolidPlus in patients with essential NYHA class III or IV heart failure is contraindicated.
Metformin HCl: Lactic acidosis is rare, but serious metabolic complication that can occur due to metformin accumulation during treatment. The risk of lactic acidosis increases with the degree of renal dysfunction and the patient's age. The risk of lactic acidosis may, therefore be significantly decreased by regular monitoring of renal function in patients taking metformin and by use of the minimum effective dose of metformin. The onset of lactic acidosis often is accompanied only by nonspecific symptoms eg, malaise, myalgias, respiratory distress, increasing somnolence and nonspecific abdominal distress. There may be associated hypothermia, hypotension and resistant bradyarrhythmias with more marked acidosis.