Zolid/ZolidPlus Special Precautions


pioglitazone + metformin


Getz Pharma


Getz Bros
Full Prescribing Info
Special Precautions
General: Pioglitazone exerts its antihyperglycemic effect only in the presence of insulin. Therefore, pioglitazone should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis.
ZolidPlus: Inadequate response to a combination of metformin and a sulfonylurea may indicate falling insulin release; the introduction of pioglitazone has a limited role in these circumstances and insulin treatment should not be delayed.
Hypoglycemia: Patients receiving pioglitazone in combination with insulin or oral hypoglycemic agents may be at risk for hypoglycemia, and a reduction in the dose of the concomitant agent may be necessary.
Edema: Zolid: Pioglitazone should be used with caution in patients with edema.
Hematologic: Pioglitazone may cause decreases in hemoglobin and hematocrit causing anemia. Hemoglobin monitoring is recommended if patients exhibit any signs or symptoms of anemia.
Ovulation: Therapy with pioglitazone, like other thiazolidinediones, may result in ovulation in some premenopausal anovulatory women. As a result, these patients may be at an increased risk for pregnancy while taking pioglitazone. Thus, adequate contraception in premenopausal women should be recommended.
Hepatic Effects: Therapy with pioglitazone should not be initiated if the patient exhibits clinical evidence of active liver disease or increased serum transaminase levels (ALT >2.5 times the upper limit of normal) at start of therapy.
Zolid: Liver enzyme monitoring is recommended in all patients prior to initiation of therapy with pioglitazone and periodically thereafter.
ZolidPlus: Patients with mildly elevated liver enzymes (ALT levels at 1-2.5 times the upper limit of normal) at baseline or any time during therapy with ZolidPlus should be evaluated to determine the cause of the liver enzyme elevation. Initiation or continuation of therapy with pioglitazone + metformin HCl in patients with mildly elevated liver enzymes should proceed with caution and include appropriate clinical follow-up which may include more frequent liver enzyme monitoring
ZolidPlus: 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. Fluid retention may lead to or exacerbate heart failure. If these signs and symptoms develop, the heart failure should be managed according to current standards of care.
Metformin HCl: Lactic acidosis is a very rare, but serious, metabolic complication that can occur due to metformin accumulation. Reported cases of lactic acidosis in patients on metformin have occurred primarily in diabetic patients with significant renal failure. The incidence of lactic acidosis can and should be reduced by assessing also other associated risk factors eg, poorly controlled diabetes, ketosis, prolonged fasting, excessive alcohol intake, hepatic insufficiency and any condition associated with hypoxia. Lactic acidosis is characterized by acidotic dyspnea, abdominal pain, and hypothermia followed by coma. If metabolic acidosis is suspected, treatment with ZolidPlus should be discontinued and the patient hospitalized immediately.
Intravascular administration of iodinated contrast agents in radiological studies can lead to renal failure. Therefore, due to the metformin active substance, ZolidPlus should be discontinued prior to or at the time of the test and not reinstituted until 48 hrs afterwards, and only after renal function has been re-evaluated and found to be normal.
ZolidPlus should be promptly discontinued when cardiovascular collapse (shock), acute congestive heart failure, acute myocardial infarction and other conditions characterized by hypoxemia occur in patients.
Alcohol is known to potentiate the effect of metformin on lactate metabolism. Patients, therefore, should be warned against excessive alcohol intake, acute or chronic, while receiving ZolidPlus. Since impaired hepatic function has been associated with some cases of lactic acidosis, ZolidPlus should generally be avoided in patients with clinical or laboratory evidence of hepatic disease.
Hypoglycemia does not occur in patients receiving metformin alone under usual circumstances of use, but could occur when caloric intake is deficient, when strenuous exercise is not compensated by caloric supplementation, or during concomitant use with hypoglycemic agents (eg, sulfonylureas or insulin) or ethanol. Hypoglycemia may be difficult to recognize in the elderly and in people who are taking β-adrenergic blocking drugs.
Use in Pregnancy: Zolid: Pioglitazone should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Use in Lactation: Zolid: It is not known whether pioglitazone is secreted in human milk. Because many drugs are excreted in human milk, pioglitazone should not be administered to a breastfeeding woman.
Use in Children: Zolid: Since data is unavailable for pediatric patients, use of pioglitazone is not recommended.
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