Pioglitazone precautions

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Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1] Phone:617-632-7753

List of precautions

Nursing Mothers

Pediatric Use

Elderly Use

Type 1 diabetes

Hypoglycemia

Cardiovascular

Edema

Weight Gain

Ovulation

Hematologic

Hepatic Effects

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Nursing Mothers

Pioglitazone is secreted in the milk of lactating rats. 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 breast-feeding woman. Return to top

Pediatric Use

Safety and effectiveness of Pioglitazone in pediatric patients have not been established. Return to top

Elderly Use

Approximately 500 patients in placebo-controlled clinical trials of Pioglitazone were 65 and over. No significant differences in effectiveness and safety were observed between these patients and younger patients. Return to top

Type 1 diabetes

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. Return to top

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. Return to top

Cardiovascular

In U.S. placebo-controlled clinical trials that excluded patients with New York Heart Association (NYHA) Class III and IV cardiac status, the incidence of serious cardiac adverse events related to volume expansion was not increased in patients treated with Pioglitazone as monotherapy or in combination with sulfonylureas or metformin vs. placebo-treated patients. In insulin combination studies, a small number of patients with a history of previously existing cardiac disease developed congestive heart failure when treated with Pioglitazone in combination with insulin. Patients with NYHA Class III and IV cardiac status were not studied in Pioglitazone clinical trials. Pioglitazone is not indicated in patients with NYHA Class III or IV cardiac status. Return to top

Edema

Pioglitazone should be used with caution in patients with edema. In all U.S. clinical trials, edema was reported more frequently in patients treated with Pioglitazone than in placebo- treated patients. In postmarketing experience, reports of initiation or worsening of edema have been received. Return to top

Weight Gain

Dose related weight gain was seen with Pioglitazone alone and in combination with other hypoglycemic agents. The mechanism of weight gain is unclear but probably involves a combination of fluid retention and fat accumulation. Return to top

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. This possible effect has not been investigated in clinical studies so the frequency of this occurrence is not known. Return to top

Hematologic

Pioglitazone may cause decreases in hemoglobin and hematocrit. Across all clinical studies, mean hemoglobin values declined by 2% to 4% in patients treated with Pioglitazone. These changes primarily occurred within the first 4 to 12 weeks of therapy and remained relatively constant thereafter. These changes may be related to increased plasma volume and have not been associated with any significant hematologic clinical effects. Return to top

Hepatic Effects

Another drug of the thiazolidinedione class, troglitazone, has been associated with idiosyncratic hepatotoxicity, and very rare cases of liver failure, liver transplants, and death have been reported during postmarketing clinical use. In pre-approval controlled clinical trials in patients with type 2 diabetes, troglitazone was more frequently associated with clinically significant elevations of hepatic enzymes (ALT > 3 times the upper limit of normal) compared to placebo, and very rare cases of reversible jaundice were reported. Return to top

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The content of this page is taken from the FDA package insert for this drug and should not be edited.