Utmos Special Precautions

Ovulation: Therapy with thiazolidinediones may result in ovulation in some premenopausal anovulatory women. Thus, adequate contraception in premenopausal women should be recommended.
Hypoglycemia: Patients receiving pioglitazone in combination with insulin or oral hypoglycemic agents may be at risk for hypoglycemia, also it may be necessary to reduce the dose of the concomitant agent.
Cardiovascular: Pioglitazone can cause fluid retention when used alone or in combination with other antidiabetic agents, including insulin. If necessary, the patients may be treated with diuretic drugs. Weight gain possibly associated with fluid retention has been observed during therapy with pioglitazone alone or in combination with other antidiabetic agents. In case of patients with previously known heart disease, pioglitazone in combination with insulin may increase risk of congestive heart failure. Patients should be observed for signs and symptoms of heart failure (e.g. dyspnea, weight gain, and edema).
Pioglitazone should be discontinued if any deterioration in cardiac status occurs.
Pioglitazone is not recommended in patients with New York Heart Association (NYHA) class III and IV.
Edema: Pioglitazone can cause edema when used alone or in combination with other antidiabetic agents, including insulin, also pioglitazone should be used with caution in patients with edema.
Hepatic effects: Reports of hepatitis and hepatic enzyme elevations to 3 or more times the upper limit of normal have been received. Therefore, serum ALT (alanine transaminase) levels should be evaluated prior to the initiation of therapy with pioglitazone in all patients, and periodically thereafter per the clinical judgement of the health care professional. If ALT levels remain > 3 times the upper limit of normal, pioglitazone therapy should be discontinued.
Hematologic: Pioglitazone may cause decreases in hemoglobin and hematocrit. 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 rarely been associated with any significant hematologic clinical effects.
Anemia: Use with caution in patients with anemia. Anemia occurred in 1% of patients treated with pioglitazone compared to 0% of patients treated with placebo.
Weight gain: In clinical trials with pioglitazone there was evidence of dose related weight gain which may be due to fat accumulation and in some cases associated with fluid retention.
Bone fracture: Female patients with type 2 diabetes mellitus receiving pioglitazone had a higher incidence of bone fractures, with a majority of distal upper limb (forearm, hand, and wrist), or distal lower limb (foot, ankle, fibula, and tibia) than those receiving a comparator.
Macular retinal edema: Reports of new onset or worsening of diabetic macular edema with decreased visual acuity have occurred during postmarketing use of pioglitazone hydrochloride or other thiazolidinedione. Presenting symptoms have been blurred vision or decreased visual acuity. However, for some patients the macular edema was asymptomatic and detected on routine eye exam. Regular eye exams by an ophthalmologist are recommended.
Use of pioglitazone is not recommended for patients with NYHA class III and IV heart failure, as these patients were not studied during clinical trials.
This drug is not recommended in patients with hepatic disorders or patients with abnormal liver function.
Patients should be observed for signs and symptoms of heart failure (e.g. rapid weight gain, edema, dyspnea, or signs and symptoms of heart disease) and the drug should be discontinued and reported to the doctor immediately if any deterioration in cardiac status occurs.