Pio-LN Special Precautions

There are no clinical studies of the three combinations, between pioglitazone with other oral antidiabetic. Pioglitazone should not be given as monotherapy. Pioglitazone can cause water retention and precipitation may exacerbate heart failure. Patients should be monitored for signs and symptoms of heart failure. Discontinue administration of pioglitazone in case of cardiac dysfunction. Coadministration of pioglitazone with insulin is contraindicated.
NSAIDs and pioglitazone associated with water retention, coadministration may increase the risk of edema. Patients receiving pioglitazone therapy of liver enzymes should be monitored regularly. Perform liver function tests before administration of pioglitazone therapy. Pioglitazone should not be administered to patients with elevated levels of liver enzymes (ALT >2.5 x Upper Limit of Normal/ULN) or the presence of liver disease.
It is recommended that liver function tests be monitor every two months in the first 12 months and periodically thereafter. If ALT levels are increased to > 3 x ULN during pioglitazone therapy, test reassessed, if ALT levels remain >3 x ULN, therapy should be discontinued. If the patient has symptoms suggesting liver dysfunction such as nausea, vomiting, abdominal pain, fatigue, anorexia and dark urine, liver function tests done. Discontinuation decision based on the evaluation of laboratory results. If jaundice is observed, drug therapy should be discontinued.
Pioglitazone can cause weight gain so it is necessary to supervise. Diet is one way to control diabetes. Patients should be advised to adhere strictly to a calorie-controlled diet.
Pioglitazone can cause decreased levels of hemoglobin and heamatocrit, according to haemodilution. Anemia is one of the side effects of administration of pioglitazone. Provision of pioglitazone on polycystic ovary syndrome can lead to stimulation of ovulation so that patients at risk of pregnancy. If the patients is planning become pregnant or if pregnancy occurs, the treatment should be discontinued.
Use in pregnancy and lactation: There are no clinical data on the use of pioglitazone during pregnancy. Pioglitazone should not be used in pregnancy. It is not known whether pioglitazone is secreted in human milk. Pioglitazone should not be administered to breastfeeding women.
Use in children: Pioglitazone is not recommended for children <18 years.