Brand Name, Dosage Format and Strength
30 mg Tablet
Endocrine and Metabolic System
Serotonin and Noradrenaline Reuptake Inhibitor (SNRI), Sulfonylurea, Biguanide, Biguanide + Sulfonylurea, Thiazolidinedione
STATEMENT ON USAGE FOR HIGH RISK GROUPS
Pregnancy and Lactation: Pregnancy Category C
Pioglitazone teratogenicity was not seen in rats at oral doses of 80 mg/kg (17 times the maximum recommended human oral dose) and in rabbits given in doses up to 160 mg/kg (40 times the maximum recommended human oral dose) during organogenesis. In rats, oral doses of 40 mg/kg/day and above resulted in delayed parturition and embryotoxicity (increased post-implantation losses, delayed development and delayed fetal weights) but functional or behavioral toxicity was not observed in the offspring. Also in rats, oral doses of 10 mg/kg and above given during late gestation and lactation periods resulted in delayed postnatal development in rat offspring. This was attributed to decreased BW. Embroyotoxicity was observed in rabbits at an oral dose of 160 mg/kg. No adequate and well-controlled studies in pregnant women are available.
Oral hypoglycemic agents (including pioglitazone) are not recommended during pregnancy. Maintaining blood glucose levels as close to normal as possible is necessary during pregnancy since abnormal blood glucose levels are associated with a higher incidence of congenital abnormalities. Insulin is recommended during pregnancy.
It is not known whether pioglitazone is excreted in human breast milk although pioglitazone is secreted in the milk of lactating rats. Pioglitazone use in breastfeeding women is not recommended.
Elderly: There are no significant differences in the PK, efficacy and safety of pioglitazone between geriatric and younger patients.
Children: Safety and efficacy of pioglitazone in children have not been established.
Hepatic Impairment: Pioglitazone is not recommended in patients with moderate to severe hepatic impairment (ALT more than 2.5 times the upper limit of normal, or active liver disease). It is also not recommended in patients who experienced troglitazone-associated jaundice. Exercise caution when using pioglitazone in patients with mild hepatic impairment. (See WARNINGS AND PRECAUTIONS, Hepatic Effects)
Renal Impairment: Dose adjustment is not necessary in patients with renal dysfunction.