Adult Dosing
Monotherapy
- Initial: 15-30 mg PO qd; begin with 15 mg PO qd in patients with NYHA class I or II heart failure
- May increase the dose in 15-mg increments up to 45 mg qd in patients with inadequate glycemic response to the initial dose
- Max: 45 mg/day
Notes:- Consider combination therapy in patients not responding adequately to monotherapy
- Obtain liver tests before starting pioglitazone. If abnormal, exercise caution when treating with pioglitazone; identify and treat the probable cause and follow appropriately
Combination therapy with sulfonylurea
- Start pioglitazone at 15-30 mg PO qd; may increase up to a maximum of 45 mg/day. However, should hypoglycemic episodes occur, the dose of the sulfonylurea should be reduced
Combination therapy with metformin
- Start pioglitazone at 15-30 mg PO qd; may increase up to a maximum of 45 mg/day
- Metformin dose will not require any adjustment because of hypoglycemia during concomitant use with pioglitazone
Combination therapy with insulin
- Initial: 15-30 mg PO qd; may increase up to a maximum of 45 mg/day
- Decrease insulin dose by 10-25% if hypoglycemia occurs or plasma glucose concentrations decrease <100 mg/dL
Combination therapy with strong CYP2C8 inhibitors
- Maximum recommended dose of pioglitazone is 15 mg/day when administered with strong CYP2C8 inhibitors, as it increases pioglitazone exposure approximately 3-fold
Pediatric Dosing
- Safety and effectiveness in pediatric patients have not been established
[Outline]
See Supplemental Patient Information
- Pioglitazone may cause fluid retention when used alone or in combination with other antidiabetic agents, especially with insulin; this may lead to or exacerbate CHF
- Monitor patients for signs and symptoms of heart failure. If CHF develops, manage according to current standards of care and consider discontinuation or dose reduction of pioglitazone [US Black Box Warning]
- Therapy with pioglitazone is contraindicated in patients with NYHA class III or IV heart failure [US Black Box Warning]
- Patients who report with symptoms of fatigue, anorexia, right upper abdominal discomfort, dark urine and jaundice should be evaluated for any liver injury; if ALT level >3x the ULN, interrupt treatment and investigate for probable cause. Do not restart treatment in patients without another explanation for the liver test abnormalities
- Patients with ALT level
3x the ULN and serum total bilirubin 2x the ULN without alternative etiologies are at risk for severe drug-induced liver injury. Therapy should not be restarted in such patients - Pioglitazone increases the risk of fracture in female patients; assess and maintain bone health as per the current standards of care
- Concomitant use with insulin/other antidiabetic agents may increase the risk of hypoglycemia; if essential, consider reducing the dose of the concomitant agent
- Macular edema has been reported in postmarketing experience in patients taking pioglitazone. Patients with diabetes should undergo regular eye examination, regardless of the patient’s underlying medications
- Thiazolidinediones may result in ovulation in some premenopausal anovulatory women, thereby increasing the risk of pregnancy; recommend adequate contraception for premenopausal women treated with pioglitazone
Cautions: Use cautiously in
- Mild hepatic impairment
- History of CHF (NYHA class I-II)
- Presence of risk factors for CHF
- Patients with edema
- Use of insulin
- History of bladder cancer
Supplemental Patient Information
- Advise patients to adhere to dietary instructions and have blood glucose and glycosylated hemoglobin levels tested regularly
- Instruct patients to promptly report their physician if any unusual rapid weight gain or edema occurs or if they develop shortness of breath or other symptoms of heart failure during therapy
- Advise patients to seek immediate medical advice if they develop any sign of macroscopic hematuria or other symptoms including dysuria or urinary urgency during treatment as these may be due to bladder cancer
Pregnancy Category:C
Breastfeeding: No information is available on pioglitazone use during breastfeeding; an alternate drug may be preferred, especially while nursing a newborn or preterm infant. Monitoring of the breastfed infant's blood glucose is advisable during maternal therapy with hypoglycemic agents. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 7 February 2011). As per manufacturer's data, because of the potential of pioglitazone to cause adverse effects in nursing infants, a decision should be made to discontinue nursing or to discontinue the drug, analyzing the importance of the drug to the mother.
Pricing data from www.DrugStore.com in U.S.A.
- Actos 45 MG TABS [Bottle] (TAKEDA PHARMACEUTICALS)
30 mg = $310
90 mg = $907 - Actos 15 MG TABS [Bottle] (TAKEDA PHARMACEUTICALS)
30 mg = $193.48
90 mg = $554.66 - Actos 30 MG TABS [Bottle] (TAKEDA PHARMACEUTICALS)
30 mg = $289.98
90 mg = $859.99
Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.
