Pioglitazone

What it is and how it works

Mechanism class: Peroxisome Proliferator-activated Receptor alpha Agonists · Peroxisome Proliferator-activated Receptor gamma Agonists

Indications

Monotherapy and Combination Therapy Pioglitazone tablets are indicated as adjuncts to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus in multiple clinical settings . Important Limitations of Use Pioglitazone tablets exert their antihyperglycemic effects only in the presence of endogenous insulin. Pioglitazone tablets should not be used to treat type 1 diabetes or diabetic ketoacidosis, as it would not be effective in these settings. Use caution in patients with liver disease . Pioglitazone is a thiazolidinedione and an agonist for peroxisome proliferator-activated receptor (PPAR) gamma indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus in multiple clinical settings. ( 1 , 14 ) Important Limitations of Use: • Not for treatment of type 1 diabetes or diabetic ketoacidosis.

Dosage and administration (summary)

• Initiate pioglitazone tablets at 15 mg or 30 mg once daily. Limit initial dose to 15 mg once daily in patients with NYHA Class I or II heart failure. • If there is inadequate glycemic control, the dose can be increased in 15 mg increments up to a maximum of 45 mg once daily. • Obtain liver tests before starting pioglitazone tablets. If abnormal, use caution when treating with pioglitazone tablets, investigate the probable cause, treat (if possible) and follow appropriately. Monitoring liver tests while on pioglitazone tablets are not recommended in patients without liver disease.

Contraindications

• Initiation in patients with established NYHA Class III or IV heart failure . • Use in patients with known hypersensitivity to pioglitazone or any other component of pioglitazone tablets. • Initiation in patients with established New York Heart Association (NYHA) Class III or IV heart failure . • Use in patients with known hypersensitivity to pioglitazone or any other component of pioglitazone tablets.

Warnings and precautions

• Congestive heart failure: Fluid retention may occur and can exacerbate or lead to congestive heart failure. Combination use with insulin and use in congestive heart failure NYHA Class I and II may increase risk. Monitor patients for signs and symptoms. • Hypoglycemia: When used with insulin or an insulin secretagogue, a lower dose of the insulin or insulin secretagogue may be needed to reduce the risk of hypoglycemia. • Hepatic effects: Postmarketing reports of hepatic failure, sometimes fatal. Causality cannot be excluded.

Storage and supply

Pioglitazone tablets, USP, are available in 15 mg, 30 mg, and 45 mg tablets as follows: 15 mg tablet: White to off-white, round, convex, nonscored tablet with “295” on one side, and “S” on the other, available in: NDC 43547-426-03 Bottles of 30 NDC 43547-426-09 Bottles of 90 NDC 43547-426-50 Bottles of 500 30 mg tablet: White to off-white, round, f…

Source: Pioglitazone (Pioglitazone) — US FDA prescribing information, 2020-01-01, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.