Pioglitazone

PIOGLITAZONE- pioglitazone hydrochloride tablet
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WARNING: CONGESTIVE HEART FAILURE

Thiazolidinediones , including pioglitazone tablets, cause or exacerbate congestive heart failure in some patients . [see ] Warnings and Precautions (5.1)
After initiation of pioglitazone tablets, and after dose increases, monitor patients carefully for signs and symptoms of heart failure (e.g., excessive, rapid weight gain, dyspnea , and/or edema). If heart failure develops, it should be managed according to current standards of care and discontinuation or dose reduction of pioglitazone tablets must be considered.
Pioglitazone tablets are not recommended in patients with symptomatic heart failure.
Initiation of pioglitazone tablets in patients with established New York Heart Association (NYHA) Class III or IV heart failure is contraindicated [see and ]. Contraindications (4)Warnings and Precautions (5.1)

1 INDICATIONS AND USAGE

1.1 Monotherapy and Combination Therapy

Pioglitazone tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus in multiple clinical settings . [see ] Clinical Studies (14)

1.2 Important Limitation of Use

Pioglitazone tablets exert their antihyperglycemic effect 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 [see ]. Warnings and Precautions (5.3)

2 DOSAGE AND ADMINISTRATION

2.1 Recommendations for All Patients

Pioglitazone tablets should be taken once daily and can be taken without regard to meals.

The recommended starting dose for patients without congestive heart failure is 15 mg or 30 mg once daily.

The recommended starting dose for patients with congestive heart failure (NYHA Class I or II) is 15 mg once daily.

The dose can be titrated in increments of 15 mg up to a maximum of 45 mg once daily based on glycemic response as determined by HbA1c.

After initiation of pioglitazone tablets or with dose increase, monitor patients carefully for adverse reactions related to fluid retention such as weight gain, edema, and signs and symptoms of congestive heart failure . [see and ] Boxed WarningWarnings and Precautions (5.2)

Liver tests (serum alanine and aspartate aminotransferases, alkaline phosphatase, and total bilirubin) should be obtained prior to initiating pioglitazone tablets. Routine periodic monitoring of liver tests during treatment with pioglitazone tablets is not recommended in patients without liver disease. Patients who have liver test abnormalities prior to initiation of pioglitazone tablets or who are found to have abnormal liver tests while taking pioglitazone tablets should be managed as described under Warnings and Precautions . [see and ] Warnings and Precautions (5.3)Clinical Pharmacology (12.3)

2.2 Concomitant Use with an Insulin Secretagogue or Insulin

If hypoglycemia occurs in a patient coadministered pioglitazone tablets and an insulin secretagogue (e.g., sulfonylurea), the dose of the insulin secretagogue should be reduced.

If hypoglycemia occurs in a patient coadministered pioglitazone tablets and insulin, the dose of insulin should be decreased by 10% to 25%. Further adjustments to the insulin dose should be individualized based on glycemic response.

2.3 Coadministration with Strong CYP2C8 Inhibitors

Coadministration of pioglitazone tablets and gemfibrozil, a strong CYP2C8 inhibitor, increases pioglitazone exposure approximately 3-fold. Therefore, the maximum recommended dose of pioglitazone tablets is 15 mg daily when used in combination with gemfibrozil or other strong CYP2C8 inhibitors [see and ]. Drug Interactions (7.1)Clinical Pharmacology (12.3)

3 DOSAGE FORMS AND STRENGTHS

Round tablet contains pioglitazone as follows:

15 mg: White to off-white, debossed with “ACTOS” on one side and “15” on the other
30 mg: White to off-white, debossed with “ACTOS” on one side and “30” on the other
45 mg: White to off-white, debossed with “ACTOS” on one side and “45” on the other

4 CONTRAINDICATIONS

Do not initiate in patients with NYHA Class III or IV heart failure . [see ] Boxed Warning

Do not use in patients with a history of a serious hypersensitivity reaction to pioglitazone tablets or any of their ingredients.

5 WARNINGS AND PRECAUTIONS

5.1 Congestive Heart Failure

Pioglitazone tablets, like other thiazolidinediones, can cause dose-related fluid retention when used alone or in combination with other antidiabetic medications and is most common when pioglitazone tablets are used in combination with insulin. Fluid retention may lead to or exacerbate congestive heart failure. Patients should be observed for signs and symptoms of congestive heart failure. If congestive heart failure develops, it should be managed according to current standards of care and discontinuation or dose reduction of pioglitazone tablets must be considered , . [see , Boxed WarningContraindications (4)and ] Adverse Reactions (6.1)

5.2 Edema

In controlled clinical trials, edema was reported more frequently in patients treated with pioglitazone tablets than in placebo-treated patients and is dose-related . In postmarketing experience, reports of new onset or worsening edema have been received. [see ] Adverse Reactions (6.1)

Pioglitazone tablets should be used with caution in patients with edema. Because thiazolidinediones, including pioglitazone tablets, can cause fluid retention, which can exacerbate or lead to congestive heart failure, pioglitazone tablets should be used with caution in patients at risk for congestive heart failure. Patients treated with pioglitazone tablets should be monitored for signs and symptoms of congestive heart failure , . [see Boxed Warning and ] Warnings and Precautions (5.1)Patient Counseling Information (17.1)

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