Pioglitazone Hydrochloride

PIOGLITAZONE HYDROCHLORIDE- pioglitazone hydrochloride tablet
Golden State Medical Supply

WARNING: CONGESTIVE HEART FAILURE

  • Thiazolidinediones, including Pioglitazone Tablets, USP, cause or exacerbate congestive heart failure in some patients [see Warnings and Precautions (5.1)].
  • After initiation of Pioglitazone Tablets, USP, 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, USP must be considered.
  • Pioglitazone Tablets, USP are not recommended in patients with symptomatic heart failure.
  • Initiation of Pioglitazone Tablets, USP in patients with established New York Heart Association (NYHA) Class III or IV heart failure is contraindicated [see Contraindications (4) and Warnings and Precautions (5.1)].

1 INDICATIONS AND USAGE

1.1 Monotherapy and Combination Therapy

Pioglitazone Tablets, USP 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, USP exert their antihyperglycemic effect only in the presence of endogenous insulin. Pioglitazone Tablets, USP 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, USP 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, USP 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 Boxed Warning and Warnings and Precautions (5.2)].

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

2.2 Concomitant use with an insulin secretagogue or insulin

If hypoglycemia occurs in a patient co-administered Pioglitazone Tablets, USP and an insulin secretagogue (e.g., sulfonylurea), the dose of the insulin secretagogue should be reduced.

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

3 DOSAGE FORMS AND STRENGTHS

Round tablet contains pioglitazone as follows:

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

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, USP or any of its ingredients.

5 WARNINGS AND PRECAUTIONS

5.1 Congestive Heart Failure

Pioglitazone Tablets, USP, 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, USP 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, USP must be considered [see Boxed Warning, Contraindications (4), and Adverse Reactions (6.1)].

5.2 Edema

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

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

5.3 Hepatic Effects

There have been postmarketing reports of fatal and non-fatal hepatic failure in patients taking Pioglitazone Tablets, USP, although the reports contain insufficient information necessary to establish the probable cause. There has been no evidence of drug-induced hepatotoxicity in the Pioglitazone Tablets, USP controlled clinical trial database to date [see Adverse Reactions (6.1)].

Patients with type 2 diabetes may have fatty liver disease or cardiac disease with episodic congestive heart failure, both of which may cause liver test abnormalities, and they may also have other forms of liver disease, many of which can be treated or managed. Therefore, obtaining a liver test panel (serum alanine aminotransferase [ALT], aspartate aminotransferase [AST], alkaline phosphatase, and total bilirubin) and assessing the patient is recommended before initiating Pioglitazone Tablets, USP therapy. In patients with abnormal liver tests, Pioglitazone Tablets, USP should be initiated with caution.

Measure liver tests promptly in patients who report symptoms that may indicate liver injury, including fatigue, anorexia, right upper abdominal discomfort, dark urine or jaundice. In this clinical context, if the patient is found to have abnormal liver tests (ALT greater than 3 times the upper limit of the reference range), Pioglitazone Tablets, USP treatment should be interrupted and investigation done to establish the probable cause. Pioglitazone Tablets, USP should not be restarted in these patients without another explanation for the liver test abnormalities.

Patients who have serum ALT greater than three times the reference range with serum total bilirubin greater than two times the reference range without alternative etiologies are at risk for severe drug-induced liver injury, and should not be restarted on Pioglitazone Tablets, USP. For patients with lesser elevations of serum ALT or bilirubin and with an alternate probable cause, treatment with Pioglitazone Tablets, USP can be used with caution.

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