Label: PIOGLITAZONE tablet

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated June 20, 2024

If you are a consumer or patient please visit this version.

  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use PIOGLITAZONE TABLETS safely and effectively. See full prescribing information for PIOGLITAZONE TABLETS. PIOGLITAZONE ...
  • Table of Contents
    Table of Contents
  • BOXED WARNING (What is this?)

    WARNING: CONGESTIVE HEART FAILURE

     

    • Thiazolidinediones, including pioglitazone, cause or exacerbate congestive heart failure in some patients [see Warnings and Precautions (5.1)] .
    • After initiation of pioglitazone, 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 must be considered.
    • Pioglitazone is not recommended in patients with symptomatic heart failure.
    • Initiation of pioglitazone 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)] .
    Close
  • 1 INDICATIONS AND USAGE
    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 ...
  • 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 ...
  • 3 DOSAGE FORMS AND STRENGTHS
    15 mg are white to off-white, round, biconvex, uncoated tablets, debossed with “31” on one side and “H” on other side. 30 mg are white to off-white, round, flat ...
  • 4 CONTRAINDICATIONS
    Initiation in patients with established NYHA Class III or IV heart failure - [see - Boxed Warning].  Use in patients with known hypersensitivity to ...
  • 5 WARNINGS AND PRECAUTIONS
    5.1 Congestive Heart Failure - Pioglitazone, like other thiazolidinediones, can cause dose-related fluid retention when used alone or in combination with other antidiabetic medications and is ...
  • 6 ADVERSE REACTIONS
    The following serious adverse reactions are discussed elsewhere in the labeling: Congestive heart failure - [see - Boxed Warning and ...
  • 7 DRUG INTERACTIONS
    7.1 Strong CYP2C8 Inhibitors - An inhibitor of CYP2C8 (e.g., gemfibrozil) significantly increases the exposure (area under the serum concentration-time curve or AUC) and half-life (t ...
  • 8 USE IN SPECIFIC POPULATIONS
    8.1 Pregnancy - Risk Summary - Limited data with pioglitazone in pregnant women are not sufficient to determine a drug-associated risk for major birth defects or miscarriage. There are risks to ...
  • 10 OVERDOSAGE
    During controlled clinical trials, one case of overdose with pioglitazone was reported. A male patient took 120 mg per day for four days, then 180 mg per day for seven days. The patient denied ...
  • 11 DESCRIPTION
    Pioglitazone tablets are a thiazolidinedione and an agonist for peroxisome proliferator-activated receptor (PPAR) gamma that contains an oral antidiabetic medication: pioglitazone ...
  • 12 CLINICAL PHARMACOLOGY
    12.1 Mechanism of Action - Pioglitazone is a thiazolidinedione that depends on the presence of insulin for its mechanism of action. Pioglitazone decreases insulin resistance in the periphery ...
  • 13 NONCLINICAL TOXICOLOGY
    13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility - A two-year carcinogenicity study was conducted in male and female rats at oral doses up to 63 mg/kg (approximately 14 times the maximum ...
  • 14 CLINICAL STUDIES
    14.1 Monotherapy - Three randomized, double-blind, placebo-controlled trials with durations from 16 to 26 weeks were conducted to evaluate the use of pioglitazone as monotherapy in patients ...
  • 16 HOW SUPPLIED/STORAGE AND HANDLING
    Pioglitazone Tablets USP, 30 mg are white to off-white, round, flat faced, beveled edge uncoated tablets, debossed with 32 on one side and H on other side. NDC 68071-5210-1 BOTTLES OF ...
  • 17 PATIENT COUNSELING INFORMATION
    See FDA-Approved Patient Labeling (Medication Guide). It is important to instruct patients to adhere to dietary instructions and to have blood glucose and glycosylated hemoglobin tested ...
  • MEDICATION GUIDE
    Pioglitazone Tablets, USP - (pye" oh gli' ta zone) Read this Medication Guide carefully before you start taking pioglitazone tablets and each time you get a refill. There may be new ...
  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -
    PDP
  • INGREDIENTS AND APPEARANCE
    Product Information