Label: PIOGLITAZONE tablet

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

Drug Label Information

Updated November 8, 2024

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  • 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 tablets for ...
  • Table of Contents
    Table of Contents
  • BOXED WARNING (What is this?)

    BOXED WARNING

    WARNING: CONGESTIVE HEART FAILURE

    ·   Thiazolidinediones, includingpioglitazone hydrochloride tablets, cause or exacerbate congestive heart failure in some patients  [see Warnings and Precautions ( 5.1)]

    ·   After initiation ofpioglitazone hydrochloride tablets, and after dose increases, monitor patients carefully for signs andsymptoms 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 hydrochlorideis not recommended in patients with symptomatic heart failure. ( 5.1

    ·   Initiation of pioglitazone tablets 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)]

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  • 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 multiple ...
  • 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 ...
  • 3 DOSAGE FORMS AND STRENGTHS
    Round tablet contains pioglitazone as follows: 15 mg: White to off white, circular, flat face, bevelled edge, uncoated tablet debossed with "ML 86" on one side and plain on the other side - 30 mg ...
  • 4 CONTRAINDICATIONS
    • Initiation in patients with established New York Heart Association (NYHA) Class III or IV heart failure [see Boxed Warning]. ( 4) • Use in patients with known hypersensitivity to ...
  • 5 WARNINGS AND PRECAUTIONS
    5.1 Congestive Heart Failure - Pioglitazone hydrochloride, like other thiazolidinediones, can cause dose-related fluid retention when used alone or in combination with other antidiabetic ...
  • 6 ADVERSE REACTIONS
    The following serious adverse reactions are discussed elsewhere in the labeling: Congestive heart failure - [see - Boxed Warningand Warnings and Precautions ( 5.1)] Edema - [see ...
  • 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 (t1/2) of ...
  • 8 USE IN SPECIFIC POPULATIONS
    8.1 Pregnancy - Risk Summary - Limited data with pioglitazone hydrochloride in pregnant women are not sufficient to determine a drug-associated risk for major birth defects or miscarriage ...
  • 10 OVERDOSAGE
    During controlled clinical trials, one case of overdose with pioglitazone hydrochloride was reported. A male patient took 120 mg per day for four days, then 180 mg per day for seven days. The ...
  • 11 DESCRIPTION
    Pioglitazone tablets USP are a thiazolidinedione and an agonist for peroxisome proliferator-activated receptor (PPAR) gamma that contains an oral antidiabetic medication ...
  • 12 CLINICAL PHARMACOLOGY
    12.1 Mechanism of Action - Pioglitazone hydrochloride is a thiazolidinedione that depends on the presence of insulin for its mechanism of action. Pioglitazone hydrochloride decreases insulin ...
  • 13 NONCLINICAL TOXICOLOGY
    13.1 Carcinogenesis And 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 ...
  • 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 hydrochloride as monotherapy in ...
  • 16 HOW SUPPLIED/STORAGE AND HANDLING
    Pioglitazone hydrochloride USP is available in 15 mg, 30 mg, and 45 mg tablets as follows: 15 mg tablet: White to off white, circular, flat face, bevelled edge, uncoated tablet debossed with "ML ...
  • 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 - (PYE o GLIT a zone) Read this Medication Guide carefully before you start taking pioglitazone tablets and each time you get a refill. There may be new ...
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