Label: PIOGLITAZONE tablet
- NDC Code(s): 67046-2076-3
- Packager: Coupler LLC
- This is a repackaged label.
- Source NDC Code(s): 33342-055
- 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 INFORMATIONThese 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 ...
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Table of ContentsTable of Contents
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BOXED WARNING
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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 USAGEMonotherapy 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 ...
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2 DOSAGE AND ADMINISTRATION2.1 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 ...
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3 DOSAGE FORMS AND STRENGTHSRound 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 ...
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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 ...
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5 WARNINGS AND PRECAUTIONS5.1 Congestive Heart Failure - Pioglitazone hydrochloride, like other thiazolidinediones, can cause dose-related fluid retention when used alone or in combination with other antidiabetic ...
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6 ADVERSE REACTIONSThe following serious adverse reactions are discussed elsewhere in the labeling: Congestive heart failure - [see - Boxed Warningand Warnings and Precautions ( 5.1)] Edema - [see ...
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7 DRUG INTERACTIONS7.1 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 ...
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8 USE IN SPECIFIC POPULATIONS8.1 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 ...
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10 OVERDOSAGEDuring 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 ...
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11 DESCRIPTIONPioglitazone tablets USP are a thiazolidinedione and an agonist for peroxisome proliferator-activated receptor (PPAR) gamma that contains an oral antidiabetic medication ...
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12 CLINICAL PHARMACOLOGY12.1 Mechanism of Action - Pioglitazone hydrochloride is a thiazolidinedione that depends on the presence of insulin for its mechanism of action. Pioglitazone hydrochloride decreases insulin ...
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13 NONCLINICAL TOXICOLOGY13.1 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 ...
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14 CLINICAL STUDIES14.1 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 ...
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16 HOW SUPPLIED/STORAGE AND HANDLINGPioglitazone 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 ...
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17 PATIENT COUNSELING INFORMATIONSee 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 ...
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MEDICATION GUIDEPioglitazone 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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