PIOGLITAZONE HYDROCHLORIDE tablet

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

PIOGLITAZONE HYDROCHLORIDE (UNII: JQT35NPK6C) (PIOGLITAZONE - UNII:X4OV71U42S)

Mevcut itibaren:

REMEDYREPACK INC.

INN (International Adı):

PIOGLITAZONE HYDROCHLORIDE

Kompozisyon:

PIOGLITAZONE 15 mg

Reçete türü:

PRESCRIPTION DRUG

Yetkilendirme durumu:

Abbreviated New Drug Application

Ürün özellikleri

PIOGLITAZONE HYDROCHLORIDE- PIOGLITAZONE HYDROCHLORIDE TABLET
REMEDYREPACK INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
PIOGLITAZONE TABLETS, USP SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR PIOGLITAZONE
TABLETS, USP.
PIOGLITAZONE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1999
WARNING: CONGESTIVE HEART FAILURE
SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING.
THIAZOLIDINEDIONES, INCLUDING PIOGLITAZONE HYDROCHLORIDE, CAUSE OR
EXACERBATE CONGESTIVE HEART
FAILURE IN SOME PATIENTS. ( 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. ( 5.1)
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. ( 4, 5.1)
RECENT MAJOR CHANGES
Indications and Usage
Important Limitations of Use ( 1.2)
01/2011
Dosage and Administration
Recommendations for All Patients ( 2.1)
01/2011
Coadministration with Strong CYP2C8 Inhibitors ( 2.3)
01/2011
Warnings and Precautions
Hepatic Effects ( 5.3)
01/2011
Urinary Bladder Tumors ( 5.5)
07/2011
INDICATIONS AND USAGE
Pioglitazone tablet is a thiazolidinedione and an agonist for
peroxisome proliferator-activated receptor (PPAR) gamma
indicated as an adjunct to diet and exercise to improve glycemic
control in adults with type 2 diabetes mellitus in multiple
clinical settings. ( 1.1, 14)
Important Limitation of Use:
Not for treatment of type 1 diabetes or diabetic ketoacidosis. ( 1.2)
DOSAGE AND ADMINISTRATION
Initiate pioglitazone tablets at 15 mg or 30 mg once daily. Limit
initial dose to 15 mg once daily in