PIOGLITAZONE HYDROCHLORIDE tablet

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

pioglitazone hydrochloride (UNII: JQT35NPK6C) (pioglitazone - UNII:X4OV71U42S)

Mevcut itibaren:

Golden State Medical Supply

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
GOLDEN STATE MEDICAL SUPPLY
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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, USP FOR ORAL USE
INITIAL U.S. APPROVAL: 1999
WARNING: CONGESTIVE HEART FAILURE
SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING.
THIAZOLIDINEDIONES, INCLUDING PIOGLITAZONE TABLETS, USP, CAUSE OR
EXACERBATE CONGESTIVE HEART FAILURE
IN SOME PATIENTS. (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. (5.1)
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. (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 Tablets, USP are 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, USP at 15 mg or 30 mg once daily. Limit