PIOGLITAZONE AND METFORMIN HYDROCHOLRIDE hydrochloride tablet film coated

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

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

זמין מ:

Teva Pharmaceuticals USA

INN (שם בינלאומי):

pioglitazone hydrochloride

הרכב:

pioglitazone 15 mg

סוג מרשם:

PRESCRIPTION DRUG

מצב אישור:

New Drug Application Authorized Generic

מאפייני מוצר

PIOGLITAZONE AND METFORMIN HYDROCHOLRIDE- PIOGLITAZONE AND METFORMIN
HYDROCHLORIDE TABLET, FILM COATED
TEVA PHARMACEUTICALS USA
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
PIOGLITAZONE AND METFORMIN HYDROCHLORIDE
TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
PIOGLITAZONE AND METFORMIN HYDROCHLORIDE
T ABLE TS.
PIOGLITAZONE AND METFORMIN HYDROCHLORIDE TABLETS FOR ORAL USE
INITIAL U.S. APPROVAL: 2005
WARNING: CONGESTIVE HEART FAILURE AND LACTIC ACIDOSIS
SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING
CONGESTIVE HEART FAILURE
•
•
•
•
LACTIC ACIDOSIS
•
•
•
RECENT MAJOR CHANGES
Dosage and Administration
Recommendations for All Patients (2.1)
02/2012
Concomitant Use with an Insulin Secretagogue or Insulin (2.2)
02/2012
Coadministration with Strong CYP2C8 Inhibitors (2.3)
02/2012
Warnings and Precautions
Hepatic Effects (5.4)
02/2012
Urinary Bladder Tumors (5.6)
07/2011
INDICATIONS AND USAGE
Pioglitazone and metformin hydrochloride tablets are a
thiazolidinedione and biguanide combination product indicated as an
adjunct to diet and exercise to improve glycemic control in adults
with type 2 diabetes mellitus when treatment with both
pioglitazone and metformin is appropriate. (1, 14)
Important Limitation of Use:
•
THIAZOLIDINEDIONES, INCLUDING PIOGLITAZONE, WHICH IS A COMPONENT OF
PIOGLITAZONE AND METFORMIN
HYDROCHLORIDE TABLETS, CAUSE OR EXACERBATE CONGESTIVE HEART FAILURE IN
SOME PATIENTS. (5.1)
AFTER INITIATION OF PIOGLITAZONE AND METFORMIN HYDROCHLORIDE 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 AND METFORMIN
HYDROCHLORIDE TABLETS MUST BE CONSIDERED. (5.1)
PIOGLITAZONE AND METFORMIN HYDROCHLORIDE TABLETS ARE NOT RECOMMENDED
IN PATIENTS WITH
SY