PIOGLITAZONE tablet

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

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

Saatavilla:

Avera McKennan Hospital

INN (Kansainvälinen yleisnimi):

PIOGLITAZONE HYDROCHLORIDE

Koostumus:

PIOGLITAZONE 15 mg

Prescription tyyppi:

PRESCRIPTION DRUG

Valtuutuksen tilan:

Abbreviated New Drug Application

Valmisteyhteenveto

PIOGLITAZONE- PIOGLITAZONE TABLET
AVERA MCKENNAN HOSPITAL
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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_
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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. (1,14)
Important Limitation of Use:
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DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
Tablets: 15 mg, 30 mg and 45 mg (3)
CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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THIAZOLIDINEDIONES, INCLUDING PIOGLITAZONE TABLETS, 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 DISCONTINUE OR
DOSE REDUCTION OF PIOGLITAZONE TABLETS MUST BE CONSIDERED. (5.1)
PIOGLITAZONE TABLETS ARE 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. (4, 5.1)
Not for treatment of type 1 diabetes or diabetic ketoacidosis. (1)
Initiate pioglitazone tablets at 15 mg or 30 mg once daily. Limit
initial dose to 15 mg once daily in patients with NYHA
Class I or II heart failure. (2.1)
If there is inadequate glycemic control, the dose can be increased in
15 mg increments up to a maximum of 45 mg
once daily. (2.1)