国: アメリカ合衆国
言語: 英語
ソース: NLM (National Library of Medicine)
PIOGLITAZONE HYDROCHLORIDE (UNII: JQT35NPK6C) (PIOGLITAZONE - UNII:X4OV71U42S)
Teva Pharmaceuticals USA, Inc.
PIOGLITAZONE HYDROCHLORIDE
PIOGLITAZONE 15 mg
PRESCRIPTION DRUG
Abbreviated New Drug Application
PIOGLITAZONE AND METFORMIN HYDROCHLORIDE- PIOGLITAZONE AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED TEVA PHARMACEUTICALS USA, INC. ---------- 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 TABLETS. 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 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 SYMPTOMATIC HEART FAILURE. (5.1) INITIATION OF PIOGLITAZONE AND METFORMIN HYDROCHLORIDE TABLETS IN PATIENTS WITH ESTABLISHED NEW YORK HEART ASSOCIATION (NYHA) CLASS III OR IV HEART FAILURE IS CONTRAINDICATED. (4, 5.1) LACTIC ACIDOSIS POST-MARKETING CASES OF METFORMIN-ASSOCIATED LACTIC ACIDOSIS HAVE RESULTED IN DEATH, HYPOTHERMIA, HYPOTENSION, AND RESISTANT BRADYARRHYTHMIAS. SYMPTOMS INCLUDED MALAISE, MYALGIAS, RESPIRATORY DISTRESS, SOMNOLENCE, AND ABDOMINAL PAIN. LABORATORY ABNORMALITIES INCLUDED ELEVATED BLOOD LACTATE LEVELS, ANION GAP ACIDOSIS, INCREASED LACTATE:PYRUVATE RATIO; AND METFORMIN PLASMA LEVELS GENERALLY GREATER THAN 5 MCG/ML. (5.2) RISK FACTORS INCLUDE RENAL IMPAIRMENT, CONCOMITANT USE 完全なドキュメントを読む