PIOGLITAZONE AND METFORMIN HYDROCHLORIDE tablet film coated

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

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

Disponível em:

Teva Pharmaceuticals USA, Inc.

DCI (Denominação Comum Internacional):

PIOGLITAZONE HYDROCHLORIDE

Composição:

PIOGLITAZONE 15 mg

Tipo de prescrição:

PRESCRIPTION DRUG

Status de autorização:

Abbreviated New Drug Application

Características técnicas

PIOGLITAZONE AND METFORMIN HYDROCHLORIDE- PIOGLITAZONE AND METFORMIN
HYDROCHLORIDE TABLET, FILM COATED
TEVA PHARMACEUTICALS USA, INC.
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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 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