PIOGLITAZONE AND METFORMIN tablet, film coated

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

PIOGLITAZONE HYDROCHLORIDE (UNII: JQT35NPK6C) (PIOGLITAZONE - UNII:X4OV71U42S), METFORMIN HYDROCHLORIDE (UNII: 786Z46389E) (METFORMIN - UNII:9100L32L2N)

Commercializzato da:

Cambridge Therapeutics Technologies, LLC

INN (Nome Internazionale):

PIOGLITAZONE HYDROCHLORIDE

Composizione:

PIOGLITAZONE 15 mg

Via di somministrazione:

ORAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

Pioglitazone and metformin hydrochloride tablets are 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 [see CLINICAL STUDIES (14)]. Important Limitations of Use Pioglitazone exerts its antihyperglycemic effect only in the presence of endogenous insulin. Pioglitazone and metformin hydrochloride tablets should not be used to treat type 1 diabetes or diabetic ketoacidosis, as it would not be effective in these settings. Use caution in patients with liver disease [see WARNINGS AND PRECAUTIONS (5.5)]. - •Initiation in patients with established NYHA Class III or IV heart failure [see Boxed Warning]. - •Renal impairment (e.g., serum creatinine levels ≥1.5 mg/dL [males], ≥1.4 mg/dL [females], or abnormal creatinine clearance) which may also result from conditions such as cardiovascular collapse (shock), acute myocardial infarction, and septicemia [see WARNINGS AND PRECAUTIONS (5.2, 5.10)].

Dettagli prodotto:

Pioglitazone and metformin hydrochloride tablets, USP are available in 15 mg pioglitazone (as the base)/500 mg metformin hydrochloride as follows: Pioglitazone and metformin hydrochloride 15 mg/500 mg tablets are white, oval, biconvex, film-coated tablets with “SZ441” on one side and are supplied as follows: NDC 70882-105-56, Package of 56 tablets (4 x 14 unit-of-dose blisters) Storage Store at 20° to 25° C (68° to 77°F) [see USP Controlled Room Temperature]. Keep container tightly closed, and protect from moisture and humidity.

Stato dell'autorizzazione:

Abbreviated New Drug Application

Scheda tecnica

PIOGLITAZONE AND METFORMIN- PIOGLITAZONE AND METFORMIN TABLET, FILM
COATED
CAMBRIDGE THERAPEUTICS TECHNOLOGIES, LLC
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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, CAUSE OR EXACERBATE CONGESTIVE HEART FAILURE IN SOME
PATIENTS. (5.1)
•AFTER INITIATION OF PIOGLITAZONE AND METFORMIN HYDROCHLORIDE, 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 MUST BE
CONSIDERED. (5.1)
•PIOGLITAZONE AND METFORMIN HYDROCHLORIDE IS NOT RECOMMENDED IN
PATIENTS WITH SYMPTOMATIC HEART
FAILURE .
•INITIATION OF PIOGLITAZONE AND METFORMIN HYDROCHLORIDE IN PATIENTS
WITH ESTABLISHED NEW YORK HEART
ASSOCIATION (NYHA) CLASS III OR IV HEART FAILURE IS CONTRAINDICATED.
(4, 5.1)
LACTIC ACIDOSIS
•LACTIC ACIDOSIS CAN OCCUR DUE TO METFORMIN ACCUMULATION. THE RISK
INCREASES WITH CONDITIONS SUCH AS
SEPSIS, DEHYDRATION, EXCESS ALCOHOL INTAKE, HEPATIC IMPAIRMENT, RENAL
IMPAIRMENT, AND ACUTE
CONGESTIVE HEART FAILURE. (5.2)
•SYMPTOMS INCLUDE MALAISE, MYALGIAS, RESPIRATORY DISTRESS,
INCREASING SOMNOLENCE, AND NONSPECIFIC
ABDOMINAL DISTRESS. LABORATORY ABNORMALITIES INCLUDE LOW PH, INCREASED
ANION GAP, AND ELEVATED BLOOD
LACTATE. (5.2)
•IF ACIDOSIS IS SUSPECTED, DISCONTINUE PIOGLITAZONE AND METFORMIN
HYDROCHLORIDE AN