Država: Sjedinjene Američke Države
Jezik: engleski
Izvor: NLM (National Library of Medicine)
PIOGLITAZONE HYDROCHLORIDE (UNII: JQT35NPK6C) (PIOGLITAZONE - UNII:X4OV71U42S), METFORMIN HYDROCHLORIDE (UNII: 786Z46389E) (METFORMIN - UNII:9100L32L2N)
Cambridge Therapeutics Technologies, LLC
PIOGLITAZONE HYDROCHLORIDE
PIOGLITAZONE 15 mg
ORAL
PRESCRIPTION DRUG
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)].
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.
Abbreviated New Drug Application
PIOGLITAZONE AND METFORMIN- PIOGLITAZONE AND METFORMIN TABLET, FILM COATED CAMBRIDGE THERAPEUTICS TECHNOLOGIES, LLC ---------- 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 Pročitajte cijeli dokument