Država: Sjedinjene Američke Države
Jezik: engleski
Izvor: NLM (National Library of Medicine)
PIOGLITAZONE HYDROCHLORIDE (UNII: JQT35NPK6C) (PIOGLITAZONE - UNII:X4OV71U42S)
NuCare Pharmaceuticals,Inc.
PIOGLITAZONE HYDROCHLORIDE
PIOGLITAZONE 30 mg
ORAL
PRESCRIPTION DRUG
Pioglitazone tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus in multiple clinical settings [see Clinical Studies (14)] . Pioglitazone tablet exerts its antihyperglycemic effect only in the presence of endogenous insulin. Pioglitazone 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 (5.3)]. Do not initiate in patients with NYHA Class III or IV heart failure [see Boxed Warning] . Do not use in patients with a history of a serious hypersensitivity reaction to pioglitazone tablets or any of its ingredients. Pregnancy Category C. There are no adeq
30 mg tablet: White to off-white, flat, round, uncoated tablets with beveled edges debossed with PIO on one side and 30 on the other side, available in: NDC 68071-1729-9 Bottles of 90 Storage: Store at 20º to 25ºC (68º to 77 ºF); excursions permitted to 15º to 30ºC (59º to 86ºF) [see USP Controlled Room Temperature]. Protect from moisture. Dispense in a tight, light-resistant container.
Abbreviated New Drug Application
NuCare Pharmaceuticals,Inc. ---------- MEDICATION GUIDE Pioglitazone Tablets USP Read this Medication Guide carefully before you start taking pioglitazone tablets and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment. If you have any questions about pioglitazone tablets, ask your doctor or pharmacist. What is the most important information I should know about pioglitazone tablets? Pioglitazone tablets can cause serious side effects, including new or worse heart failure. • Pioglitazone tablets can cause your body to keep extra fluid (fluid retention), which leads to swelling (edema) and weight gain. Extra body fluid can make some heart problems worse or lead to heart failure. Heart failure means your heart does not pump blood well enough • Do not take pioglitazone tablets if you have severe heart failure • If you have heart failure with symptoms (such as shortness of breath or swelling), even if these symptoms are not severe, pioglitazone tablets may not be right for you Call your doctor right away if you have any of the following: • swelling or fluid retention, especially in the ankles or legs • shortness of breath or trouble breathing, especially when you lie down • an unusually fast increase in weight • unusual tiredness Pioglitazone tablets can have other serious side effects. See " What are the possible side effects of pioglitazone tablets?" What are pioglitazone tablets? Pioglitazone tablet is a prescription medicine used with diet and exercise to improve blood sugar (glucose) control in adults with type 2 diabetes. Pioglitazone tablet is a diabetes medicine called pioglitazone hydrochloride that may be taken alone or with other diabetes medicines. It is not known if pioglitazone tablet is safe and effective in children. Who should not take pioglitazone tablets? See " What is the most important information I should know about pioglitazone tablets?" Do not take pioglitazone Pročitajte cijeli dokument
PIOGLITAZONE HYDROCHLORIDE- PIOGLITAZONE HYDROCHLORIDE TABLET NUCARE PHARMACEUTICALS,INC. ---------- 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, FOR ORAL USE INITIAL U.S. APPROVAL: 1999 WARNING: CONGESTIVE HEART FAILURE SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING. THIAZOLIDINEDIONES, INCLUDING PIOGLITAZONE HYDROCHLORIDE, 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 DISCONTINUATION OR DOSE REDUCTION OF PIOGLITAZONE TABLETS MUST BE CONSIDERED. ( 5.1) PIOGLITAZONE TABLETS ARE NOT RECOMMENDED IN PATIENTS WITH SYMPTOMATIC HEART FAILURE. INITIATION OF PIOGLITAZONE TABLETS IN PATIENTS WITH ESTABLISHED NEW YORK HEART ASSOCIATION (NYHA) CLASS III OR IV HEART FAILURE IS CONTRAINDICATED. ( 4, 5.1) RECENT MAJOR CHANGES Indications and Usage Important Limitations of Use ( 1.2) 01/2011 Dosage and Administration Recommendations for All Patients ( 2.1) 01/2011 Coadministration with Strong CYP2C8 Inhibitors ( 2.3) 01/2011 Warnings and Precautions Hepatic Effects ( 5.3) 01/2011 Urinary Bladder Tumors ( 5.5) 07/2011 INDICATIONS AND USAGE Pioglitazone tablet is 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. ( 1.1, 14) Important Limitation of Use: Not for treatment of type 1 diabetes or diabetic ketoacidosis. ( 1.2) DOSAGE AND ADMINISTRATION Initiate pioglitazone tablets at 15 mg or 30 mg once daily. Limit initial dose to 15 mg onc Pročitajte cijeli dokument