国家: 美国
语言: 英文
来源: NLM (National Library of Medicine)
PIOGLITAZONE HYDROCHLORIDE (UNII: JQT35NPK6C) (PIOGLITAZONE - UNII:X4OV71U42S)
Aphena Pharma Solutions - Tennessee, LLC
PIOGLITAZONE HYDROCHLORIDE
PIOGLITAZONE 45 mg
ORAL
PRESCRIPTION DRUG
Monotherapy and Combination Therapy Pioglitazone tablets, USP 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)] . Important Limitations of Use Pioglitazone tablets, USP exert its antihyperglycemic effect only in the presence of endogenous insulin. Pioglitazone tablets, USP 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)] . - Initiation in patients with established NYHA Class III or IV heart failure [see Boxed Warning]. - Use in patients with known hypersensitivity to pioglitazone or any other component of Pioglitazone tablets. Teratogenic Effects Pregnancy Category C. There are no adequate and well-controlled studies of pioglitazone in pregnant women. Animal studies show increased rates of post-implantation
Pioglitazone is available in 15 mg, 30 mg, and 45 mg tablets as follows: Pioglitazone Tablets USP, 15 mg are white to off-white, round, biconvex, uncoated tablets, debossed with "31" on one side and "H" on other side. Bottles of 30 NDC 52343-053-30 Bottles of 90 NDC 52343-053-90 Bottles of 500 NDC 52343-053-05 Pioglitazone Tablets USP, 30 mg are white to off-white, round, flat faced, beveled edge uncoated tablets, debossed with "32" on one side and "H" on other side. Bottles of 30 NDC 52343-054-30 Bottles of 90 NDC 52343-054-90 Bottles of 500 NDC 52343-054-05 Pioglitazone Tablets USP, 45 mg are white to off-white, round, flat faced, beveled edge uncoated tablets, debossed with "33" on one side and "H" on other side. Bottles of 30 NDC 52343-055-30 Bottles of 90 NDC 52343-055-90 Bottles of 500 NDC 52343-055-05 Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Keep container tightly closed, and protect from light, moisture and humidity.
Abbreviated New Drug Application
PIOGLITAZONE HYDROCHLORIDE - PIOGLITAZONE HYDROCHLORIDE TABLET Aphena Pharma Solutions - Tennessee, LLC ---------- MEDICATION GUIDE Pioglitazone Tablets, USP [Pioglitazone (PYE o GLIT a zone)] 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 tablets are a prescription medicine used with diet and exercise to improve blood sugar (glucose) control in adults with type 2 diabetes. Pioglitazone tablets are a diabetes medicine called pioglitazone that may be taken alone or with other diabetes medicines. It is not known if pioglitazone tablets are safe and effective in children under the age of 18. Pioglitazone tablets are no 阅读完整的文件
PIOGLITAZONE HYDROCHLORIDE - PIOGLITAZONE HYDROCHLORIDE TABLET APHENA PHARMA SOLUTIONS - TENNESSEE, LLC ---------- 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 USP, FOR ORAL USE INITIAL U.S. APPROVAL: 1999 WARNING: CONGESTIVE HEART FAILURE _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ THIAZOLIDINEDIONES, INCLUDING PIOGLITAZONE, CAUSE OR EXACERBATE CONGESTIVE HEART FAILURE IN SOME PATIENTS. (5.1) AFTER INITIATION OF PIOGLITAZONE, 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 MUST BE CONSIDERED. (5.1) PIOGLITAZONE IS NOT RECOMMENDED IN PATIENTS WITH SYMPTOMATIC HEART FAILURE. (5.1) INITIATION OF PIOGLITAZONE IN PATIENTS WITH ESTABLISHED NEW YORK HEART ASSOCIATION (NYHA) CLASS III OR IV HEART FAILURE IS CONTRAINDICATED. (4, 5.1) INDICATIONS AND USAGE Pioglitazone 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, 14) Important Limitations of Use: Not for treatment of type 1 diabetes or diabetic ketoacidosis. (1) DOSAGE AND ADMINISTRATION Initiate pioglitazone tablets at 15 mg or 30 mg once daily. Limit initial dose to 15 mg once daily in patients with NYHA Class I or II heart failure. (2.1) If there is inadequate glycemic control, the dose can be increased in 15 mg increments up to a maximum of 45 mg once daily. (2.1) Obtain liver tests before starting pioglitazone tablets. If abnormal, use caution when treating with pioglitazone tablets, investigate the probable cause, tre 阅读完整的文件