Ülke: ABD
Dil: İngilizce
Kaynak: NLM (National Library of Medicine)
pioglitazone hydrochloride (UNII: JQT35NPK6C) (pioglitazone - UNII:X4OV71U42S)
Ranbaxy Pharmaceuticals Inc.
pioglitazone hydrochloride
pioglitazone 15 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 tablets exert their 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 their ingredients. Pregnancy Category C. There are no adequate and well-controlled studies of pioglitazone tablets in pregnant women. Animal studies show increased rates of post-implantation loss, delayed development, reduced fetal weights, and delayed parturition at doses 10 to 40 times the maximum r
Pioglitazone Tablets are available in 15 mg, 30 mg, and 45 mg tablets as follows: 15-mg tablet: White to off-white, round, convex, nonscored tablet with "ACTOS" on one side, and "15" on the other, available in: NDC 63304-311-30 Bottles of 30 NDC 63304-311-90 Bottles of 90 NDC 63304-311-05 Bottles of 500 30-mg tablet: White to off-white, round, flat, nonscored tablet with "ACTOS" on one side, and "30" on the other, available in: NDC 63304-312-30 Bottles of 30 NDC 63304-312-90 Bottles of 90 NDC 63304-312-05 Bottles of 500 45-mg tablet: White to off-white, round, flat, nonscored tablet with "ACTOS" on one side, and "45" on the other, available in: NDC 63304-313-30 Bottles of 30 NDC 63304-313-90 Bottles of 90 NDC 63304-313-05 Bottles of 500 Storage Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature]. Keep container tightly closed, and protect from light, moisture and humidity.
New Drug Application Authorized Generic
PIOGLITAZONE- PIOGLITAZONE TABLET Ranbaxy Pharmaceuticals Inc. ---------- MEDICATION GUIDE Pioglitazone Tablets 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 that may be taken alone or with other diabetes medicines. It is not known if Pioglitazone Tablets are 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 Pioglitazon Belgenin tamamını okuyun
PIOGLITAZONE- PIOGLITAZONE TABLET RANBAXY PHARMACEUTICALS INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE PIOGLITAZONE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR PIOGLITAZONE TABLETS. PIOGLITAZONE TABLETS FOR ORAL USE INITIAL U.S. APPROVAL: 1999 WARNING: CONGESTIVE HEART FAILURE SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING. • • • • RECENT MAJOR CHANGES Warnings and Precautions Urinary Bladder Tumors (5.5) 07/2011 INDICATIONS AND USAGE Pioglitazone tablets are 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: • DOSAGE AND ADMINISTRATION • • • • DOSAGE FORMS AND STRENGTHS Tablets: 15 mg, 30 mg, and 45 mg (3) CONTRAINDICATIONS • • THIAZOLIDINEDIONES, INCLUDING PIOGLITAZONE TABLETS, 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) Not for treatment of type 1 diabetes or diabetic ketoacidosis. (1.2) 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 Belgenin tamamını okuyun