国家: 美国
语言: 英文
来源: NLM (National Library of Medicine)
PIOGLITAZONE HYDROCHLORIDE (UNII: JQT35NPK6C) (PIOGLITAZONE - UNII:X4OV71U42S), GLIMEPIRIDE (UNII: 6KY687524K) (GLIMEPIRIDE - UNII:6KY687524K)
Sandoz Inc
PIOGLITAZONE HYDROCHLORIDE
PIOGLITAZONE 30 mg
ORAL
PRESCRIPTION DRUG
Pioglitazone and glimepiride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus who are already treated with a thiazolidinedione and sulfonylurea or who have inadequate glycemic control on a thiazolidinedione alone or a sulfonylurea alone [see Clinical Studies (14)]. Important Limitations of Use Pioglitazone exerts its antihyperglycemic effect only in the presence of endogenous insulin. Pioglitazone and glimepiride 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)]. Reported hypersensitivity reactions with glimepiride include cutaneous eruptions with or without pruritus as well as more serious reactions (e.g., anaphylaxis, angioedema, Stevens-Johnson Syndrome, dyspnea) [see Warnings and Precautions (5.3) and Adverse Reactions (6.2)] Risk Summary Limited data with pioglitazone and
Pioglitazone and glimepiride tablets, USP are available in 30 mg pioglitazone plus 2 mg glimepiride or 30 mg pioglitazone plus 4 mg glimepiride tablets as follows: 30 mg/2 mg tablets are, white, oval, biconvex, embossed with ‘SZ 468’ on one side. NDC 0781-5634-31, bottle of 30 tablets NDC 0781-5634-10, bottle of 1000 tablets NDC 0781-5634-08, carton of 28 tablets (4 x 7 Unit-Dose) 30 mg/4 mg tablets are white, oval, biconvex, embossed with “SZ 469” on one side. NDC 0781-5635-31, bottle of 30 tablets NDC 0781-5635-10, bottle of 1000 tablets NDC 0781-5635-08, carton of 28 tablets (4 x 7 Unit-Dose) 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 HYDROCHLORIDE AND GLIMEPIRIDE- PIOGLITAZONE HYDROCHLORIDE AND GLIMEPIRIDE TABLET Sandoz Inc ---------- MEDICATION GUIDE Pioglitazone and Glimepiride Tablets, USP (pie-oh-GLIT-ah-zohn and glye-MEH-per-ide) Read this Medication Guide carefully before you start taking pioglitazone and glimepiride 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 and glimepiride tablets, ask your doctor or pharmacist. What is the most important information I should know about pioglitazone and glimepiride tablets? Pioglitazone and glimepiride tablets can cause serious side effects, including new or worse heart failure. • Pioglitazone, one of the medicines in pioglitazone and glimepiride 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 and glimepiride 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 and glimepiride 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 and glimepiride tablets can have other serious side effects. See “What are the possible side effects of pioglitazone and glimepiride tablets?” What are pioglitazone and glimepiride tablets? Pioglitazone and glimepiride tablets are a prescription medicine used with diet and exercise to improve blood sugar (glucose) control in adults with type 2 diabetes. Piogli 阅读完整的文件
PIOGLITAZONE HYDROCHLORIDE AND GLIMEPIRIDE- PIOGLITAZONE HYDROCHLORIDE AND GLIMEPIRIDE TABLET SANDOZ INC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE PIOGLITAZONE AND GLIMEPIRIDE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR PIOGLITAZONE AND GLIMEPIRIDE TABLETS. PIOGLITAZONE AND GLIMEPIRIDE TABLETS, FOR ORAL USE INITIAL U.S. APPROVAL: 2006 WARNING: CONGESTIVE HEART FAILURE _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ • • • • INDICATIONS AND USAGE Pioglitazone and glimepiride tablets are a thiazolidinedione and a sulfonylurea combination product 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 glimepiride is appropriate. (1) Important Limitations of Use: • DOSAGE AND ADMINISTRATION • • • • DOSAGE FORMS AND STRENGTHS • • CONTRAINDICATIONS • • • THIAZOLIDINEDIONES, INCLUDING PIOGLITAZONE, WHICH IS A COMPONENT OF PIOGLITAZONE AND GLIMEPIRIDE, CAUSE OR EXACERBATE CONGESTIVE HEART FAILURE IN SOME PATIENTS. (5.1) AFTER INITIATION OF PIOGLITAZONE AND GLIMEPIRIDE, 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 GLIMEPIRIDE MUST BE CONSIDERED. (5.1) PIOGLITAZONE AND GLIMEPIRIDE IS NOT RECOMMENDED IN PATIENTS WITH SYMPTOMATIC HEART FAILURE. (5.1) INITIATION OF PIOGLITAZONE AND GLIMEPIRIDE 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) Individualize the starting dose of pioglitazone and glimepiride tablets based on the patient’s current regimen. (2.1) May adjust the dosing based on effectiveness a 阅读完整的文件