国: アメリカ合衆国
言語: 英語
ソース: NLM (National Library of Medicine)
PIOGLITAZONE HYDROCHLORIDE (UNII: JQT35NPK6C) (PIOGLITAZONE - UNII:X4OV71U42S), METFORMIN HYDROCHLORIDE (UNII: 786Z46389E) (METFORMIN - UNII:9100L32L2N)
Sandoz Inc
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)] . Risk Summary Limited data with pioglitazone and metformin hydrochloride or pioglitazone in pregnant women are not sufficient to determine a drug-associated risk for major birth defects or miscarriage. Published studies with metformin use during pregnancy have not reported a clear association with metformin and major birth defect or miscarriage risk [see Data]. There are risks to the mot
Pioglitazone and metformin hydrochloride tablets, USP are available in 15 mg pioglitazone (as the base)/500 mg metformin hydrochloride and 15 mg pioglitazone (as the base)/850 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: Pioglitazone and metformin hydrochloride 15 mg/850 mg tablets are white, oval, biconvex, film-coated tablets with “SZ442” on one side and are supplied as follows: 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 Sandoz Inc ---------- MEDICATION GUIDE Pioglitazone and Metformin Hydrochloride Tablets, USP (pie-oh-GLIT-ah-zohn and met-FORE-min) Read this Medication Guide carefully before you start taking pioglitazone and metformin hydrochloride 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 metformin hydrochloride, ask your doctor or pharmacist. What is the most important information I should know about pioglitazone and metformin hydrochloride tablets? Pioglitazone and metformin hydrochloride tablets can cause serious side effects, including: • new or worse heart failure. Pioglitazone, one of the medicines in pioglitazone and metformin hydrochloride 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. o Do not take pioglitazone and metformin hydrochloride tablets if you have severe heart failure o If you have heart failure with symptoms (such as shortness of breath or swelling), even if these symptoms are not severe, pioglitazone and metformin hydrochloride tablets may not be right for you. Call your doctor right away if you have any of the following: o swelling or fluid retention, especially in the ankles or legs o shortness of breath or trouble breathing, especially when you lie down o an unusually fast increase in weight o unusual tiredness • lactic acidosis. Metformin, one of the medicines in pioglitazone and metformin hydrochloride tablets, can cause a rare but serious condition called lactic acidosis (a buildup of an acid in the blood) that can cause death. Lactic acidosis is a medical emergency and must be treated in the hospital. Call your doctor righ 完全なドキュメントを読む
PIOGLITAZONE AND METFORMIN- PIOGLITAZONE AND METFORMIN TABLET, FILM COATED SANDOZ INC ---------- 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 • • • • LACTIC ACIDOSIS • • • INDICATIONS AND USAGE Pioglitazone and metformin hydrochloride tablets are a thiazolidinedione and biguanide 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 metformin is appropriate. (1, 14) Important Limitations of Use: • DOSAGE AND ADMINISTRATION • • • • 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. (5.1) 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) POST-MARKETING CASES OF METFORMIN-ASSOCIATED LACTIC ACIDOSIS HAVE RESULTED IN DEATH, HYPOTHERMIA, HYPOTENSION, AND RESISTANT BRADYARRHYTHMIA 完全なドキュメントを読む