Χώρα: Ηνωμένες Πολιτείες
Γλώσσα: Αγγλικά
Πηγή: NLM (National Library of Medicine)
ROSIGLITAZONE MALEATE (UNII: KX2339DP44) (ROSIGLITAZONE - UNII:05V02F2KDG)
GlaxoSmithKline LLC
ROSIGLITAZONE MALEATE
ROSIGLITAZONE 2 mg
ORAL
PRESCRIPTION DRUG
AVANDIA is a thiazolidinedione antidiabetic agent indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Important Limitations of Use: Risk Summary Limited data with AVANDIA in pregnant women are not sufficient to determine a drug-associated risk for major birth defects or miscarriage. There are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy (see Clinical Considerations) . In animal reproduction studies, no adverse developmental effects were observed when rosiglitazone was administered to pregnant rats and rabbits during organogenesis at exposures up to 4 times the maximum recommended human dose (MRHD) of 8 mg daily (see Data). The estimated background risk of major birth defects is 6% to 10% in women with pre-gestational diabetes with a HbA1c >7 and has been reported to be as high as 20% to 25% in women with a HbA1c >10. The estimated background risk of miscarriage for the indicated population is unknown. In the
Each pentagonal film-coated TILTAB tablet contains rosiglitazone as the maleate as follows: 2 mg: pink, debossed with GSK on one side and 2 on the other; bottles of 60: NDC 0173-0861-18 4 mg: orange, debossed with GSK on one side and 4 on the other; bottles of 30: NDC 0173-0863-13. Store at 25°C (77°F); excursions 15° to 30°C (59° to 86°F). Dispense in a tight, light-resistant container.
New Drug Application
AVANDIA 4MG- ROSIGLITAZONE MALEATE TABLET, FILM COATED GlaxoSmithKline LLC ---------- MEDICATION GUIDE AVANDIA (ah-VAN-dee-a) (rosiglitazone maleate tablets), for oral use What is the most important information I should know about AVANDIA? AVANDIA may cause serious side effects, including: New or worse heart failure • The risk of heart failure may be higher in people who take AVANDIA with insulin. Most people who take insulin should not also take AVANDIA. • AVANDIA 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. • If you have severe heart failure, you cannot start AVANDIA. • If you have heart failure with symptoms (such as shortness of breath or swelling), even if these symptoms are not severe, AVANDIA 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 AVANDIA can have other serious side effects. Be sure to read the section below “What are possible side effects of AVANDIA?” What is AVANDIA? AVANDIA is a prescription medicine used with diet and exercise to treat adults with type 2 (“adult- onset” or “non-insulin dependent”) diabetes mellitus (“high blood sugar”). AVANDIA helps to control high blood sugar. AVANDIA may be used alone or with other diabetes medicines. AVANDIA can help your body respond better to insulin made in your body. AVANDIA does not cause your body to make more insulin. AVANDIA is not for people with type 1 diabetes mellitus or to treat a condition called diabetic ketoacidosis. It is not known if AVANDIA is safe and effective in children younger than 18 years old. Who should not take AVANDIA? Many people with heart failure should not sta Διαβάστε το πλήρες έγγραφο
AVANDIA 2MG- ROSIGLITAZONE MALEATE TABLET, FILM COATED AVANDIA 4MG- ROSIGLITAZONE MALEATE TABLET, FILM COATED GLAXOSMITHKLINE LLC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE AVANDIA SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR AVANDIA. AVANDIA (ROSIGLITAZONE MALEATE TABLETS), FOR ORAL USE INITIAL U.S. APPROVAL: 1999 WARNING: CONGESTIVE HEART FAILURE _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ • • INDICATIONS AND USAGE AVANDIA is a thiazolidinedione antidiabetic agent indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. (1) Important Limitations of Use: • • DOSAGE AND ADMINISTRATION • • • DOSAGE FORMS AND STRENGTHS Pentagonal, film-coated tablets in the following strengths: 2 mg and 4 mg (3) CONTRAINDICATIONS • • WARNINGS AND PRECAUTIONS • • • • THIAZOLIDINEDIONES, INCLUDING ROSIGLITAZONE, CAUSE OR EXACERBATE CONGESTIVE HEART FAILURE IN SOME PATIENTS (5.1). AFTER INITIATION OF AVANDIA, AND AFTER DOSE INCREASES, OBSERVE PATIENTS CAREFULLY FOR SIGNS AND SYMPTOMS OF HEART FAILURE (INCLUDING EXCESSIVE, RAPID WEIGHT GAIN; DYSPNEA; AND/OR EDEMA). IF THESE SIGNS AND SYMPTOMS DEVELOP, THE HEART FAILURE SHOULD BE MANAGED ACCORDING TO CURRENT STANDARDS OF CARE. FURTHERMORE, DISCONTINUATION OR DOSE REDUCTION OF AVANDIA MUST BE CONSIDERED. AVANDIA IS NOT RECOMMENDED IN PATIENTS WITH SYMPTOMATIC HEART FAILURE. INITIATION OF AVANDIA IN PATIENTS WITH ESTABLISHED NYHA CLASS III OR IV HEART FAILURE IS CONTRAINDICATED. (4, 5.1) AVANDIA should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis. (1) Coadministration of AVANDIA and insulin is not recommended. (1, 5.1, 5.2) Start at 4 mg daily in single or divided doses; do not exceed 8 mg daily. (2) Dose increases should be accompanied by careful monitoring for adverse events related to fluid retention. (2) Do not initiate AVANDIA if the patient e Διαβάστε το πλήρες έγγραφο