Avandia Medication Summary
No separate FDA Medication Guide was found for this label. This summary is based on FDA/DailyMed prescribing information.
What is this medication?
This medication is described in FDA/DailyMed prescribing information. No separate FDA Medication Guide was found for this label. This summary is based on FDA/DailyMed prescribing information.
What is this medication used for?
1.1 Monotherapy and Combination Therapy AVANDIA is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. 1.2 Important Limitations of Use Due to its mechanism of action, AVANDIA is active only in the presence of endogenous insulin. Therefore, AVANDIA should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis. The coadministration of AVANDIA and insulin is not recommended. The use of AVANDIA with nitrates is not recommended.
What should I know before taking it?
Initiation of AVANDIA in patients with established New York Heart Association (NYHA) Class III or IV heart failure is contraindicated [see Boxed Warning].
What important warnings are listed?
WARNING: CONGESTIVE HEART FAILURE AND MYOCARDIAL ISCHEMIAThiazolidinediones, including rosiglitazone, cause or exacerbate congestive heart failure in some patients . 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.
How is this medication usually taken?
The management of antidiabetic therapy should be individualized. All patients should start AVANDIA at the lowest recommended dose. Further increases in the dose of AVANDIA should be accompanied by careful monitoring for adverse events related to fluid retention [see Boxed Warning and Warnings and Precautions (5.1)]. AVANDIA may be administered at a starting dose of 4 mg either as a single daily dose or in 2 divided doses. For patients who respond inadequately following 8 to 12 weeks of treatment, as determined by reduction in fasting plasma glucose (FPG), the dose may be increased to 8 mg daily as monotherapy or in combination with metformin, sulfonylurea, or sulfonylurea plus metformin.
What side effects are listed?
6.1 Clinical Trial Experience Adult In clinical trials, approximately 9,900 patients with type 2 diabetes have been treated with AVANDIA. Short-Term Trials of AVANDIA as Monotherapy and in Combination With Other Hypoglycemic Agents The incidence and types of adverse events reported in short-term clinical trials of AVANDIA as monotherapy are shown in Table 4. Preferred Term AVANDIA Monotherapy N = 2,526% Placebo N = 601% Metformin N = 225% Sulfonylureas† N = 626% Upper respiratory tract infection 9.9 8.7 8.9 7.3 Injury 7.6 43.3 7.6 6.1 Headache 5.9 5.0 8.9 5.4 Back pain 4.0 3.8 4.0 5.0 Hyperglycemia 3.9 5.7 4.4 8.1 Fatigue 3.6 5.0 4.0 1.9 Sinusitis 3.2 4.5 5.3 3.0 Diarrhea 2.3 3.3 15.6 3.0.
What interactions are listed?
7.1 CYP2C8 Inhibitors and Inducers An inhibitor of CYP2C8 (e.g., gemfibrozil) may increase the AUC of rosiglitazone and an inducer of CYP2C8 (e.g., rifampin) may decrease the AUC of rosiglitazone. Therefore, if an inhibitor or an inducer of CYP2C8 is started or stopped during treatment with rosiglitazone, changes in diabetes treatment may be needed based upon clinical response. [See Clinical Pharmacology (12.4).]
Where can I find the official prescribing information?
Review the full prescribing information on DailyMed: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ef14122b-7fff-45fa-b13b-0ea9e48bd57d
⚠️ Disclaimer
This summary is for educational purposes only and is not medical advice. Always consult your doctor, pharmacist, or other licensed healthcare professional before starting, stopping, or changing any medicine. Read full medical disclaimer.