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Avandia Generic Name & Formulations
Legal Class
Rx
General Description
Rosiglitazone (as maleate) 2mg, 4mg; tabs.
Pharmacological Class
Thiazolidinedione.
How Supplied
Tabs 2mg—60; 4mg—30
Manufacturer
Avandia Indications
Indications
Adjunct to diet and exercise in type 2 diabetes. Limitations of use: not for treating type 1 diabetes or diabetic ketoacidosis. Not for use with insulin.
Avandia Dosage and Administration
Adult
≥18yrs: Give once daily or in two divided doses (AM & PM). Initially 4mg/day; may increase after 8–12 weeks; max 8mg/day.
Children
<18yrs: not recommended.
Avandia Contraindications
Contraindications
Concomitant metformin in renal impairment. NYHA Class III or IV heart failure.
Avandia Boxed Warnings
Boxed Warning
Congestive heart failure.
Avandia Warnings/Precautions
Warnings/Precautions
Symptomatic HF or acute coronary syndromes: not recommended. CHF: NYHA Class I or II: increased risk of cardiovascular events (monitor); discontinue or reduce dose if develops. Edema. Monitor for signs/symptoms of heart failure. Hepatic disease. Do not start therapy in active liver disease or if ALT >2.5xULN. Monitor transaminases at baseline, then periodically. If ALT is mildly elevated (≤2.5xULN), follow-up and monitor closely; discontinue if ALT >3xULN or jaundice occurs. Monitor fasting blood glucose and HbA1c levels periodically. Perform regular eye exams. Resumption of premenopausal ovulation in anovulatory patients may occur (may result in unintended pregnancy). Pregnancy. Nursing mothers.
Avandia Pharmacokinetics
See Literature
Avandia Interactions
Interactions
Concomitant insulin: not recommended. Potentiated by other CYP2C8 inhibitors (eg, gemfibrozil). Antagonized by CYP2C8 inducers (eg, rifampin). Increased risk of hypoglycemia with concomitant other hypoglycemics; may need to reduce dose.
Avandia Adverse Reactions
Adverse Reactions
Upper respiratory tract infection, injury, headache, edema, weight gain, anemia, changes in serum lipids, macular edema (possible); also women: risk of fracture. See full labeling re: risk of myocardial ischemic events.
Avandia Clinical Trials
See Literature
Avandia Note
Not Applicable
Avandia Patient Counseling
See Literature
