Avandia (rosiglitazone maleate)
Thiazolidinediones, including rosiglitazone, cause or exacerbate congestive heart failure (CHF) in some patients. After initiation and dose increases, observe for signs and symptoms of heart failure (HF); manage accordingly and consider discontinuation or dose reduction if signs/symptoms develop. Not recommended in patients with symptomatic HF. Contraindicated with established NYHA Class III or IV HF.
View FDA-Approved Full Prescribing Information for Avandia
Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus (DM).
Type 2 Diabetes Mellitus
Initial: 4mg as qd dose or in 2 divided doses
Titrate: May increase to 8mg/day if response is inadequate after 8-12 weeks
Other Hypoglycemic Agents: May need to reduce dose of the concomitant agent
Do not initiate therapy in patients w/ clinical evidence of active liver disease or increased serum transaminase levels (ALT >2.5X ULN at start of therapy)
Take w/ or w/o food
Tab: 2mg, 4mg, 8mg
NYHA Class III or IV HF.
Not for use in patients with type 1 DM or for the treatment of diabetic ketoacidosis. Increased risk of cardiovascular events in patients with CHF NYHA Class I and II. Treatment initiation is not recommended for patients experiencing an acute coronary event; consider discontinuation during this acute phase. Increased risk for myocardial infarction (MI) reported. Caution in patients with edema or at risk for HF. Edema and dose-related weight gain reported. Do not initiate in patients with active liver disease or increased baseline LFTs (ALT levels >2.5X ULN). Caution in patients with mild LFT elevations (ALT levels ≤2.5X ULN). If ALT levels increase to >3X ULN during therapy, recheck LFTs as soon as possible; d/c if ALT levels remain >3X ULN. Check LFTs if symptoms suggesting hepatic dysfunction develop; d/c if jaundice is observed. Macular edema reported; promptly refer to an ophthalmologist if visual symptoms develop. Increased incidence of bone fracture, particularly in females. Dose-related decreases in Hgb and Hct reported. May result in ovulation in some premenopausal anovulatory women, which may increase risk for pregnancy; adequate contraception is recommended. Review benefits of continued therapy if unexpected menstrual dysfunction occurs.
CHF, upper respiratory tract infection, headache, back pain, hyperglycemia, fatigue, sinusitis, edema.
See Dosage. Risk for hypoglycemia when given with other hypoglycemic agents; a reduction in the dose of concomitant agent may be necessary. CYP2C8 inhibitors (eg, gemfibrozil) may increase exposure and CYP2C8 inducers (eg, rifampin) may decrease exposure; if an inhibitor or an inducer of CYP2C8 is started or stopped during treatment, changes in diabetes treatment may be needed based upon clinical response. Increased risk of CHF with insulin; coadministration is not recommended.
PREGNANCY AND LACTATION
Category C, not for use in nursing.
MECHANISM OF ACTION
Thiazolidinedione; improves glycemic control by improving insulin sensitivity.
Absorption: Administration of variable doses resulted in different parameters. Absolute bioavailability (99%); Tmax=1 hr. Distribution: Vd=17.6L; plasma protein binding (99.8%); crosses the placenta. Metabolism: Extensive by N-demethylation and hydroxylation, followed by conjugation with sulfate and glucuronic acid; CYP2C8 (major), 2C9 (minor). Elimination: Urine (64%), feces (23%). T1/2=3-4 hrs.
Assess for HF or risk factors for HF, presence of an acute coronary event, cardiac status, edema, drug hypersensitivity, pregnancy/nursing status, and possible drug interactions. Obtain baseline LFTs, FPG and HbA1c levels, and bone health.
Monitor for signs/symptoms of HF, MI, edema, weight gain, macular edema, fractures, hematologic effects, menstrual dysfunction, and other adverse reactions. Periodically monitor LFTs, FPG, and HbA1c levels.
Inform of the risks and benefits of therapy. Advise on the importance of adherence to dietary instructions and regular testing of blood glucose, HbA1c, and liver function. Instruct to immediately report to physician any symptoms of HF or hepatic dysfunction. Inform about the risk of hypoglycemia, its symptoms and treatment, and conditions that predispose to its development when using in combination with other hypoglycemic agents. Counsel premenopausal women to use adequate contraception during treatment.
25°C (77°F); excursions permitted to 15-30°C (59-86°F).
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