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Avandia

Generic Name: Rosiglitazone Maleate
Drug Category: TZD
Litigation Alert Level: High
This drug has been approved for use by males and females over the age of 18 years old for a maximum duration of 6 years.

Approved Uses

Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

AVANDIA should not be used in patients taking nitrates or in patients with type 1 diabetes mellitus. AVANDIA should not be used for the treatment of diabetic ketoacidosis. 

The total daily dose of AVANDIA should not exceed 8 mg.

Thiazolidinediones, including rosiglitazone, cause or exacerbate congestive heart failure in some patients.

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.

AVANDIA should be used with caution in patients with edema.

Dose-related weight gain was seen with AVANDIA alone and in combination with other hypoglycemic agents.

Long-term trials show an increased incidence of bone fracture in patients, particularly female patients, taking AVANDIA.

Administration of metformin and AVANDIA is contraindicated in patients with renal impairment.

Therapy with AVANDIA should not be initiated if the patient exhibits clinical evidence of active liver disease or increased serum transaminase levels (ALT >2.5X upper limit of normal at start of therapy).

Macular edema has been reported in postmarketing experience in some diabetic patients who were taking AVANDIA or another thiazolidinedione.

Decreases in mean hemoglobin and hematocrit occurred in a dose-related fashion in adult patients treated with AVANDIA.

Co-administration of AVANDIA and insulin is not recommended.

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.

Given the potential for dose-related adverse events with rosiglitazone, a decrease in the dose of rosiglitazone may be needed when gemfibrozil is introduced.

Rifampin administration (600 mg once a day), an inducer of CYP2C8, for 6 days is reported to decrease rosiglitazone AUC by 66%, compared with the administration of rosiglitazone (8 mg) alone.

Therapy with AVANDIA, like other thiazolidinediones, may result in ovulation in some premenopausal anovulatory women. As a result, these patients may be at an increased risk for pregnancy while taking AVANDIA.

Rosiglitazone has been reported to cross the human placenta and be detectable in fetal tissue.

Drug-related material was detected in milk from lactating rats. It is not known whether AVANDIA is excreted in human milk. Because many drugs are excreted in human milk, a decision should be made whether to discontinue nursing or to discontinue AVANDIA, taking into account the importance of the drug to the mother.

GoToSource 

Off-label Uses

• Type 1 diabetes mellitus. GoToSource

• Diabetic ketoacidosis. GoToSource

• Use in patients under the age of 18 years of age. GoToSource

• Psoriasis. GoToSource

• Alzheimer’s disease. GoToSource

• Polycystic ovarian syndrome. GoToSource

• Dosage greater than 8 mg per day. GoToSource 

• Parkinson’s disease. GoToSource

• Inhibitor of COPD inflammation. GoToSource

• Prevention of graft-versus-host disease. GoToSource

• Progressive differentiated thyroid carcinoma. GoToSource

Adverse Events

Heart attacks and heart-related deaths. GoToSource

Osteoporosis and bone fractures. GoToSource

Macular edema (fluid buildup in an area in the center of the retina). GoToSource

Liver injury. GoToSource

Strokes. GoToSource

Litigation

Lawsuits filed for death, congestive heart failure, heart attacks, liver toxicity, severe allergic reactions, macular edema and strokes. 

The material contained in GoToPills is for informational purposes only and not intended to replace the judgment, evaluation and treatment of physicians, pharmacists and other healthcare providers. GoToPills does not provide medical advice, diagnoses or treatment. Always seek the advice of your physician or other qualified health provider regarding a medical condition or treatment.

 

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Site Last Updated March 29, 2024