Avandia (rosiglitazone)
Avandia
Rosiglitazone Maleate
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Avandia
Rosiglitazone Maleate
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Rosiglitazone Maleate (Generic)
Rosiglitazone Maleate
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Select product strength & quantity:
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WHAT IS AVANDIA?

Avandia, also known as rosiglitazone, is an oral prescription medication. It is indicated in adults with type 2 diabetes mellitus (T2DM) to improve glycemic control in addition to diet and exercise. Avandia has some limitations to its use. These include:

  • Because of its mechanism, Avandia only works if endogenous insulin is available. Therefore, Avandia is not indicated for type 1 diabetes mellitus (T1DM) or diabetic ketoacidosis
  • Avandia is not recommended to be used concomitantly with insulin

Controlling hyperglycemia with Avandia prevents downstream complications such as kidney damage, loss of limbs, blindness, heart attack, stroke, or nerve problems. It is important that diabetes remains controlled to lessen the chance of related complications.

HOW DOES AVANDIA WORK?

Rosiglitazone is an antidiabetic agent belonging to the thiazolidinedione class. It betters glycemic control by increasing the body’s sensitivity to insulin. It is a potent and selective agonist of the peroxisome proliferator-activated receptor-gamma (PPAR?). The PPAR receptor is located in tissues key to insulin activity. These include adipose tissue, the liver, and skeletal muscle. When the PPAR? is activated, the body initiates transcription of genes that promote insulin response and glucose control. They PPAR? is also a key player in fatty acid metabolism.

Insulin resistance plays a key role in the pathophysiology diabetes. In animal models, Avandia decreases concentrations of blood glucose and lessens hyperinsulinemia through action in the muscle, liver, and adipose tissues. Avandia has also been shown to block gluconeogenesis in the liver. Avandia has also not demonstrated hypoglycemia or altered glucose tolerance in animal studies.

 SIDE EFFECTS

Common side effects of Avandia include:

  • Headache
  • Cough
  • Upper respiratory tract infection
  • Cold symptoms such as a stuffy nose, sore throat, or sneezing
  • Back pain
  • Diarrhea
  • Drowsiness

WARNINGS AND PRECAUTIONS

Cardiac Failure

The thiazolidinedione class is known to exacerbate or cause heart failure. Avandia, alone or with other antidiabetic agents, can cause fluid retention leading to heart failure. Physicians should monitor patients for signs and symptoms of heart failure, including:

  • Shortness of breath at rest or with activity
  • Fatigue and weakness
  • Swelling

If patients demonstrate symptoms of heart failure, providers should implement proper standards of care. Additionally, Avandia should be discontinued or dose-reduced. If patients have confirmed NYHA Class III or IV heart failure, Avandia is contraindicated. It is not recommended in those who have symptomatic heart failure.

Major Adverse Cardiovascular Events

A meta-analysis of short-term trials demonstrated an elevated risk of myocardial infarction with Avandia treatment versus placebo. However, longer-term studies did not show any increase in mortality or major adverse cardiovascular events (MACE) with Avandia compared with placebo.

Edema

In one study, there was a significant increase in median plasma volume in those treated with Avandia compared with placebo. Patients were more likely to experience adverse events if they were on concomitant therapy with Avandia and insulin. Therefore, in patients with edema, Avandia should be used cautiously.

Additionally, because thiazolidinediones can cause fluid retention, congestive heart failure can be worsened. Providers should monitor patients for heart failure symptoms.

Weight Gain

Patients on Avandia both alone and in combination with other antidiabetic agents have demonstrated dose-related weight gain. Weight gain was likely associated with fat accumulation and fluid retention. Patients who exhibit weight gain should be evaluated for edema and congestive heart failure.

Hepatic Effects

Providers should measure liver enzymes in all patients prior to starting Avandia and frequently throughout therapy. Avandia should not be used in those who have elevated baseline liver enzyme levels with ALT greater than 2.5 times the upper limit of normal. Those with only mildly increase liver enzyme levels (less than 2.5 times the upper limit of normal) should use caution and be closely monitored. If enzyme levels increase to more than three times the upper limit of normal, Avandia should be stopped. Additionally, if the patient develops jaundice, Avandia should be discontinued.

Macular Edema

Thiazolidinediones, including Avandia, have been shown to cause macular edema. In trials, macular edema presented as blurred vision and lessened visual acuity. Some patients were asymptomatic. However, most individuals also were experiencing peripheral edema in addition to their macular edema. Diabetic patients and patients on Avandia should have routine eye exams.

Fractures

Studies have demonstrated an