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Related to Avandia: Vioxx, metformin


(roe-zi-glit-a-zone) ,


(trade name)


Therapeutic: antidiabetics
Pharmacologic: thiazolidinediones
Pregnancy Category: C


Type 2 diabetes mellitus (with diet and exercise); may be used with metformin, sulfonylureas, or insulin (patients should only be newly initiated on this drug if they are unable to achieve glucose control with other medications and are unable to take pioglitazone).


Improves sensitivity to insulin by acting as an agonist at receptor sites involved in insulin responsiveness and subsequent glucose production and utilization.
Requires insulin for activity.

Therapeutic effects

Decreased insulin resistance, resulting in glycemic control without hypoglycemia.


Absorption: Well absorbed (99%) following oral administration.
Distribution: Unknown.
Protein Binding: 99.8% bound to plasma proteins.
Metabolism and Excretion: Entirely metabolized by the liver.
Half-life: 3.2–3.6 hr (↑ in liver disease).

Time/action profile (effects on blood glucose)

POunknownunknown12–24 hr


Contraindicated in: Hypersensitivity;Diabetic ketoacidosis;Clinical evidence of active liver disease or increased ALT (>2.5 times upper limit of normal);Renal dysfunction (creatinine >1.5 mg/dL in males or 1.4 mg/dL in females; Obstetric / Lactation: Potential for fetal or infant harm. Insulin monotherapy should be used; Pediatric: Safety and effectiveness not established.
Use Cautiously in: Edema;HF (avoid use in moderate to severe HF unless benefits outweigh risks);Concurrent use with insulin (may ↑ risk of adverse cardiovascular reactions);Hepatic impairment; Obstetric: May restore ovulation and risk of pregnancy in premenopausal women; Geriatric: Dose ↓ and careful titration recommended due to age-related ↓ in renal function. Avoid maximum dose. Should not be given to patients >80 yr.

Adverse Reactions/Side Effects

Central nervous system

  • stroke (life-threatening)


  • hf (life-threatening)
  • myocardial infarction (life-threatening)
  • edema

Ear, Eye, Nose, Throat

  • new onset and worsening diabetic macular edema


  • urticaria


  • hepatitis
  • ↑ liver enzymes


  • anemia


  • ↑ total cholesterol, LDL and HDL
  • weight gain


  • angioedema (life-threatening)
  • fractures (arm, hand, foot) in female patients


Drug-Drug interaction

Concurrent use with rifampin ↓ levels and may ↓ effectiveness.Gemfibrozil ↑ levels and may ↑ risk of hypoglycemia (↓ dose of rosiglitazone).Glucosamine may worsen blood glucose control.Chromium and coenzyme Q-10 may produce additive hypoglycemic effects.


Oral (Adults) 4 mg as a single dose once daily or 2 mg twice daily; after 8 wk, may be ↑ if necessary to 8 mg once daily or 4 mg twice daily.

Availability (generic available)

Tablets: 2 mg, 4 mg, 8 mg
In combination with: metformin (Avandamet), glimepiride (Avandaryl). See combination drugs.

Nursing implications

Nursing assessment

  • Observe patient taking concurrent insulin for signs and symptoms of hypoglycemia (sweating, hunger, weakness, dizziness, tremor, tachycardia, anxiety).
  • Assess patient for edema and signs of HF (dyspnea, rales/crackles, peripheral edema, weight gain, jugular venous distention). May require discontinuation of rosiglitazone.
  • Lab Test Considerations: Monitor serum glucose and glycosylated hemoglobin periodically during therapy to evaluate effectiveness.
    • Monitor CBC with differential periodically during therapy. May cause ↓ in hemoglobin, hematocrit, and WBC, usually during the first 4–8 wk of therapy; then levels stabilize.
    • Monitor AST and ALT prior to initiating therapy and periodically thereafter or if jaundice or symptoms of hepatic dysfunction occur. May cause irreversible ↑ in AST and ALT or hepatic failure (rare). If ALT increases to >3 times the upper limit of normal, recheck ALT promptly. Discontinue rosiglitazone if ALT remains >3 times normal.
    • May cause ↑ in total cholesterol, LDL, and HDL and ↓ in free fatty acids.
    • Monitor renal function tests prior to initiating therapy and periodically thereafter (BUN, creatinine, creatinine clearance), especially in older adults.

Potential Nursing Diagnoses

Imbalanced nutrition: more than body requirements (Indications)


  • Do not confuse Avandia (rosiglitazone) with Prandin (repaglinide) or Coumadin (warfarin).
  • Rosiglitazone is available only through a restricted distribution program called the Rosiglitazone REMS Program. Both prescribers and patients need to enroll in the program. To enroll, call 1-800-AVANDIA or visit www.AVANDIA.com.
  • Patients stabilized on a diabetic regimen who are exposed to stress, fever, trauma, infection, or surgery may require administration of insulin.
  • Oral: May be administered with or without meals.

Patient/Family Teaching

  • Instruct patient to take medication as directed. If dose for 1 day is missed, do not double dose the next day. Explain the Rosiglitazone REMS Program to patient.
  • Explain to patient that this medication controls hyperglycemia but does not cure diabetes. Therapy is long term.
  • Review signs of hypoglycemia and hyperglycemia with patient. If hypoglycemia occurs, advise patient to take a glass of orange juice or 2–3 tsp of sugar, honey, or corn syrup dissolved in water and notify health care professional.
  • Encourage patient to follow prescribed diet, medication, and exercise regimen to prevent hypoglycemic or hyperglycemic episodes.
  • Instruct patient in proper testing of serum glucose and ketones. These tests should be closely monitored during periods of stress or illness and health care professional notified if significant changes occur.
  • Advise patient to notify health care professional immediately if signs of hepatic dysfunction or HF occur.
  • Advise patient to inform health care professional of medication regimen prior to treatment, studies using IV contrast, or surgery.
  • Advise patient to carry a form of sugar (sugar packets, candy) and identification describing disease process and medication regimen at all times.
  • Insulin is the preferred method of controlling blood glucose during pregnancy. Counsel female patients that higher doses of oral contraceptives or a form of contraception other than oral contraceptives may be required and to notify health care professional promptly if pregnancy is planned or suspected.
  • Emphasize the importance of routine follow-up exams.

Evaluation/Desired Outcomes

  • Control of blood glucose levels.


A trademark for the drug rosiglitazone maleate.


a trademark for an oral antidiabetic (rosiglitazone).


Rosiglitazone Diabetes An agent used with conventional therapy as a first-line monotherapy for type 2 diabetes. See Type 2 diabetes.
References in periodicals archive ?
In November 2007 the FDA extended the warning to cover an increased risk for myocardial infarction, based on "a meta-analysis of 42 clinical studies (mean duration 6 months; 14,237 total patients), most of which compared Avandia to placebo, and showed Avandia to be associated with an increased risk of myocardial ischemic events such as angina or myocardial infarction.
The agency, following its review of a large clinical trial (called Record) aimed at determining the drug's heart safety, said it found that the trial showed no elevated risk of heart attack or death in patients being treated with Avandia when compared with standard-of-care diabetes drugs.
The company noted that it does not accept any wrongdoing with the marketing of Avandia, and the settlement is to avoid lengthy trials.
He developed diabetes 20 years ago and was prescribed Avandia in 2003 but stopped when a report revealed users had a 43 per cent increased risk of potentially fatal heart problems.
As part of the settlement, the pharmaceutical company is admitting to promoting the drugs Paxil and Wellbutrin for off-label uses and failing to report safety data about Avandia to the Food and Drug Administration.
GSK also has spent more than $700 million to resolve patient lawsuits claiming Avandia caused heart attacks and strokes.
5bn in its last financial year to cover long-standing legal claims, including many relating to its controversial diabetes drug Avandia, which was taken off the market in Europe following allegations it increased risks of heart attack.
If the FDA had been aware of the increased cardiovascular risk that arises from drugs that cause fluid retention, Vioxx, Bextra, and Avandia might never have been approved.
The story of the approval of Avandia over the objection of agency medical reviewers (and FDA defense of the drug for more than a decade) reveals precisely why the agency cannot be counted upon to protect the American public.
European regulators last month suspended Avandia and further restrictions were placed on its US sales following evidence linking the treatment to an increased risk of heart attack.
MUSCAT: Avandia (Rosiglitazone Maleate), the anti-diabetes drug produced by GlaxoSmithKline (GSK), has been withdrawn from the Omani market.
PEOPLE with diabetes taking the drug Avandia have been told to contact their doctor urgently.