rosiglitazone maleate
Avandia
Pregnancy Risk Category C
How supplied
Tablets: 2 mg, 4 mg, 8 mg
Action
Lowers blood glucose levels by improving insulin sensitivity.
Indications & dosage
Adjunct to diet and exercise to improve glycemic control in patients with type 2 non-insulin-dependent diabetes mellitus; with metformin to lower blood glucose levels in patients whose hyperglycemia can't be controlled by diet, exercise, and either rosiglitazone or metformin--
Adults: initially, 4 mg P.O. daily in the morning or in divided doses b.i.d. in the morning and evening. Dosage may be increased to 8 mg P.O. daily or in divided doses b.i.d. if fasting plasma glucose level doesn't improve after 12 weeks of treatment.
Adverse reactions
CNS: headache, fatigue.
CV: edema.
EENT: sinusitis.
GI: diarrhea.
Hematologic: anemia.
Metabolic: hyperglycemia.
Musculoskeletal: back pain.
Respiratory: upper respiratory tract infection.
Other: injury.
Interactions
None significant.
Effects on diagnostic tests
None reported.
Contraindications
Contraindicated in patients with known hypersensitivity to drug or its components and in those with New York Heart Association class III and I.V. cardiac status unless expected benefits outweigh potential risks. Also contraindicated in patients with active liver disease, increased baseline liver enzyme levels (ALT level over 21/2 times upper limit of normal), type 1 diabetes, or diabetic ketoacidosis and in those who experienced jaundice while taking troglitazone. Because metformin is contraindicated in patients with renal impairment, combination therapy with rosiglitazone is also contraindicated in patients with renal impairment. Rosiglitazone can be used as monotherapy in patients with renal impairment.
Nursing considerations
- Use cautiously in patients with edema or heart failure.
- Before starting drug therapy, patient should be treated for secondary causes of poor glycemic control, such as infection.
- Alert:
Liver enzyme levels should be checked before therapy starts. Drug shouldn't be used in patients with increased baseline liver enzyme levels. In patients with normal baseline liver enzyme levels, monitor these levels every 2 months for first 12 months and periodically thereafter. If ALT level is elevated during treatment, recheck levels as soon as possible. Drug should be discontinued if levels remain elevated.
- Because ovulation may resume in premenopausal, anovulatory women with insulin resistance, recommend use of contraceptives.
- Management of type 2 diabetes should include diet control. Because caloric restriction, weight loss, and exercise help improve insulin sensitivity and help make drug therapy effective, these measures are essential to proper diabetes treatment.
- Blood glucose and glycosylated hemoglobin levels should be checked periodically to monitor therapeutic response to drug.
- Monitor patients with heart failure for increased edema.
- Hemoglobin level and hematocrit may decrease during therapy, usually during first 4 to 8 weeks. Increases in total cholesterol, low-density lipoprotein, and high-density lipoprotein levels and decreases in free fatty acid levels may also occur.
- Patients with normal hepatic enzyme levels who are switched from troglitazone should undergo a 1-week washout before starting rosiglitazone.
- For patients whose blood glucose levels are inadequately controlled with metformin, rosiglitazone should be added to--not substituted for--metformin.
- Alert:
Don't confuse rosiglitazone with pioglitazone or troglitazone.
Patient teaching
- Advise patient that drug can be taken with or without food.
- Notify patient that blood will be tested to check liver function before therapy starts, every 2 months for first 12 months, and then periodically thereafter.
- Tell patient to immediately notify doctor if unexplained signs and symptoms occur, such as nausea, vomiting, abdominal pain, fatigue, anorexia, or dark urine; these may indicate potential liver problems.
- Recommend use of contraceptives to premenopausal, anovulatory women with insulin resistance because ovulation may resume with therapy.
- Advise patient that management of diabetes should include diet control. Because caloric restriction, weight loss, and exercise help improve insulin sensitivity and help make drug therapy effective, these measures are essential to proper diabetes treatment.
*Liquid contains alcohol. **May contain tartrazine. †Canada ‡Australia §U.K. OTCOver the counter
Reactions may be common, uncommon, life-threatening, or COMMON AND LIFE-THREATENING