Adult Dosing
Type II diabetes mellitus (NIDDM)
Monotherapy
- Initial: 4 mg PO qd or 2 mg PO bid
- Titrate: If fasting plasma glucose level does not improve after 12 wks; increase to 8 mg PO qd or 4 mg PO bid
- Max: 8 mg/day
Combination therapy with metformin/sulfonylurea
- Start rosiglitazone 4 mg PO qd or 2 mg PO bid, may increase to max 8 mg/day
Combination therapy with sulfonylurea plus metformin
- Start rosiglitazone 4 mg PO qd or 2 mg PO bid, may increase to max 8 mg/day
Pediatric Dosing
- Safety and effectiveness in pediatric patients have not been established
[Outline]
See Supplemental Patient Information
- Significantly restricted access due to severe cardiovascular events
- Thiazolidinediones, including rosiglitazone can cause or exacerbate CHF. Observe patients for signs and symptoms of heart failure (e.g. dyspnea, rapid weight gain, edema, unexplained cough or fatigue) especially during initiation of therapy and dosage titration. If these signs and symptoms develop, heart failure should be managed according to current standards of care. Discontinuation or dose reduction may also be considered [US Black Box Warning]
- It is not indicated in patients with NYHA class III or IV heart failure [US Black Box warning]
- It is not recommended in patients with known ischemic heart disease; a meta-analysis of 42 studies (comparing rosiglitazone and placebo) showed increased risk of myocardial ischemic events including angina and MI; other studies have not confirmed or excluded this risk. Thus the available data on the risk of myocardial ischemia are inconclusive [US Black Box Warning]
- Co-administration with insulin is not recommended
- Thiazolidinediones causes fluid retention which can exacerbate or lead to congestive heart failure
- Fluid retention and fat accumulation due to thiazolidinediones causes weight gain in the patients
- Hepatitis or liver function test abnormalities (i.e., elevations in hepatic enzymes to at least 3 times the upper limit of normal), have been reported
- Monitor LFTs at baseline, every 2 month × first year, then periodically. Use cautiously in patients with mildly elevated liver enzymes (ALT levels 2.5X upper limit of normal) and discontinue drug if ALT >3 times the upper limit of normal, or if jaundice develops
- Do not initiate therapy if the patient exhibits clinical evidence of active liver disease or increased serum transaminase levels
- Increases the risk of fracture in female patients; assess and maintain bone health as per the current standards of care
- Rosiglitazone causes decreases in the mean hemoglobin and hematocrit level
- Monitor the patient receiving rosiglitazone in combination with other hypoglycemic agents as it increases the risk of hypoglycemia, measure fasting blood glucose and HbA1c periodically
- Thiazolidinediones, may result in ovulation in some premenopausal anovulatory women thereby increasing the risk of pregnancy
Cautions: Use cautiously in
- History of CHF (NYHA class I-II)
- Presence of risk factors for CHF
- Patients with edema
- Hepatic impairment
- Females patients (increased risk of fracture and may restore ovulation in premenopausal women)
Supplemental Patient Information
- Advise patients to report symptoms of nausea, vomiting, abdominal pain, fatigue, anorexia, or dark urine
- Advise patients to report unusually rapid increase in weight or edema, shortness of breath
Pregnancy Category:C
Breastfeeding: No information available, alternate drug may be preferred, especially while nursing a newborn or preterm infant. Monitor infant's blood glucose during maternal therapy with rosiglitazone. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 27 December 2010). According to manufacturer's data, excretion of rosiglitazone in breast milk is not known. Manufacturer recommends drug should not to administered to a nursing woman.
