Applies to the following strengths: 2 mg; 4 mg; 8 mg
Usual Adult Dose for:
Additional dosage information:
Usual Adult Dose for Diabetes Type 2
Initial dose: 4 mg orally once a day
Maintenance dose: If inadequate response is not achieved after 8 to 12 weeks, increase to 8 mg/day
Maximum dose: 8 mg/day
- May take as a single daily dose or in 2 divided doses.
- Monitor closely for fluid related adverse events with initiation and dose titration.
Use: To improve glycemic control in adult patients with type 2 diabetes mellitus as an adjunct to diet and exercise.
Renal Dose Adjustments
No adjustment recommended when used as monotherapy
Liver Dose Adjustments
Active liver disease or ALT elevations 2.5 times the upper limit of normal (2.5 x ULN): Therapy should not be initiated
- If, during therapy, ALT elevations are greater than 3 x ULN, recheck as soon as possible; discontinue therapy if ALT remains greater than 3 x ULN
- If symptoms suggestive of liver dysfunction develop, liver enzymes should be checked; if jaundice develops, treatment should be discontinued
- If signs or symptoms of heart failure develop, dose reduction or drug discontinuation should be considered.
- Concomitant use with other Hypoglycemic Agents:
- If hypoglycemia develops, dose reduction of concomitant agent may be necessary.
US BOXED WARNING: Congestive Heart Failure
- Thiazolidinediones, including rosiglitazone, cause or exacerbate congestive heart failure in some patients.
- After initiation of therapy and with any dosage increase, observe patients carefully for signs and symptoms of heart failure including excessive, rapid weight gain, dyspnea, and/or edema; if signs and symptoms of heart failure develop, manage in accordance to current standards of care.
- Drug discontinuation or dosage reduction should be considered in patients showing signs and symptoms of heart failure; this drug is not recommended in patients with symptomatic heart failure.
- Initiation in patients with established NYHA Class II or IV heart failure is contraindicated.
- Hypersensitivity to drug or to any of the product ingredients
- Initiation in patients with established New York Heart Association (NYHA) Class III or IV heart failure
Safety and efficacy have not been established in patients younger than 18 years.
Consult WARNINGS section for additional precautions.
Hemodialysis: No adjustment recommended.
Peritoneal dialysis: Data not available
- Take orally with or without food
- This drug is active only in the presence of endogenous insulin, therefore, it should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.
- Coadministration with insulin is not recommended.
- A reduction in blood glucose may be seen in 2 weeks, however it may be 2 to 3 months to realize the full therapeutic effect.
- Hypoglycemia may occur if used in combination with other hypoglycemic agents; dose reduction of concomitant drug may be necessary.
- Observe closely for signs and symptoms of heart failure
- Hepatic: Monitor liver enzymes baseline and periodically
- Monitor glycemic control
- Patients should be instructed to read the US FDA-approved patient labeling (Medication Guide).
- This drug may cause edema; patients experiencing rapid weight gain, shortness of breath or other symptoms of heart failure should notify their health care professional promptly.
- Premenopausal anovulatory women may be at risk for pregnancy while on this drug; patients should be informed of risk and adequate contraception should be offered.
- Patients with unexplained nausea, vomiting, abdominal pain, fatigue, anorexia, or dark urine should be advised to report these symptoms to their health care professional.
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