Rosiglitazone Dosage

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Usual Adult Dose for:

Additional dosage information:

Usual Adult Dose for Diabetes Type 2

Initial dose: 4 mg/day orally as a single daily dose or in two divided doses. Doses may be taken without regard to meals.

Maintenance dose: The dose may be increased to 8 mg daily in patients who fail to respond adequately following 12 weeks of initial therapy.

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Patients with mildly elevated serum transaminase levels at baseline (ALT 1 to 2.5 times the upper limit of normal) or during therapy, should be evaluated to determine the cause of the liver enzyme elevation. Initiation or continuation of therapy should proceed with caution and include close clinical monitoring in addition to frequent evaluation of liver enzymes. Rosiglitazone therapy should not be initiated in patients with increased serum transaminase levels (ALT greater than 2.5 times the upper limit of normal). If at any time liver enzymes increase to greater than 3 times the upper limit of normal, liver enzymes should be rechecked as soon as possible. If ALT levels remain greater than 3 times the upper limit of normal, rosiglitazone should be discontinued.

Dose Adjustments

For patients receiving metformin, the current dose of metformin should be continued upon initiation of rosiglitazone therapy. If the patient does not show adequate response, the dosage of rosiglitazone may be increased to 8 mg per day (either once daily or in divided doses) after 12 weeks of therapy.
For patients receiving a sulfonylurea, the dosage recommendation above still applies. However, if patients report hypoglycemia, a decrease in the dose of the sulfonylurea is recommended.

Precautions

All patients should start at the lowest recommended dose. Further increases in the dose should be accompanied by careful monitoring for adverse events related to fluid retention.

Safety and effectiveness have not been established in pediatric patients (less than 18 years of age).

Dialysis

Data not available

Other Comments

The US FDA requires a Risk Evaluation and Mitigation Strategy (REMS) for rosiglitazone. It includes a Medication Guide, elements to assure safe use, and implementation system. Additional information is available at www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm111350.htm.

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