Metformin / Rosiglitazone Dosage

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Usual Adult Dose for:

Additional dosage information:

Usual Adult Dose for Diabetes Type 2

Doses are based on patient's current doses of rosiglitazone and/or metformin:

For patients inadequately controlled on metformin monotherapy: 4 mg rosiglitazone (total daily dose) plus the dose of metformin already being taken. If the patient was taking metformin 1000 mg/ day, the dose of metformin-rosiglitazone is 500 mg-2 mg orally twice daily. If the patient was taking metformin 2000 mg/day, the dose of metformin-rosiglitazone is 1000 mg-2 mg orally twice daily.

For patients inadequately controlled on rosiglitazone monotherapy: 1000 mg metformin (total daily dose) plus the dose of rosiglitazone already being taken. If the patient was taking rosiglitazone 4 mg/day, the dose of metformin-rosiglitazone is 500 mg-2 mg orally twice daily. If the patient was taking rosiglitazone 8 mg/day, the dose of metformin-rosiglitazone is 500 mg-4 mg orally twice daily.

Renal Dose Adjustments

Metformin-rosiglitazone is contraindicated in patients with renal disease or dysfunction as suggested by serum creatinine levels equal to or greater than 1.5 mg/dl for males; equal to or greater than 1.4 mg/dl for females or abnormal creatinine clearance.

Liver Dose Adjustments

Therapy with metformin-rosiglitazone should not be initiated if the patient exhibits clinical evidence of active liver disease or increased serum transaminase levels (ALT greater than 2.5 times the upper limit of normal).

Dose Adjustments

If additional glycemic control is needed: the daily dose of metformin-rosiglitazone may be increased by increments of 4 mg rosiglitazone and/or metformin, up to the maximum recommended total daily dose of 8 mg rosiglitazone with 2000 mg of metformin.

Precautions

The initiation and maintenance dosing of metformin-rosiglitazone should be conservative in patients with advanced age, due to the potential for decreased renal function in the population. Monitoring of renal function is necessary to aid in the prevention of metformin associated lactic acidosis. Metformin treatment should not be initiated in patients 80 or more years of age unless measurement of creatinine clearance demonstrates that renal function is not reduced.

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 metformin-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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