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Avandamet

[rosiglitazone maleate and metformin HCl]

After an increase in metformin dosage, dose titration is recommended if patients are not adequately controlled after 1 to 2 weeks. After an increase in rosiglitazone dosage, dose titration is recommended if patients are not adequately controlled after 8 to 12 weeks. Dosage Recommendations: For patients inadequately controlled on metformin monotherapy, the usual starting dose of AVANDAMET is 4 mg rosiglitazone (total daily dose) plus the dose of metformin already being taken (see Table 5). For patients inadequately controlled on rosiglitazone monotherapy, the usual starting dose of AVANDAMET is 1,000 mg metformin (total daily dose) plus the dose of rosiglitazone already being taken (see Table 5).
Table 5. AVANDAMET Starting Dose
PRIOR THERAPY Usual AVANDAMET Starting Dose Total daily dose
Tablet strength Number of tablets
Metformin HCl*
1,000 mg/ day 2 mg/ 500 mg 1 tablet twice a day
2,000 mg/ day 2 mg/ 1,000 mg 1 tablet twice a day
Rosiglitazone
4 mg/ day 2 mg/ 500 mg 1 tablet twice a day
8 mg/ day 4 mg/ 500 mg 1 tablet twice a day
*For patients on doses of metformin HCl between 1,000 and 2,000 mg/ day, initiation of AVANDAMET requires individualization of therapy.
When switching from combination therapy of rosiglitazone plus metformin as separate tablets, the usual starting dose of AVANDAMET is the dose of rosiglitazone and metformin already being taken. If additional glycemic control is needed, the daily dose of AVANDAMET may be increased by increments of 4 mg rosiglitazone and/ or 500 mg metformin, up to the maximum recommended total daily dose of 8 mg/ 2,000 mg. No studies have been performed specifically examining the safety and efficacy of AVANDAMET in patients previously treated with other oral hypoglycemic agents and switched to AVANDAMET. Any change in therapy of type 2 diabetes should be undertaken with care and appropriate monitoring as changes in glycemic control can occur.

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