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The selection of the dose of Rosiglitazone and Metformin combination should be based on the patient’s current doses of Rosiglitazone and/or Metformin. The safety and efficacy of Rosiglitazone and Metformin combination as initial therapy for patients with type 2 diabetes mellitus have not been established.
The following recommendations regarding the use of Rosiglitazone and Metformin combination in patients inadequately controlled on Rosiglitazone and Metformin monotherapies are based on clinical practice experience with Rosiglitazone and Metformin combination therapy.
- The dosage of antidiabetic therapy with Rosiglitazone and Metformin combination should be individualized on the basis of effectiveness and tolerability while not exceeding the maximum recommended daily dose of 8 mg/2,000 mg.
- Rosiglitazone and Metformin combination should be given in divided doses with meals, with gradual dose escalation. This reduces GI side effects (largely due to Metformin) and permits determination of the minimum effective dose for the individual patient.
- Sufficient time should be given to assess adequacy of therapeutic response. Fasting plasma glucose (FPG) should be used to determine the therapeutic response to Rosiglitazone and Metformin combination . 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.
For patients inadequately controlled on Metformin monotherapy: The usual starting dose of Rosiglitazone and Metformin combination is 4 mg Rosiglitazone (total daily dose) plus the dose of Metformin already being taken.
For patients inadequately controlled on Rosiglitazone monotherapy: The usual starting dose of Rosiglitazone and Metformin combination is 1,000 mg Metformin (total daily dose) plus the dose of Rosiglitazone already being taken.
Pediatric Use: Safety and effectiveness of combination of Rosiglitazone and Metformin in pdiatric patients have not been established.
Geriatric Use: Because aging is associated with reduced renal function, combination of Rosi litazone and Metformin should be used with caution as age increases. Care should be taken in dose selection and should be based on careful and regular monitoring of renal function. Generally, elderly patients should not be titrated to the maximum dose of combination of Rosiglitazone and Metformin.
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